Pantoprazole Side Effects
Medically reviewed by Drugs.com. Last updated on Sep 24, 2023.
For Healthcare Professionals
Applies to pantoprazole: intravenous powder for injection, intravenous solution, oral delayed release tablet, oral granule enteric coated, oral suspension.
General
The most commonly reported side effects were headache, diarrhea, and injection site thrombophlebitis (in IV formulations).[Ref]
Nervous system
Very common (10% or more): Headache (Up to 26.4%), taste pervasion (Up to 18.2%)
Common (1% to 10%): Dizziness, metallic/bitter taste, somnolence
Rare (0.01% to 0.1%): Taste disorders
Very rare (less than 0.01%): Change to the sense of taste, reduced movement, speech disorder
Frequency not reported: Paresthesia, vertigo
Postmarketing reports: Ageusia, dysgeusia[Ref]
Headache was a very commonly reported side effect in pediatric patients 2 to 16 years of age. In adults, headache occurred most frequently in patients given quadruple therapy (pantoprazole, bismuth, metronidazole, tetracycline) for H pylori infections, but was also very common in triple therapy (pantoprazole, amoxicillin, clarithromycin).
Taste pervasion most frequently occurred in patients given triple therapy, but it was also very common in patients given quadruple therapy.[Ref]
Respiratory
Nasopharyngitis and pharyngolaryngeal pain occurred in pediatric patients between the ages of 2 to 16 years.[Ref]
Very common (10% or more): Nasopharyngitis (up to 13.6%), pharyngolaryngeal pain (up to 13.2%)
Common (1% to 10%): Cough, nasal congestion, pharyngitis
Very rare (less than 0.01%): Change to the sense of smell, dyspnea
Frequency not reported: Upper respiratory tract infection[Ref]
Gastrointestinal
Very common (10% or more): Diarrhea (Up to 11.6%)
Common (1% to 10%): Abdominal pain, benign fundic gland polyps/fundic gland polyps, buccal inflammation, constipation, dry mouth, dyspepsia, fecal discoloration, flatulence, heartburn, nausea, oral moniliasis, pruritus ani, tongue discoloration, tongue pain, upper abdominal pain, vomiting
Uncommon (0.1% to 1%): Abdominal discomfort/distention, bloating, loose stools
Rare (0.01% to 0.1%): Colon polyp, rectal disorder
Very rare (less than 0.01%): Increased saliva
Frequency not reported: Clostridium difficile-associated diarrhea, severe eructation[Ref]
Diarrhea occurred most frequently in patients given quadruple therapy (pantoprazole, bismuth, metronidazole, tetracycline) for Helicobacter pylori infections, but was also very common in triple therapy (pantoprazole, amoxicillin, clarithromycin).
Nausea, vomiting, abdominal pain, dry mouth, and constipation were more commonly reported in patients given triple therapy, compared to patients given quadruple therapy.
Fecal and/or tongue discoloration occurred more commonly in patients given quadruple therapy versus patients given triple therapy.[Ref]
Other
Common (1% to 10%): Tiredness
Uncommon (0.1% to 1%): Asthenia, fatigue, malaise
Rare (0.01% to 0.1%): Body temperature increased, fever
Very rare (less than 0.01%): Pain, tinnitus
Frequency not reported: Facial edema[Ref]
Psychiatric
Confusion, depression, hallucinations, and disorientation, especially in predisposed patients, occurred with use, and was aggravated in patients with preexisting conditions.[Ref]
Common (1% to 10%): Depression (and all aggravations)
Uncommon (0.1% to 1%): Sleep disorders
Rare (0.01% to 0.1%): Confusion (and all aggravations), disorientation (and all aggravations), hallucination (and all aggravations)
Very rare (less than 0.01%): Anxiety
Postmarketing reports: Insomnia[Ref]
Hepatic
Common (1% to 10%): Increased liver enzymes (transaminases, GGT)
Rare (0.01% to 0.1%): Increased bilirubin
Very rare (less than 0.01%): Cholestatic hepatitis, hepatitis, hepatocellular failure, jaundice
Frequency not reported: Hepatic effects, hepatocellular injury, liver function tests abnormal
Postmarketing reports: Hepatocellular damage[Ref]
Severe hepatocellular damage leading to jaundice/hepatic failure is predicted to have a frequency of 1 in 1,000,000 patients.[Ref]
Dermatologic
Common (1% to 10%): Exanthema/exanthemata, rash
Uncommon (0.1% to 1%): Eruption, increased sweating, pruritus
Rare (0.01% to 0.1%): Urticaria
Very rare (less than 0.01%): Erythema multiforme, flushing, Lyell syndrome, photosensitivity/photosensitivity reaction, severe skin reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN)
Frequency not reported: Cutaneous lupus erythematosus, facial edema, fatal skin reactions, fatal TEN, subacute cutaneous lupus erythematosus[Ref]
Cardiovascular
Common (1% to 10%): Chest pain
Rare (0.01% to 0.1%): Hypertension, peripheral edema, thrombophlebitis
Very rare (less than 0.01%): Circulatory collapse, flushing, hot flushes, substernal chest pain
Frequency not reported: Generalized edema[Ref]
Musculoskeletal
Common (1% to 10%): Arthralgia
Uncommon (0.1% to 1%): Fracture of the hip/wrist/spine
Rare (0.01% to 0.1%): Myalgia
Very rare (less than 0.01%): Skeletal pain
Frequency not reported: Bone fracture, elevated creatine phosphokinase (CPK)/elevated creatine kinase (CK), muscle spasm, systemic lupus erythematosus
Postmarketing reports: Rhabdomyolysis[Ref]
Muscle spasm occurred as a consequence of electrolyte disturbances.[Ref]
Metabolic
Hypocalcemia occurred in association with hypomagnesemia.
Anorexia commonly occurred in patients with H pylori.[Ref]
Common (1% to 10%): Anorexia
Rare (0.01% to 0.1%): Hyperlipidemia, increased cholesterol, increased triglycerides, lipid increases, weight changes
Frequency not reported: Cyanocobalamin (vitamin B12) deficiency), electrolyte disturbances, hypocalcemia, hypokalemia, hypomagnesemia, hyponatremia, potential for exacerbation of zinc deficiency[Ref]
Local
Common (1% to 10%): Injection site thrombophlebitis
Frequency not reported: Injection site reactions[Ref]
Immunologic
Common (1% to 10%): Influenza-like symptoms, moniliasis
Rare (0.01% to 0.1%): Sepsis[Ref]
Hypersensitivity
Rare (0.01% to 0.1%): Anaphylactic reactions, anaphylactic shock, angioedema/Quincke's edema, hypersensitivity, hypersensitivity reactions
Frequency not reported: Allergic reactions
Postmarketing reports: Anaphylaxis[Ref]
Hematologic
Rare (0.01% to 0.1%): Agranulocytosis, anemia
Very rare (less than 0.01%): Increased coagulation time, leukopenia, pancytopenia, thrombocytopenia[Ref]
Ocular
Uncommon (0.1% to 1%): Blurred vision, visual disturbances
Very rare (less than 0.01%): Conjunctivitis[Ref]
Endocrine
Rare (0.01% to 0.1%): Gynecomastia[Ref]
Renal
Very rare (less than 0.01%): Interstitial nephritis (with possible progression to renal failure)
Frequency not reported: Acute interstitial nephritis[Ref]
Frequently asked questions
- Pantoprazole vs. omeprazole: What's the difference between them?
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References
1. (2001) "Product Information. Protonix (pantoprazole)." Wyeth-Ayerst Laboratories
2. "Product Information. Protonix IV (pantoprazole)." Wyeth-Ayerst Laboratories
3. Cerner Multum, Inc. "UK Summary of Product Characteristics."
4. Cerner Multum, Inc. "Australian Product Information."
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.