Pantoprazole is an active pharmaceutical ingredient in the Proton Pump Inhibitors group (A02BC). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
CAOfficial regulatory label· revised March 22, 2025[1]
PANTOLOC® (pantoprazole sodium) is indicated for the treatment of conditions where a reduction of gastric acid secretion is required, such as the following: • Duodenal ulcer • Gastric ulcer • Reflux esophagitis • Symptomatic gastro-esophageal reflux disease (such as, acid regurgitation and heartburn) • Prevention of gastrointestinal lesions induced by non-steroidal anti-inflammatory drugs (NSAIDs) in patients with a need for continuous NSAID treatment, who have increased risk to develop NSAID-associated upper gastrointestinal lesions • Helicobacter pylori (H.
pylori) associated duodenal ulcer Pantoprazole, in combination with clarithromycin and either amoxicillin or metronidazole, is indicated for the treatment of patients with an active duodenal ulcer who are H. pylori positive (see 4 DOSAGE AND ADMINISTRATION and 14 CLINICAL TRIALS).
1 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 4 Geriatrics).
GBUnited Kingdom· MHRA
47 products
Uses
GBOfficial regulatory label· revised January 10, 2025[2]
Pantoprazole is indicated for use in adults and adolescents 12 years of age and above for: Symptomatic gastro-oesophageal reflux disease. For long-term management and prevention of relapse in reflux oesophagitis. 4).
How to take
GB
USUnited States· FDA
25 products
Uses
USOfficial regulatory label· revised June 27, 2025[3]
1 INDICATIONS AND USAGE Pantoprazole Sodium for Injection is indicated for treatment of: gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults. pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults.
Limitations of Use The safety and effectiveness of Pantoprazole Sodium for Injection for the treatment of upper gastrointestinal bleeding have not been established in adult or pediatric patients. V. (pantoprazole sodium) for Injection.
's marketing exclusivity rights, this drug product is not labeled with that information. Pantoprazole Sodium for Injection is a proton pump inhibitor (PPI) indicated for treatment of: gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults.
( 1 ) pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome in adults. ( 1 ) Limitations of Use The safety and effectiveness of pantoprazole sodium for injection for the treatment of upper gastrointestinal bleeding have not been established in adult or pediatric patients.
EUEuropean Union· EMA
3 products
Uses
EUOfficial regulatory label· revised May 25, 2023[4]
PANTOZOL
g. heartburn, acid regurgitation) in adults.
How to take
EU
Drug interactions
Known interactions involving Pantoprazole. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 577. 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]Health Canada (DPD) · 02229453 · revised March 22, 2025
[2]MHRA (UK) · PL366870340 · revised January 10, 2025
[3]FDA DailyMed · 014f9762-6948-46… · revised June 27, 2025 [PDF]
[4]European Medicines Agency · EMEA/H/C/001013 · revised May 25, 2023
[5]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.
How to take
CAOfficial regulatory label· revised March 22, 2025[1]
and 14 CLINICAL TRIALS). 1 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 4 Geriatrics). 2 CONTRAINDICATIONS • Pantoprazole sodium is contraindicated in patients who are hypersensitive to pantoprazole, substituted benzimidazoles, or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[1]
Renal The daily dose used in renal insufficient patients, as a rule, should not exceed the recommended dosage regimens. 3 Pharmacokinetics, Special Populations and Conditions. Pantoprazole should not be used in combination treatment for the eradication of H.
pylori in patients with renal dysfunction since currently no data are available on the efficacy and safety of pantoprazole in combination treatment of these patients. Skin See 7 WARNINGS AND PRECAUTIONS – Immune. 1 Pregnant Women There are no adequate or well-controlled studies in pregnant women.
Studies in animals have shown reproductive toxicity, the potential risk for humans is unknown. PANTOLOC® should not be administered to pregnant women unless the expected benefits outweigh the potential risks to the fetus. See 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology.
2 Breast-feeding Animal studies have shown excretion of pantoprazole in breast milk. Excretion into human milk has been reported. Pantoprazole sodium should not be given to nursing mothers unless its use is believed to outweigh the potential risks to the infant.
3 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 4 Geriatrics Geriatrics (> 65 years of age): No dose adjustment is recommended based on age.
The daily dose used in elderly patients, as a rule, should not exceed the recommended dosage regimens. 3 Pharmacokinetics, Special Populations and Conditions. Benefits of use of PPIs should be weighed against the increased risk of fractures as patients in this category (> 71 years of age) may already be at high risk for osteoporosis-related fractures.
