Gemfibrozil Side Effects

Not all side effects for gemfibrozil may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to gemfibrozil: oral capsule, oral tablet

In addition to its needed effects, some unwanted effects may be caused by gemfibrozil. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking gemfibrozil:

More common
  • Bladder pain
  • bloody or cloudy urine
  • cough or hoarseness
  • difficult, burning, or painful urination
  • fever or chills
  • frequent urge to urinate
  • lower back or side pain
Incidence not known
  • Black, tarry stools
  • chest pain
  • dark-colored urine
  • indigestion
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • muscle cramps or spasms
  • muscle pain or stiffness
  • muscular pain, tenderness, wasting, or weakness
  • pale skin
  • severe nausea or vomiting
  • shortness of breath
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • stomach pain
  • swollen glands
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness

Some of the side effects that can occur with gemfibrozil may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Acid or sour stomach
  • belching
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • change in taste bad unusual or unpleasant (after) taste
  • diarrhea
  • heartburn
  • stomach discomfort or upset
Less common
  • Difficulty having a bowel movement (stool)
  • dizziness or lightheadedness
  • feeling of constant movement of self or surroundings
  • headache
  • nausea
  • sensation of spinning
  • skin rash, encrusted, scaly and oozing
  • vomiting

For Healthcare Professionals

Applies to gemfibrozil: compounding powder, oral tablet

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

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

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.

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

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.

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.

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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