Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [see Warnings and Precautions (5.1)] GI Bleeding, Ulceration, and Perforation [see Warnings and Precautions (5.2)] Hepatotoxicity [see Warnings and Precautions (5.4)] Hypertension [see Warnings and Precautions (5.5)] Heart Failure and Edema [see Warnings and Precautions (5.6)] Renal Toxicity and Hyperkalemia [see Warnings and Precautions (5.7)] Anaphylactic Reactions [see Warnings and Precautions (5.8)] Seizures [see Warnings and Precautions (5.9)] Serious Skin Reactions [see Warnings and Precautions (5.11)] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions (5.12)] Fetal Toxicity [see Warnings and Precautions (5.13)] Hematologic Toxicity [see Warnings and Precautions (5.14)] Aseptic Meningitis [see Warnings and Precautions (5.18)] Ophthalmological Effects [see Warnings and Precautions (5.19)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of ibuprofen and famotidine tablet was evaluated in 1022 patients in controlled clinical studies, including 508 patients treated for at least 6 months and 107 patients treated for approximately 1 year.
Patients treated with ibuprofen and famotidine tablet ranged in age from 39 to 80 years (median age 55 years), with 67% female, 79% Caucasian, 18% African-American, and 3% other races.
Two randomized, active-controlled clinical studies (Study 301 and Study 303) were conducted for the reduction of the risk of development of ibuprofen-associated, upper gastrointestinal ulcers in patients who required use of ibuprofen, which included 1022 patients on ibuprofen and famotidine tablet and 511 patients on ibuprofen alone.
Approximately 15% of patients were on low-dose aspirin.
Patients were assigned randomly, in a 2:1 ratio, to treatment with either ibuprofen and famotidine tablet or ibuprofen 800 mg three times a day for 24 consecutive weeks.
Three serious cases of acute renal failure were observed in patients treated with ibuprofen and famotidine tablet in the two controlled clinical trials.
All three patients recovered to baseline levels after discontinuation of ibuprofen and famotidine tablet.
Additionally, increases in serum creatinine were observed in both treatment arms in the two clinical studies.
Many of these patients were taking concomitant diuretics and/or angiotensin-converting enzyme inhibitors, or angiotensin receptor blockers.
5.1 Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI), and stroke, which can be fatal.
Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDS.
The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease.
However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate.
Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment.
Like all medications, Ibuprofen Famotidine can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: