Medicine guide

Gemfibrozil

600 mg · Tablet

Prescription only
Peroxisome Proliferator Receptor alpha Agonist

Active substance: Gemfibrozil
Used in: Heart, blood pressure and circulation
Made by: Zydus Lifesciences Limited
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2023-12-15

What it is

Peroxisome Proliferator Receptor alpha Agonist

Used for

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…

The label’s usual adult dose

Adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY ).

Full directions ↓

Do not take it if

Hepatic or severe renal dysfunction, including primary biliary cirrhosis.

All warnings ↓

Good to know

Prescription only
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

30other products contain Gemfibrozil — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

Gemfibrozil tablets, USP are indicated as adjunctive therapy to diet for:

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.
Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia).
Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis.
Gemfibrozil tablets therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis.
It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil tablets therapy on the risk of pancreatitis in such situations has not been adequately studied.
Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL).
Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia.
Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL- and raise HDL-cholesterol) and who have the following triad of lipid abnormalities:
low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS , PRECAUTIONS , and CLINICAL PHARMACOLOGY ).
The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease.
Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil.
In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol.
BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS.
GEMFIBROZIL TABLETS ARE ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY.
In a subgroup analysis of patients in the Helsinki Heart Study with above-median HDL-cholesterol values at baseline (greater than 46.4 mg/dL), the incidence of serious coronary events was similar for gemfibrozil and placebo subgroups (see Table I).
The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality.
Excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be managed prior to any drug therapy.
Physical exercise can be an important ancillary measure, and has been associated with rises in HDL-cholesterol.
Diseases contributory to hyperlipidemia such as hypothyroidism or diabetes mellitus should be looked for and adequately treated.
Estrogen therapy is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia.
In such cases, discontinuation of estrogen therapy may obviate the need for specific drug therapy of hypertriglyceridemia.
The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with nondrug methods.
If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.

From the official label · 2023-12-15 · DailyMed

How it works

From this product’s own US prescribing label.

Gemfibrozil is a lipid regulating agent which decreases serum triglycerides and very low density lipoprotein (VLDL) cholesterol, and increases high density lipoprotein (HDL) cholesterol.
While modest decreases in total and low density lipoprotein (LDL) cholesterol may be observed with gemfibrozil therapy, treatment of patients with elevated triglycerides due to Type IV hyperlipoproteinemia often results in a rise in LDL-cholesterol.

Peak level after1–2 h

How it leaves the body

Approximately seventy percent of the administered human dose is excreted in the urine, mostly as the glucuronide conjugate, with less than 2% excreted as unchanged gemfibrozil.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2023-12-15

Do not take it if

Hepatic or severe renal dysfunction, including primary biliary cirrhosis.
Preexisting gallbladder disease (see WARNINGS ).
Hypersensitivity to gemfibrozil.
Combination therapy of gemfibrozil with simvastatin (see WARNINGS and PRECAUTIONS ).
Combination therapy of gemfibrozil with repaglinide (see PRECAUTIONS ).
Combination therapy of gemfibrozil with dasabuvir (see PRECAUTIONS ).
Combination therapy of gemfibrozil with selexipag (see PRECAUTIONS ).

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

The recommended dose for
adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY ).

Quoted from the official label, section “Dosage & Administration”.

