Plain-language summary, compiled from the cited regulatory records
Ciprofloxacin is an antibiotic belonging to the fluoroquinolone drug class [1]. It is approved for treating infections caused by specific susceptible microorganisms in conditions such as corneal ulcers and conjunctivitis [1]. For corneal ulcers, it is indicated for use against strains of *Pseudomonas aeruginosa*, *Serratia marcescens*, *Staphylococcus aureus*, *Staphylococcus epidermidis*, *Streptococcus pneumoniae*, and the Viridans Group of *Streptococcus* [1]. For conjunctivitis, it is indicated for use against strains of *Haemophilus influenzae*, *Staphylococcus aureus*, *Staphylococcus epidermidis*, and *Streptococcus pneumoniae* [1].
Ciprofloxacin is available under various brand names, including CILOXAN [1]. In the past 12 months, there have been 3770 adverse event reports associated with this active ingredient [2]. The most frequently reported adverse events include vomiting, pneumonia, drug hypersensitivity, off-label use, and dyspnea [2].
This is not medical advice. Consult a qualified healthcare professional.
GBOfficial regulatory label· revised May 22, 2026[1]
8) this product must only be prescribed when other antibiotics that are commonly recommended for the infection are inappropriate. This applies to all indications listed below. Situations where other antibiotics are considered to be inappropriate are where: •there is resistance to other first-line antibiotics recommended for the infection; •other first-line antibiotics are contraindicated in an individual patient; •other first-line antibiotics have caused side effects requiring treatment to be stopped; •treatment with other first-line antibiotics has failed.
1). Special attention should be paid to available information on resistance to ciprofloxacin before commencing therapy. Consideration should be given to official guidance on the appropriate use of antibacterial agents. Adults • Lower respiratory tract infections due to Gram-negative bacteria - exacerbations of chronic obstructive pulmonary disease.
Ciprofloxacin 250 mg film-coated tablets should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections. - broncho-pulmonary infections in cystic fibrosis or in bronchiectasis - pneumonia • Chronic suppurative otitis media • Acute exacerbation of chronic sinusitis especially if these are caused by Gram- negative bacteria • Complicated urinary tract infections • Gonococcal urethritis and cervicitis due to susceptible Neisseria gonorrhoeae • Epididymo-orchitis including cases due to Neisseria gonorrhoeae • Pelvic inflammatory disease including cases due to Neisseria gonorrhoeae • Uncomplicated acute cystitis.
CACanada· Health Canada
54 products
Uses
CAOfficial regulatory label· revised May 22, 2026[2]
CIPROFLOXACIN (ciprofloxacin hydrochloride tablets) may be indicated for the treatment of patients with the following infections caused by susceptible strains of the indicated microorganisms: Respiratory Tract Infections Acute exacerbation of chronic bronchitis caused by: Haemophilus influenzae Moraxella catarrhalis Acute pneumonia caused by: Enterobacter cloacae Escherichia coli Haemophilus influenzae Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa Staphylococcus aureus Acute sinusitis caused by: Haemophilus influenzae Moraxella catarrhalis CIPROFLOXACIN should not be prescribed to patients with acute bacterial exacerbations of simple/uncomplicated chronic obstructive pulmonary disease (ie.
1 CIPROFLOXACIN are not indicated for acute bronchitis. Due to the nature of the underlying conditions which usually predispose patients to pseudomonas infections of the respiratory tract, bacterial eradications may not be achieved in patients who display clinical improvement despite evidence of in vitro sensitivity.
USUnited States· FDA
27 products
Uses
USOfficial regulatory label· revised May 13, 2026[3]
12 ) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin tablets and other antibacterial drugs, ciprofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
1 Skin and Skin Structure Infections Ciprofloxacin tablets are indicated in adult patients for treatment of skin and skin structure infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus aureus, methicillin-susceptible Staphylococcus epidermidis, or Streptococcus pyogenes.
2 Bone and Joint Infections Ciprofloxacin tablets are indicated in adult patients for treatment of bone and joint infections caused by Enterobacter cloacae, Serratia marcescens , or Pseudomonas aeruginosa. 3 Complicated Intra-Abdominal Infections Ciprofloxacin tablets are indicated in adult patients for treatment of complicated intra-abdominal infections (used in combination with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis.
Drug interactions
Known interactions involving Ciprofloxacin. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 600. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[2]Health Canada (DPD) · 02353318 · revised May 22, 2026
[3]FDA DailyMed · 1496ea0f-1419-c8… · revised May 13, 2026 [PDF]
[4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
Ciprofloxacin 250 mg film-coated tablets should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections. • Acute pyelonephritis • Bacterial prostatitis • Genital tract infections - gonococcal uretritis and cervicitis due to susceptible Neisseria gonorrhoeae - epididymo-orchitis including cases due susceptible to Neisseria gonorrhoeae - pelvic inflammatory disease including cases due susceptible to Neisseria gonorrhoeae In the above genital tract infections when thought or known to be due to Neisseria gonorrhoeae it is particularly important to obtain local information on the prevalence of resistance to ciprofloxacin and to confirm susceptibility based on laboratory testing.
g. travellers' diarrhoea) • Intra-abdominal infections • Infections of the skin and soft tissue caused by Gram-negative bacteria • Malignant external otitis • Infections of the bones and joints • Treatment of infections in neutropenic patients • Prophylaxis of infections in neutropenic patients Ciprofloxacin may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection • Prophylaxis of invasive infections due to Neisseria meningitidis • Inhalation anthrax (post-exposure prophylaxis and curative treatment) Children and adolescents • Broncho-pulmonary infections in cystic fibrosis caused by Pseudomonas aeruginosa • Complicated urinary tract infections and acute pyelonephritis • Inhalation anthrax (post-exposure prophylaxis and curative treatment) Ciprofloxacin may also be used to treat severe infections in children and adolescents when this is considered to be necessary.
1).
How to take
GBOfficial regulatory label· revised May 22, 2026[1]
Posology The dosage is determined by the indication, the severity and the site of the infection, the susceptibility to ciprofloxacin of the causative organism(s), the renal function of the patient and, in children and adolescents the body weight.
The duration of treatment depends on the severity of the illness and on the clinical and bacteriological course. g. Pseudomonas aeruginosa, Acinetobacter or Staphylococci) may require higher ciprofloxacin doses and co- administration with other appropriate antibacterial agents.
g. pelvic inflammatory disease, intraabdominal infections, infections in neutropenic patients and infections of bones and joints) may require co- administration with other appropriate antibacterial agents depending on the pathogens involved.
