Hydroxychloroquine is an active pharmaceutical ingredient in the Aminoquinolines group (P01BA). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised January 27, 2023[1]
Adults Treatment of rheumatoid arthritis, discoid and systemic lupus erythematosus, and dermatological conditions caused or aggravated by sunlight. Paediatric Population Treatment of juvenile idiopathic arthritis (in combination with other therapies), discoid and systemic lupus erythematosus.
How to take
GB
USUnited States· FDA
3 products
Uses
USOfficial regulatory label· revised October 9, 2025[2]
1 INDICATIONS AND USAGE Hydroxychloroquine sulfate tablets are an antimalarial and antirheumatic indicated for the: Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients.
1 ) Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. 1 ) Treatment of rheumatoid arthritis in adults. 2 ) Treatment of systemic lupus erythematosus in adults. 3 ) Treatment of chronic discoid lupus erythematosus in adults.
1 ): Hydroxychloroquine sulfate tablets are not recommended for the: Treatment of complicated malaria. Treatment of chloroquine or hydroxychloroquine-resistant strains of Plasmodium species. Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified.
Prophylaxis of malaria in geographic areas where chloroquine resistance occurs. Prevention of relapses of P. vivax or P. ovale because it is not active against the hypnozoite liver stage forms of these parasites. For radical cure of P.
CACanada· Health Canada
1 product
Uses
CAOfficial regulatory label· revised October 22, 2025[3]
). Carcinogenesis and Mutagenesis Long term studies in animals have not been conducted to evaluate the carcinogenic potential (see 16 NON-CLINICAL TOXICOLOGY). In humans, there are insufficient data to rule out an increased risk of cancer in patients receiving-long term treatment.
Cardiovascular Cardiomyopathy Cases of cardiomyopathy resulting in cardiac failure, in some cases with a fatal outcome, have been reported in patients treated with hydroxychloroquine sulfate tablets. In multiple cases, endomyocardial biopsy showed association of the cardiomyopathy with phospholipidosis in the absence of inflammation, infiltration, or necrosis.
Drug-induced phospholipidosis may occur in other organ systems. HYDROXYCHLOROQUINE should be discontinued if signs and symptoms of cardiomyopathy develop. 2 Clinical Trial Adverse Reactions, Cardiac disorders). Monitor cardiac function as clinically indicated during therapy.
Discontinue HYDROXYCHLOROQUINE (hydroxychloroquine sulfate tablets) Page 10 of 45 HYDROXYCHLOROQUINE if cardiotoxicity is suspected or demonstrated by tissue biopsy. Electrocardiogram (ECG) Changes and Potential for Cardiac Arrhythmias HYDROXYCHLOROQUINE can prolong the PR, QRS and QTc intervals, especially in patients with underlying risk factors.
Drug interactions
Known interactions involving Hydroxychloroquine. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 587. 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.
[1]MHRA (UK) · PL332710009 · revised January 27, 2023
[2]FDA DailyMed · 04139607-f7c0-4f… · revised October 9, 2025 [PDF]
[3]Health Canada (DPD) · 02519348 · revised October 22, 2025
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.
Adults (including the elderly) The minimum effective dose should be employed. 5/kg/day (calculated from ideal body weight) and will be either 200mg, 300mg or 400mg per day.
In patients able to receive 300mg daily:
Initially 300mg daily in a single dose. The dose can be reduced to 200mg when no further improvement is evident. The maintenance dose should be increased to 300mg daily if the response lessens. 5mg/kg/day based on ideal body weight. The 300mg tablet is therefore not suitable for use in children with an ideal body weight of less than 46kg.
Hydroxychloroquine is cumulative in action and will require several weeks to exert its beneficial effects, whereas minor side effects may occur relatively early. For rheumatic disease treatment should be discontinued if there is no improvement by 6 months.
In light-sensitive diseases, treatment should only be given during periods of maximum exposure to light. Method of Administration For oral administration. Each dose should be taken with a meal or glass of milk.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised January 27, 2023[1]
The following MedDRA frequency convention is used to evaluate adverse reactions, when applicable: Very common(>1/10); Common (>1/100, <1/10); Uncommon (>1/1,000, <1/100); Rare >1/10,000, <1/1000); Very rare (<1/10,000) including isolated reports.
Tabulated list of adverse reactions:
System Organ class Frequency Adverse reaction Immune system disorders Not known Urticaria, angioedema, bronchospasm Eye disorders Common Blurring of vision due to a disturbance of accommodation which is dose dependent and reversible Uncommon Retinopathy with changes in pigmentation and visual field defects can occur but appears to be uncommon if the recommended daily dose is not exceeded.
In its early form it appears reversible on discontinuation of hydroxychloroquine sulfate. If allowed to develop, there may be a risk of progression even after treatment withdrawal. Patients with retinal changes may be asymptomatic initially, or may have scotomatous vision with paracentral, pericentral ring types, temporal scotomas and abnormal colour vision.
