Pantoprazole Side Effects

Brand Names: Protonix

Please note - some side effects for Pantoprazole may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Pantoprazole - for the Consumer

Pantoprazole

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Pantoprazole:

Diarrhea; headache; nausea; stomach pain; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest pain; dark urine; fast or irregular heartbeat; fever, chills, or sore throat; red, swollen, blistered, or peeling skin; unusual bruising or bleeding; unusual tiredness; vision changes; yellowing of the skin or eyes.

Pantoprazole Delayed-Release Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Pantoprazole Delayed-Release Tablets:

Diarrhea; headache; nausea; stomach pain; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, hands, eyes, throat, or tongue; unusual hoarseness); chest pain; dark urine; fast or irregular heartbeat; fever, chills, or sore throat; red, swollen, blistered, or peeling skin; unusual bruising or bleeding; unusual tiredness; vision changes; yellowing of the eyes or skin.

Pantoprazole Suspension

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Pantoprazole Suspension:

Diarrhea; headache; nausea; stomach pain; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, hands, eyes, throat, or tongue; unusual hoarseness); chest pain; dark urine; fast or irregular heartbeat; fever, chills, or sore throat; red, swollen, blistered, or peeling skin; unusual bruising or bleeding; unusual tiredness; vision changes; yellowing of the eyes or skin.

Pantoprazole Side Effects - for the Professional

Pantoprazole

Worldwide, more than 11,100 patients have been treated with Pantoprazole in clinical trials involving various dosages and duration of treatment. In general, Pantoprazole has been well tolerated in both short-term and long-term trials.

In two U.S. controlled clinical trials involving Pantoprazole sodium 10, 20, or 40 mg doses for up to 8 weeks, there were no dose-related effects on the incidence of adverse events. The following adverse events considered by investigators to be possibly, probably, or definitely related to drug occurred in 1% or more in the individual studies of GERD patients on therapy with Pantoprazole sodium.

Note: Only adverse events with an incidence greater than or equal to the comparators are shown.

In international short-term, double-blind or open-label clinical trials involving 20 mg to 80 mg per day, the following adverse events were reported to occur in 1% or more of 2805 GERD patients receiving Pantoprazole for up to 8 weeks.

In two U.S. controlled clinical trials involving Pantoprazole sodium 10, 20, or 40 mg doses for up to 12 months, the following adverse events considered by investigators to be possibly, probably, or definitely related to drug occurred in 1% or more of GERD patients on long-term therapy.

In addition, in these short- and long-term domestic and international trials, the following treatment-emergent events, regardless of causality, occurred at a rate of ≥ 1% in Pantoprazole-treated patients: anxiety, arthralgia, asthenia, back pain, bronchitis, chest pain, constipation, cough increased, dizziness, dyspepsia, dyspnea, flu syndrome, gastroenteritis, gastrointestinal disorder, hyperlipemia, hypertonia, infection, liver function tests abnormal, migraine, nausea, neck pain, pain, pharyngitis, rectal disorder, rhinitis, SGPT increased, sinusitis, upper respiratory tract infection, urinary frequency, urinary tract infection, and vomiting.

Additional treatment-emergent adverse experiences occurring in < 1% of Pantoprazole-treated patients from these trials are listed below by body system. In most instances the relationship to Pantoprazole was unclear.

BODY AS A WHOLE: abscess, allergic reaction, chills, cyst, face edema, fever, generalized edema, heat stroke, hernia, laboratory test abnormal, malaise, moniliasis, neoplasm, non-specified drug reaction, photosensitivity reaction.

CARDIOVASCULAR SYSTEM: abnormal electrocardiogram, angina pectoris, arrhythmia, atrial fibrillation/flutter, cardiovascular disorder, chest pain substernal, congestive heart failure, hemorrhage, hypertension, hypotension, myocardial infarction, myocardial ischemia, palpitation, retinal vascular disorder, syncope, tachycardia, thrombophlebitis, thrombosis, vasodilatation.

DIGESTIVE SYSTEM: anorexia, aphthous stomatitis, cardiospasm, colitis, dry mouth, duodenitis, dysphagia, enteritis, esophageal hemorrhage, esophagitis, gastrointestinal carcinoma, gastrointestinal hemorrhage, gastrointestinal moniliasis, gingivitis, glossitis, halitosis, hematemesis, increased appetite, melena, mouth ulceration, oral moniliasis, periodontal abscess, periodontitis, rectal hemorrhage, stomach ulcer, stomatitis, stools abnormal, tongue discoloration, ulcerative colitis.

ENDOCRINE SYSTEM: diabetes mellitus, glycosuria, goiter.

HEPATO-BILIARY SYSTEM: biliary pain, hyperbilirubinemia, cholecystitis, cholelithiasis, cholestatic jaundice, hepatitis, alkaline phosphatase increased, gamma glutamyl transpeptidase increased, SGOT increased.

HEMIC AND LYMPHATIC SYSTEM: anemia, ecchymosis, eosinophilia, hypochromic anemia, iron deficiency anemia, leukocytosis, leukopenia, thrombocytopenia.

METABOLIC AND NUTRITIONAL: dehydration, edema, gout, peripheral edema, thirst, weight gain, weight loss.

MUSCULOSKELETAL SYSTEM: arthritis, arthrosis, bone disorder, bone pain, bursitis, joint disorder, leg cramps, neck rigidity, myalgia, tenosynovitis.

NERVOUS SYSTEM: abnormal dreams, confusion, convulsion, depression, dry mouth, dysarthria, emotional lability, hallucinations, hyperkinesia, hypesthesia, libido decreased, nervousness, neuralgia, neuritis, neuropathy, paresthesia, reflexes decreased, sleep disorder, somnolence, thinking abnormal, tremor, vertigo.

RESPIRATORY SYSTEM: asthma, epistaxis, hiccup, laryngitis, lung disorder, pneumonia, voice alteration.

SKIN AND APPENDAGES: acne, alopecia, contact dermatitis, dry skin, eczema, fungal dermatitis, hemorrhage, herpes simplex, herpes zoster, lichenoid dermatitis, maculopapular rash, pruritus, skin disorder, skin ulcer, sweating, urticaria.

SPECIAL SENSES: abnormal vision, amblyopia, cataract specified, deafness, diplopia, ear pain, extraocular palsy, glaucoma, otitis externa, taste perversion, tinnitus.

UROGENITAL SYSTEM: albuminuria, balanitis, breast pain, cystitis, dysmenorrhea, dysuria, epididymitis, hematuria, impotence, kidney calculus, kidney pain, nocturia, prostatic disorder, pyelonephritis, scrotal edema, urethral pain, urethritis, urinary tract disorder, urination impaired, vaginitis.

In an open-label US clinical trial conducted in 35 patients with pathological hypersecretory conditions treated with Pantoprazole sodium for up to 27 months, the adverse events reported were consistent with the safety profile of the drug in other populations.

Postmarketing Reports

There have been spontaneous reports of adverse events with the postmarketing use of Pantoprazole. These reports include the following:

BODY AS A WHOLE: anaphylaxis (including anaphylactic shock), angioedema (Quincke's edema).

DIGESTIVE SYSTEM: increased salivation, nausea, pancreatitis.

HEMIC AND LYMPHATIC SYSTEM: pancytopenia.

HEPATO-BILIARY SYSTEM: hepatocellular damage leading to jaundice and hepatic failure.

MUSCULOSKELETAL SYSTEM: elevated CPK (creatine phosphokinase), rhabdomyolysis.

NERVOUS SYSTEM: confusion, hypokinesia, speech disorder, vertigo.

SKIN AND APPENDAGES: severe dermatologic reactions, including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis (TEN, some fatal).

SPECIAL SENSES: anterior ischemic optic neuropathy, blurred vision, tinnitus.

