Protonix Side Effects

Generic name: pantoprazole

Generic Name: Pantoprazole

Please note - some side effects for Protonix 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 Protonix - for the consumer

Protonix I.V.

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 Protonix I.V.:

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.

Protonix 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 Protonix 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.

Protonix 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 Protonix 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.

For the professional

Protonix

Safety Experience with Intravenous Pantoprazole

Intravenous pantoprazole has been studied in clinical trials in several populations including patients with GERD and a history of erosive esophagitis, patients with Zollinger-Ellison Syndrome, patients involved in clinical trials for other disorders which may respond to proton pump inhibitor therapy, and healthy subjects. Adverse experiences occurring in >1% of patients treated with intravenous pantoprazole (n=836) in domestic or international clinical trials are shown below by body system. In most instances, the relationship to pantoprazole was unclear.

BODY AS A WHOLE: abdominal pain, headache, injection site reaction (including thrombophlebitis and abscess).

DIGESTIVE SYSTEM: constipation, dyspepsia, nausea, diarrhea.

NERVOUS SYSTEM: insomnia, dizziness.

RESPIRATORY SYSTEM: rhinitis.

Head-to-head comparative studies between Protonix I.V. for Injection and oral Protonix, other proton pump inhibitors (oral or I.V.), or H2 receptor antagonists (oral or I.V.) have been limited. The available information does not provide sufficient evidence to distinguish the safety profile of these regimens.

Safety Experience with Oral Pantoprazole

In short-term clinical trials in patients with erosive esophagitis associated with GERD treated with oral pantoprazole, the following adverse events, regardless of causality, occurred at a rate of ≥1%.

BODY AS A WHOLE: headache, asthenia, back pain, chest pain, neck pain, flu syndrome, infection, pain.

CARDIOVASCULAR SYSTEM: migraine.

DIGESTIVE SYSTEM: diarrhea, flatulence, abdominal pain, eructation, constipation, dyspepsia, gastroenteritis, gastrointestinal disorder, nausea, rectal disorder, vomiting.

HEPATO-BILIARY SYSTEM: liver function tests abnormal, SGPT increased.

METABOLIC AND NUTRITIONAL: hyperglycemia, hyperlipemia.

MUSCULOSKELETAL SYSTEM: arthralgia.

NERVOUS SYSTEM: insomnia, anxiety, dizziness, hypertonia.

RESPIRATORY SYSTEM: bronchitis, cough increased, dyspnea, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection.

SKIN AND APPENDAGES: rash.

UROGENITAL SYSTEM: urinary frequency, and urinary tract infection.

Additional adverse experiences occurring in <1% of patients with erosive esophagitis associated with GERD receiving oral pantoprazole based on pooled results from either short-term domestic or international trials are shown below within each 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.

CARDIOVASCULAR SYSTEM: abnormal electrocardiogram, angina pectoris, arrhythmia, cardiovascular disorder, chest pain substernal, congestive heart failure, hemorrhage, hypertension, hypotension, 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, 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, pain, 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 addition, the following adverse experiences occurred at a rate of <1% in long-term clinical trials in patients treated with oral pantoprazole: atrial fibrillation/flutter, myocardial infarction, neuropathy, photosensitivity reaction. In most instances, the relationship to pantoprazole was unclear.

Postmarketing Reports

The postmarketing safety profile of intravenous pantoprazole is not substantially different from that of oral pantoprazole (described below).

There have been spontaneous reports of adverse events with postmarketing use of intravenous or oral 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 U.S. clinical trials of patients with GERD and a history of erosive esophagitis and international clinical trials of patients with erosive esophagitis associated with GERD, the overall percentages of transaminase elevations did not increase during treatment with intravenous pantoprazole. For other laboratory parameters, there were no clinically important changes identified.

In two U.S. controlled trials of oral pantoprazole in patients with erosive esophagitis associated with GERD, 0.4% of the patients on 40 mg oral pantoprazole experienced SGPT elevations of greater than three 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 value change, such as intercurrent illness, the elevations tended to be mild and sporadic. The following changes in laboratory parameters were reported as adverse events: creatinine increased, hypercholesterolemia, and hyperuricemia.

By body system

General side effects

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 side effects

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 side effects

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 side effects

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 side effects

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 side effects

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 side effects

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 side effects

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.

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.

Hematologic side effects

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 side effects

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

Respiratory side effects

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 side effects

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 side effects

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 side effects

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 side effects

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.

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.

Other side effects

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

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