Corneal changes including oedema and opacities have been reported. They are either symptomless or may cause disturbances such as haloes, blurring of vision or photophobia. They may be transient and are reversible on stopping treatment.
Not known Cases of maculopathies and macular degeneration have been reported (the onset ranging from 3 months to several years of exposure to hydroxychloroquine) and may be irreversible Common Skin rash, Pruritus Uncommon Pigmentary disorders in skin and mucous membranes, bleaching of hair, alopecia These usually resolve readily on stopping treatment.
Skin and subcutaneous tissue disorders Not known Bullous eruptions including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis, Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome) photosensitivity, exfoliative dermatitis, acute generalised exanthematous pustulosis (AGEP).
Acute generalised exanthematous pustulosis (AGEP) has to be distinguished from psoriasis, although hydroxychloroquine may precipitate attacks of psoriasis. It may be associated with fever and hyperleukocytosis. Outcome is usually favourable after drug withdrawal.
Very common Abdominal pain, nauseaGastrointestinal disorders Common Diarrhoea, vomiting These symptoms usually resolve immediately on reducing the dose or on stopping treatment. Common Headache Uncommon Dizziness Nervous system disorders Not known Convulsions have been reported with this class of drugs.
4). 9) Chronic toxicity should be considered when conduction disorders (bundle branch block/atrioventricular heart block) as well as biventricular hypertrophy are found. Drug withdrawal may lead to recovery. Uncommon Sensory motor disordersMusculoskeletal and connective tissue disorders Not known Skeletal muscle myopathy or neuromyopathy leading to progressive weakness and atrophy of proximal muscle groups.
Myopathy may be reversible after drug discontinuation, but recovery may take many months. Depression of tendon reflexes and abnormal nerve conduction studies. 4), Hydroxychloroquine may precipitate or exacerbate porphyria. Uncommon Vertigo, tinnitusEar and labyrinth disorders Not known Hearing loss Common Affect lability Uncommon Nervousness Psychiatric disorders Not known Psychosis, suicidal behaviour, psychosis, depression, hallucinations, anxiety, agitation, confusion, delusions, mania and sleep disorders.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
GBOfficial regulatory label· Warnings and precautions· revised January 27, 2023[1]
Visual effects The occurrence of retinopathy is uncommon if the recommended daily dose is not exceeded. The administration of doses in excess of the recommended maximum is likely to increase the risk of retinopathy, and accelerate its onset.
73m2). Patients should be referred to a hospital eye department to have a baseline ocular examination within 6 to 12 months after initiation of therapy to screen for hydroxychloroquine retinopathy. Subsequent follow-up should be directed by an Ophthalmologist.
It should be emphasized that the lowest effective dose should be used to minimize the risk of ocular toxicity. Hydroxychloroquine sulfate should be discontinued immediately in any patient who develops a pigmentary abnormality, visual field defect, or any other abnormality not explainable by difficulty in accommodation or presence of corneal opacities.
Patients should continue to be observed for possible progression of the changes. Patients should be advised to stop taking the drug immediately and seek the advice of their prescribing doctor if any disturbances of vision are noted, including abnormal colour vision.
9). Clinical monitoring for signs and symptoms of cardiomyopathy is advised and hydroxychloroquine sulfate should be discontinued if cardiomyopathy develops. 8).
Caution is required in the following circumstances:
Hydroxychloroquine sulfate should be used with caution in patients taking medicines which may cause adverse ocular or skin reactions. 5). Caution should also be applied when it is used in the following: o patients with hepatic or renal disease, and in those taking drugs known to affect those organs.
Estimation of plasma hydroxychloroquine levels should be undertaken in patients with severely compromised renal or hepatic function and dosage adjusted accordingly. o patients with severe gastrointestinal, neurological or blood disorders.
o caution is also advised in patients with a sensitivity to quinine, those with glucose-6-phosphate dehydrogenase deficiency, those with porphyria cutanea tarda which can be exacerbated by hydroxychloroquine and in patients with psoriasis since it appears to increase the risk of skin reactions.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised January 27, 2023[1]
5
This is not medical advice. Consult a qualified healthcare professional.
vivax and P. ovale infections, concomitant therapy with an 8-aminoquinoline drug is necessary. 1 Malaria Hydroxychloroquine sulfate tablets are indicated in adult and pediatric patient for the: Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium vivax, and Plasmodium ovale.
Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported.
Limitations of Use :
Hydroxychloroquine sulfate tablets are not recommended for: Treatment of complicated malaria. 4) ]. Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified.
