Protonix I.V. Side Effects

Please note - some side effects for Protonix I.V. may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Protonix I.V. - for the Consumer

Protonix I.V.

Applies to: injection

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); bone pain; chest pain; fast or irregular heartbeat; fever, chills, or sore throat; pain, redness, swelling, tenderness, or warmth at the injection site; red, swollen, blistered, or peeling skin; symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, nausea, stomach pain, loss of appetite, unusual tiredness); unusual bruising or bleeding; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

Applies to: intravenous powder for injection; oral delayed release tablet; oral granule, enteric coated

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, fatigue, 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 and other bone fractures have 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 hepatitis, elevated serum liver transaminase enzyme concentrations, and hepatocellular damage leading to jaundice and hepatic failure.

Hematologic

Hematologic side effects have 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, hyponatremia, and thrombocytopenia.

Metabolic

FDA warns that prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year). Patients who develop hypomagnesemia may experience seizures, dizziness, abnormal or fast heart beat, or skipped heartbeat, jitteriness, jerking movements or tremors, muscle weakness, spasms of the hands and feet, cramps or muscle aches, and spasm of the voice box. Hyponatremia has also been reported.

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.

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