4) Prostatitis 500 mg twice daily to 750 mg twice daily 2 to 4 weeks (acute) to 4 to 6 weeks (chronic) Gonococcal urethritis and cervicitis 500 mg as a single dose 1 day (single dose)Genital tract infections Epididymo-orchitis and pelvic inflammatory diseases 500 mg twice daily to 750 mg twice daily at least 14 days Infections of the gastro- intestinal tract and intra abdominal infections Diarrhoea caused by bacterial pathogens including Shigella spp.
other than Shigella dysenteriae type 1 and empirical treatment of severe travellers' diarrhoea 500 mg twice daily 1 day Diarrhoea caused by Shigella dysenteriae type 1 500 mg twice daily 5 days Diarrhoea caused by Vibrio cholerae 500 mg twice daily 3 days Typhoid fever 500 mg twice daily 7 days Intra-abdominal infections due to Gram-negative bacteria 500 mg twice daily to 750 mg twice daily 5 to 14 days Infections of the skin and soft tissue 500 mg twice daily to 750 mg twice daily 7 to 14 days Bone and joint infections 500 mg twice daily to 750 mg twice daily max.
of 3 months Treatment of bacterial infections or prophylaxis of infections in neutropenic patients Ciprofloxacin should be co- administered with appropriate antibacterial agent(s) in accordance to official guidance. 500 mg twice daily to 750 mg twice daily Therapy should be continued over the entire period of neutropenia Prophylaxis of invasive infections due to Neisseria meningitidis 500 mg as a single dose 1 day (single dose) Inhalation anthrax post-exposure prophylaxis and curative treatment for persons able to receive treatment by oral route when clinically appropriate.
Drug administration should begin as soon as possible after suspected or confirmed exposure. 500 mg twice daily 60 days from the confirmation of Bacillus anthracis exposure Paediatric population Indications Daily dose in mg Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin) Cystic fibrosis 20 mg/kg body weight twice daily with a maximum of 750 mg per dose.
10 to 14 days Complicated urinary tract infections and pyelonephritis 10 mg/kg body weight twice daily to 20 mg/kg body weight twice daily with a maximum of 750 mg per dose. 10 to 21 days Inhalation anthrax post- exposure prophylaxis and curative treatment for persons able to receive treatment by oral route when clinically appropriate.
Drug administration should begin as soon as possible after suspected or confirmed exposure. 10 mg/kg body weight twice daily to 15 mg/kg body weight twice daily with a maximum of 500 mg per dose. 60 days from the confirmation of Bacillus anthracis exposure Other severe infections 20 mg/kg body weight twice daily with a maximum of 750 mg per dose.
According to the type of infections Elderly patients Elderly patients should receive a dose selected according to the severity of the infection and the patient's creatinine clearance. 73 m²] Serum Creatinine [μmol/L] Oral Dose [mg] > 60 < 124 See Usual Dosage.
30-60 124 to 168 250-500 mg every 12 h < 30 > 169 250-500 mg every 24 h Patients on haemodialysis > 169 250-500 mg every 24 h (after dialysis) Patients on peritoneal dialysis > 169 250-500 mg every 24 h In patients with impaired liver function no dose adjustment is required.
Dosing in children with impaired renal and/or hepatic function has not been studied. Method of administration Tablets are to be swallowed unchewed with fluid. They can be taken independent of mealtimes. If taken on an empty stomach, the active substance is absorbed more rapidly.
g. g. 5). g. patients on enteral nutrition), it is recommended to commence therapy with intravenous ciprofloxacin until a switch to oral administration is possible.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised May 22, 2026[1]
The most commonly reported adverse drug reactions (ADRs) are nausea and diarrhoea. ADRs derived from clinical studies and post-marketing surveillance with Ciprofloxacin (oral, intravenous, and sequential therapy) sorted by categories of frequency are listed below.
The frequency analysis takes into account data from both oral and intravenous administration of ciprofloxacin. 4) Psychiatric Disorders* Psychomotor hyperactivity / agitation Confusion and disorientation Psychotic Reactions (potentially Mania, incl.
g. g. 4). A range of psychiatric symptoms may occur as part of these side effects, which may include, but are not necessarily limited to, sleep disorders, anxiety, panic attacks, confusion, or depression. There are no pharmacological treatments established to be effective treatments of the symptoms of long lasting or disabling side effects associated with fluoroquinolones.
The frequency of these prolonged, disabling and potentially irreversible serious drug reactions cannot be estimated with precision using available data, but the reporting incidence from adverse drug reaction reports indicates the frequency is at minimum between 1/1,000 and 1/10,000 (corresponding to the Rare frequency category).
4). Paediatric population The incidence of arthropathy (arthralgia, arthritis), mentioned above, is referring to data collected in studies with adults. 4).
Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorisation of Tubulointerstitial nephritis General Disorders And Administration Site Conditions* Asthenia Fever Oedema Sweating (hyperhidrosis) Investigations Increase in blood alkaline phosphatase Increased amylase Internationa normalised increased (in patients trea with Vitami antagonists) the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal […]
GBOfficial regulatory label· Warnings and precautions· revised May 22, 2026[1]
8). 3). Prolonged, disabling and potentially irreversible serious adverse drug reactions Cases of prolonged (continuing for months or years), disabling and potentially irreversible serious adverse drug reactions affecting different, sometimes multiple, body systems (including musculoskeletal, nervous, psychiatric and senses) have been reported in patients receiving quinolones and fluoroquinolones irrespective of their age and pre- existing risk factors.
There are no pharmacological treatments established to be effective treatments of the symptoms of long lasting or disabling side effects associated with fluoroquinolones. Ciprofloxacin should be discontinued immediately at the first signs or symptoms of any serious adverse reaction and patients should be advised to contact their prescriber for advice, so that symptoms can be appropriately investigated and to avoid further exposure which could potentially worsen adverse reactions.
Severe infections and mixed infections with Gram-positive and anaerobic pathogens Ciprofloxacin monotherapy is not suited for treatment of severe infections and infections that might be due to Gram-positive or anaerobic pathogens. In such infections ciprofloxacin must be co-administered with other appropriate antibacterial agents.
Streptococcal Infections (including Streptococcus pneumoniae) Ciprofloxacin is not recommended for the treatment of streptococcal infections due to inadequate efficacy. Genital tract infections Gonococcal urethritis, cervicitis, epididymo-orchitis and pelvic inflammatory diseases may be caused by fluoroquinolone-resistant Neisseria gonorrhoeae isolates.
Therefore, Ciprofloxacin should be administered for the treatment of gonococcal urethritis or cervicitis only if ciprofloxacin resistant Neisseria gonorrhoeae can be excluded. g. a cephalosporin) unless ciprofloxacin-resistant Neisseria gonorrhoeae can be excluded.