Other warnings

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, 1000 subjects with previous myocardial infarction were treated for five years with clofibrate.
There was no difference in mortality between the clofibrate-treated subjects and 3000 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), 5000 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 ).
Noncoronary heart disease related mortality showed an excess in the group originally randomized to gemfibrozil primarily due to cancer deaths observed during the open-label extension.
During the five year primary prevention component of the Helsinki Heart Study, mortality from any cause was 44 (2.2%) in the gemfibrozil group and 43 (2.1%) in the placebo group; including the 3.5 year follow-up period since the trial was completed, cumulative mortality from any cause was 101 (4.9%) in the gemfibrozil group and 83 (4.1%) in the group originally randomized to placebo (hazard ratio 1:20 in favor of placebo).
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 at Year-5 or at Year-8.5 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.
Noncoronary heart disease related mortality showed an excess in the group originally randomized to gemfibrozil at the 8.5 year follow-up (65 gemfibrozil versus 45 placebo noncoronary deaths).
The incidence of cancer (excluding basal cell carcinoma) discovered during the trial and in the 3.5 years after the trial was completed was 51 (2.5%) in both originally randomized groups.
In addition, there were 16 basal cell carcinomas in the group originally randomized to gemfibrozil and 9 in the group originally randomized to placebo (p=0.22).
There were 30 (1.5%) deaths attributed to cancer in the group originally randomized to gemfibrozil and 18 (0.9%) in the group originally randomized to placebo (p=0.11).
Adverse outcomes, including coronary events, were higher in gemfibrozil patients in a corresponding study in men with a history of known or suspected coronary heart disease in the secondary prevention component of the Helsinki Heart Study (see CLINICAL PHARMACOLOGY ).
A comparative carcinogenicity study was also done in rats comparing three drugs in this class:
fenofibrate (10 and 60 mg/kg; 0.3 and 1.6 times the human dose, respectively), clofibrate (400 mg/kg; 1.6 times the human dose), and gemfibrozil (250 mg/kg; 1.7 times the human dose).
Pancreatic acinar adenomas were increased in males and females on fenofibrate; hepatocellular carcinoma and pancreatic acinar adenomas were increased in males and hepatic neoplastic nodules in females treated with clofibrate; hepatic neoplastic nodules were increased in males and females treated with clofibrate; hepatic neoplastic nodules were increased in males and females treated with gemfibrozil while testicular interstitial cell (Leydig cell) tumors were increased in males on all three drugs. 2.
A gallstone prevalence substudy of 450 Helsinki Heart Study participants showed a trend toward a greater prevalence of gallstones during the study within the gemfibrozil treatment group (7.5% versus 4.9% for the placebo group, a 55% excess for the gemfibrozil group).
A trend toward a greater incidence of gallbladder surgery was observed for the gemfibrozil group (17 versus 11 subjects, a 54% excess).
This result did not differ statistically from the increased incidence of cholecystectomy observed in the WHO study in the group treated with clofibrate.
Both clofibrate and gemfibrozil may increase cholesterol excretion into the bile, leading to cholelithiasis.
If cholelithiasis is suspected, gallbladder studies are indicated.
Gemfibrozil therapy should be discontinued if gallstones are found.
Cases of cholelithiasis have been reported with gemfibrozil therapy. 3.
Since a reduction of mortality from coronary heart disease has not been demonstrated and because liver and interstitial cell testicular tumors were increased in rats, gemfibrozil should be administered only to those patients described in the INDICATIONS AND USAGE section.
If a significant serum lipid response is not obtained, gemfibrozil tablets should be discontinued. 4.
Concomitant Anticoagulants – Caution should be exercised when warfarin is given in conjunction with gemfibrozil.
The dosage of warfarin should be reduced to maintain the prothrombin time at the desired level to prevent bleeding complications.
Frequent prothrombin determinations are advisable until it has been definitely determined that the prothrombin level has stabilized. 5.
The concomitant administration of gemfibrozil with simvastatin is contraindicated (see CONTRAINDICATIONS and PRECAUTIONS ).
Concomitant therapy with gemfibrozil tablets and an HMG-CoA reductase inhibitor is associated with an increased risk of skeletal muscle toxicity manifested as rhabdomyolysis, markedly elevated creatine kinase (CPK) levels, and myoglobinuria, leading in a high proportion of cases to acute renal failure and death.
IN PATIENTS WHO HAVE HAD AN UNSATISFACTORY LIPID RESPONSE TO EITHER DRUG ALONE, THE BENEFIT OF COMBINED THERAPY WITH GEMFIBROZIL AND an HMG-CoA REDUCTASE INHIBITOR DOES NOT OUTWEIGH THE RISKS OF SEVERE MYOPATHY, RHABDOMYOLYSIS, AND ACUTE RENAL FAILURE (see PRECAUTIONS, Drug Interactions ).
The use of fibrates alone, including gemfibrozil, may occasionally be associated with myositis.
Patients receiving gemfibrozil and complaining of muscle pain, tenderness, or weakness should have prompt medical evaluation for myositis, including serum creatine–kinase level determination.
