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).
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For the consumer For the professional
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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:
Seek medical attention right away if any of these SEVERE side effects occur when using Gemfibrozil:Blurred vision; diarrhea; dizziness; gas; headache; indigestion; nausea; stomach pain; tiredness; vomiting.
TopSevere 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.
For the professional
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 | PLACEBO | |
| (N = 2046) | (N = 2035) | |
| Frequency in percent of subjects | ||
| Gastrointestinal reactions | 34.2 | 23.8 |
| Dyspepsia | 19.6 | 11.9 |
| Abdominal pain | 9.8 | 5.6 |
| Acute appendicitis | 1.2 | 0.6 |
| (histologically confirmed in most | ||
| cases where data were available) | ||
| Atrial fibrillation | 0.7 | 0.1 |
| Adverse events reported by more than 1% of subjects, but without a significant difference between groups: | ||
| Diarrhea | 7.2 | 6.5 |
| Fatigue | 3.8 | 3.5 |
| Nausea/Vomiting | 2.5 | 2.1 |
| Eczema | 1.9 | 1.2 |
| Rash | 1.7 | 1.3 |
| Vertigo | 1.5 | 1.3 |
| Constipation | 1.4 | 1.3 |
| Headache | 1.2 | 1.1 |
Gallbladder surgery 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 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, 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 is probable or not established:
| CAUSAL RELATIONSHIP | CAUSAL RELATIONSHIP | |
| PROBABLE | NOT ESTABLISHED | |
| General: | weight loss | |
| Cardiac: | extrasystoles | |
| Gastrointestinal: | cholestatic jaundice | pancreatitis |
| hepatoma | ||
| colitis | ||
| Central Nervous System: | dizziness | confusion |
| somnolence | convulsions | |
| paresthesia | syncope | |
| peripheral neuritis | ||
| decreased libido | ||
| depression | ||
| headache | ||
| Eye: | blurred vision | retinal edema |
| Genitourinary: | impotence | decreased male fertility |
| renal dysfunction | ||
| Musculoskeletal: | myopathy | |
| myasthenia | ||
| myalgia | ||
| painful extremities | ||
| arthralgia | ||
| synovitis | ||
| rhabdomyolysis | ||
| Clinical Laboratory: | increased creatine | positive antinuclear |
| phosphokinase | antibody | |
| increased bilirubin | ||
| increased liver | ||
| transaminases (AST [SGOT], ALT [SGPT]) | ||
| increased alkaline | ||
| phosphatase | ||
| Hematopoietic: | anemia | thrombocytopenia |
| leukopenia | ||
| bone marrow hypoplasia | ||
| eosinophilia | ||
| Immunologic: | angioedema | anaphylaxis |
| laryngeal edema | Lupus-like syndrome | |
| urticaria | vasculitis | |
| Integumentary: | exfoliative dermatitis | alopecia |
| rash | photosensitivity | |
| dermatitis | ||
| pruritus |
Additional adverse reactions that have been reported include cholecystitis and cholelithiasis (ref. 12).
TopMore resources:
Gemfibrozil - Includes detailed dosage instructions.
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