If clinical improvement is not achieved after 3 days of treatment, the therapy should be reconsidered. Urinary tract infections Resistance to fluoroquinolones of Escherichia coli - the most common pathogen involved in urinary tract infections - varies across the European Union.
Prescribers are advised to take into account the local prevalence of resistance in Escherichia coli to fluoroquinolones. The single dose of ciprofloxacin that may be used in uncomplicated cystitis in pre- menopausal women is expected to be associated with lower efficacy than the longer treatment duration.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised May 22, 2026[1]
1). 5).
This is not medical advice. Consult a qualified healthcare professional.
In patients requiring subsequent courses of therapy, CIPROFLOXACIN should be used alternately with other antipseudomonal agents. Some strains of Pseudomonas aeruginosa may develop resistance during treatment. Therefore, susceptibility testing should be performed periodically during therapy to detect the emergence of bacterial resistance.
Urinary Tract Infections Upper and lower urinary tract infections, such as complicated and uncomplicated cystitis, pyelonephritis, and pyelitis caused by: Citrobacter diversus 1 Canadian Thoracic Society recommendations for management of chronic obstructive pulmonary disease - 2008 update - highlights for primary care.
O'Donnell et al. Can Respir J 2008; 15(Suppl A):1A-8A. CIPROFLOXACIN Page 5 of 59 Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Klebsiella oxytoca Morganella morganii Proteus mirabilis Pseudomonas aeruginosa Serratia marcescens Staphylococcus aureus Staphylococcus epidermidis Staphylococcus saprophyticus Streptococcus faecalis Acute uncomplicated cystitis: in females caused by Eschericia coli In cases of uncomplicated acute bacterial cystitis, limit the use of CIPROFLOXACIN to circumstances where no other treatment options are available.
A urine culture should be obtained prior to treatment to ensure ciprofloxacin susceptibility.
Chronic Bacterial Prostatitis Caused by:
Escherichia coli Skin and Soft Tissue Infections Caused by: Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Proteus mirabilis Proteus vulgaris Pseudomonas aeruginosa Staphylococcus aureus Staphylococcus epidermidis Streptococcus pyogenes Bone and Joint Infections Caused by: Enterobacter cloacae Pseudomonas aeruginosa Serratia marcescens Staphylococcus aureus Infectious Diarrhea (when antibacterial therapy is indicated) Caused by: CIPROFLOXACIN Page 6 of 59 Campylobacter jejuni Escherichia coli (enterotoxigenic strains) Shigella dysenteriae Shigella flexneri Shigella sonnei Meningococcal Carriers Treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx.
A minimal inhibitory concentration (MIC) determination on the isolate from the index case should be performed as soon as possible. Ciprofloxacin is not indicated for the treatment of meningococcal meningitis.
Typhoid Fever (enteric fever) Caused by:
Salmonella paratyphi Salmonella typhi Uncomplicated Gonorrhea Cervical/urethral/rectal/pharyngeal infections caused by Neisseria gonorrhoea. Because co- infection with Chlamydia trachomatis is common, consideration should be given to treating presumptively with an additional regimen that is effective against C.
trachomatis. To reduce the development of drug-resistant bacteria and maintain the effectiveness of CIPROFLOXACIN, and other antibacterial drugs, CIPROFLOXACIN should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.
When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Limit the use of CIPROFLOXACIN to patients where no other treatment options exist AND where ciprofloxacin susceptibility is demonstrated, OR ciprofloxacin susceptibility is highly likely, typically greater than or equal to 95%, based on local susceptibility patterns.
Appropriate culture and susceptibility tests should be performed prior to initiating treatment in order to isolate and identify organisms causing the infection and to determine their susceptibilities to ciprofloxacin. Therapy with CIPROFLOXACIN may be initiated before results of these tests are known.
However, modification of this treatment may be required once results become available or if there is no clinical improvement. Culture and susceptibility testing performed periodically during therapy will provide information on the possible emergence of bacterial resistance.
If anaerobic organisms are suspected to be contributing to the infection, appropriate therapy should be administered. 1 Pediatrics The safety and efficacy of CIPROFLOXACIN in individuals less than 18 years of age has not been established.
3 Pediatrics). 2 Geriatrics Elderly patients should receive a dose dependent on the severity of their illness and their creatinine clearance ( see 4 DOSAGE AND ADMINISTRATION : Special Populations : Impaired Renal Function for dose modification based on creatinine clearance or serum creatinine).
How to take
CAOfficial regulatory label· revised May 22, 2026[2]
Special Populations :
Impaired Renal Function for dose modification based on creatinine clearance or serum creatinine). 2 CONTRAINDICATIONS • CIPROFLOXACIN (ciprofloxacin hydrochloride tablets) are contraindicated in patients who have shown hypersensitivity to ciprofloxacin, or other quinolone antibacterial agents or any of the excipients.
For a complete listing, see the 4 DOSAGE AND ADMINISTRATION section. • Concurrent administration of ciprofloxacin and agomelatinea is contraindicated since it may result in an undesirable increase in agomelatine exposure (see 9 DRUG INTERACTIONS).
• Concurrent administration of ciprofloxacin and tizanidine is contraindicated since it may result in an undesirable increase in serum tizanidine concentrations. This can be associated with clinically relevant tizanidine-induced side effects (hypotension, somnolence, drowsiness) (see 9 DRUG INTERACTIONS) aCurrently not marketed in Canada 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • Fluoroquinolones, including CIPROFLOXACIN, have been associated with disabling and potentially persistent adverse reactions which to date include, but are not limited to: tendonitis, tendon rupture, peripheral neuropathy and neuropsychiatric effects.
• Ciprofloxacin has been shown to prolong the QT interval of the electrocardiogram in some patients (see 7 WARNINGS AND PRECAUTIONS: Cardiovascular). • Serious hypersensitivity and/or anaphylactic reactions have been reported in patients receiving fluoroquinolone therapy, including CIPROFLOXACIN (see 7 WARNINGS AND PRECAUTIONS: Immune).
• Fluoroquinolones including CIPROFLOXACIN are associated with an increased risk of tendinitis and tendon rupture in all ages. The risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants (see 7 WARNINGS AND PRECAUTIONS: Musculoskeletal).
• Fluroquinolones including CIPROFLOXACIN may exacerbate muscle weakness in persons with myasthenia gravis. Avoid using CIPROFLOXACIN in patients with a known history of myasthenia gravis (see 7 WARNINGS AND PRECAUTIONS: Musculoskeletal).
