Protonix Side Effects
Generic name: pantoprazole
Note: This document contains side effect information about pantoprazole. Some of the dosage forms listed on this page may not apply to the brand name Protonix.
Some side effects of Protonix may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to pantoprazole: oral packet, oral tablet, oral tablet enteric coated
Other dosage forms:
Along with its needed effects, pantoprazole (the active ingredient contained in Protonix) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking pantoprazole:Less common
- Abdominal or stomach pain
- blurred vision
- dry mouth
- flushed, dry skin
- fruit-like breath odor
- increased hunger
- increased thirst
- increased urination
- troubled breathing
- unexplained weight loss
- Absence of or decrease in body movements
- blistering, peeling, or loosening of the skin
- bloody or cloudy urine
- bloody, black, or tarry stools
- blurred vision
- clay-colored stools
- continuous ringing or buzzing or other unexplained noise in the ears
- dark-colored urine
- decreased vision
- difficulty with speaking
- difficulty with swallowing
- dizziness or lightheadedness
- fast heartbeat
- feeling of constant movement of self or surroundings
- general feeling of tiredness or weakness
- greatly decreased frequency of urination or amount of urine
- hearing loss
- high fever
- joint pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- light-colored stools
- loss of appetite
- mood or mental changes
- muscle cramps
- muscle pain or stiffness
- muscle spasms (tetany) or twitching
- pains in the stomach, side, or abdomen, possibly radiating to the back
- pale skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red skin lesions, often with a purple center
- red, irritated eyes
- sensation of spinning
- shortness of breath
- skin rash
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- stomach pain, continuing
- swelling of the feet or lower legs
- swollen glands
- tightness in the chest
- unexplained bleeding or bruising
- unpleasant breath odor
- unusual tiredness or weakness
- vomiting of blood
- yellow eyes or skin
Some side effects of pantoprazole may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:Less common
- bloated or full feeling
- excess air or gas in the stomach or intestines
- passing gas
- trouble sleeping
- unable to sleep
- Increased watering of the mouth
For Healthcare Professionals
Applies to pantoprazole: intravenous powder for injection, oral delayed release tablet, oral granule enteric coated
In general, pantoprazole (the active ingredient contained in Protonix) 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 may be due to underlying diseases among treated patients. In placebo-controlled trials, the use of pantoprazole (the active ingredient contained in Protonix) 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 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 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 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 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 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.
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 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.
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 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 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 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 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.
Acute interstitial nephritis has been reported in a 77-year-old woman following treatment with oral pantoprazole (the active ingredient contained in Protonix) 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 side effects have included changes in laboratory parameters including increase in creatinine, hypercholesterolemia, and hyperuricemia.
More Protonix resources
- Protonix Monograph (AHFS DI)
- Protonix Prescribing Information (FDA)
- Protonix Consumer Overview
- Protonix Advanced Consumer (Micromedex) - Includes Dosage Information
- Protonix delayed-release tablets MedFacts Consumer Leaflet (Wolters Kluwer)
- pantoprazole MedFacts Consumer Leaflet (Wolters Kluwer)
- Pantoprazole Prescribing Information (FDA)
- Protonix IV Advanced Consumer (Micromedex) - Includes Dosage Information
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