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Protonix (Pantoprazole Sodium) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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
Study Event PROTONIX
(n = 521)
Placebo
(n = 82)
PROTONIX
(n = 161)
Nizatidine
(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 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
Study Event ------------% Incidence-----------
  Pantoprazole
Total
(N=2805)
Ranitidine
300 mg
(N=594)
  Omeprazole
20 mg
(N=474)
Famotidine
40 mg
(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-------
Study Event PROTONIX
(n = 536)
Ranitidine
(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 anaphylaxis (including anaphylactic shock); angioedema (Quincke's edema); anterior ischemic optic neuropathy; elevated CPK (creatine phosphokinase); severe dermatologic reactions, including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis (TEN, some fatal); hepatocellular damage leading to jaundice and hepatic failure; interstitial nephritis; pancreatitis; pancytopenia; and rhabdomyolysis. In addition, also observed have been confusion, hypokinesia, speech disorder, increased salivation, vertigo, nausea, tinnitus, and blurred vision.

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.



REPORTS OF SUSPECTED PROTONIX SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Protonix. The information is not vetted and should not be considered as verified clinical evidence.

Possible Protonix side effects / adverse reactions in 35 year old male

Reported by a consumer/non-health professional from United States on 2011-10-03

Patient: 35 year old male

Reactions: Drug Dose Omission, Dyspepsia, Drug Ineffective, Accident AT Work, Rotator Cuff Syndrome

Suspect drug(s):
Nexium
    Administration route: Oral

Prilosec OTC
    Administration route: Oral

Prilosec
    Administration route: Oral

Protonix



Possible Protonix side effects / adverse reactions in 53 year old male

Reported by a consumer/non-health professional from United States on 2011-10-04

Patient: 53 year old male weighing 77.0 kg (169.4 pounds)

Reactions: Road Traffic Accident, Drug Screen False Positive

Adverse event resulted in: hospitalization

Suspect drug(s):
Protonix

Other drugs received by patient: Acetylsalicylic Acid; Xopenex



Possible Protonix side effects / adverse reactions in 79 year old female

Reported by a consumer/non-health professional from United States on 2011-10-21

Patient: 79 year old female

Reactions: Diarrhoea

Suspect drug(s):
Protonix
    Dosage: 40 mg, 1x/day
    Administration route: Oral
    Indication: Abdominal Discomfort
    Start date: 2006-01-01
    End date: 2011-01-01

Pantoprazole
    Dosage: 40 mg, 1x/day
    Administration route: Oral
    Indication: Abdominal Discomfort
    Start date: 2010-01-01

Other drugs received by patient: Vitamin D; Atenolol



See index of all Protonix side effect reports >>

Drug label data at the top of this Page last updated: 2006-03-07

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