• Seizures and toxic psychoses may occur with fluoroquinolone therapy. Convulsions, increased intracranial pressure (including pseudotumor cerebri) and toxic psychoses CIPROFLOXACIN Page 8 of 59 have been reported in patients receiving fluoroquinolones, including CIPROFLOXACIN.
CIPROFLOXACIN should be used with caution in patients with known or suspected CNS disorders which may predispose them to seizures or lower the seizure threshold (see 7 WARNINGS AND PRECAUTIONS: Neurologic). • Cases of hepatic necrosis and life-threatening hepatic failure have been reported with ciprofloxacin (see 7 WARNINGS AND PRECAUTIONS: Hepatic/Biliary/Pancreatic).
1 Dosing Considerations The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defence mechanisms, and the status of renal function.
Oral Administration CIPROFLOXACIN (ciprofloxacin hydrochloride tablets) may be taken before or after meals. Absorption is faster on an empty stomach. Patients should be advised to drink fluids liberally and avoid taking dairy products or antacids containing magnesium or aluminum.
, hospital-acquired pneumonia, osteomyelitis CIPROFLOXACIN Page 9 of 59 Depending on the severity of the infections, as well as the clinical and bacteriological responses, the average treatment period should be approximately 7 to 14 days.
Generally, treatment should last 3 days beyond the disappearance of clinical symptoms or until cultures are sterile. Patients with osteomyelitis may require treatment for a minimum of 6 to 8 weeks and up to 3 months. With acute cystitis in females a 3- to 5-day treatment may be sufficient.
With infectious diarrhea a five-day treatment may be sufficient. Typhoid fever should be treated for 14 days. Acute sinusitis should be treated for 10 days with 500 mg q12h. Chronic bacterial prostatitis should be treated for 28 days with 500 mg q12h.
Special Populations Impaired Renal Function Ciprofloxacin is eliminated primarily by renal excretion. However, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine (see 10 CLINICAL PHARMACOLOGY, Detailed Human Pharmacology).
This alternate pathway of drug elimination appears to compensate for the reduced renal excretion of patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction.
The following table provides a guideline for dosage adjustment of CIPROFLOXACIN. However, monitoring of serum drug levels provides the most reliable basis for dosage adjustments. 0 Maximum daily doses are not to be […]
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised May 22, 2026[2]
). Aortic Aneurysm and Aortic Dissection CIPROFLOXACIN Page 12 of 59 Epidemiologic studies report an increased risk of aortic aneurysm and aortic dissection after intake of fluoroquinolones, particularly in the older population. , Marfan syndrome, vascular Ehlers- Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behcet’s disease, hypertension, atherosclerosis).
In case of sudden severe abdominal, chest or back pain, patients should be advised to immediately consult a physician in an emergency department. , glyburide) or with insulin. In these patients, careful monitoring of blood glucose is recommended.
SEVERE CASES OF HYPOGLYCEMIA RESULTING IN COMA OR DEATH HAVE BEEN REPORTED. If a hypoglycemic reaction occurs, discontinue CIPROFLOXACIN immediately and initiate appropriate therapy (see 8 ADVERSE REACTIONS and
CAOfficial regulatory label· Warnings and precautions· revised May 22, 2026[2]
3 Pediatrics). 2 Geriatrics Elderly patients should receive a dose dependent on the severity of their illness and their creatinine clearance ( see 4 DOSAGE AND ADMINISTRATION : Special Populations : Impaired Renal Function for dose modification based on creatinine clearance or serum creatinine).
2 CONTRAINDICATIONS • CIPROFLOXACIN (ciprofloxacin hydrochloride tablets) are contraindicated in patients who have shown hypersensitivity to ciprofloxacin, or other quinolone antibacterial agents or any of the excipients. For a complete listing, see the 4 DOSAGE AND ADMINISTRATION section.
• Concurrent administration of ciprofloxacin and agomelatinea is contraindicated since it may result in an undesirable increase in agomelatine exposure (see 9 DRUG INTERACTIONS). • Concurrent administration of ciprofloxacin and tizanidine is contraindicated since it may result in an undesirable increase in serum tizanidine concentrations.
This can be associated with clinically relevant tizanidine-induced side effects (hypotension, somnolence, drowsiness) (see 9 DRUG INTERACTIONS) aCurrently not marketed in Canada 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • Fluoroquinolones, including CIPROFLOXACIN, have been associated with disabling and potentially persistent adverse reactions which to date include, but are not limited to: tendonitis, tendon rupture, peripheral neuropathy and neuropsychiatric effects.
• Ciprofloxacin has been shown to prolong the QT interval of the electrocardiogram in some patients (see 7 WARNINGS AND PRECAUTIONS: Cardiovascular). • Serious hypersensitivity and/or anaphylactic reactions have been reported in patients receiving fluoroquinolone therapy, including CIPROFLOXACIN (see 7 WARNINGS AND PRECAUTIONS: Immune).
• Fluoroquinolones including CIPROFLOXACIN are associated with an increased risk of tendinitis and tendon rupture in all ages. The risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants (see 7 WARNINGS AND PRECAUTIONS: Musculoskeletal).
• Fluroquinolones including CIPROFLOXACIN may exacerbate muscle weakness in persons with myasthenia gravis. Avoid using CIPROFLOXACIN in patients with a known history of myasthenia gravis (see 7 WARNINGS AND PRECAUTIONS: Musculoskeletal).
• Seizures and toxic psychoses may occur with fluoroquinolone therapy. Convulsions, increased intracranial pressure (including pseudotumor cerebri) and toxic psychoses CIPROFLOXACIN Page 8 of 59 have been reported in patients receiving fluoroquinolones, including CIPROFLOXACIN.
CIPROFLOXACIN should be used with caution in patients with known or suspected CNS disorders which may predispose them to seizures or lower the seizure threshold (see 7 WARNINGS AND PRECAUTIONS: Neurologic). • Cases of hepatic necrosis and life-threatening hepatic failure have been reported with ciprofloxacin (see 7 WARNINGS AND PRECAUTIONS: Hepatic/Biliary/Pancreatic).
1 Dosing Considerations The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defence mechanisms, and the status of renal function.
Oral Administration CIPROFLOXACIN (ciprofloxacin hydrochloride tablets) may be taken before or after meals. Absorption is faster on an empty stomach. Patients should be advised to drink fluids liberally and avoid taking dairy products or antacids containing magnesium or aluminum.
, hospital-acquired pneumonia, osteomyelitis CIPROFLOXACIN Page 9 of 59 Depending on the severity of the infections, as well as the clinical and bacteriological responses, the average treatment period should be approximately 7 to 14 days.
