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The adverse reactions listed below have been reported during domestic and international clinical trials in approximately 2500 patients. In those controlled clinical trials in which famoti-dine tablets were compared to placebo, the incidence of adverse experiences in the group which received famotidine tablets, 40 mg at bedtime, was similar to that in the placebo group.
The following adverse reactions have been reported to occur in more than 1% of patients on therapy with famotidine in controlled clinical trials, and may be causally related to the drug: headache (4.7%), dizziness (1.3%), constipation (1.2%) and diarrhea (1.7%).
The following other adverse reactions have been reported infrequently in clinical trials or since the drug was marketed.The relationship to therapy with famotidine hasbeen unclear in many cases. Within each category the adverse reactions are listed in order of decreasing severity:
Cardiovascular: arrhythmia, AV block, palpitation
Musculoskeletal: musculoskeletal pain including muscle cramps, arthralgia
Nervous System/Psychiatric: grand mal seizure; psychic disturbances, which were reversible in cases for which follow-up was obtained, including hallucinations, confusion, agitation, depression, anxiety, decreased libido; paresthesia; insomnia; somnolence
Special Senses: tinnitus, taste disorder
Other: rare cases of impotence and rare cases of gynecomastia have been reported; however, in controlled clinical trials, the inci-dences were not greater than those seen with placebo.
The adverse reactions reported for famotidine tablets may also occur with famotidine for oral suspension, famotidine orally disintegrating tablets, famotidine injection preservative free in plastic container or famotidine injection.
Read the Famotidine Injection (famotidine injection) Side Effects Center for a complete guide to possible side effects
No drug interactions have been identified. Studies with famotidine in man, in animal models, and in vitrohave shown no significant interference with the disposition of compounds metabolized by the hepatic microsomal enzymes, e.g., cytochrome P450 system. Compounds tested in man include warfarin, theophylline, phenytoin, diazepam, aminopyrine and antipyrine. Indocyanine green as an index of hepatic drug extraction has been tested and no significant effects have been found.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/29/2009
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