If myositis is suspected or diagnosed, gemfibrozil tablets therapy should be withdrawn. 6.
Cataracts – Subcapsular bilateral cataracts occurred in 10%, and unilateral in 6.3%, of male rats treated with gemfibrozil tablets at 10 times the human dose. 7.
CYP2C8 substrates - Gemfibrozil, a strong inhibitor of CYP2C8, may increase exposure of CYP2C8 substrates when administered concomitantly (see PRECAUTIONS, Drug Interactions ). 8.
OATP1B1 substrates – Gemfibrozil is an inhibitor of organic anion-transporter polyprotein (OATP) 1B1 and may increase exposure of drugs that are substrates of OATP1B1 (e.g., atrasentan, atorvastatin, bosentan, ezetimibe, fluvastatin, glyburide, SN-38 [active metabolite of irinotecan], rosuvastatin, pitavastatin, pravastatin, rifampin, valsartan, olmesartan).
Therefore, dosing reductions of drugs that are substrates of OATP1B1 may be required when gemfibrozil is used concomitantly (see PRECAUTIONS, Drug Interactions ).
Combination therapy of gemfibrozil with simvastatin or with repaglinide, which are OATP1B1 substrates, is contraindicated (see CONTRAINDICATIONS ).
1.
Initial Therapy – Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal.
Before instituting gemfibrozil therapy, every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. 2.
Continued Therapy – Periodic determination of serum lipids should be obtained, and the drug withdrawn if lipid response is inadequate after three months of therapy. 3.
Drug Interactions (A) HMG-CoA Reductase Inhibitors:
The concomitant administration of gemfibrozil with simvastatin is contraindicated (see CONTRAINDICATIONS and WARNINGS ).
Avoid concomitant use of gemfibrozil with rosuvastatin.
If concomitant use cannot be avoided, initiate rosuvastatin at 5 mg once daily.
The dose of rosuvastatin should not exceed 10 mg once daily.
The risk of myopathy and rhabdomyolysis is increased with combined gemfibrozil and HMG-CoA reductase inhibitor therapy.
Myopathy or rhabdomyolysis with or without acute renal failure have been reported as early as three weeks after initiation of combined therapy or after several months (see WARNINGS ).
There is no assurance that periodic monitoring of creatine kinase will prevent the occurrence of severe myopathy and kidney damage .
(B) Anticoagulants:
CAUTION SHOULD BE EXERCISED WHEN WARFARIN IS GIVEN IN CONJUNCTION WITH GEMFIBROZIL.
THE DOSAGE OF WARFARIN SHOULD BE REDUCED TO MAINTAIN THE PROTHROMBIN TIME AT THE DESIRED LEVEL TO PREVENT BLEEDING COMPLICATIONS.
FREQUENT PROTHROMBIN DETERMINATIONS ARE ADVISABLE UNTIL IT HAS BEEN DEFINITELY DETERMINED THAT THE PROTHROMBIN LEVEL HAS STABILIZED.
(C) CYP2C8 Substrates:
Gemfibrozil is a strong inhibitor of CYP2C8 and may increase exposure of drugs mainly metabolized by CYP2C8 (e.g., dabrafenib, enzalutamide, loperamide, montelukast, paclitaxel, pioglitazone, rosiglitazone).
Therefore, dosing reduction of drugs that are mainly metabolized by CYP2C8 enzyme may be required when gemfibrozil is used concomitantly (see WARNINGS ).
Repaglinide:
In healthy volunteers, co-administration with gemfibrozil (600 mg twice daily for 3 days) resulted in an 8.1-fold (range 5.5- to 15- fold) higher repaglinide AUC and a 28.6-fold (range 18.5- to 80.1-fold) higher repaglinide plasma concentration 7 hours after the dose.
In the same study, gemfibrozil (600 mg twice daily for 3 days) + itraconazole (200 mg in the morning and 100 mg in the evening at Day 1, then 100 mg twice daily at Day 2 to 3) resulted in a 19.4- (range 12.9- to 24.7-fold) higher repaglinide AUC and a 70.4-fold (range 42.9- to 119.2-fold) higher repaglinide plasma concentration 7 hours after the dose.
In addition, gemfibrozil alone or gemfibrozil + itraconazole prolonged the hypoglycemic effects of repaglinide.
Co-administration of gemfibrozil and repaglinide increases the risk of severe hypoglycemia and is contraindicated (see CONTRAINDICATIONS ).
Dasabuvir:
Co-administration of gemfibrozil with dasabuvir increased dasabuvir AUC and C max (ratios:
11.3 and 2.01, respectively) due to CYP2C8 inhibition.
Increased dasabuvir exposure may increase the risk of QT prolongation, therefore, co-administration of gemfibrozil with dasabuvir is contraindicated (see CONTRAINDICATIONS ).
Selexipag:
Coadministration of gemfibrozil with selexipag doubled exposure to selexipag and increased exposure to the active metabolite by approximately 11-fold.
Concomitant administration of gemfibrozil with selexipag is contraindicated (see CONTRAINDICATIONS ).
Enzalutamide:
In healthy volunteers given a single 160 mg dose of enzalutamide after gemfibrozil 600 mg twice daily, the AUC of enzalutamide plus active metabolite (N-desmethyl enzalutamide) was increased by 2.2 fold and corresponding C max was decreased by 16%.
Increased enzalutamide exposure may increase the risk of seizures.
If co-administration is considered necessary, the dose of enzalutamide should be reduced (see WARNINGS ).
(D) OATP1B1 substrates:
Gemfibrozil is an inhibitor of OATP1B1 transporter and may increase exposure of drugs that are substrates of OATP1B1 (e.g., atrasentan, atorvastatin, bosentan, ezetimibe, fluvastatin, glyburide, SN-38 [active metabolite of irinotecan], rosuvastatin, pitavastatin, pravastatin, rifampin, valsartan, olmesartan).
Therefore, dosing reductions of drugs that are substrates of OATP1B1 may be required when gemfibrozil is used concomitantly (see WARNINGS ).
