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Adverse reactions that were reported for pantoprazole in adults with a frequency of ≤2% are listed as follows by body system: Body as a Whole: allergic reaction, pyrexia, photosensitivity reaction, facial edema.
Gastrointestinal: constipation, dry mouth, hepatitis.
Hematologic: leukopenia, thrombocytopenia.
Metabolic/Nutritional: elevated CK (creatine kinase), generalized edema, elevated triglycerides, liver enzymes elevated.
Musculoskeletal: myalgia.
Nervous: depression, vertigo.
Skin and Appendages: urticaria, rash, pruritus.
Special Senses: blurred vision.
All adult adverse reactions to pantoprazole are considered relevant to pediatric patients. In patients ages 1 year through 16 years, the most commonly reported (>4%) adverse reactions include: URI, headache, fever, diarrhea, vomiting, rash, and abdominal pain.
Additional adverse reactions that were reported for pantoprazole in pediatric patients with a frequency of ≤4% are listed as follows by body system: Body as a Whole: allergic reaction, facial edema.
Gastrointestinal: constipation, flatulence, nausea.
Metabolic/Nutritional: elevated triglycerides, elevated liver enzymes, elevated CK (creatine kinase).
Musculoskeletal: arthralgia, myalgia.
Nervous: dizziness, vertigo.
Skin and Appendages: urticaria.
The following adverse reactions seen in adults were not reported in pediatric patients, but are considered relevant to pediatric patients: photosensitivity reaction, dry mouth, hepatitis, thrombocytopenia, generalized edema, depression, pruritus, leukopenia, and blurred vision.
Pantor IV: Headache, diarrhea, and skin rashes: Other effects include pruritus, dizziness, fatigue, constipation, nausea and vomiting, flatulence, abdominal pain, arthralgia and myalgia, urticaria, and dry mouth. Isolated cases of photosensitivity, bullous eruption, erythema multiforme, angioedema, and anaphylaxis have been reported.
Effects on the CNS include occasional insomnia, somnolence, and vertigo; reversible confusional states, agitation, depression, and hallucination have occurred in severely ill patients raised liver enzymes, and isolated cases of hepatitis, jaundice, and hepatic encephalopathy, have been reported. Other adverse effects reported rarely or in isolated cases include paraesthesia, blurred vision, alopecia, stomatitis, sweating, taste disturbances, peripheral oedema, malaise, hyponatraemia, blood disorder (including agranulocytosis, leucopenia, and thrombocytopenia), and interstitial nephritis.
Proton pump inhibitors may increase the risk of gastrointestinal infections because of their acid suppressive effects.
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