Prophylaxis of malaria in geographic areas where chloroquine resistance occurs. Prevention of relapses of P. vivax or P. ovale because it is not active against the hypnozoite liver stage forms of these parasites. For radical cure of P.
vivax and P. 4) ]. For the most current information about drug resistance, refer to the latest recommendations from the Center for Disease Control and Prevention1. 2 Rheumatoid Arthritis Hydroxychloroquine sulfate tablets are indicated for the treatment of acute and chronic rheumatoid arthritis in adults.
3 Systemic Lupus Erythematosus Hydroxychloroquine sulfate tablets are indicated for the treatment of systemic lupus erythematosus in adults. 4 Chronic Discoid Lupus Erythematosus Hydroxychloroquine sulfate tablets are indicated for the treatment of chronic discoid lupus erythematosus in adults.
How to take
USOfficial regulatory label· revised October 9, 2025[2]
5 mg/kg up to 400 mg, once a week ● Treatment of Uncomplicated Malaria: See Full Prescribing Information (FPI) for complete dosing information. 1 Important Administration Instructions Administer hydroxychloroquine sulfate tablets orally with food or milk.
Do not crush or divide the tablets. 2 Dosage for Malaria in Adult and Pediatric Patients Hydroxychloroquine sulfate tablets are not recommended in pediatric patients less than 31 kg because the lowest available strength (200 mg) exceeds the recommended dose for these patients and it cannot be divided.
Prophylaxis Treatment must start 2 weeks before travel to an endemic area. Advise the patient to take the prophylaxis dosage once a week, staring 2 weeks prior to travel to the endemic area, on the same day every week, continuing the same weekly dose while in the endemic area, and for 4 weeks after leaving the endemic area.
5 mg/kg actual body weight (up to 400 mg) once a week Treatment of Uncomplicated Malaria The dosages for the treatment of uncomplicated malaria are: Adult patients: Administer 800 mg initially; subsequently administer 400 mg at 6 hours, 24 hours, and 48 hours after the initial dose (total dosage = 2000 mg).
5 mg/kg (up to 400 mg) at 6 hours, 24 hours, and 48 hours after the initial dose (total dosage = 31 mg/kg - up to 2000 mg). For radical cure of P. vivax and P. 4) ]. 3 Dosage for Rheumatoid Arthritis in Adults The recommended dosage is: Initial dosage: 400 mg to 600 mg daily as a single daily dose or two divided doses.
The action of hydroxychloroquine is cumulative and may require weeks to months for maximum therapeutic effect. 2) ]. Chronic dosage: 200 mg once daily to 400 mg daily, as a single dose or two divided doses. Corticosteroids, salicylates, and other antirheumatic agents may be used concomitantly with hydroxychloroquine sulfate tablets.
4 Dosage for Systemic Lupus Erythematosus in Adults The recommended dosage is 200 mg given once daily, or 400 mg given once daily or in two divided doses. 5 Dosage for Chronic Discoid Lupus Erythematosus in Adults The recommended dosage is 200 mg given once daily, or 400 mg given once daily or in two divided doses.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised October 9, 2025[2]
11) ] The following adverse reactions have been identified during post-approval use of 4-aminoquinoline drugs, including hydroxychloroquine sulfate tablets. 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: Blood and lymphatic system disorders : Bone marrow depression, anemia, aplastic anemia, agranulocytosis, leukopenia, thrombocytopenia Cardiac disorders : Cardiomyopathy, cardiac failure, QT-interval prolongation, ventricular tachycardia, torsades de pointes, atrioventricular block, bundle branch block, sick sinus syndrome, pulmonary hypertension Ear and labyrinth disorders : Vertigo, tinnitus, nystagmus, sensorineural hearing loss Eye disorders : Retinopathy, retinal pigmentation changes (typically bull's eye appearance), visual field defects (paracentral scotomas), macular degeneration, corneal edema, corneal opacities, decreased dark adaptation Gastrointestinal disorders : Nausea, vomiting, diarrhea, abdominal pain General disorders : Fatigue Hepatobiliary disorders : Abnormal liver function tests, fulminant hepatic failure Immune system disorders : Urticaria, angioedema, bronchospasm Metabolism and nutrition disorders : Anorexia, hypoglycemia, weight loss Musculoskeletal and connective tissue disorders : Proximal myopathy, depressed tendon reflexes, abnormal nerve conduction Nervous system disorders : Ataxia, dizziness, headache, seizure, extrapyramidal disorders (dystonia, dyskinesia, tremor) Neuropsychiatric disorders : Affect/emotional lability, irritability, nervousness, psychosis, suicidal ideation, suicidal behavior, depression, hallucinations, anxiety, agitation, confusion, delusions, paranoia, mania and sleep disorders (insomnia, night terrors, nightmares) Skin and subcutaneous tissue disorders : Alopecia, hair color changes, rash, pruritus, photosensitivity, psoriasis exacerbation, hyperpigmentation, exfoliative dermatitis, erythema multiforme, acute generalized exanthematous pustulosis, Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) The most common adverse reactions reported are: nausea, vomiting, diarrhea, and abdominal pain.