PANTOLOC® (pantoprazole sodium) Page 12 of 51 If the use of PPIs is required, they should be managed carefully according to established treatment guidelines. See 4 DOSAGE AND ADMINISTRATION and 8 ADVERSE REACTIONS. 1 Adverse Reaction Overview PANTOLOC® (pantoprazole sodium) is well tolerated.
Most adverse events have been mild and transient showing no consistent relationship with treatment. 2%). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. Therefore, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Adverse events have been recorded during controlled clinical investigations in over 13,000 patients exposed to pantoprazole sodium as the single therapeutic agent for treatment of conditions requiring acid suppression.
The following adverse reactions considered possibly, probably, or definitely related by the investigator have been reported in individuals receiving pantoprazole therapy (20 mg or 40 mg once daily) in long-term clinical trials (duration of at least 6 months).
There were a limited number of H. pylori positive patients in these studies and therefore, definitive conclusions with regard to long-term consequences of H. pylori infection and acid suppressive treatment on gastric inflammation in this sub-group cannot be made.
Table 2. 2 For long-term treatment with 20 mg, no such events were reported with a frequency of more than 1%. In addition, the following adverse events with a frequency of ≥ 1% considered unrelated, or unlikely related by the investigator have been reported in individuals receiving pantoprazole therapy (20 mg or 40 mg once daily) in short-term and long-term clinical trials.
PANTOLOC® (pantoprazole sodium) Page 13 of 51 Table 3. Adverse Events with a frequency of ≥ 1 %, 20 or 40 mg pantoprazole sodium Gastrointestinal Disorders: Diarrhea General Disorders Influenza Like Illness Nervous System Disorders Headache A total of 1217 patients were treated with triple combination therapy including pantoprazole sodium and two antibiotics.
Adverse events noted at a frequency of greater than or equal to 1% when pantoprazole sodium was used in combination with antibiotics for the eradication of an H. pylori infection included the following: Table 4. 1%) Regardless of the combination regimen, the most frequently reported events were gastrointestinal system disorders, followed by autonomic nervous system disorders and “body as a whole”, or generalized disorders.
1 to 1% related to 20 mg pantoprazole are listed below by body system: […]
CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[1]
4 Drug-Drug Interactions. 1 Dosing Considerations • Patients should use the lowest dose and shortest duration of proton pump inhibitor (PPI) therapy appropriate to the condition being treated. • Withdrawal of long-term PPI therapy can lead to aggravation of acid related symptoms and may result in rebound acid hypersecretion.
• For the maintenance treatment of patients with reflux esophagitis and the resolution of symptoms associated with reflux esophagitis, such as heartburn with or without regurgitation, 20 or 40 mg pantoprazole once daily have been used for 3 years in controlled clinical trials.
In continuous maintenance treatment, 20 mg pantoprazole has been used in a limited number of patients for up to eight years. 2 Recommended Dose and Dosage Adjustment Duodenal Ulcer • The recommended adult dose of PANTOLOC® for the oral treatment of duodenal ulcer is 40 mg as pantoprazole given once daily in the morning.
Healing usually occurs within 2 weeks. For patients not healed after this initial course of therapy, an additional course of 2 weeks is recommended. Gastric Ulcer • The recommended adult oral dose of PANTOLOC® for the oral treatment of gastric ulcer is 40 mg given once daily in the morning.
Healing usually occurs within 4 weeks. For patients not healed after this initial course of therapy, an additional course of 4 weeks is recommended. Helicobacter pylori Associated Duodenal Ulcer • Pantoprazole/Clarithromycin/Metronidazole Triple Combination Therapy: The recommended dose for H.
pylori eradication is treatment for seven days with PANTOLOC® 40 mg together with clarithromycin 500 mg and metronidazole 500 mg, all twice daily. • Pantoprazole/Clarithromycin/Amoxicillin Triple Combination Therapy: The recommended dose for H.
pylori eradication is treatment for seven days with PANTOLOC® 40 mg together with clarithromycin 500 mg and amoxicillin 1000 mg, all twice daily. • When PANTOLOC® is prescribed in combination with clarithromycin, amoxicillin or metronidazole for the eradication of an H.
pylori infection, the Product Monograph for the antibiotics used should be consulted and followed. PANTOLOC® (pantoprazole sodium) Page 6 of 51 Symptomatic Gastro-Esophageal Reflux Disease (GERD) • The recommended adult oral dose for the treatment of symptoms of GERD, including heartburn and regurgitation, is PANTOLOC® 40 mg once daily for up to 4 weeks.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised March 22, 2025[1]
• Pantoprazole sodium is contraindicated in patients who are hypersensitive to pantoprazole, substituted benzimidazoles, 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. • Pantoprazole sodium is contraindicated with co-administration of rilpivirine. 4 Drug-Drug Interactions. PANTOLOC® (pantoprazole sodium) Page 5 of 51
This is not medical advice. Consult a qualified healthcare professional.
