Prescription medicine
Gemfibrozil Brand names: Lopid
Gemfibrozil (Lopid) is a prescription medicine with an FDA approval on record since 1981. FDA's NDC Directory lists it from 27 generic labelers, and pharmacies paid $0.104 per gemfibrozil 600 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the gemfibrozil FDA label on DailyMed (effective April 10, 2026, Northstar RxLLC); the NDA 18422 record on Drugs@FDA; every gemfibrozil label on DailyMed.
Highlights of the record
FDA label of April 10, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageGemfibrozil Tablets 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.
Forms and strengths
- 600 mg
Tablet; film-coated tablet.
On the market
- Earliest approval on file
- December 21, 1981 Lopid, Pfizer Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 17 first January 25, 1993; 8 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 28 of which 27 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.104 per tablet Gemfibrozil 600 mg tablet
- Shortage (FDA)
- None current 1 past records
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 15,090 through July 30, 2026
What is gemfibrozil used for?
From the label: indications and usageGemfibrozil Tablets 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. […]
Conditions named in the indications of gemfibrozil's FDA labels, with every medicine labeled for each:
From other gemfibrozil labelsHeart attack and coronary artery disease: 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 …
FDA pharmacologic class: Peroxisome Proliferator Receptor alpha Agonist.
Source: FDA drug label (Gemfibrozil), Northstar RxLLC, effective April 10, 2026 (SPL set 75cac02c-56e3-4dfe-b1e2-4ce166b28833), via openFDA; the full label on DailyMed
Is there a generic for gemfibrozil (Lopid)?
The FDA approved the first generic gemfibrozil on January 25, 1993. 17 generic applications are approved; 8 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists gemfibrozil from 27 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1981 earliest approval on file
- 1993 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for gemfibrozil (Lopid)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.104 per Gemfibrozil 600 mg tablet, up 2% from $0.102 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Gemfibrozil 600 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Gemfibrozil 600 mg tablet | Generic | $0.104 per tablet | $3.11 | +2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is gemfibrozil in shortage?
No gemfibrozil presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 1 record is all marked to be discontinued, the latest updated February 10, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Lopid, Tablet, 600 mg (NDC 0071-0737-20) | Pfizer Inc. | To Be Discontinued | February 10, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
What does the gemfibrozil label say about other medicines?
The gemfibrozil label names 27 other medicines in its interaction, contraindication or warning sections. The labels of 31 other medicines name gemfibrozil. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Atorvastatin | drug interactions | (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 … |
| Atrasentan | drug interactions | (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 … |
| Bosentan | drug interactions | (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 … |
| Colchicine | drug interactions | Caution should be excercised when prescribing gemfibrozil with colchicine, especially in elderly patients or patients with renal dysfunction. |
| Colestipol | drug interactions | (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). |
| Dabrafenib | drug interactions | (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). |
| Enzalutamide | drug interactions | (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). |
| Ezetimibe | drug interactions | (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 … |
| Fenofibrate | warnings | 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; … |
| Fluvastatin | drug interactions | (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 … |
| Glyburide | drug interactions | (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 … |
| Irinotecan | drug interactions | (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 … |
| Itraconazole | drug interactions | 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 2-3) 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 … |
| Loperamide | drug interactions | (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). |
Every other medicine the gemfibrozil label names
| Medicine named | Section | What the label says |
|---|---|---|
| Montelukast | drug interactions | … metabolized by CYP2C8 (e.g., dabrafenib, enzalutamide, loperamide, montelukast, paclitaxel, pioglitazone, rosiglitazone). |
| Olmesartan | drug interactions | … irinotecan], rosuvastatin, pitavastatin, pravastatin, rifampin, valsartan, olmesartan). |
| Paclitaxel | drug interactions | … by CYP2C8 (e.g., dabrafenib, enzalutamide, loperamide, montelukast, paclitaxel, pioglitazone, rosiglitazone). |
| Pioglitazone | drug interactions | … (e.g., dabrafenib, enzalutamide, loperamide, montelukast, paclitaxel, pioglitazone, rosiglitazone). |
| Pitavastatin | drug interactions | … glyburide, SN-38 [active metabolite of irinotecan], rosuvastatin, pitavastatin, pravastatin, rifampin, valsartan, olmesartan). |
| Pravastatin | drug interactions | … SN-38 [active metabolite of irinotecan], rosuvastatin, pitavastatin, pravastatin, rifampin, valsartan, olmesartan). |
| Repaglinide | contraindications | Combination therapy of gemfibrozil with repaglinide (see PRECAUTIONS ). |
| Rifampin | drug interactions | … metabolite of irinotecan], rosuvastatin, pitavastatin, pravastatin, rifampin, valsartan, olmesartan). |
| Rosuvastatin | drug interactions | Avoid concomitant use of gemfibrozil with rosuvastatin. |
| Selexipag | contraindications | Combination therapy of gemfibrozil with selexipag (see PRECAUTIONS ). |
| Simvastatin | contraindications | Combination therapy of gemfibrozil with simvastatin (see WARNINGS and PRECAUTIONS ). |
| Valsartan | drug interactions | … of irinotecan], rosuvastatin, pitavastatin, pravastatin, rifampin, valsartan, olmesartan). |
| Warfarin | drug interactions | (B) Anti-coagulants: CAUTION SHOULD BE EXERCISED WHEN WARFARIN IS GIVEN IN CONJUNCTION WITH GEMFIBROZIL. |
Other labels that name gemfibrozil
Source: FDA drug label (Gemfibrozil), Northstar RxLLC, effective April 10, 2026 (SPL set 75cac02c-56e3-4dfe-b1e2-4ce166b28833), via openFDA; the full label on DailyMed
What do FAERS reports show for gemfibrozil?
The FDA Adverse Event Reporting System holds 15,090 reports that list gemfibrozil among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,220 are coded as a death and 5,332 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as gemfibrozil?
19 other medicines are given the same way (oral) and in the same FDA class as gemfibrozil or labeled mainly for the same use (high cholesterol), the same class first. High cholesterol lists all 25 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Fenofibrate | High cholesterol | 54 labelers | $0.103 per tablet 160 mg tablet | No current entry |
| Fenofibric acid | High cholesterol | 7 labelers | $0.286 per capsule 135 mg capsule | No current entry |
| Atorvastatin | Heart attack and coronary artery disease, High cholesterol | 61 labelers | $0.0228 per tablet 10 mg tablet | No current entry |
| Rosuvastatin | Heart attack and coronary artery disease, High cholesterol | 46 labelers | $0.0692 per tablet 40 mg tablet | No current entry |
| Pravastatin | Heart attack and coronary artery disease, High cholesterol | 37 labelers | $0.058 per tablet 20 mg tablet | No current entry |
| Simvastatin | Heart attack and coronary artery disease, High cholesterol | 27 labelers | $0.0321 per tablet 20 mg tablet | No current entry |
| Lovastatin | Heart attack and coronary artery disease, High cholesterol | 19 labelers | $0.0436 per tablet 20 mg tablet | No current entry |
| Pitavastatin | High cholesterol | 12 labelers | $0.954 per tablet 2 mg tablet | No current entry |
Every medicine labeled for the same conditions as gemfibrozil
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does gemfibrozil compare with medicines for the same use?
6 side-by-side pages set gemfibrozil beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to gemfibrozil
- 19 medicines for the same use
- Other peroxisome proliferator receptor alpha agonists
- the pharmacologic class, with prices and generics
- Gemfibrozil side effects
- the label's list beside FAERS reports
- Gemfibrozil shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other