USOfficial regulatory label· Warnings and precautions· revised October 9, 2025[2]
5 WARNINGS AND PRECAUTIONS Cardiomyopathy and Ventricular Arrhythmias : Fatal or life-threatening cardiomyopathy and ventricular arrhythmias were reported. 1 ) Retinal Toxicity : Irreversible retinal damage is related to cumulative dosage and treatment duration.
Baseline retinal exam and exams during treatment are recommended. 2 ) Serious Skin Reactions : Stevens Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, acute generalized exanthematous pustulosis have been reported.
3 ) Worsening of Psoriasis : Avoid in patients with psoriasis. 4 ) Risks Associated with Use in Porphyria : Avoid in patients with porphyria. 5 ).
Hematologic Toxicity :
Discontinue if myelosuppression occurs. 6 ) Renal Toxicity : Consider phospholipidosis as a possible cause of renal injury in patients with underlying connective tissue disorders. Discontinue hydroxychloroquine sulfate tablets if renal toxicity is suspected or demonstrated by tissue biopsy in any organ system.
1 Cardiomypathy and Ventricular Arrhythmias Fatal and life-threatening cases of cardiotoxicity, including cardiomyopathy, have been reported in patients treated with hydroxychloroquine sulfate tablets. Signs and symptoms of cardiac compromise have occurred during acute and chronic hydroxychloroquine sulfate tablets treatment.
In multiple cases, endomyocardial biopsy showed association of the cardiomyopathy with phospholipidosis in the absence of inflammation, infiltration, or necrosis. 11 )]. Patients may present with ventricular hypertrophy, pulmonary hypertension and conduction disorders including sick sinus syndrome.
ECG findings include atrioventricular, right or left bundle branch block. Hydroxychloroquine sulfate tablets has a potential to prolong the QT interval. Ventricular arrhythmias (including torsades de pointes) have been reported in hydroxychloroquine sulfate tablets-treated patients.
The magnitude of QT prolongation may increase with increasing concentrations of the drug. Therefore, the recommended dose should not be exceeded [see Adverse Reactions (6) , Overdosage (10) ]. , heart failure, myocardial infarction. , bradycardia (< 50 bpm).
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised October 9, 2025[2]
4 CONTRAINDICATIONS Hydroxychloroquine sulfate tablets are contraindicated in patients with known hypersensitivity to 4-aminoquinoline compounds. Patients with hypersensitivity to 4-aminoquinoline compounds ( 4 )
This is not medical advice. Consult a qualified healthcare professional.
2 Clinical Trial Adverse Reactions, Cardiac disorders and 9 DRUG INTERACTIONS). QTc prolongation may lead to an increased risk of ventricular arrhythmias including torsade de pointes. Torsade de pointes may be asymptomatic or experienced by the patient as dizziness, palpitations, syncope, or seizures.
If sustained, torsade de pointes can progress to ventricular fibrillation and sudden cardiac death. Permanently discontinue HYDROXYCHLOROQUINE in patients who develop torsade de pointes or polymorphic ventricular tachycardia or signs/symptoms of serious arrhythmia.
If cardiac complications due to HYDROXYCHLOROQUINE are suspected, treatment should be discontinued. , congenital or acquired Long QT Syndrome), second-or third-degree atrioventricular block. hypokalemia/hypomagnesemia/hypocalcemia) must be corrected prior to use.
Use of HYDROXYCHLOROQUINE should be undertaken with extreme caution in patients with other risk factors for torsade de pointes. , intracranial or subarachnoid haemorrhage, stroke, intracranial trauma); diabetes mellitus; and autonomic neuropathy.
Concomitant use with other QTc, PR or QRS interval prolonging drugs should be avoided or undertaken with particular caution (see 9 DRUG INTERACTIONS). Carefully consider the benefits and risks before prescribing azithromycin or other macrolide antibiotics for any patients taking HYDROXYCHLOROQUINE, because of the potential for an increased risk of cardiovascular events and cardiovascular mortality (see 9 DRUG INTERACTIONS).
The magnitude of QT, PR or QRS prolongation with HYDROXYCHLOROQUINE may increase with increasing concentrations of the drug. Therefore, the recommended dose should not be exceeded (see 4 DOSAGE AND ADMINISTRATION and 5 OVERDOSAGE). HYDROXYCHLOROQUINE (hydroxychloroquine sulfate tablets) Page 11 of 45 Driving and Operating Machinery Patients should be warned about driving and operating machinery since HYDROXYCHLOROQUINE can impair accommodation and cause blurring of vision.