Posology Recommended dose Adults and adolescents 12 years of age and above Symptomatic gastro-oesophageal reflux disease The recommended oral dose is one pantoprazole 20 mg gastro-resistant tablet per day. Symptom relief is generally accomplished within 2-4 weeks.
If this is not sufficient, symptom relief will normally be achieved within a further 4 weeks. When symptom relief has been achieved, reoccurring symptoms can be controlled using an on-demand regimen of 20 mg once daily, when required.
A switch to continuous therapy may be considered in case satisfactory symptom control cannot be maintained with on-demand treatment. Long-term management and prevention of relapse in reflux oesophagitis For long-term management, a maintenance dose of one pantoprazole 20 mg gastro-resistant tablet per day is recommended, increasing to 40 mg pantoprazole per day if a relapse occurs.
Pantoprazole 40 mg is available for this case. After healing of the relapse the dose can be reduced again to 20 mg pantoprazole. Adults Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti- inflammatory drugs (NSAIDs) in patients at risk with a need for continuous NSAID treatment.
The recommended oral dose is one pantoprazole 20 mg gastro-resistant tablet per day. 4). 2). 2). 2). Method of administration Oral use. Tablets should not be chewed or crushed and should be swallowed whole 1 hour before a meal with some water.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised January 10, 2025[2]
Approximately 5% of patients can be expected to experience adverse drug reactions (ADRs). The most commonly reported ADRs are diarrhoea and headache, both occurring in approximately 1% of patients. The table below lists adverse reactions reported with pantoprazole, ranked under the following frequency classification: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
For all adverse reactions reported from post-marketing experience, it is not possible to apply any Adverse Reaction frequency and therefore they are mentioned with a “not known” frequency. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 1. 4) Arthralgia; Myalgia Muscle spasm2 Renal and urinary disorders Tubulointerstitial nephritis (TIN) (with possible progression to renal failure) Reproductive system and breast disorders Gynaecomastia General disorders and administratio n site conditions Asthenia, fatigue and malaise Body temperature increased; Oedema peripheral 1 in association with hypomagnesaemia 2 as a consequence of electrolyte disturbances Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation 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. By reporting side effects you can help provide more information on the safety of this medicine.
GBOfficial regulatory label· Warnings and precautions· revised January 10, 2025[2]
Hepatic Impairment In patients with severe liver impairment the liver enzymes should be monitored regularly during treatment with pantoprazole, particularly on long-term use. 2). Co-administration with NSAIDs The use of Pantoprazole 20 mg as a preventive of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) should be restricted to patients who require continued NSAID treatment and have an increased risk to develop gastrointestinal complications.
g. high age (>65 years), history of gastric or duodenal ulcer or upper gastrointestinal bleeding. Gastric malignancy Symptomatic response to pantoprazole may mask the symptoms of gastric malignancy and may delay diagnosis. g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, anaemia or melaena) and when gastric ulcer is suspected or present, malignancy should be excluded.
Further investigation is to be considered if symptoms persist despite adequate treatment. 5). Influence on vitamin B12 absorption Pantoprazole, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria.
This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy or if respective clinical symptoms are observed. Long term treatment In long-term treatment, especially when exceeding a treatment period of 1 year, patients should be kept under regular surveillance.
Gastrointestinal infections caused by bacteria Treatment with pantoprazole may lead to a slightly increased risk of gastrointestinal infections caused by bacteria such as Salmonella, Campylobacter and C. difficile. Hypomagnesaemia Severe hypomagnesaemia has been rarely reported in patients treated with PPIs like pantoprazole for at least three months, and in most cases for a year.
Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia can occur but they may begin insidiously and be overlooked. 8). In most affected patients, hypomagnesaemia (and hypomagnesaemia associated hypocalcaemia and/or hypokalaemia) improved after magnesium replacement and discontinuation of the PPI.
, diuretics), health care professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment. Bone fractures Proton pump inhibitors, especially if used in high doses and over long durations (>1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in presence of other recognised risk factors.
Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10– 40%. Some of this increase may be due to other risk factors. Patients at risk of osteoporosis should receive care according to current clinical guidelines and they should have an adequate intake of vitamin D and calcium.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised January 10, 2025[2]
1.
This is not medical advice. Consult a qualified healthcare professional.
( 1 )
How to take
USOfficial regulatory label· revised June 27, 2025[3]
2 DOSAGE AND ADMINISTRATION GERD and a History of EE Adults: The recommended dosage is 40 mg once daily by intravenous injection (over at least 2 minutes) or intravenous infusion (for 15 minutes) for up to 10 days. 1 ) Discontinue as soon as the patient is able to receive oral treatment.
Switch to an appropriate oral medication within 10 days of starting pantoprazole sodium for injection. 1 ) Pathological Hypersecretion Conditions, Including ZE Syndrome The recommended adult dosage is 80 mg every 12 hours by intravenous injection (over at least 2 minutes) or intravenous infusion (for 15 minutes).
2 ) For information on how to adjust dosing for individual patient needs, see the full prescribing information. 2 ) When switching between intravenous to oral formulations of gastric acid inhibitors, consider the pharmacodynamic action of the drugs to ensure continuity of acid suppression.
2 ) Preparation and Administration Instructions See full prescribing information for preparation and administration instructions by indication. 1 Recommended Dosage for GERD Associated with a History of EE Adult Patients The recommended adult dosage of pantoprazole sodium for injection is 40 mg once daily by intravenous injection (over at least 2 minutes) or intravenous infusion (for 15 minutes) for up to 10 days.
Discontinue pantoprazole sodium for injection as soon as the patient is able to tolerate oral treatment. Switch to an appropriate oral medication within 10 days of starting pantoprazole sodium for injection. V. (pantoprazole sodium) for Injection.
's marketing exclusivity rights, this drug product is not labeled with that information. 2 Recommended Dosage for Pathological Hypersecretion Including Zollinger-Ellison Syndrome The recommended adult dosage of pantoprazole for injection is 80 mg every 12 hours by intravenous injection (over at least 2 minutes) or intravenous infusion (for 15 minutes).
Adjust the frequency of dosing to individual patient needs based on acid output measurements. In those patients who need a higher dosage, 80 mg intravenously every 8 hours is expected to maintain acid output below 10 mEq/h. When switching between intravenous to oral formulations of gastric acid inhibitors, consider the pharmacodynamic action of the drugs to ensure continuity of acid suppression.
3 Preparation and Administration Instructions for GERD Associated with a History of EE 15-Minute Intravenous Infusion for Adult Patients 1. 9% Sodium Chloride Injection. 2. 4 mg per mL. 3. Inspect the diluted pantoprazole sodium for injection solution visually for particulate matter and discoloration prior to and during administration.
4. Withdraw the dose of the diluted pantoprazole sodium for injection solution for an adult dose. 6. 5 ) ] . 7. 9% Sodium Chloride Injection. Storage a. Store the reconstituted solution for up to 6 hours at room temperature up to 30°C (86°F) prior to further dilution.
b. Store the diluted solution at room temperature up to 30°C (86°F) and must be used within 24 hours from the time of initial reconstitution. c. Do not freeze the reconstituted or diluted solution. 2-Minute Intravenous Injection for Adult Patients 1.
9% Sodium Chloride Injection, to a final concentration of approximately 4 mg per mL. 2. Withdraw the dose of 40 mg of reconstituted pantoprazole sodium for injection solution. 3. Inspect the diluted pantoprazole sodium for injection solution visually for particulate matter and discoloration prior to and during administration.
4. Administer intravenously over a period of at least 2 minutes. 5. 9% Sodium Chloride Injection. Storage Store the reconstituted solution for up to 24 hours at room temperature up to 30°C (86°F) prior to intravenous infusion. Do not freeze the reconstituted solution.
V. (pantoprazole sodium) for Injection. 's marketing exclusivity rights, this drug product is not labeled with that information. 9% Sodium Chloride Injection. 8 mg per mL. Inspect the diluted pantoprazole sodium for injection solution visually for particulate matter and discoloration prior to and during administration.
Administer intravenously over a period of approximately 15 minutes at a rate of approximately 7 mL/min. 9% Sodium Chloride Injection. Storage The reconstituted solution can be stored at room temperature up to 30°C (86°F) for up to 6 hours prior to further dilution.