Generally, treatment should last 3 days beyond the disappearance of clinical symptoms or until cultures are sterile. Patients with osteomyelitis may require treatment for a minimum of 6 to 8 weeks and up to 3 months. With acute cystitis in females a 3- to 5-day treatment may be sufficient.
With infectious diarrhea a five-day treatment may be sufficient. Typhoid fever should be treated for 14 days. Acute sinusitis should be treated for 10 days with 500 mg q12h. Chronic bacterial prostatitis should be treated for 28 days with 500 mg q12h.
Special Populations Impaired Renal Function Ciprofloxacin is eliminated primarily by renal excretion. However, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine (see 10 CLINICAL PHARMACOLOGY, Detailed Human Pharmacology).
This alternate pathway of drug elimination appears to compensate for the reduced renal excretion of patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction.
The following table provides a guideline for dosage adjustment of CIPROFLOXACIN. However, monitoring of serum drug levels provides the most reliable basis for dosage adjustments.
Table 2:
Maximum […]
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised May 22, 2026[2]
• CIPROFLOXACIN (ciprofloxacin hydrochloride tablets) are contraindicated in patients who have shown hypersensitivity to ciprofloxacin, or other quinolone antibacterial agents or any of the excipients. For a complete listing, see the
This is not medical advice. Consult a qualified healthcare professional.
4 Infectious Diarrhea Ciprofloxacin tablets are indicated in adult patients for treatment of infectious diarrhea caused by Escherichia coli (enterotoxigenic isolates), Campylobacter jejuni, Shigella boydii † , Shigella dysenteriae, Shigella flexneri or Shigella sonnei † when antibacterial therapy is indicated.
† Although treatment of infections due to this organism in this organ system demonstrated a clinically significant outcome, efficacy was studied in fewer than 10 patients. 5 Typhoid Fever (Enteric Fever) Ciprofloxacin tablets are indicated in adult patients for treatment of typhoid fever (enteric fever) caused by Salmonella typhi .
The efficacy of ciprofloxacin in the eradication of the chronic typhoid carrier state has not been demonstrated. 17) ] . 7 Inhalational Anthrax (Post-Exposure) Ciprofloxacin tablets are indicated in adults and pediatric patients from birth to 17 years of age for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis .
Ciprofloxacin serum concentrations achieved in humans served as a surrogate endpoint reasonably likely to predict clinical benefit and provided the initial basis for approval of this indication. 2) ] . 8 Plague Ciprofloxacin tablets are indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y.
pestis) and prophylaxis for plague in adults and pediatric patients from birth to 17 years of age. Efficacy studies of ciprofloxacin could not be conducted in humans with plague for feasibility reasons. 3) ] . 9 Chronic Bacterial Prostatitis Ciprofloxacin tablets are indicated in adult patients for treatment of chronic bacterial prostatitis caused by Escherichia coli or Proteus mirabilis .
10 Lower Respiratory Tract Infections Ciprofloxacin tablets are indicated in adult patients for treatment of lower respiratory tract infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, or Streptococcus pneumoniae.
Ciprofloxacin tablets are not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to Streptococcus pneumoniae . Ciprofloxacin tablets are indicated for the treatment of acute exacerbations of chronic bronchitis (AECB) caused by Moraxella catarrhalis.
16) ] and for some patients AECB is self-limiting, reserve ciprofloxacin tablets for treatment of AECB in patients who have no alternative treatment options. 11 Urinary Tract Infections Urinary Tract Infections in Adults Ciprofloxacin tablets are indicated in adult patients for treatment of urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter koseri, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus epidermidis, Staphylococcus saprophyticus, or Enterococcus faecalis.
Acute Uncomplicated Cystitis Ciprofloxacin tablets are indicated in adult female patients for treatment of acute uncomplicated cystitis caused by Escherichia coli or Staphylococcus saprophyticus. 16) ] and for some patients acute uncomplicated cystitis is self-limiting, reserve ciprofloxacin tablets for treatment of acute uncomplicated cystitis in patients who have no alternative treatment options.
4) ]. Although effective in clinical trials, ciprofloxacin tablets are not a drug of first choice in the pediatric population due to an increased incidence of adverse reactions compared to controls, including reactions related to joints and/or surrounding tissues.
2) ] . 12 Acute Sinusitis Ciprofloxacin tablets are indicated in adult patients for treatment of acute sinusitis caused by Haemophilus influenzae, Streptococcus pneumoniae, or Moraxella catarrhalis . 16) ] and for some patients acute sinusitis is self-limiting, reserve ciprofloxacin tablets for treatment of acute sinusitis in patients who have no alternative treatment options.
13 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin tablets and other antibacterial drugs, ciprofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
If anaerobic organisms are suspected of contributing to the infection, appropriate therapy should be administered. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to ciprofloxacin.
Therapy with ciprofloxacin tablets may be initiated before results of these tests are known; once results become available appropriate therapy should be continued. As with other drugs, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with ciprofloxacin.
Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent but also on the possible emergence of bacterial resistance.
How to take
USOfficial regulatory label· revised May 13, 2026[3]
2 DOSAGE AND ADMINISTRATION Ciprofloxacin tablets should be administered orally as described in the appropriate Dosage Guidelines tables. 1 Dosage in Adults The determination of dosage and duration for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative microorganism, the integrity of the patient’s host-defense mechanisms, and the status of renal and hepatic function.
Ciprofloxacin tablets may be administered to adult patients when clinically indicated at the discretion of the physician.
Table 1:
Adult Dosage Guidelines 1. Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure). 2. Used in conjunction with metronidazole.
3. Begin drug administration as soon as possible after suspected or confirmed exposure. 3) ]. 2 Dosage in Pediatric Patients Dosing and initial route of therapy (that is, IV or oral) for cUTI or pyelonephritis should be determined by the severity of the infection.
Ciprofloxacin tablets should be administered as described in Table 3.
Table 3:
Pediatric Dosage Guidelines 1. The total duration of therapy for cUTI and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days). 2. Begin drug administration as soon as possible after suspected or confirmed exposure.
3. Begin drug administration as soon as possible after suspected or confirmed exposure to Y. pestis . Infection Dose Frequency Total Duration Complicated Urinary Tract or Pyelonephritis (patients from 1 to 17 years of age) 10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing more than 51 kg).
3 Dosage Modifications in Patients with Renal Impairment Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine.
These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction.
Dosage guidelines for use in patients with renal impairment are shown in Table 4.
Table 4:
Recommended Starting and Maintenance Doses for Adult Patients with Impaired Renal Function Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage. 85 x the value calculated for men. The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored. Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of cUTI and pyelonephritis.