If the condition is not self- limiting, dosage may need to be temporarily reduced (see 4 DOSAGE AND ADMINISTRATION). Endocrine and Metabolism Hydroxychloroquine sulfate tablets has been shown to cause severe hypoglycemia including loss of consciousness that could be life threatening in patients treated with and without antidiabetic medications.
Patients treated with HYDROXYCHLOROQUINE should be warned about the risk of hypoglycemia and the associated clinical signs and symptoms. Patients presenting with clinical symptoms suggestive of hypoglycemia during treatment with HYDROXYCHLOROQUINE should have their blood glucose level checked and the need for HYDROXYCHLOROQUINE treatment reviewed as necessary.
In cases of severe hypoglycemia, HYDROXYCHLOROQUINE should be discontinued and alternative therapy should be considered. 2 Clinical Trial Adverse Reactions and 9 DRUG INTERACTIONS). 2 Clinical Trial Adverse Reactions). If […]
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised October 22, 2025[3]
), Healthcare professionals should assess the benefits/risk of continuing the treatment. If active liver diseases or unexplained transaminases elevations develop during therapy, HYDROXYCHLOROQUINE should be discontinued. Immune Reactivation of Infections Based on limited data, the reactivation of hepatitis B virus, herpes zoster virus and tuberculosis has been reported in patients treated with hydroxychloroquine administered alone or more often in combination with other immunosuppressants.
Consider the risk of reactivation prior to using hydroxychloroquine in patients with previous history of these infections. Monitoring and Laboratory Tests ECG assessments are recommended at baseline and periodically during treatment with HYDROXYCHLOROQUINE.
More frequent monitoring is recommended if HYDROXYCHLOROQUINE is administered to patients with baseline ECG abnormalities or who are being treated concomitantly with other QTc-, QRS-, or PR-interval prolonging drugs. Monitor electrolytes regularly (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular, and
CAOfficial regulatory label· Warnings and precautions· revised October 22, 2025[3]
, General, Malaria). 1 Pediatrics Pediatrics (< 18 years of age): HYDROXYCHLOROQUINE is contraindicated in children below 6 years of age (see 2 CONTRAINDICATIONS). 2 Recommended Dose and Dosage Adjustment, Rheumatoid Arthritis). 3 Pediatrics).
2 Geriatrics Geriatrics (≥ 65 years of age): Clinical trials of hydroxychloroquine sulfate tablets did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.
HYDROXYCHLOROQUINE can prolong the QTc interval, especially in patients with underlying risk factors, which may lead to an increased risk of ventricular arrhythmias including torsade de pointes. Risk factors for torsade de pointes in the general population include the age of ≥ 65 years (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular, Electrocardiogram Changes and Potential for Cardiac Arrhythmias).
4 Geriatrics). CONTRAINDICATIONS HYDROXYCHLOROQUINE (hydroxychloroquine sulfate tablets) Page 5 of 45 HYDROXYCHLOROQUINE is contraindicated in: • Patients with pre-existing retinopathy of the eye. • Patients with known hypersensitivity to 4-aminoquinoline compounds.
• Patients who are hypersensitive to hydroxychloroquine sulfate or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
3 Pediatrics). 5 mg (salt form)/kg ideal (lean) body weight. Exceeding the recommended daily dose sharply increase the risk of retinal toxicity as well as cardiac arrhythmias (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular and Ophthalmologic).
• HYDROXYCHLOROQUINE should be discontinued if signs and symptoms of cardiomyopathy develop, in patients who develop torsade de pointes, polymorphic ventricular tachycardia, signs/symptoms of serious arrhythmia, severe hypoglycemia, severe blood disorder, muscular weakness, or extrapyramidal reactions.
HYDROXYCHLOROQUINE dosage may need to be temporarily reduced in patients who develop impaired accommodation and blurring of vision that is not self-limiting (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular, Driving and Operating Machinery, Endocrine and Metabolism, Hematologic, Musculoskeletal, and Neurologic).
• The dosages cited below are stated in terms of hydroxychloroquine sulfate. One 200 mg tablet is equivalent to 155 mg base. Each dose should be taken with a meal or a glass of milk. 2 Recommended Dose and Dosage Adjustment Rheumatoid Arthritis The compound is cumulative in action and will require several weeks to exert its beneficial therapeutic effects, whereas minor side effects may occur somewhat early.
Several months of therapy may be required before maximum effects can be obtained. If objective improvement (such as reduced joint swelling, increased mobility) does not occur within six months, the drug should be stopped. Safe use of the drug in the treatment of juvenile rheumatoid arthritis has not been established.
Initial dosage – In adults, from 400 to 600 mg daily. In a few patients, the side effects may require temporary reduction of the initial dosage. Generally, after five to ten days the dose may be gradually increased to the optimum response level, frequently, without return of HYDROXYCHLOROQUINE (hydroxychloroquine sulfate tablets) Page 6 of 45 side effects.