Combination therapy of gemfibrozil with simvastatin or with repaglinide, which are OATP1B1 substrates, is contraindicated (see CONTRAINDICATIONS ).
(E) In vitro studies of CYP enzymes, UGTA enzymes and OATP1B1 transporter:
In vitro studies have shown that gemfibrozil is an inhibitor of CYP1A2, CYP2C8, CYP2C9, CYP2C19, OATP1B1, and UDP-glucuronosyltransferase (UGT) 1A1 and 1A3 (see WARNINGS ).
(F) Bile Acid-Binding Resins :
Gemfibrozil AUC was reduced by 30% when gemfibrozil was given (600 mg) simultaneously with resin-granule drugs such as colestipol (5 g).
Administration of the drugs two hours or more apart is recommended because gemfibrozil exposure was not significantly affected when it was administered two hours apart from colestipol (G) Colchicine:
Myopathy, including rhabdomyolysis, has been reported with chronic administration of colchicine at therapeutic doses.
Concomitant use of gemfibrozil may potentiate the development of myopathy.
Patients with renal dysfunction and elderly patients are at increased risk.
Caution should be exercised when prescribing gemfibrozil with colchicine, especially in elderly patients or patients with renal dysfunction. 4.
Carcinogenesis, Mutagenesis, Impairment of Fertility – Long-term studies have been conducted in rats at 0.2 and 1.3 times the human exposure (based on AUC).
The incidence of benign liver nodules and liver carcinomas was significantly increased in high dose male rats.
The incidence of liver carcinomas increased also in low dose males, but this increase was not statistically significant (p=0.1).
Male rats had a dose-related and statistically significant increase of benign Leydig cell tumors.
The higher dose female rats had a significant increase in the combined incidence of benign and malignant liver neoplasms.
Long-term studies have been conducted in mice at 0.1 and 0.7 times the human exposure (based on AUC).
There were no statistically significant differences from controls in the incidence of liver tumors, but the doses tested were lower than those shown to be carcinogenic with other fibrates.
Electron microscopy studies have demonstrated a florid hepatic peroxisome proliferation following gemfibrozil administration to the male rat.
An adequate study to test for peroxisome proliferation has not been done in humans but changes in peroxisome morphology have been observed.
Peroxisome proliferation has been shown to occur in humans with either of two other drugs of the fibrate class when liver biopsies were compared before and after treatment in the same individual.
Administration of approximately 2 times the human dose (based on surface area) to male rats for 10 weeks resulted in a dose-related decrease of fertility.
Subsequent studies demonstrated that this effect was reversed after a drug-free period of about eight weeks, and it was not transmitted to the offspring. 5.
Pregnancy – Gemfibrozil tablets have been shown to produce adverse effects in rats and rabbits at doses between 0.5 and 3 times the human dose (based on surface area).
There are no adequate and well-controlled studies in pregnant women.
Gemfibrozil tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Administration of gemfibrozil tablets to female rats at 2 times the human dose (based on surface area) before and throughout gestation caused a dose-related decrease in conception rate, an increase in stillborns, and a slight reduction in pup weight during lactation.
There were also dose-related increased skeletal variations.
Anophthalmia occurred, but rarely.
Administration of 0.6 and 2 times the human dose (based on surface area) of gemfibrozil tablets to female rats from gestation day 15 through weaning caused dose-related decreases in birth weight and suppressions of pup growth during lactation.
Administration of 1 and 3 times the human dose (based on surface area) of gemfibrozil tablets to female rabbits during organogenesis caused a dose-related decrease in litter size and, at the high dose, an increased incidence of parietal bone variations. 6.
Nursing Mothers – It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk and because of the potential for tumorigenicity shown for gemfibrozil in animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. 7.
Hematologic Changes – Mild hemoglobin, hematocrit, and white blood cell decreases have been observed in occasional patients following initiation of gemfibrozil therapy.
However, these levels stabilize during long-term administration.
Rarely, severe anemia, leukopenia, thrombocytopenia, and bone marrow hypoplasia have been reported.
Therefore, periodic blood counts are recommended during the first 12 months of gemfibrozil tablets administration. 8.
Liver Function – Abnormal liver function tests have been observed occasionally during gemfibrozil tablets administration, including elevations of AST, ALT, LDH, bilirubin, and alkaline phosphatase.
These are usually reversible when gemfibrozil tablets are discontinued.
Therefore, periodic liver function studies are recommended and gemfibrozil therapy should be terminated if abnormalities persist. 9.
Kidney Function – There have been reports of worsening renal insufficiency upon the addition of gemfibrozil therapy in individuals with baseline plasma creatinine >2 mg/dL.
In such patients, the use of alternative therapy should be considered against the risks and benefits of a lower dose of gemfibrozil tablets. 10.
Pediatric Use – Safety and efficacy in pediatric patients have not been established.

