Two medicines, side by side

Gemfibrozil vs simvastatin

Gemfibrozil and simvastatin are both labeled for heart attack and coronary artery disease and high cholesterol. Drugs@FDA records approvals of gemfibrozil since 1981 and of simvastatin since 1991. Pharmacies paid $0.104 per gemfibrozil 600 mg tablet and $0.0321 per simvastatin 20 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, gemfibrozil is a peroxisome proliferator receptor alpha agonist and simvastatin a hmg-coa reductase inhibitor.

Check it at the source: the gemfibrozil FDA label on DailyMed (effective April 10, 2026); the simvastatin FDA label on DailyMed (effective March 28, 2025).

Highlights of the gemfibrozil record

Gemfibrozil (Lopid) · label of April 10, 2026

Used for

From the label: indications
Gemfibrozil 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. […]

On the market

Earliest approval on file: December 21, 1981
Generic labelers: 27 labelers
Pharmacy cost: $0.104 per tablet

Supply and safety

Shortage: A presentation being discontinued
Recalls: 0

Highlights of the simvastatin record

Simvastatin (Zocor) · label of March 28, 2025

Used for

From the label: indications
ZOCOR ® is indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. […]

On the market

Earliest approval on file: December 23, 1991
Generic labelers: 27 labelers
Pharmacy cost: $0.0321 per tablet

Supply and safety

Shortage: No current entry
Recalls: 26

Source: FDA drug labels via openFDA (Gemfibrozil label of April 10, 2026, Simvastatin label of March 28, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do gemfibrozil and simvastatin differ on the record?

In FDA's classes, gemfibrozil is a peroxisome proliferator receptor alpha agonist and simvastatin a hmg-coa reductase inhibitor.

Only the gemfibrozil label carries a boxed warning.

Generics: gemfibrozil since 1993; simvastatin since 2006 (Drugs@FDA).

	Gemfibrozil	Simvastatin
Labeled for	High cholesterol, Heart attack and coronary artery disease	Heart attack and coronary artery disease, High cholesterol, High triglycerides
Pharmacologic class	Peroxisome Proliferator Receptor alpha Agonist	HMG-CoA Reductase Inhibitor
How it works (label)	n/a	Simvastatin is a prodrug and is hydrolyzed to its active β-hydroxyacid form, simvastatin acid, after administration.
Half-life (label)	Peak plasma levels occur in 1 to 2 hours with a plasma half-life of 1.5 hours following multiple doses.	n/a
Earliest approval on file (Drugs@FDA)	December 21, 1981	December 23, 1991
First generic approved	January 25, 1993	June 23, 2006
Generic labelers (NDC)	27 labelers	27 labelers
Pharmacy cost (NADAC, each one's most listed form; strengths differ)	$0.104 per tablet (Gemfibrozil 600 mg tablet)	$0.0321 per tablet (Simvastatin 20 mg tablet)
12-month price change	+2%	+5%
Boxed warning	Yes	No
Shortage now	A presentation being discontinued	No current entry
Recalls recorded	0	26
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)	15,090	248,728
DEA schedule	none	none

Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)

Do their labels mention each other?

Gemfibrozil label, contraindications
Combination therapy of gemfibrozil with simvastatin (see WARNINGS and PRECAUTIONS ).

Gemfibrozil label, drug interactions
Drug Interactions (A) HMG-CoA Reductase Inhibitors: The concomitant administration of gemfibrozil with simvastatin is contraindicated ( see CONTRAINDICATIONS and WARNINGS ).

Simvastatin label, contraindications
Concomitant use of strong CYP3A4 inhibitors (select azole anti-fungals, macrolide antibiotics, anti-viral medications, and nefazodone) ( 4 , 7.1 ) Concomitant use of cyclosporine, danazol or gemfibrozil ( 4 , 7.1 ) Acute liver failure or decompensated cirrhosis ( 4 , 5.3 ) Hypersensitivity to simvastatin or any excipient in ZOCOR

Simvastatin label, drug interactions
Cyclosporine, Danazol, or Gemfibrozil Clinical Impact: The risk of myopathy and rhabdomyolysis is increased with concomitant use of cyclosporine, danazol, or gemfibrozil with ZOCOR. Gemfibrozil may cause myopathy when given alone. Intervention: Concomitant use of cyclosporine, danazol, or gemfibrozil with ZOCOR is contraindicated [see ].

What both labels say about taking them together

Source: FDA drug labels via openFDA

What next?

Gemfibrozil: the full record
Simvastatin: the full record
Alternatives to gemfibrozil: every medicine labeled for the same conditions