Once further diluted, the diluted solution can be stored at room temperature up to 30°C (86°F) for up to 24 hours from the time of initial reconstitution. Do not freeze the reconstituted or diluted solution. 9% Sodium Chloride Injection, per vial to a final concentration of approximately 4 mg per mL.
Inspect the diluted pantoprazole sodium for injection solution visually for particulate matter and discoloration prior to and during administration. Administer the total volume from both vials intravenously over a period of at least 2 minutes.
9% Sodium Chloride Injection. Storage The reconstituted solution may be stored for up to 24 hours at room temperature. Do not freeze the reconstituted solution. 5 Compatibility Information Administer pantoprazole sodium for injection intravenously through a dedicated line or through a Y-site.
9% Sodium Chloride Injection Midazolam hydrochloride is incompatible with Y-site administration of pantoprazole sodium for injection. 3) ] . Stop administering pantoprazole sodium for injection immediately through a Y-site if precipitation or discoloration occurs.
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 18,839 reports total. [5]
Off Label Use 1,867
Fatigue 1,597
Nausea 1,498
Diarrhoea 1,486
Headache 1,330
Drug Ineffective 1,237
Dyspnoea 1,162
Pain 1,107
Vomiting 1,078
Arthralgia 926
Asthenia 892
Rash 855
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised June 27, 2025[3]
11) ] Most common adverse reactions (> 2%) are: headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia. 1 ) To report SUSPECTED ADVERSE REACTIONS, contact Meitheal Pharmaceuticals 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 clinical practice.
Gastroesophageal Reflux Disease (GERD) Adults Safety in nine randomized comparative US clinical trials in patients with GERD included 1,473 patients on oral pantoprazole (20 mg or 40 mg), 299 patients on an H 2 -receptor antagonist, 46 patients on another PPI, and 82 patients on placebo.
The most frequently occurring adverse reactions are listed in Table 2. The number of patients treated in comparative studies with pantoprazole sodium for injection is limited; however, the adverse reactions seen were similar to those seen in the oral studies.
Thrombophlebitis was the only new adverse reaction identified with pantoprazole sodium for injection. 2 Additional adverse reactions that were reported for oral pantoprazole sodium in US clinical trials with a frequency of ≤2% are listed below by body system: Body as a Whole: allergic reaction, fever, photosensitivity reaction, facial edema, thrombophlebitis (intravenous only) Gastrointestinal: constipation, dry mouth, hepatitis Hematologic: leukopenia (reported in ex-US clinical trials only), thrombocytopenia Metabolic/Nutritional: elevated CPK (creatine phosphokinase), generalized edema, elevated triglycerides, liver function tests abnormal Musculoskeletal: myalgia Nervous: depression, vertigo Skin and Appendages: urticaria, rash, pruritus Special Senses: blurred vision Zollinger-Ellison (ZE) Syndrome In clinical studies of ZE Syndrome, adverse reactions reported in 35 patients administered pantoprazole sodium for injection doses of 80 mg to 240 mg per day for up to 2 years were similar to those reported in adult patients with GERD.
V. (pantoprazole sodium) for Injection. 's marketing exclusivity rights, this drug product is not labeled with that information. 2 Postmarketing Experience The following adverse reactions have been identified during post approval use of pantoprazole sodium products.
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.
These adverse reactions are listed below by body system:
General disorders and administration conditions: asthenia, fatigue, malaise Immune system disorders: anaphylaxis (including anaphylactic shock), systemic lupus erythematosus Investigations: weight changes Skin and subcutaneous tissue disorders: severe dermatologic reactions (some fatal), including erythema multiforme, SJS/TEN, DRESS, AGEP, angioedema (Quincke’s edema) and cutaneous lupus erythematosus Musculoskeletal disorders: rhabdomyolysis, bone fracture Renal and genitourinary disorders: acute tubulointerstitial nephritis, erectile dysfunction Hepatobiliary disorders: hepatocellular damage leading to jaundice and hepatic failure Psychiatric disorder: hallucinations, confusion, insomnia, somnolence Metabolism and nutritional disorders: hyponatremia, hypomagnesemia, hypocalcemia, hypokalemia, hyponatremia Infections and infestations: Clostridioides difficile associated diarrhea Hematologic: pancytopenia, agranulocytosis Nervous: ageusia, dysgeusia Gastrointestinal disorders: fundic gland polyps
USOfficial regulatory label· Warnings and precautions· revised June 27, 2025[3]
5 WARNINGS AND PRECAUTIONS Gastric Malignancy : In adults, symptomatic response to therapy with pantoprazole sodium does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing. 1 ) Injection Site Reactions : Thrombophlebitis is associated with the administration of intravenous pantoprazole sodium.