UROGENITAL SYSTEM: interstitial nephritis.

Laboratory Values

In two U.S. controlled, short-term trials in patients with erosive esophagitis associated with GERD, 0.4% of the patients on Pantoprazole sodium 40 mg experienced SGPT elevations of greater than three times the upper limit of normal at the final treatment visit. In two U.S. controlled, long-term trials in patients with erosive esophagitis associated with GERD, none of 178 patients (0%) on Pantoprazole sodium 40 mg and two of 181 patients (1.1%) on Pantoprazole sodium 20 mg experienced significant transaminase elevations at 12 months (or earlier if a patient discontinued prematurely). Significant elevations of SGOT or SGPT were defined as values at least three times the upper limit of normal that were non-sporadic and had no clear alternative explanation. The following changes in laboratory parameters were reported as adverse events: creatinine increased, hypercholesterolemia, and hyperuricemia.

Side Effects by Body System

General

In general, pantoprazole has been very well tolerated. At the time of its approval by the FDA, pantoprazole had been tested in over 11,100 patients in clinical trials involving various dosages and duration of treatment. In 2 controlled trials where daily doses up to 40 mg were given for up to 8 weeks, there were no dose-related adverse side effects associated with the use of this drug.

Gastrointestinal

Gastrointestinal side effects may be due to underlying diseases among treated patients. In placebo-controlled trials, the use of pantoprazole was associated with the following (incidence vs. placebo): diarrhea (4% vs. 1%), flatulence (2% vs. 2%), abdominal pain (1% vs. 2%), and eructation (belching) (1% vs. 1%). Rare cases of pancreatitis have been described in postmarketing reports.

In addition, the following gastrointestinal problems have been reported in up to 1% of patients (causal relationship is unclear): constipation, dyspepsia, gastroenteritis, nausea, vomiting, anorexia, aphthous stomatitis, cardiospasm, colitis, dry mouth, duodenitis, dysphagia, esophageal hemorrhage, esophagitis, gastrointestinal carcinoma, gastrointestinal hemorrhage, gastrointestinal moniliasis, gingivitis, glossitis, halitosis, hematemesis, increased appetite, increased salivation, melena, mouth ulceration, oral moniliasis, periodontal abscess, periodontitis, rectal hemorrhage, stomach ulcer, tongue discoloration, abnormal stools, hernia, and ulcerative colitis.

Nervous system

Nervous system side effects have included headache in 6% and insomnia in less than 1% of patients (compared to 6% and 2% of placebo patients, respectively) in controlled trials. Less common nervous system side effects that have occurred in approximately 1% of patients and where there is an unclear causal association include asthenia, pain, migraine, anxiety, dizziness, abnormal dreams, confusion, convulsion, depression, dysarthria, emotional lability, hallucinations, hyperkinesia, hypesthesia, libido decreased, nervousness, neuralgia, neuritis, paresthesia, reflexes decreased, malaise, sleep disorder, somnolence, thinking abnormal, tremor, vertigo, speech disorder, deafness, ear pain, taste perversion, hypokinesia, or tinnitus.

Musculoskeletal

Musculoskeletal aches side effects have been reported in approximately 1% of patients. These complaints have ranged from back pain, neck pain, chest pain, arthralgias, arthritis, arthrosis, bone disorders, bone pain, bursitis, joint disorders, leg cramps, neck rigidity, myalgias, and tenosynovitis. Rhabdomyolysis and hypokinesia have been described in postmarketing reports. An increased risk of hip fracture has been reported in a recent cohort study with information on patients in the United Kingdom (1987 to 2003). The risk of hip fracture was significantly increased among patients prescribed long-term high dose PPIs.

Hypersensitivity

Hypersensitivity side effects have been rare. Allergic reactions, usually manifest as a rash, have appeared in less than 1% of patients. Other possible signs of allergy have included facial and generalized edema. Rare cases of anaphylaxis, angioedema, and severe dermatologic reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis--some fatal--and erythema multiforme) have been described in postmarketing reports.

Cardiovascular

Cardiovascular side effects have been reported in less than 1% of patients. A causal relationship is unclear. These possible side effects have included angina pectoris, arrhythmia, congestive heart failure, abnormal ECG, hyper- or hypotension, myocardial ischemia, palpitation, retinal vascular disorder, syncope, tachycardia, thrombophlebitis, thrombosis, vasodilation, dehydration, and peripheral edema.

Endocrine

Endocrine side effects have included hyperglycemia in 1% of patients (vs. 0% among placebo patients) glycosuria, goiter, increased thirst, and weight changes. Hypercholesterolemia or hyperuricemia has occurred in less than 1% of patients.

Hepatic

In 2 US controlled trials, 0.4% of patients who were taking daily doses of 40 mg experienced SGPT elevations of greater than 3 times the upper limit of normal at the final treatment visit. Except in those patients where there was a clear alternative explanation for a laboratory change, such as concomitant illness, the elevations tended to be mild and sporadic.

Hepatic side effects have been reported in less than 1% of patients. A causal relationship is unclear. These possible side effects have included biliary pain, hyperbilirubinemia, cholecystitis, cholelithiasis, cholestatic jaundice, hepatitis, and elevated serum liver transaminase enzyme concentrations.

Hematologic

Hematologic side effects have been also been rarely reported (less than 1% of patients), and a causal relationship has not been established. These side effects have included anemia, ecchymosis, eosinophilia, hypochromic anemia, iron deficiency anemia, leukocytosis, leukopenia, or thrombocytopenia.

Metabolic

Metabolic side effects including gout have been reported in less than 1% of patients.

Respiratory

Respiratory side effects have been reported in less than 1% of patients, and have included asthma, epistaxis, hiccups, laryngitis, lung disorder, pneumonia, and voice alterations. A causal relationship has not been established.

Dermatologic

Dermatologic side effects have included acne, alopecia, contact dermatitis, dry skin, eczema, fungal dermatitis, hemorrhage, herpes simplex or zoster, lichenoid dermatitis, maculopapular rash, pain, pruritus, skin ulcer, sweating, or urticaria in approximately 1% or less of patients. Rare cases of anaphylaxis, angioedema, and severe dermatologic reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis--some fatal--and erythema multiforme) have been described in postmarketing reports.

Ocular

Ocular side effects have occurred in less than 1% of patients. Symptoms have included amblyopia, abnormal vision, cataracts, diplopia, extraocular palsy, and glaucoma. Rare cases of blurred vision and anterior ischemic optic neuropathy have been described in postmarketing reports.

Genitourinary

Genitourinary side effects have been reported in less than 1% of patients during therapy and have included albuminuria, balanitis, cystitis, dysmenorrhea, dysuria, epididymitis, hematuria, impotence, nocturia, prostatic disorder, pyelonephritis, scrotal edema, urethral pain, urethritis, urinary tract disorder, urination impaired, and vaginitis.

Renal

Acute interstitial nephritis has been reported in a 77-year-old woman following treatment with oral pantoprazole 40 mg per day. She stopped taking pantoprazole 5 weeks after the start of therapy because of general malaise. Her symptoms on admission to hospital included: elevated serum creatinine, oliguria for the previous 24 hours, arthralgia, fatigue, fever, and bilateral flank pain. On day 4 of admission to the hospital after rechallenge with pantoprazole, her serum creatinine increased to 6.1 mg/dL. Pantoprazole therapy was discontinued and prednisone 40 mg per day was initiated. The serum creatinine level gradually decreased over 2 weeks.

Renal side effects have included kidney calculus, kidney pain, acute interstitial nephritis, and pyelonephritis. Increases in serum creatinine have occurred in less than 1% of patients.

Other

Other side effects have included changes in laboratory parameters including increase in creatinine, hypercholesterolemia, and hyperuricemia.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.