Adverse Reactions to Gemfibrozil
In the double-blind controlled phase of the primary prevention component of the Helsinki Heart Study, 2046 patients received gemfibrozil for up to five years. In that study, the following adverse reactions were statistically more frequent in subjects in the gemfibrozil group:
|GEMFIBROZIL (N = 2046)||PLACEBO (N = 2035)|
|Frequency in percent of subjects|
|(histologically confirmed in most cases where data were available)|
|Adverse events reported by more than 1% of subjects, but without a significant difference between groups:|
was performed in 0.9% of gemfibrozil and 0.5% of placebo subjects in the primary prevention component, a 64% excess, which is not statistically different from the excess of gallbladder surgery observed in the clofibrate compared to the placebo group of the WHO study. Gallbladder surgery
Gallbladder surgery was also performed more frequently in the gemfibrozil group compared to placebo (1.9% vs 0.3%, p=0.07) in the secondary prevention component. A statistically significant increase in appendectomy in the gemfibrozil group was seen also in the secondary prevention component (6 on gemfibrozil vs 0 on placebo, p=0.014).
Nervous system and special senses adverse reactions were more common in the gemfibrozil group. These included hypesthesia, paresthesias, and taste perversion. Other adverse reactions that were more common among gemfibrozil treatment group subjects but where a causal relationship was not established include cataracts, peripheral vascular disease, and intracerebral hemorrhage.
From other studies it seems probable that gemfibrozil is causally related to the occurrence of MUSCULOSKELETAL SYMPTOMS (see ), and to ABNORMAL LIVER FUNCTION TESTS and HEMATOLOGIC CHANGES (see ). WARNINGSPRECAUTIONS
Reports of viral and bacterial infections (common cold, cough, urinary tract infections) were more common in gemfibrozil treated patients in other controlled clinical trials of 805 patients. Additional adverse reactions that have been reported for gemfibrozil are listed below by system. These are categorized according to whether a causal relationship to treatment with gemfibrozil is probable or not established:
|CAUSAL RELATIONSHIP PROBALE||CAUSAL RELATIONSHIP NOT ESTABLISHED|
|Gastrointestinal:||cholestatic jaundice||pancreatitis hepatoma colitis|
|Central Nervous System:||dizziness Somnolence Paresthesiaperipheral neuritisdecreased libidodepression headache||confusion convulsions syncope|
|Eye:||blurred vision||Retinal edema|
|Genitourinary:||impotence||decreased male fertility renal dysfunction|
|Musculoskeletal:||myopathy myasthenia myalgia painful extremities arthralgia synovitis rhabdomyolysis (see and under ) WARINGSDrug InteractionsPRECUATIONS|
|Clinical Laboratory:||increased creatine phosphokinase increased bilirubin increased liver transaminases (AST [SGOT],ALT [SGPT]) increased alkaline phosphatase||positive antinuclear antibody|
|Hematopoietic:||anemia leukopenia bone marrow hypoplasiaeosinophilia||thrombocytopenia|
|Immunologic:||angicedema laryngeal edema urticaria||anaphylaxis lupus like syndrome vasculitis|
|Integumentary:||exfoliative dermatitisrash dermatitis pruritus||alopeciaphotosensitivity|
Additional adverse reactions that have been reported include cholecystitis and cholelithiasis (see WARNINGS ).
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meal (see ). CLINICAL PHARMACOLOGY
There have been reported cases of overdosage with gemfibrozil. In one case, a 7-year-old child recovered after ingesting up to 9 grams of gemfibrozil. Symptoms reported with overdosage were abdominal cramps, abnormal liver function tests, diarrhea, increased CPK, joint and muscle pain, nausea and vomiting. Symptomatic supportive measures should be taken, should an overdose occur.
NDC:68151-2893-8 in a CUP of 1 TABLETS
GEMFIBROZIL TABLETfbfdad8d-figure-01Label Image
|GEMFIBROZIL gemfibrozil tablet|
|Labeler — Carilion Materials Management (079239644)|
|Registrant — Carilion Materials Management (079239644)|
|Carilion Materials Management||079239644||REPACK (68151-2893)|
Revised: 03/2015 Carilion Materials Management
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