Assess the patient and remove the catheter if clinically indicated. 2 ) Potential Exacerbation of Zinc Deficiency : Consider zinc supplementation in patients who are prone to zinc deficiency. Caution should be used when other EDTA containing products are also co-administered intravenously.
3 ) Acute Tubulointerstitial Nephritis : Discontinue treatment and evaluate patients. 4 ) Clostridioides difficile -Associated Diarrhea : PPI therapy may be associated with increased risk. 5 ) Bone Fracture : Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine.
6 ) Severe Cutaneous Adverse Reactions : Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. 7 ) Cutaneous and Systemic Lupus Erythematosus : Mostly cutaneous; new onset or exacerbation of existing disease; discontinue treatment and refer to specialist for evaluation.
8 ) Hepatic Effects : Elevations of transaminases observed. 9 ) Hypomagnesemia and Mineral Metabolism : Reported rarely with prolonged treatment with PPIs. 10 ) Fundic Gland Polyp s : Risk increases with long-term use, especially beyond one year.
Use the shortest duration of therapy. 1 Presence of Gastric Malignancy In adults, symptomatic response to therapy with pantoprazole sodium does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI.
In older patients, also consider an endoscopy. 2 Injection Site Reactions Thrombophlebitis was associated with the administration of pantoprazole sodium. Assess the patient and remove the catheter if clinically indicated. 3 Potential for Exacerbation of Zinc Deficiency Pantoprazole sodium for injection contains edetate disodium (the salt form of EDTA), a chelator of metal ions including zinc.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised June 27, 2025[3]
4 CONTRAINDICATIONS Pantoprazole sodium is contraindicated in patients with known hypersensitivity reactions including anaphylaxis to the formulation or any substituted benzimidazole. 4 ) and Adverse Reactions (6) ] . Proton pump inhibitors (PPIs), including pantoprazole sodium, are contraindicated in patients receiving rilpivirine-containing products [see Drug Interactions (7) ] .
Known hypersensitivity to any component of the formulation or to substituted benzimidazoles. ( 4 ) Patients receiving rilpivirine-containing products. ( 4 , 7 )
This is not medical advice. Consult a qualified healthcare professional.
Posology The recommended dose is 20 mg pantoprazole (one tablet) per day. It might be necessary to take the tablets for 2-3 consecutive days to achieve improvement of symptoms. Once complete relief of symptoms has occurred, treatment should be discontinued.
The treatment should not exceed 4 weeks without consulting a doctor. If no symptom relief is obtained within 2 weeks of continuous treatment, the patient should be instructed to consult a doctor. Special populations No dose adjustment is necessary in elderly patients or in those with impaired renal or liver function.
Paediatric population PANTOZOL Control is not recommended for use in children and adolescents below 18 years of age due to insufficient data on safety and efficacy. Method of administration PANTOZOL Control 20 mg gastro-resistant tablets should not be chewed or crushed, and should be swallowed whole with liquid before a meal.
3
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
EUOfficial regulatory label· Adverse reactions· revised May 25, 2023[4]
Summary of the safety profile Approximately 5% of patients can be expected to experience adverse reactions. Tabulated list of adverse reactions The following adverse reactions have been reported with pantoprazole. Within the following table, adverse reactions are ranked under the MedDRA frequency classification: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Within each frequency grouping adverse reactions are presented in order of decreasing seriousness. Table 1. Adverse reactions with pantoprazole in clinical trials and post-marketing experience Frequency System organ class Common Uncommon Rare Very rare Not known Blood and lymphatic system disorders Agranulocytosis Thrombocytopenia; Leukopenia; Pancytopenia Immune system disorders Hypersensitivity (incl.
4). Musculoskeletal and connective tissue disorders Fracture of wrist, hip and spine. 4) Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
EUOfficial regulatory label· Warnings and precautions· revised May 25, 2023[4]
Patients should be instructed to consult a doctor if: • They have unintentional weight loss, anaemia, gastrointestinal bleeding, dysphagia, persistent vomiting or vomiting with blood, since pantoprazole may alleviate symptoms and delay diagnosis of a severe condition.
In these cases, malignancy should be excluded. • They have had previous gastric ulcer or gastrointestinal surgery. • They are on continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks. • They have jaundice, hepatic impairment, or liver disease.
• They have any other serious disease affecting general well-being. • They are aged over 55 years with new or recently changed symptoms. Patients with long-term recurrent symptoms of indigestion or heartburn should see their doctor at regular intervals.
Especially, patients over 55 years taking any non-prescription indigestion or heartburn remedy on a daily basis should inform their pharmacist or doctor. Patients should not take another proton pump inhibitor or H2 antagonist concomitantly.
Patients should consult their doctor before taking this medicinal product if they are due to have an endoscopy or urea breath test. Patients should be advised that the tablets are not intended to provide immediate relief. Patients may start to experience symptomatic relief after approximately one day of treatment with pantoprazole, but it might be necessary to take it for 7 days to achieve complete heartburn control.
Patients should not take pantoprazole as a preventive medicinal product. Gastrointestinal infections caused by bacteria Decreased gastric acidity, due to any means - including proton pump inhibitors - increases gastric counts of bacteria normally present in the gastrointestinal tract.
Treatment with acid-reducing medicinal products leads to a slightly increased risk of gastrointestinal infections such as Salmonella, Campylobacter, or Clostridium difficile. 8). Patients should be advised of the signs and symptoms and monitored closely for skin reactions.
If signs and symptoms suggestive of these reactions appear, pantoprazole should be withdrawn immediately and an alternative treatment considered. Subacute cutaneous lupus erythematosus (SCLE) Proton pump inhibitors are associated with very infrequent cases of SCLE.
If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping PANTOZOL Control. SCLE 4 after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.
Interference with laboratory tests Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. 1). If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
EUOfficial regulatory label· Contraindications· revised May 25, 2023[4]
1. 5).
This is not medical advice. Consult a qualified healthcare professional.
If significant symptom relief is not obtained in 4 weeks, further investigation is required. Reflux Esophagitis • The recommended adult oral dose of PANTOLOC® is 40 mg, given once daily in the morning. In most patients, healing usually occurs within 4 weeks.
For patients not healed after this initial course of therapy, an additional 4 weeks of treatment is recommended. • Both 20 mg and 40 mg once daily have been demonstrated to be effective in the maintenance of healing of reflux esophagitis.
If maintenance therapy fails when using 20 mg once daily, consideration may be given to the 40 mg daily dose as maintenance therapy. Prevention of Gastrointestinal Lesions Induced by NSAIDs • The recommended adult oral dose of PANTOLOC® is 20 mg, given once daily in the morning.
Geriatrics • No dose adjustment is recommended for elderly patients. The daily dose used in elderly patients, as a rule, should not exceed the recommended dosage regimens. 3 Pharmacokinetics, Special Populations and Conditions. Health Canada has not authorized an indication for pediatric use.
1 Pediatrics. 4 Administration PANTOLOC® is formulated as an enteric-coated tablet. A whole tablet should not be chewed or crushed, and should be swallowed with fluid in the morning either before, during, or after breakfast. 5 Missed Dose If a dose is forgotten, the missed dose should be taken as soon as possible unless it is close to the next scheduled dose.
Two doses should never be taken at one time to make up for a missed dose; patients should just return to the regular schedule. 5 OVERDOSAGE Some reports of overdosage with pantoprazole have been received. No consistent symptom profile was observed after ingestion of high doses of pantoprazole.
v. administered over 2 minutes, have been administered and were well tolerated. PANTOLOC® (pantoprazole sodium) Page 7 of 51 As pantoprazole is extensively protein bound, it is not readily dialyzable. In the case of overdosage with clinical signs of intoxication, apart from symptomatic and supportive treatment, no specific therapeutic recommendations can be made.
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1. Dosage Forms, Strengths, Composition and Packaging PANTOLOC® is available as enteric-coated tablets for oral administration. 1 mg pantoprazole sodium sesquihydrate). 6 mg pantoprazole sodium sesquihydrate).
Tablets are available in bottles of 2, 14, 28, and 100, and blister packs of 2, 7, 14, 28, and 100 tablets. Not all pack sizes may be marketed. 7 WARNINGS AND PRECAUTIONS General Symptomatic response with pantoprazole does not preclude the presence of gastric malignancy.
Antibiotic Combination Therapy Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clarithromycin and amoxicillin, and may range in severity from mild to life threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.
Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of Clostridia. Studies […]
Subacute cutaneous lupus erythematosus (SCLE) Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping pantoprazole .
SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors. Interference with laboratory tests Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours.
1). If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment. Sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free '.
Therefore, zinc supplementation should be considered in patients treated with pantoprazole sodium for injection who are prone to zinc deficiency. 5) ] . 4 Acute Tubulointerstitial Nephritis Acute tubulointerstitial nephritis (TIN) has been observed in patients taking PPIs and may occur at any point during PPI therapy.