73 m 2 ). 4 Important Administration Instructions With Multivalent Cations Administer ciprofloxacin tablets at least 2 hours before or 6 hours after magnesium/aluminum antacids; polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate; Videx ® (didanosine) chewable/buffered tablets or pediatric powder for oral solution; other highly buffered drugs; or other products containing calcium, iron or zinc.
With Dairy Products Concomitant administration of ciprofloxacin tablets with dairy products (like milk or yogurt) or calcium-fortified juices alone should be avoided since decreased absorption is possible; however, ciprofloxacin tablets may be taken with a meal that contains these products.
Hydration of Patients Receiving Ciprofloxacin Tablets Assure adequate hydration of patients receiving ciprofloxacin tablets to prevent the formation of highly concentrated urine. Crystalluria has been reported with quinolones. Instruct the patient of the appropriate ciprofloxacin tablets administration [see Patient Counseling Information (17) ].
Missed Doses If a dose is missed, it should be taken anytime but not later than 6 hours prior to the next scheduled dose. If less than 6 hours remain before the next dose, the missed dose should not be taken and treatment should be continued as prescribed with the next scheduled dose.
Double doses should not be taken to compensate for a missed dose.
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 3,770 reports total. [4]
Vomiting 374
Pneumonia 366
Drug Hypersensitivity 355
Off Label Use 354
Dyspnoea 328
Pain 323
Drug Ineffective 288
Oedema 273
Asthma 270
Wheezing 265
Malaise 262
Fatigue 254
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised May 13, 2026[3]
15) ] The most common adverse reactions ≥1% were nausea, diarrhea, liver function tests abnormal, vomiting, and rash. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. gov/medwatch. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adult Patients During clinical investigations with oral and parenteral ciprofloxacin, 49,038 patients received courses of the drug. 3%), vomiting (1%), and rash (1%).
Table 8:
Medically Important Adverse Reactions That Occurred in less than 1% of Ciprofloxacin Patients System Organ Class Adverse Reactions Body as a Whole Headache Abdominal Pain/Discomfort Pain Cardiovascular Syncope Angina Pectoris Myocardial Infarction Cardiopulmonary Arrest Tachycardia Hypotension Central Nervous System Restlessness Dizziness Insomnia Nightmares Hallucinations Paranoia Psychosis (toxic) Manic Reaction Irritability Tremor Ataxia Seizures (including Status Epilepticus) Malaise Anorexia Phobia Depersonalization Depression (potentially culminating in self-injurious behavior (such as suicidal ideations/thoughts and attempted or completed suicide) Paresthesia Abnormal Gait Migraine Gastrointestinal Intestinal Perforation Gastrointestinal Bleeding Cholestatic Jaundice Hepatitis Pancreatitis Hemic/Lymphatic Petechia Metabolic/Nutritional Hyperglycemia Hypoglycemia Musculoskeletal Arthralgia Joint Stiffness Muscle Weakness Renal/Urogenital Interstitial Nephritis Renal Failure Respiratory Dyspnea Laryngeal Edema Hemoptysis Bronchospasm Skin/Hypersensitivity Anaphylactic Reactions including life-threatening anaphylactic shock Erythema Multiforme/Stevens-Johnson syndrome Exfoliative Dermatitis Toxic Epidermal Necrolysis Pruritus Urticaria Photosensitivity/Phototoxicity reaction Flushing Fever Angioedema Erythema Nodosum Sweating Special Senses Blurred Vision Disturbed Vision (chromatopsia and photopsia) Decreased Visual Acuity Diplopia Tinnitus Hearing Loss Bad Taste In randomized, double-blind controlled clinical trials comparing ciprofloxacin tablets [500 mg two times daily (BID)] to cefuroxime axetil (250 mg to 500 mg BID) and to clarithromycin (500 mg BID) in patients with respiratory tract infections, ciprofloxacin demonstrated a CNS adverse reaction profile comparable to the control drugs.
Pediatric Patients Short (6 weeks) and long term (1 year) musculoskeletal and neurological safety of oral/intravenous ciprofloxacin, was compared to a cephalosporin for treatment of cUTI or pyelonephritis in pediatric patients 1 to 17 years of age (mean age of 6 ± 4 years) in an international multicenter trial.
The duration of therapy was 10 to 21 days (mean duration of treatment was 11 days with a range of 1 to 88 days). A total of 335 ciprofloxacin- and 349 comparator-treated patients were enrolled. An Independent Pediatric Safety Committee (IPSC) reviewed all cases of musculoskeletal adverse reactions including abnormal gait or abnormal joint exam (baseline or treatment-emergent).
3% (31/335) in the ciprofloxacin-treated group versus 6% (21/349) in comparator-treated patients. All musculoskeletal adverse reactions occurring by 6 weeks resolved (clinical resolution of signs and symptoms), usually within 30 days of end of treatment.
Radiological evaluations were not routinely used to confirm resolution of the adverse reactions. Ciprofloxacin-treated patients were more likely to report more than one adverse reaction and on more than one occasion compared to control patients.
The rate of musculoskeletal adverse reactions was consistently higher in the ciprofloxacin group compared to the control group across all age subgroups. 5% (33/349) in the comparator-treated patients (Table 9).
Table 9:
Musculoskeletal Adverse Reactions 1 as Assessed by the IPSC 1. Included: arthralgia, abnormal gait, abnormal joint exam, joint sprains, leg pain, back pain, arthrosis, bone pain, pain, myalgia, arm pain, and decreased range of motion in a joint (knee, elbow, ankle, hip, wrist, and shoulder) 2.
The study was designed to demonstrate that the arthropathy rate for the ciprofloxacin group did not exceed that of the control group by more than + 6%. At both the 6 week and 1 year evaluations, the 95% confidence interval indicated that it could not be concluded that the ciprofloxacin group had findings comparable to the control group.
1%) The incidence rates of neurological adverse reactions within 6 weeks of treatment initiation were 3% (9/335) in the ciprofloxacin group versus 2% (7/349) in the comparator group and included dizziness, nervousness, insomnia, and somnolence.
In this trial, the overall incidence rates of adverse reactions within 6 weeks of treatment initiation were 41% (138/335) in the ciprofloxacin group versus 31% (109/349) in the comparator group. The most frequent adverse reactions were gastrointestinal: 15% (50/335) of ciprofloxacin patients compared to 9% (31/349) of comparator patients.
7% (20/349) of control patients. 4% (5/349) of comparator patients. 8%. Short-term safety data for ciprofloxacin was also collected in a randomized, double-blind clinical trial for the treatment of acute pulmonary exacerbations in cystic fibrosis patients (ages 5 to 17 years).