Maintenance dosage – When a good response is obtained (usually in four to twelve weeks), the dosage is reduced by 50 percent and continued at an acceptable maintenance level of 200 to 400 mg daily. The incidence of retinopathy has been reported to be higher when the maintenance dose is exceeded.
If a relapse occurs after medication is withdrawn, therapy may be resumed or continued on an intermittent schedule if there are no ocular contraindications.
Use in Combination Therapy:
HYDROXYCHLOROQUINE may be used safely and effectively in combination with corticosteroids, salicylates, NSAIDS, and methotrexate and other second line therapeutic agents. Corticosteroids and salicylates can generally be decreased gradually in dosage or eliminated after the drug has been used for several weeks.
5 mg. No definitive dose combinations have been established. Lupus Erythematosus Initially, the average adult dose is 400 mg once or twice daily. This may be continued for several weeks or months, depending upon the response of the patient.
For prolonged maintenance therapy, a smaller dose, from 200 to 400 mg daily will suffice. The incidence of retinopathy has been reported to be higher when this maintenance dose is exceeded. Malaria Suppression – In adults, 400 mg on exactly the same day of each week.
In children (6 years of age and older), the weekly suppressive dose is 5 mg base/kg, but should not exceed the adult dose regardless of body weight. Suppressive therapy […]
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised October 22, 2025[3]
). 2 Recommended Dose and Dosage Adjustment, Rheumatoid Arthritis). 3 Pediatrics). 2 Geriatrics Geriatrics (≥ 65 years of age): Clinical trials of hydroxychloroquine sulfate tablets did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.
HYDROXYCHLOROQUINE can prolong the QTc interval, especially in patients with underlying risk factors, which may lead to an increased risk of ventricular arrhythmias including torsade de pointes. Risk factors for torsade de pointes in the general population include the age of ≥ 65 years (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular, Electrocardiogram Changes and Potential for Cardiac Arrhythmias).
4 Geriatrics). CONTRAINDICATIONS HYDROXYCHLOROQUINE (hydroxychloroquine sulfate tablets) Page 5 of 45 HYDROXYCHLOROQUINE is contraindicated in: • Patients with pre-existing retinopathy of the eye. • Patients with known hypersensitivity to 4-aminoquinoline compounds.
• Patients who are hypersensitive to hydroxychloroquine sulfate or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
3 Pediatrics). 5 mg (salt form)/kg ideal (lean) body weight. Exceeding the recommended daily dose sharply increase the risk of retinal toxicity as well as cardiac arrhythmias (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular and Ophthalmologic).
• HYDROXYCHLOROQUINE should be discontinued if signs and symptoms of cardiomyopathy develop, in patients who develop torsade de pointes, polymorphic ventricular tachycardia, signs/symptoms of serious arrhythmia, severe hypoglycemia, severe blood disorder, muscular weakness, or extrapyramidal reactions.
HYDROXYCHLOROQUINE dosage may need to be temporarily reduced in patients who develop impaired accommodation and blurring of vision that is not self-limiting (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular, Driving and Operating Machinery, Endocrine and Metabolism, Hematologic, Musculoskeletal, and Neurologic).
• The dosages cited below are stated in terms of hydroxychloroquine sulfate. One 200 mg tablet is equivalent to 155 mg base. Each dose should be taken with a meal or a glass of milk. 2 Recommended Dose and Dosage Adjustment Rheumatoid Arthritis The compound is cumulative in action and will require several weeks to exert its beneficial therapeutic effects, whereas minor side effects may occur somewhat early.
Several months of therapy may be required before maximum effects can be obtained. If objective improvement (such as reduced joint swelling, increased mobility) does not occur within six months, the drug should be stopped. Safe use of the drug in the treatment of juvenile rheumatoid arthritis has not been established.
Initial dosage – In adults, from 400 to 600 mg daily. In a few patients, the side effects may require temporary reduction of the initial dosage. Generally, after five to ten days the dose may be gradually increased to the optimum response level, frequently, without return of HYDROXYCHLOROQUINE (hydroxychloroquine sulfate tablets) Page 6 of 45 side effects.
Maintenance dosage – When a good response is obtained (usually in four to twelve weeks), the dosage is reduced by 50 percent and continued at an acceptable maintenance level of 200 to 400 mg daily. The incidence of retinopathy has been reported to be higher when the maintenance dose is exceeded.
If a relapse occurs after medication is withdrawn, therapy may be resumed or continued on an intermittent schedule if there are no ocular contraindications.
Use in Combination Therapy:
HYDROXYCHLOROQUINE may be used safely and effectively in combination with corticosteroids, salicylates, NSAIDS, and methotrexate and other second line therapeutic agents. Corticosteroids and salicylates can generally be decreased gradually in dosage or eliminated after the drug has been used for several weeks.