, malaise, nausea, anorexia). , fever, rash or arthralgia). Discontinue pantoprazole sodium and evaluate patients with suspected acute TIN [see Contraindications (4) ] . 5 Clostridioides difficile -Associated Diarrhea Published observational studies suggest that PPI therapy like pantoprazole sodium may be associated with an increased risk of Clostridioides difficile associated diarrhea, especially in hospitalized patients.
2) ]. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. 6 Bone Fracture Several published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine.
The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
4 ) and Adverse Reactions (6) ] . 2) ] . Discontinue pantoprazole sodium at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. 8 Cutaneous and Systemic Lupus Erythematosus Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including pantoprazole sodium.
These events have occurred as both new onset and an exacerbation of existing autoimmune disease. The majority of PPI-induced lupus erythematous cases were CLE. The most common form of CLE reported in patients treated with PPIs was subacute CLE (SCLE) and occurred within weeks to years after continuous drug therapy in patients ranging from infants to the elderly.
Generally, histological findings were observed without organ involvement. Systemic lupus erythematosus (SLE) is less commonly reported than CLE in patients receiving PPIs. PPI associated SLE is usually milder than non-drug induced SLE.
Onset of SLE typically occurred within days to years after initiating treatment primarily in patients ranging from young adults to the elderly. The majority of patients presented with rash; however, arthralgia and cytopenia were also reported.
Avoid administration of PPIs for longer than medically indicated. If signs or symptoms consistent with CLE or SLE are noted in patients receiving pantoprazole sodium, discontinue the drug and refer the patient to the appropriate specialist for evaluation.
Most patients improve with discontinuation of the PPI alone in 4 to 12 weeks. , ANA) may be positive and elevated serological test results may take longer to resolve than clinical manifestations. 9 Hepatic Effects Mild, transient transaminase elevations have been observed in clinical studies.
The clinical significance of this finding in a large population of subjects administered pantoprazole sodium is unknown [see Adverse Reactions (6) ]. 10 Hypomagnesemia and Mineral Metabolism Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, and in most cases after a year of therapy.
Serious adverse events include tetany, arrhythmias, and seizures. Hypomagnesemia may lead to hypocalcemia and/or hypokalemia and may exacerbate underlying hypocalcemia in at-risk patients. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI.
2) ]. , hypoparathyroidism). Supplement with magnesium and/or calcium as necessary. If hypocalcemia is refractory to treatment, consider discontinuing the PPI. 11 Fundic Gland Polyps PPI use is associated with an increased risk of fundic gland polyps that increases with long-term use, especially beyond one year.
Most PPI users who developed fundic gland polyps were asymptomatic and fundic gland polyps were identified incidentally on endoscopy. Use the shortest duration of PPI therapy appropriate to the condition being treated. 12 Interference with Investigations for Neuroendocrine Tumors Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity.
The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors. Healthcare providers should temporarily stop pantoprazole sodium treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high.
2) ] . 13 Interference with Urine Screen for THC Pantoprazole sodium may produce false-positive urine screen for THC (tetrahydrocannabinol) [see Drug Interactions (7) ]. 14 Concomitant Use of Pantoprazole Sodium with Methotrexate Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities.
In high-dose methotrexate administration, a temporary withdrawal of the PPI may be considered in some patients [see Drug Interactions (7) ].
2). Patients should be warned about additional risks with long-term use of the medicinal products and the need for prescription and regular surveillance should be emphasised. Influence on vitamin B12 absorption Pantoprazole, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria.
This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy or if respective clinical symptoms are observed. Bone fracture Proton pump inhibitors, especially if used in high doses and over long durations (> 1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in the presence of other recognised risk factors.
Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10–40%. Some of this increase may be due to other risk factors. Patients at risk of osteoporosis should receive care according to current clinical guidelines and they should have an adequate intake of vitamin D and calcium.
Hypomagnesaemia Severe hypomagnesaemia has been rarely reported in patients treated with proton pump inhibitors (PPIs) like pantoprazole for at least three months, and in most cases for a year. Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness, and ventricular arrhythmia can occur, but they may begin insidiously and be overlooked.
8). In most affected patients, hypomagnesaemia (and hypomagnesaemia associated hypocalcaemia and/or hypokalaemia) improved after magnesium replacement and discontinuation of the PPI. , diuretics), health care professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment.
PANTOZOL Control contains sodium This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. 5