pharmacopeia
GET
/api/v1/drug/gemfibrozil
2D structure
5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid
SMILES CC1=CC(=C(C=C1)C)OCCCC(C)(C)C(=O)O
InChIKey HEMJJKBWTPKOJG-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Peroxisome Proliferator-activated Receptor alpha Agonists.

Peroxisome Proliferator-activated Receptor alpha

Indications

Sourced from openFDA
  • Gemfibrozil Tablets are indicated as adjunctive therapy to diet for: 1. Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them.ICD-10: E78.5

Contraindications

Sourced from openFDA
  • Hepatic or severe renal dysfunction, including primary biliary cirrhosis. Preexisting gallbladder disease (see WARNINGS ).contraindicated

Dosage & administration

Sourced from openFDA

The recommended dose for adults is 1,200 mg administered in two divided doses 30 minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY ).

Warnings & precautions

Sourced from openFDA

1. Because of chemical, pharmacological, and clinical similarities between gemfibrozil and clofibrate, the adverse findings with clofibrate in two large clinical studies may also apply to gemfibrozil. In the first of those studies, the Coronary Drug Project, 1,000 subjects with previous myocardial infarction were treated for five years with clofibrate. There was no difference in mortality between the clofibrate-treated subjects and 3,000 placebo-treated subjects, but twice as many clofibrate-treated subjects developed cholelithiasis and cholecystitis requiring surgery. In the other study, conducted by the World Health Organization (WHO), 5,000 subjects without known coronary heart disease were treated with clofibrate for five years and followed one year beyond. There was a statistically significant (44%) higher age-adjusted total mortality in the clofibrate-treated group than in a comparable placebo-treated control group during the trial period. The excess mortality was due to a 33% increase in non-cardiovascular causes, including malignancy, post-cholecystectomy complications, and pancreatitis. The higher risk of clofibrate-treated subjects for gallbladder disease was confirmed. Because of the more limited size of the Helsinki Heart Study, the observed difference in mortality from any cause between the gemfibrozil and placebo groups is not statistically significantly different from the 29% excess mortality reported in the clofibrate group in the separate WHO study at the nine year follow-up (see CLINICAL PHARMACOLOGY ).

Adverse reactions

Sourced from openFDA

In the double-blind controlled phase of the primary prevention component of the Helsinki Heart Study, 2,046 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 = 2,046 ) PLACEBO ( N = 2,035 ) 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 group compared to the placebo group of the WHO study. Gallbladder surgery was also performed more frequently in the gemfibrozil 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 gemfibrozil group.

Overdosage

Sourced from openFDA

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.

Approval history

Sourced from openFDA
  • Dec 21, 1981NDANDA018422Pfizer Pharms
  • Sep 27, 1993ANDAANDA074270Chartwell Molecules
  • Jul 27, 2006ANDAANDA077836Invagen Pharms
  • Sep 13, 2010ANDAANDA079072Northstar Hlthcare
  • Sep 16, 2015ANDAANDA202726Aurobindo Pharma Ltd
  • Jun 17, 2016ANDAANDA203266Cadila Pharms Ltd
  • Aug 28, 2018ANDAANDA204189Cadila
  • Jan 13, 2021ANDAANDA214603Ascent Pharms Inc

FDA shortages

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Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Lopid, Tablet, 600 mg (NDC 0071-0737-20)To be discontinued
    Sponsor: Pfizer Inc.
    Updated

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
15,021 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Nausea8845.9%
  2. 2Fatigue8255.5%
  3. 3Drug Ineffective7695.1%
  4. 4Diarrhoea7294.9%
  5. 5Pain6934.6%
  6. 6Dizziness6174.1%
  7. 7Rhabdomyolysis6054.0%
  8. 8Dyspnoea5994.0%
  9. 9Asthenia5974.0%
  10. 10Headache5623.7%
  11. 11Renal Failure5593.7%
  12. 12Vomiting5103.4%
  13. 13Chronic Kidney Disease4843.2%
  14. 14Drug Interaction4673.1%
  15. 15Pain In Extremity4573.0%

Literature

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Recent PubMed references pinned to Gemfibrozil as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 42 ClinicalTrials.gov registrations naming Gemfibrozil as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Gemfibrozil work?
Mechanism-of-action class: Peroxisome Proliferator-activated Receptor alpha Agonists.
What is Gemfibrozil used for?
According to FDA labeling, Gemfibrozil carries indications including: Gemfibrozil Tablets are indicated as adjunctive therapy to diet for: 1. Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Gemfibrozil?
Gemfibrozil is classified as Fibrates, Peroxisome Proliferator-activated Receptor alpha Agonist, Peroxisome Proliferator-activated Receptor alpha Agonists, Increased Lipolysis.
What are the brand names for Gemfibrozil?
Gemfibrozil is marketed under brand names including Lopid.
What are the contraindications for Gemfibrozil?
Gemfibrozil labeling lists contraindications including: Hepatic or severe renal dysfunction, including primary biliary cirrhosis. Preexisting gallbladder disease (see WARNINGS ).. Always consult the full prescribing information and a clinician.
Note. Data for gemfibrozil is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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