Quoted from the official label, section “Warnings”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

There have been reported cases of overdosage with gemfibrozil tablets.
In one case, a 7-year-old child recovered after ingesting up to 9 grams of gemfibrozil tablets.
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.

Quoted from the official label, section “Overdosage”.

Side effects

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 (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 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.
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 (see WARNINGS ), and to ABNORMAL LIVER FUNCTION TESTS and HEMATOLOGIC CHANGES (see PRECAUTIONS ).
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 tablets are listed below by system.
These are categorized according to whether a causal relationship to treatment with gemfibrozil tablets is probable or not established:
CAUSAL RELATIONSHIP PROBABLE CAUSAL RELATIONSHIP NOT ESTABLISHED General:
weight loss Cardiac:
extrasystoles Gastrointestinal:
cholestatic jaundice pancreatitis hepatoma colitis Central Nervous System:
dizziness somnolence paresthesia peripheral neuritis decreased libido depression depression headache confusion convulsions syncope Eye:
blurred vision retinal edema Genitourinary:
impotence decreased male fertility renal dysfunction Musculoskeletal:
myopathy myasthenia myalgia painful extremities arthralgia synovitis rhabdomyolysis (see WARNINGS and Drug Interactions under PRECAUTIONS ) Clinical Laboratory:
increased creatine phosphokinase increased bilirubin increased liver transaminases (AST, ALT) increased alkaline phosphatase positive antinuclear antibody Hematopoietic:
anemia leukopenia bone marrow hypoplasia eosinophilia thrombocytopenia Immunologic:
angioedema laryngeal edema urticaria anaphylaxis Lupus-like syndrome vasculitis Integumentary:
exfoliative dermatitis rash dermatitis pruritus alopecia photosensitivity Additional adverse reactions that have been reported include cholecystitis and cholelithiasis (see WARNINGS ).