Sixty-seven patients received ciprofloxacin IV 10 mg/kg/dose every 8 hours for one week followed by ciprofloxacin tablets 20 mg/kg/dose every 12 hours to complete 10 to 21 days treatment and 62 patients received the combination of ceftazidime intravenous 50 mg/kg/dose every 8 hours and tobramycin intravenous 3 mg/kg/dose every 8 hours for a total of 10 to 21 days.
Periodic musculoskeletal assessments were conducted by treatment-blinded examiners. Patients were followed for an average of 23 days after completing treatment (range 0 to 93 days). Musculoskeletal adverse reactions were reported in 22% of the patients in the ciprofloxacin group and 21% in the comparison group.
Decreased range of motion was reported in 12% of the subjects in the ciprofloxacin group and 16% in the comparison group. Arthralgia was reported in 10% of the patients in the ciprofloxacin group and 11% in the comparison group. Other adverse reactions were similar in nature and frequency between treatment arms.
The efficacy of ciprofloxacin for the treatment of acute pulmonary exacerbations in pediatric cystic fibrosis patients has not been established. In addition to the adverse reactions reported in pediatric patients in clinical trials, it should be expected that adverse reactions reported in adults during clinical trials or postmarketing experience may also occur in pediatric patients.
2 Postmarketing Experience The following adverse reactions have been reported from worldwide marketing experience with fluoroquinolones, including ciprofloxacin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure (Table 10).
3 Adverse Laboratory Changes Changes in laboratory parameters while on ciprofloxacin are listed below: Hepatic–Elevations of ALT (SGPT), AST (SGOT), alkaline phosphatase, LDH, serum bilirubin. Hematologic–Eosinophilia, leukopenia, decreased blood platelets, elevated blood platelets, pancytopenia.
Renal–Elevations of serum creatinine, BUN, crystalluria, cylindruria, and hematuria have been reported. Other changes occurring were: elevation of serum gammaglutamyl transferase, elevation of serum amylase, reduction in blood glucose, elevated uric acid, decrease in hemoglobin, anemia, bleeding diathesis, increase in blood monocytes, and leukocytosis.
USOfficial regulatory label· Warnings and precautions· revised May 13, 2026[3]
5 WARNINGS AND PRECAUTIONS Hypersensitivity and other serious reactions: Serious and sometimes fatal reactions (for example, anaphylactic reactions) may occur after the first or subsequent doses of ciprofloxacin. Discontinue ciprofloxacin at the first sign of skin rash, jaundice or any sign of hypersensitivity.
7 ) Hepatotoxicity: Discontinue immediately if signs and symptoms of hepatitis occur. 8 ) Clostridioides difficile -associated diarrhea: Evaluate if colitis occurs. 11 ) QT Prolongation: Prolongation of the QT interval and isolated cases of torsade de pointes have been reported.
Avoid use in patients with known prolongation, those with hypokalemia, and with other drugs that prolong the QT interval. 1 Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects Fluoroquinolones, including ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient.
Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion). These reactions can occur within hours to weeks after starting ciprofloxacin.
4) ] . Discontinue ciprofloxacin immediately at the first signs or symptoms of any serious adverse reaction. In addition, avoid the use of fluoroquinolones, including ciprofloxacin, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.
2) ] . This adverse reaction most frequently involves the Achilles tendon, and has also been reported with the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendons. Tendinitis or tendon rupture can occur, within hours or days of starting ciprofloxacin, or as long as several months after completion of fluoroquinolone therapy.
Tendinitis and tendon rupture can occur bilaterally. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is increased in patients over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised May 13, 2026[3]
7) ]. 2 Tizanidine Concomitant administration with tizanidine is contraindicated [see Drug Interactions (7) ].
This is not medical advice. Consult a qualified healthcare professional.
This is all the more to be taken into account as regards the increasing resistance level of Escherichia coli to quinolones Intra-abdominal infections There are limited data on the efficacy of ciprofloxacin in the treatment of postsurgical intra-abdominal infections.
Travellers' diarrhoea The choice of ciprofloxacin should take into account information on resistance to ciprofloxacin in relevant pathogens in the countries visited. Infections of the bones and joints Ciprofloxacin should be used in combination with other antimicrobial agents depending on the results of the microbiological documentation.
Inhalational anthrax Use in humans is based on in-vitro susceptibility data and on animal experimental data together with limited human data. Treating physicians should refer to national and/or international consensus documents regarding the treatment of anthrax.
Paediatric population The use of ciprofloxacin in children and adolescents should follow available official guidance. Ciprofloxacin treatment should be initiated only by physicians who are experienced in the treatment of cystic fibrosis and/or severe infections in children and adolescents.
Ciprofloxacin has been shown to cause arthropathy in weight- bearing joints of immature animals. 6%. 7%. The increase of suspected drug-related arthropathy cases over time was not statistically significant between groups. 8). Broncho-pulmonary infections in cystic fibrosis Clinical trials have included children and adolescents aged 5-17 years.
More limited experience is available in treating children between 1 and 5 years of age. Complicated urinary tract infections and pyelonephritis Ciprofloxacin treatment of urinary tract infections should be considered when other treatments cannot be used, and should be based on the results of the microbiological documentation.
Clinical trials have included children and adolescents aged 1-17 years. Other specific severe infections Other severe infections in accordance with official guidance, or after careful benefit- risk evaluation when other treatments cannot be used, or after failure to conventional therapy and when the microbiological documentation can justify a ciprofloxacin use.
The use of ciprofloxacin for specific severe infections other than those mentioned above has not been evaluated in clinical trials and the clinical experience is limited. […]
Other factors that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors.
Discontinue ciprofloxacin immediately if the patient experiences pain, swelling, inflammation or rupture of a tendon. 2) ] . 3 Peripheral Neuropathy Fluoroquinolones, including ciprofloxacin, have been associated with an increased risk of peripheral neuropathy.
Cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving fluoroquinolones, including ciprofloxacin.
2) ]. Discontinue ciprofloxacin immediately if the patient experiences symptoms of peripheral neuropathy including pain, burning, tingling, numbness, and/or weakness, or other alterations in sensations including light touch, pain, temperature, position sense and vibratory sensation, and/or motor strength in order to minimize the development of an irreversible condition.
2) ] . 4 Central Nervous System Effects Psychiatric Adverse Reactions Fluoroquinolones, including ciprofloxacin, have been associated with an increased risk of psychiatric adverse reactions, including: toxic psychosis, psychotic reactions progressing to suicidal ideations/thoughts, hallucinations, or paranoia; depression, or self-injurious behavior such as attempted or completed suicide; anxiety, agitation, or nervousness; confusion, delirium, disorientation, or disturbances in attention; insomnia or nightmares; memory impairment.
