Gemfibrozil Side Effects

Brand Names: Lopid

Please note - some side effects for Gemfibrozil may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Gemfibrozil - for the Consumer

Gemfibrozil

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Gemfibrozil:

Blurred vision; diarrhea; dizziness; gas; headache; indigestion; nausea; stomach pain; tiredness; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); diarrhea; muscle pain; nausea; persistent or severe stomach pain; tenderness; vomiting; weakness.

Gemfibrozil Side Effects - for the Professional

Gemfibrozil

In the double-blind controlled phase of the primary prevention component of the Helsinki Heart Study, 2046 patients received Gemfibrozil tablets for up to five years. In that study, the following adverse reactions were statistically more frequent in subjects in the Gemfibrozil tablets group:

Adverse events reported by more than 1% subjects, but without a significant difference between groups:

Gallbladder surgery was performed in 0.9% of Gemfibrozil tablets 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 was also performed more frequently in the Gemfibrozil tablets 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 tablets group. These included hypesthesia, paresthesias, and taste perversion. Other adverse reactions that were more common among Gemfibrozil tablets 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 tablet is causally related to the occurrence of MUSCULOSKELETAL SYMPTOMS, and to ABNORMAL LIVER FUNCTION TESTS and HEMATOLOGIC CHANGES.

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 tablet is probable or not established:

Additional adverse reactions that have been reported included cholecystitis and cholelithiasis.

Side Effects by Body System

General

Gemfibrozil is generally well tolerated. The most common side effects are those relating to the gastrointestinal tract.

Gastrointestinal

Gastrointestinal side effects of gemfibrozil include dyspepsia (19.6%), abdominal pain (9.8%), diarrhea (4.8%), nausea (4.0%), vomiting (1.2%), and dry mouth.

Hepatic

Hepatic side effects of gemfibrozil include alterations in liver function tests and increased risk of gallstone formation. Cholestatic jaundice and cases of cholelithiasis have also been reported.

Gemfibrozil decreases bile acid and increases cholesterol secretion thus increasing lithogenicity of the bile and promoting gallstone formation. If a patient develops evidence of gallstones during gemfibrozil therapy, gemfibrozil should be discontinued. In general, gemfibrozil is considered contraindicated in patients with a history of gallbladder disease.

Renal

Gemfibrozil is reported to cause rhabdomyolysis and subsequent renal failure. In one review, all patients in whom outcome was reported either significantly improved or completely recovered.

Renal side effects of gemfibrozil include acute renal failure associated with myositis and rhabdomyolysis.

Musculoskeletal

Musculoskeletal side effects of gemfibrozil include arthralgia, myopathy, myalgia, polyarthritis, and rhabdomyolysis. Myositis induced compartment syndrome is reported in one patient.

Gemfibrozil has been associated with severe myopathy and rhabdomyolysis. This is accompanied by elevations in creatine kinase, myoglobinuria, and proteinuria, as well as renal failure. Elevations in creatine kinase are more marked when gemfibrozil has been combined with another agent which is also capable of causing myopathy (i.e., HMG CoA reductase inhibitors, niacin). One review noted a case report with a creatine kinase level of 148,000 units/mL in a 79-year-old woman taking both gemfibrozil and lovastatin. Additional studies have confirmed that the combination of gemfibrozil and a HMG CoA reductase inhibitor increases the incidence and severity of myotoxicity.

Patients should be instructed to report symptoms of muscle pain, weakness, or tenderness. If such symptoms develop, creatine kinase should be measured, and, if elevated, gemfibrozil should be discontinued.

Gemfibrozil is associated with a higher incidence of myotoxicity (i.e., rhabdomyolysis) than fenofibrate when used in combination with any HMG CoA reductase inhibitor (statin). Fenofibrate is primarily metabolized by glucuronidation, whereas gemfibrozil undergoes extensive oxidative metabolism which results in higher plasma levels of statins. This pharmacokinetic difference may account for the differences in the rates of myotoxicity.

Hematologic

Hematologic side effects of gemfibrozil include minor, transient decreases in hemoglobin, hematocrit, and white blood cell count which occur occasionally when gemfibrozil therapy is initiated but normalize with continued use. Leukopenia, leukocytosis, anemia, and eosinophilia are also reported. In addition, gemfibrozil may alter blood coagulation.

Nervous system

Nervous system side effects of gemfibrozil include dizziness, somnolence, headache, vertigo, hyperesthesia, paresthesias, taste perversion, and confusion.

Cardiovascular

Cardiovascular side effects of gemfibrozil include rare cases of atrial fibrillation, vasculitis, and Raynaud's phenomenon.

Dermatologic

Dermatologic side effects of gemfibrozil include rash, dermatitis, pruritus, psoriasis, and exfoliative dermatitis.

Genitourinary

Genitourinary side effects of gemfibrozil include impotence and decreased male fertility.

Hypersensitivity

A 56-year-old women with a one month history of progressive, watery diarrhea and lower abdominal cramps was admitted to the hospital for evaluation. The only change noted in the patient's history was the initiation of gemfibrozil two weeks before the diarrhea and mild abdominal cramping began. Initial laboratory values revealed an elevated eosinophil count of 1820/mm3 and a serum IgE level of 1990 intl units/mL. The gemfibrozil was discontinued and it was later determined that the patient's presentation was consistent with eosinophilic gastroenteritis. Methylprednisolone was initiated and the patient gradually recovered. On two subsequent follow-up visits, the patient was challenged with gemfibrozil and experienced the return of mild diarrhea and peripheral eosinophilia.

Hypersensitivity reactions are reported rarely with gemfibrozil and include urticaria, angioedema, laryngeal edema, and anaphylaxis. In addition, at least one case of eosinophilic gastroenteritis associated with gemfibrozil use has been reported.

Immunologic

Immunologic effects of gemfibrozil include a Lupus-like syndrome and positive antinuclear antibody tests; causality is not established.

Ocular

Ocular side effects of gemfibrozil include blurred vision, retinal edema, and cataracts.

Metabolic

Metabolic side effects of gemfibrozil include a case report of gout of the acromioclavicular joint.

Psychiatric

Psychiatric side effects of gemfibrozil include decreased libido and depression.

Oncologic

Many lipid-lowering drugs have been associated with tumor growth in rodents. Gemfibrozil has been specifically associated with liver tumors and Leydig cell tumors. Long-term clinical trials are needed to define the risk of cancer in humans.

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