Side Effects > Protonix

Protonix Side Effects

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).

For the consumer Protonix I.V. Protonix Protonix Delayed-Release Tablets For the professional Protonix Protonix Tablets

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.

Seek medical attention right away if any of these SEVERE side effects occur when using Protonix I.V.:

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

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:

Diarrhea; headache; nausea; stomach pain; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Protonix:

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.

Seek medical attention right away if any of these SEVERE side effects occur when using Protonix Delayed-Release Tablets:

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.

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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.

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Protonix Tablets

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 Protonix 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 Protonix.

Most Frequent Adverse Events Reported as Drug Related in Short-term Domestic Trials

	–––––––––––––––––––––––––% Incidence–––––––––––––––––––––––––
	Study 300-US		Study 301-US
	Protonix	Placebo	Protonix	Nizatidine
Study Event	(n = 521)	(n = 82)	(n = 161)	(n = 82)
Headache	6	6	9	13
Diarrhea	4	1	6	6
Flatulence	2	2	4	0
Abdominal pain	1	2	4	4
Rash	<1	0	2	0
Eructation	1	1	0	0
Insomnia	<1	2	1	1
Hyperglycemia	1	0	<1	0

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.

Adverse Events in GERD Patients in Short-term International Trials

	–––––––––––––––––––––––––% Incidence––––––––––––––––––––––––
	Pantoprazole	Ranitidine	Omeprazole	Famotidine
	Total	300 mg	20 mg	40 mg
Study Event	(N = 2805)	(N = 594)	(N = 474)	(N = 239)
Headache	2	3	2	1
Diarrhea	2	2	2	<1
Abdominal Pain	1	1	<1	<1

In two U.S. controlled clinical trials involving Protonix 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.

Most Frequent Adverse Events Reported as Drug Related in Long-term Domestic Trials

	––––––––––––––––––––% Incidence––––––––––––––––––
	Protonix	Ranitidine
Study Event	(n = 536)	(n = 185)
Headache	5	2
Abdominal pain	3	1
Liver function tests abnormal	2	<1
Nausea	2	2
Vomiting	2	2

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

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 Protonix 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 Protonix 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 Protonix 40 mg and two of 181 patients (1.1%) on Protonix 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.

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Protonix - Includes detailed dosage instructions.

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