Antaxid 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 pantoprazole delayed release tablets 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 pantoprazole delayed release tablets. (See Table 6.)

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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. (See Table 7.)

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In two U.S. controlled clinical trials involving pantoprazole delayed-release tablets 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. (See Table 8.)

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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 as follows by body system. In most instances the relationship to pantoprazole was unclear.
BODY AS 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, haemorrhage, hypertension, hypotension, myocardial infarction, myocardial ischemia, palpitation, retinal vascular disorder, syncope, tachycardia, thrombophlebitis, thrombosis, vasodilation.
DIGESTIVE SYSTEM: anorexia, aphthous stomatitis, cardiospasm, colitis, dry mouth, duodenitis, dysphagia, enteritis, esophageal haemorrhage, esophagitis, gastrointestinal carcinoma, gastrointestinal haemorrhage, gastrointestinal moniliasis, gingivitis, glossitis, halitosis, hematemesis, increased appetite, melena, mouth ulceration, oral moniliasis, periodontal abscess, periodontitis, rectal haemorrhage, stomach ulcer, stomatitis, stools abnormal, tongue discoloration, ulcerative colitis.
ENDOCRINE SYSTEM: diabetes mellitus, glycosuria, goiter.
HEPATO-BILIARY SYSTEM: biliary pain, hyperbilirubinemia, cholecystitis, cholethiasis, cholestatic jaundice, hepatitis, alkaline phosphatase increased, gamma glutamyl transpeptidase increased, SGOT increased.
HEMIC AND LYMPHATIC SYSTEM: anemia, ecchymosis, eosinophilia, hypochromic anemia, iron deficiency anemia, leucocytosis, 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 increased, 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 APPENDICES: acne, alopecia, contact dermatitis, dry skin, eczema, fungal dermatitis, haemorrhage, 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 U.S. clinical trial conducted in 35 patients with pathological hypersecretory conditions treated with pantoprazole sodium delayed release tablets 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 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 (creatinine phosphokinase), rhabdomyolysis.
NERVOUS SYSTEM: confusion, hypokinesia, speech disorder, vertigo.
SKIN AND APPENDICES: 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.
In a postmarketing surveillance study of the 6-month period after the launch of pantoprazole in England (UK), the adverse effects reported most frequently were diarrhea, nausea, and headache. Other effects included malaise or lassitude, rash, other gastrointestinal disturbances, myalgia, and edema.
Laboratory Value: In U.S. controlled, short-term trials in patients with erosive esophagitis associated with GERD, 0.4% of the patients on pantoprazole delayed release 40 mg tablet 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 the 178 patients (0%) on pantoprazole delayed release 40 mg tablet and two of 181 patients (1.1%) on pantoprazole delayed release 20 mg tablet 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 the 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.