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Two medicines, side by side

Diclofenac vs indomethacin

Diclofenac and indomethacin are both labeled for osteoarthritis and rheumatoid arthritis. Drugs@FDA records approvals of diclofenac since 1988 and of indomethacin since 1965. Pharmacies paid $0.0619 per diclofenac sod DR 75 mg tablet and $0.210 per indomethacin ER 75 mg capsule (NADAC, October 7, 2026).

Check it at the source: the diclofenac FDA label on DailyMed (effective February 11, 2025); the indomethacin FDA label on DailyMed (effective December 19, 2025).

Highlights of the diclofenac record

Diclofenac (Voltaren) · label of February 11, 2025

Used for

From the label: indications

• for the temporary relief of arthritis pain ONLY in the following areas: o hand, wrist, elbow (upper body areas) o foot, ankle, knee (lower body areas) • this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use.

On the market

Earliest approval on file
July 28, 1988
Generic labelers
149 labelers
Pharmacy cost
$0.0619 per tablet

Supply and safety

Shortage
A presentation being discontinued
Recalls
6

Highlights of the indomethacin record

Indomethacin (Indocin) · label of December 19, 2025

Boxed warning

RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning.

Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal.

Used for

From the label: indications

Indomethacin capsules are indicated for: • Moderate to severe rheumatoid arthritis including acute flares of chronic disease • Moderate to severe ankylosing spondylitis • Moderate to severe osteoarthritis • Acute painful shoulder (bursitis and/or tendinitis) • Acute gouty arthritis Indomethacin capsules are nonsteroidal anti-inflammatory drug indicated for: • Moderate to severe rheumatoid arthritis including acute […]

On the market

Earliest approval on file
June 10, 1965
Generic labelers
31 labelers
Pharmacy cost
$0.210 per capsule

Supply and safety

Shortage
No current entry
Recalls
9

Source: FDA drug labels via openFDA (Diclofenac label of February 11, 2025, Indomethacin label of December 19, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do diclofenac and indomethacin differ on the record?

Both are in FDA's class nonsteroidal anti-inflammatory drugs.

Both labels carry a boxed warning; the records quote them.

Generics: diclofenac since 1995; indomethacin since 1985 (Drugs@FDA).

DiclofenacIndomethacin
Labeled forPain, Osteoarthritis, Rheumatoid arthritis, MigraineRheumatoid arthritis, Osteoarthritis
Pharmacologic classNonsteroidal Anti-inflammatory DrugNonsteroidal Anti-inflammatory Drug
How it works (label)n/aIndomethacin has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of indomethacin capsules, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and …
Half-life (label)n/aThe mean half-life of indomethacin is estimated to be about 4.5 hours.
Earliest approval on file (Drugs@FDA)July 28, 1988June 10, 1965
First generic approvedJune 29, 1995September 4, 1985
Generic labelers (NDC)149 labelers31 labelers
Pharmacy cost (NADAC, each one's most listed form; strengths differ)$0.0619 per tablet (Diclofenac sod DR 75 mg tablet)$0.210 per capsule (Indomethacin ER 75 mg capsule)
12-month price change-25%-1%
Boxed warningYesYes
Shortage nowA presentation being discontinuedNo current entry
Recalls recorded69
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)158,67513,174
DEA schedulenonenone

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

What do the labels say about using others of their kind?

Diclofenac label, drug interactions (prescription label)

The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of diclofenac and aspirin is not generally recommended because of the potential of increased adverse effects.

Indomethacin label, drug interactions

Concomitant use of indomethacin with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy [ see Warnings and Precautions ( 5.2 ) ].

Source: FDA drug labels via openFDA

What next?

Alternatives to diclofenac
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