Does Lopid (gemfibrozil) cause side effects?
Lopid (gemfibrozil) is a blood lipid and cholesterol-altering medicine used to reduce elevated triglyceride levels that are high enough to cause pancreatitis.
Because Lopid raises HDL and decreases triglycerides it is prescribed to prevent coronary heart disease in individuals without a history or symptoms of coronary heart disease who have low HDL, high LDL and high triglycerides. Lopid is prescribed after other therapies have failed, and it is not intended for treating patients who only have low HDL. Lopid is used together with diet and exercise.
Common side effects of Lopid include
Serious side effects of Lopid include
- muscle aches and pain,
- kidney damage,
- formation of gallstones and need for gallbladder surgery,
- pancreatitis,
- abnormal blood liver tests,
- low red blood cells (anemia),
- low white blood cells (leukopenia), and
- low blood platelets (thrombocytopenia).
Drug interactions of Lopid include statins such as the following because these increase the risk of rhabdomyolysis (muscle injury) that when severe can lead to kidney damage and even death. Rhabdomyolysis may occur as early as three weeks or several months after starting combination therapy.
Lopid can increase the effect of the blood thinner, warfarin, and may lead to bleeding.
Lopid increases blood levels of repaglinide in people with diabetes, increasing the likelihood of developing low blood sugar (hypoglycemia). This combination should be avoided.
Colestipol and cholestyramine reduce the absorption of Lopid and reduce its effectiveness if taken at the same time. Lopid should be administered one hour before or 4-6 hours after administering colestipol or cholestyramine.
The effect of Lopid in pregnant women has not been well-studied. Lopid should be used during pregnancy only if the potential benefit justifies the unknown but potential risk to the fetus. It is unknown if Lopid is excreted in human milk. Consult your doctor before breastfeeding.
What are the important side effects of Lopid (gemfibrozil)?
Common side effects of gemfibrozil include:
Muscle aches and pain also occur. Rarely, these muscle-related symptoms are associated with damage to muscles that releases chemicals into the blood that that can damage the kidney. Muscle damage is of greatest concern when gemfibrozil is combined with statins.
The formation of gallstones and gallbladder surgery have been associated with the use of gemfibrozil. Pancreatitis, abnormal blood liver tests, as well as reduced red blood cells (anemia), white blood cells (leukopenia) and blood platelets (thrombocytopenia) also have been reported.
Lopid (gemfibrozil) side effects list for healthcare professionals
In the double-blind controlled phase of the primary prevention component of the Helsinki Heart Study, 2046 patients received Lopid for up to five years. In that study, the following adverse reactions were statistically more frequent in subjects in the Lopid group:
Lopid (N = 2046) |
PLACEBO (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 (histologically confirmed in most cases where data were available) | 1.2 | 0.6 |
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 Lopid 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 group compared to the placebo group of the WHO study.
- Gallbladder surgery was also performed more frequently in the Lopid group compared to the placebo group (1.9% versus 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 versus 0 on placebo, p=0.014).
- Nervous system and special senses adverse reactions were more common in the Lopid group.
- These included hypesthesia, paresthesias, and taste perversion.
- Other adverse reactions that were more common among Lopid
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 Lopid 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 Lopid is probable or not established:
CAUSAL RELATIONSHIP PROBABLE | CAUSAL RELATIONSHIP NOT ESTABLISHED | |
General: | weight loss | |
Cardiac: | extrasystoles pancreatitis | |
Gastrointestinal: | cholestatic jaundice | hepatoma colitis |
Central Nervous | ||
System: | dizziness somnolence paresthesia peripheral neuritis decreased libido depression headache | confusion convulsions syncope |
Eye: | blurred vision | retinal edema decreased male fertility |
Genitourinary: | impotence | renal dysfunction |
Musculoskeletal: | myopathy myasthenia myalgia painful extremities arthralgia s yno vitis rhabdomyolysis | |
Clinical | increased creatine phosphokinase increased bilirubin | |
Laboratory: | increased liver transaminases (AST, ALT) increased alkaline phosphatase anemia | positive antinuclear antibody |
Hematopoietic: | leukopenia bone marrow hypoplasia eosinophilia angioedema | thrombocytopenia anaphylaxis |
Immunologic: | laryngeal edema urticaria exfoliative dermatitis | Lupus-like syndrome vasculitis |
Integumentary: | rash dermatitis pruritus | alopecia photosensitivity |
Additional adverse reactions that have been reported include cholecystitis and cholelithiasis.
Summary
Lopid (gemfibrozil) is a blood lipid and cholesterol-altering medicine used to reduce elevated triglyceride levels that are high enough to cause pancreatitis. Common side effects of Lopid include upset stomach, stomach pain, diarrhea, headache, tiredness, nausea, and vomiting. Lopid should be used during pregnancy only if the potential benefit justifies the unknown but potential risk to the fetus. It is unknown if Lopid is excreted in human milk.
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.