5 mg. No definitive dose combinations have been established. Lupus Erythematosus Initially, the average adult dose is 400 mg once or twice daily. This may be continued for several weeks or months, depending upon the response of the patient.
For prolonged maintenance therapy, a smaller dose, from 200 to 400 mg daily will suffice. The incidence of retinopathy has been reported to be higher when this maintenance dose is exceeded. Malaria Suppression – In adults, 400 mg on exactly the same day of each week.
In children (6 years of age and older), the weekly suppressive dose is 5 mg base/kg, but should not exceed the adult dose regardless of body weight. Suppressive therapy should begin two weeks before exposure. When not administered before exposure, give an initial loading dose of 800 mg to adults, or 10 mg base/kg to children in […]
This is not medical advice. Consult a qualified healthcare professional.
o patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Blood disorders Although the risk of bone marrow depression is low, periodic blood counts are advisable as anaemia, aplastic anaemia, agranulocytosis, a decrease in white blood cells, and thrombocytopenia have been reported.
Hydroxychloroquine should be discontinued if abnormalities develop. Toxic effects in children Small children are particularly sensitive to the toxic effects of 4- aminoquinolines; therefore patients should be warned to keep Hydroxychloroquine sulfate out of the sight and reach of children.
Hypoglycaemia Hydroxychloroquine has been shown to cause severe hypoglycaemia including loss of consciousness that could be life threatening in patients treated with and without antidiabetic medications. Patients treated with hydroxychloroquine should be warned about the risk of hypoglycaemia and the associated clinical signs and symptoms.
Patients presenting with clinical symptoms suggestive of hypoglycaemia during treatment with hydroxychloroquine should have their blood glucose level checked and treatment reviewed as necessary. Musculoskeletal effects All patients on long-term therapy should undergo periodic examination of skeletal muscle function and tendon reflexes.
If weakness occurs, the drug should be withdrawn. Dermatological reactions Life-threatening cutaneous reactions Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with the use of Hydroxychloroquine.
Patients should be advised of the signs and symptoms and monitored closely for skin reactions. The highest risk for occurrence of SJS or TEN is within the first weeks of treatment. g. progressive skin rash often with blisters or mucosal lesions) are present, Hydroxychloroquine treatment should be discontinued.
The best results in managing SJS and TEN come from early diagnosis and immediate discontinuation of any suspect drug. Early withdrawal is associated with a better prognosis. If the patient has developed SJS or TEN with the use of Hydroxychloroquine, Hydroxychloroquine must not be re-started in this patient at any time.
8). 8). Psychiatric side effects typically occur within the first month after the start of treatment with hydroxychloroquine and have been reported also in patients with no prior history of psychiatric disorders. Patients should be advised to seek medical advice promptly if they experience psychiatric symptoms during treatment.
History of ventricular dysrhythmias. Uncorrected hypokalemia and/or hypomagnesemia. 1) ]. Therefore, hydroxychloroquine sulfate tablets are not recommended in patients taking other drugs that have the potential to prolong the QT interval.
Correct electrolyte imbalances prior to use. Monitor cardiac function as clinically indicated during hydroxychloroquine sulfate tablets therapy. Discontinue hydroxychloroquine sulfate tablets if cardiotoxicity is suspected or demonstrated by tissue biopsy.
2 Retinal Toxicity Irreversible retinal damage was observed in some patients treated with hydroxychloroquine sulfate and it is related to cumulative dosage and treatment duration. In patients of Asian descent, retinal toxicity may first be noticed outside the macula.
Risk factors for retinal damage include daily hydroxychloroquine sulfate dosages ≥5 mg/kg of actual body weight, durations of use greater than five years, renal impairment, use of concomitant drug products such as tamoxifen citrate, and concurrent macular disease.
Within the first year of starting hydroxychloroquine sulfate tablets, a baseline ocular examination is recommended including best corrected distance visual acuity (BCVA), an automated threshold visual field (VF) of the central 10 degrees (with retesting if an abnormality is noted), and spectral domain ocular coherence tomography (SD-OCT).
For patients at higher risk of retinal damage, monitoring should include annual examinations which include BCVA, VF and SD-OCT. For patients without significant risk factors, annual retinal exams can usually be deferred until five years of treatment.
In patients of Asian descent, it is recommended that visual field testing be performed in the central 24 degrees instead of the central 10 degrees. If ocular toxicity is suspected, discontinue hydroxychloroquine sulfate tablets and monitor the patient closely given that retinal changes and visual disturbances may progress even after cessation of therapy.
3 Serious Skin Reactions Serious adverse reactions have been reported with the use of hydroxychloroquine sulfate tablets including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis (AGEP).
Monitor for serious skin reactions, especially in patients receiving a drug that may also induce dermatitis. 5 ), Adverse Reactions (6) ]. Discontinue hydroxychloroquine sulfate tablets if these severe reactions occur. 4 Worsening of Psoriasis Administration of hydroxychloroquine sulfate tablets to patients with psoriasis may precipitate a severe flare-up of psoriasis.
Avoid hydroxychloroquine sulfate tablets in patients with psoriasis, unless the benefit to the patient outweighs the possible risk. 5 Risks Associated with Use in Porphyria Administration of hydroxychloroquine sulfate tablets to patients with porphyria may exacerbate porphyria.
Avoid hydroxychloroquine sulfate tablets in patients with porphyria. Hepatotoxicity Associated with Porphyria Cutanea Tarda Cases of hepatotoxicity have been reported when hydroxychloroquine was used in patients with porphyria cutanea tarda (PCT).
Patients received dosages ranging from 200 mg twice weekly to 400 mg daily. Most of the PCT-related cases presented with marked elevations in transaminases (>20 times upper limit of the reference range) within days to a month of hydroxychloroquine initiation.
In some cases, PCT was diagnosed only after the occurrence of treatment-induced liver injury, when hydroxychloroquine was prescribed for an approved indication. , alcohol use, concomitant hepatotoxic medications). Measure liver tests promptly in patients who report symptoms that may indicate liver injury, such as fatigue, rash, nausea, dark urine, or jaundice.
, ALT level greater than three times the upper limit of the reference range, total bilirubin greater than two times the upper limit of the reference range), interrupt treatment with Hydroxychloroquine sulfate tablets, and investigate further to establish the probable cause.
The safety and effectiveness of hydroxychloroquine sulfate tablets for the treatment of PCT have not been established and hydroxychloroquine sulfate tablets are not approved for this use. 6 Hematologic Toxicity Hydroxychloroquine sulfate tablets may cause myelosuppression including aplastic anemia, agranulocytosis, leukopenia, or thrombocytopenia.
Monitor blood cell counts periodically in patients on prolonged hydroxychloroquine sulfate tablets therapy. If the patient develops myelosuppression which cannot be attributable to the disease, discontinue the drug. 7 Hemolytic Anemia Associated with G6PD Deficiency Hemolysis has been reported in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Monitor for hemolytic anemia as this can occur, particularly in association with other drugs that cause hemolysis. 8 Skeletal Muscle Myopathy or Neuropathy Skeletal muscle myopathy or neuropathy leading to progressive weakness and atrophy of proximal muscle groups, depressed tendon reflexes, and abnormal nerve conduction, have been reported.
Muscle and nerve biopsies have shown associated phospholipidosis. 11 )]. Assess muscle strength and deep tendon reflexes periodically in patients on long-term therapy with hydroxychloroquine sulfate tablets. Discontinue hydroxychloroquine sulfate tablets if muscle or nerve toxicity is suspected or demonstrated by tissue biopsy.
9 Neuropsychiatric Reactions Including Suicidality Suicidal behavior, suicidal ideation, and other neuropsychiatric adverse reactions have been reported in patients treated with hydroxychloroquine sulfate tablets [see Adverse Reactions (6) ].
Neuropsychiatric adverse reactions typically occurred within the first month after the start of treatment with hydroxychloroquine and have been reported in patients with and without a prior history of psychiatric disorders. The risks and benefits of continued treatment with hydroxychloroquine sulfate tablets should be assessed for patients who develop these symptoms.
Given the long half-life of the drug, some patients may require several weeks off drug for symptoms to partially or fully abate. Advise patients to contact their healthcare provider promptly if they experience new or worsening neuropsychiatric symptoms such as depression, suicidal thoughts or behavior, or mood changes.
10 Hypoglycemia Hydroxychloroquine sulfate tablets can cause severe and potentially life-threatening hypoglycemia, in the presence or absence of antidiabetic agents [see Drug Interactions (7) ]. Measure blood glucose in patients presenting with clinical symptoms suggestive of hypoglycemia and as adjust the antidiabetic treatment as necessary.
Warn hydroxychloroquine sulfate tablets-treated patients about the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia; diabetic patients should monitor their blood sugar levels. Advise patients to seek medical attention if they develop any signs and symptoms of hypoglycemia.
11 Renal Toxicity Proteinuria with or without moderate reduction in glomerular filtration rate have been reported with the use of hydroxychloroquine sulfate tablets. Renal biopsy showed phospholipidosis without immune deposits, inflammation, and/or increased cellularity.
Physicians should consider phospholipidosis as a possible cause of renal injury in patients with underlying connective tissue disorders who are receiving hydroxychloroquine sulfate tablets. 8 )]. Discontinue hydroxychloroquine sulfate tablets if renal toxicity is suspected or demonstrated by tissue biopsy.