These reactions may occur following the first dose. Advise patients receiving ciprofloxacin to inform their healthcare provider immediately if these reactions occur, discontinue the drug, and institute appropriate care. Central Nervous System Adverse Reactions Fluoroquinolones, including ciprofloxacin, have been associated with an increased risk of seizures (convulsions), increased intracranial pressure (pseudotumor cerebri), dizziness, and tremors.
Ciprofloxacin, like other fluoroquinolones, is known to trigger seizures or lower the seizure threshold. Cases of status epilepticus have been reported. As with all fluoroquinolones, use ciprofloxacin with caution in epileptic patients and patients with known or suspected CNS disorders that may predispose to seizures or lower the seizure threshold (for example, severe cerebral arteriosclerosis, previous history of convulsion, reduced cerebral blood flow, altered brain structure, or stroke), or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold (for example, certain drug therapy, renal dysfunction).
1) and Drug Interactions (7) ]. 5 Exacerbation of Myasthenia Gravis Fluoroquinolones, including ciprofloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness in patients with myasthenia gravis. Postmarketing serious adverse reactions, including deaths and requirement for ventilatory support, have been associated with fluoroquinolone use in patients with myasthenia gravis.
2) ] . 6 Other Serious and Sometimes Fatal Adverse Reactions Other serious and sometimes fatal adverse reactions, some due to hypersensitivity, and some due to uncertain etiology, have been reported in patients receiving therapy with quinolones, including ciprofloxacin.
These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following: • Fever, rash, or severe dermatologic reactions (for example, toxic epidermal necrolysis, Stevens-Johnson syndrome); • Vasculitis; arthralgia; myalgia; serum sickness; • Allergic pneumonitis; • Interstitial nephritis; acute renal insufficiency or failure; • Hepatitis; jaundice; acute hepatic necrosis or failure; • Anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia; and/or other hematologic abnormalities.
2) ] . 7 Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving fluoroquinolone therapy, including ciprofloxacin. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching.
Only a few patients had a history of hypersensitivity reactions. 1) ] . 8 Hepatotoxicity Cases of severe hepatotoxicity, including hepatic necrosis, life-threatening hepatic failure, and fatal events, have been reported with ciprofloxacin.
Acute liver injury is rapid in onset (range 1 to 39 days), and is often associated with hypersensitivity. The pattern of injury can be hepatocellular, cholestatic, or mixed. Most patients with fatal outcomes were older than 55 years old.
In the event of any signs and symptoms of hepatitis (such as anorexia, jaundice, dark urine, pruritus, or tender abdomen), discontinue treatment immediately. 3) ] . 9 Risk of Aortic Aneurysm and Dissection Epidemiologic studies report an increased rate of aortic aneurysm and dissection within two months following use of fluoroquinolones, particularly in elderly patients.
The cause for the increased risk has not been identified. In patients with a known aortic aneurysm or patients who are at greater risk for aortic aneurysms, reserve ciprofloxacin for use only when there are no alternative antibacterial treatments available.
10 Serious Adverse Reactions with Concomitant Theophylline Serious and fatal reactions have been reported in patients receiving concurrent administration of ciprofloxacin and theophylline. These reactions have included cardiac arrest, seizure, status epilepticus, and respiratory failure.
Instances of nausea, vomiting, tremor, irritability, or palpitation have also occurred. Although similar serious adverse reactions have been reported in patients receiving theophylline alone, the possibility that these reactions may be potentiated by ciprofloxacin cannot be eliminated.
If concomitant use cannot be avoided, monitor serum levels of theophylline and adjust dosage as appropriate [see Drug Interactions (7) ] . 11 Clostridioides difficile -Associated Diarrhea Clostridioides difficile (C. difficile) -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including ciprofloxacin, and may range in severity from mild diarrhea to fatal colitis.
Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing isolates of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.
CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. 1) ] . 12 Prolongation of the QT Interval Some fluoroquinolones, including ciprofloxacin, have been associated with prolongation of the QT interval on the electrocardiogram and cases of arrhythmia.
Cases of torsade de pointes have been reported during postmarketing surveillance in patients receiving fluoroquinolones, including ciprofloxacin. Avoid ciprofloxacin in patients with known prolongation of the QT interval, risk factors for QT prolongation or torsade de pointes (for example, congenital long QT syndrome, uncorrected electrolyte imbalance, such as hypokalemia or hypomagnesemia and cardiac disease, such as heart failure, myocardial infarction, or bradycardia), and patients receiving Class IA antiarrhythmic agents (quinidine, procainamide), or Class III antiarrhythmic agents (amiodarone, sotalol), tricyclic antidepressants, macrolides, and antipsychotics.
5) ] . 11 )] . 1) ] . In pre-clinical studies, oral administration of ciprofloxacin caused lameness in immature dogs. Histopathological examination of the weight-bearing joints of these dogs revealed permanent lesions of the cartilage.
2) ] . 14 Photosensitivity/Phototoxicity Moderate to severe photosensitivity/phototoxicity reactions, the latter of which may manifest as exaggerated sunburn reactions (for example, burning, erythema, exudation, vesicles, blistering, edema) involving areas exposed to light (typically the face, “V” area of the neck, extensor surfaces of the forearms, dorsa of the hands), can be associated with the use of quinolones including ciprofloxacin after sun or UV light exposure.
Therefore, avoid excessive exposure to these sources of light. 1) ] . 15 Development of Drug Resistant Bacteria Prescribing ciprofloxacin tablets in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
16 Potential Risks with Concomitant Use of Drugs Metabolized by Cytochrome P450 1A2 Enzymes Ciprofloxacin is an inhibitor of the hepatic CYP1A2 enzyme pathway. 3) ] . 17 Interference with Timely Diagnosis of Syphilis Ciprofloxacin has not been shown to be effective in the treatment of syphilis.
Antimicrobial agents used in high dose for short periods of time to treat gonorrhea may mask or delay the symptoms of incubating syphilis. Perform a serologic test for syphilis in all patients with gonorrhea at the time of diagnosis.
Perform follow-up serologic test for syphilis three months after ciprofloxacin treatment. 2) ] . Crystalluria related to ciprofloxacin has been reported only rarely in humans because human urine is usually acidic. Avoid alkalinity of the urine in patients receiving ciprofloxacin.
4) ] . 19 Blood Glucose Disturbances Fluoroquinolones, including ciprofloxacin, have been associated with disturbances of blood glucose, including symptomatic hyperglycemia and hypoglycemia, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (for example, glyburide) or with insulin.
In these patients, careful monitoring of blood glucose is recommended. Severe cases of hypoglycemia resulting in coma or death have been reported. 1) , Drug Interactions (7) ].