Quoted from the official label, section “Adverse Reactions”.

What it looks like and how it is packed

Gemfibrozil Tablets USP, 600 mg are white to off white colored, oval shaped, film coated tablets, debossed with "553" on one side and separating "5" & "53" with break line and plain on other side and are supplied as follows:
NDC 70771-1431-3 in bottles of 30 tablets NDC 70771-1431-6 in bottles of 60 tablets NDC 70771-1431-9 in bottles of 90 tablets NDC 70771-1431-1 in bottles of 100 tablets NDC 70771-1431-5 in bottles of 500 tablets NDC 70771-1431-0 in bottles of 1,000 tablets NDC 70771-1431-4 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Storage
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] .
Protect from light and humidity.
Dispense in a tight, light-resistant container (USP).
Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088.
Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India Rev.: 12/23

Quoted from the official label, section “How Supplied”.

What is in it

Gemfibrozil tablets, USP is a lipid regulating agent.
It is available as tablets for oral administration.
The chemical name is 5-(2,5-dimethylphenoxy)2,2-dimethylpentanoic acid, with the following structural formula:
The molecular formula is C 15 H 22 O 3 and the molecular weight is 250.33.
It is soluble in alcohol, methanol and chloroform.
The melting point is 58° to 61°C.
Gemfibrozil is a white, waxy, crystalline solid which is stable under ordinary conditions.
Each gemfibrozil tablet intended for oral administration contains 600 mg of gemfibrozil.
In addition, each tablet contains the following inactive ingredients:
colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, methyl cellulose and microcrystalline cellulose.
Additionally each tablet contains opadry II white 33F28398 which contains hypromellose, lactose monohydrate, polyethylene glycol, talc and titanium dioxide.
Structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

This label’s list of inactive ingredients names none of: lactose, wheat or gluten, colour dyes, sugars, sugar alcohols, alcohol (ethanol), aspartame (phenylalanine), gelatin, peanut oil, soy, parabens, sulfites, titanium dioxide.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (31)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 31 of 31

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

FranceNo exact match for this strength and form

Every strength and form (1)

Canada1 matching products

TEVA-GEMFIBROZIL 600 mg · tablet

Every strength and form (1)

Netherlands3 matching products

Every strength and form (6)

Details

Made by	Zydus Lifesciences Limited
Active substance	Gemfibrozil
Used in	Heart, blood pressure and circulation
Strength	600 mg
Form	Tablet
Route	Oral
Packs	1000 TABLET in 1 BOTTLE · 100 TABLET in 1 BOTTLE
NDC	70771-1431

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

Report wrong or outdated information on this page

Other strengths and forms

30 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Tablet21 products
- 600 mg21
  600 mg · 21 companies
  +13 more
Tablet, Film Coated9 products
- 600 mg9
  600 mg · 9 companies
  +1 more

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Gemfibrozil600 mgPrescription onlyTablet, Film Coated NCS HealthCare of KY, LLC dba Vangard Labs · Gemfibrozil Gemfibrozil600 mgPrescription onlyTablet, Film Coated Rising Pharma Holdings, Inc. · Gemfibrozil Gemfibrozil600 mgPrescription onlyTablet Northstar RxLLC · Gemfibrozil Gemfibrozil600 mgPrescription onlyTablet Camber Pharmaceuticals, Inc. · Gemfibrozil Gemfibrozil600 mgPrescription onlyTablet PD-Rx Pharmaceuticals, Inc. · Gemfibrozil Gemfibrozil600 mgPrescription onlyTablet A-S Medication Solutions · Gemfibrozil

See every product with Gemfibrozil