Two medicines, side by side
Indomethacin vs naproxen
Indomethacin and naproxen are both labeled for osteoarthritis and rheumatoid arthritis. Drugs@FDA records approvals of indomethacin since 1965 and of naproxen since 1976. Pharmacies paid $0.210 per indomethacin ER 75 mg capsule and $0.0565 per naproxen 500 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like.
Check it at the source: the indomethacin FDA label on DailyMed (effective December 19, 2025); the naproxen FDA label on DailyMed (effective March 12, 2026).
Highlights of the indomethacin record
Indomethacin (Indocin) · label of December 19, 2025
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: indicationsIndomethacin 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
Highlights of the naproxen record
Naproxen (Aleve) · label of March 12, 2026
Used for
From the label: indicationstemporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache menstrual cramps headache toothache the common cold temporarily reduces fever
On the market
- Earliest approval on file
- March 11, 1976
- Generic labelers
- 139 labelers
- Pharmacy cost
- $0.0565 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 8
Source: FDA drug labels via openFDA (Indomethacin label of December 19, 2025, Naproxen label of March 12, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do indomethacin and naproxen 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: indomethacin since 1985; naproxen since 1992 (Drugs@FDA).
| Indomethacin | Naproxen | |
|---|---|---|
| Labeled for | Rheumatoid arthritis, Osteoarthritis | Fever, Rheumatoid arthritis, Osteoarthritis, Gout, Pain, Cough and cold |
| Pharmacologic class | Nonsteroidal Anti-inflammatory Drug | Nonsteroidal Anti-inflammatory Drug |
| How it works (label) | Indomethacin 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 … | n/a |
| Half-life (label) | The mean half-life of indomethacin is estimated to be about 4.5 hours. | n/a |
| Earliest approval on file (Drugs@FDA) | June 10, 1965 | March 11, 1976 |
| First generic approved | September 4, 1985 | October 30, 1992 |
| Generic labelers (NDC) | 31 labelers | 139 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.210 per capsule (Indomethacin ER 75 mg capsule) | $0.0565 per tablet (Naproxen 500 mg tablet) |
| 12-month price change | -1% | -9% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 9 | 8 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 13,174 | 142,225 |
| 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)
What do the labels say about using others of their kind?
Indomethacin label, drug interactionsConcomitant 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 ) ].
Naproxen label, drug interactions (prescription label)Concomitant use of naproxen 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 indomethacin
- every medicine labeled for the same conditions