Etodolac is a nonsteroidal anti-inflammatory drug indicated for acute and long-term use in the management of signs and symptoms of the following. It is available as tablets, extended-release tablets and capsules for oral use. MedsAcross supplies Etodolac for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
Carefully consider the potential benefits and risks of etodolac and other treatment options before deciding to use etodolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Etodolac capsules are indicated: For acute and long-term use in the management of signs and symptoms of the following: Osteoarthritis Rheumatoid arthritis For the management of acute pain
Source: US FDA prescribing information
of etodolac, like that of other NSAIDs, is not completely understood, but may be related to prostaglandin synthetase inhibition. Etodolac is a racemic mixture of [-]R- and [+]S-etodolac. As with other NSAIDs, it has been demonstrated in animals that the [+]S-form is biologically active. Both enantiomers are stable and there is no [-]R to [+]S conversion in vivo. Pharmacokinetics Absorption The systemic bioavailability of etodolac is 100% as compared to solution and at least 80% as determined from mass balance studies. Etodolac is well absorbed and had a relative bioavailability of 100% when 200 mg capsules were compared with a solution of etodolac. Based on mass balance studies, the systemic availability of etodolac from either the tablet or capsule formulation is at least 80%. Etodolac does not undergo significant first-pass metabolism following oral administration.
Source: US FDA prescribing information
Carefully consider the potential benefits and risks of etodolac and other treatment options before deciding to use etodolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. After observing the response to initial therapy with etodolac, the dose and frequency should be adjusted to suit an individual patient’s needs. Dosage adjustment of etodolac is generally not required in patients with mild to moderate renal impairment. Etodolac should be used with caution in such patients, because, as with other NSAIDs, it may further decrease renal function in some patients with impaired renal function. Analgesia The recommended total daily dose of etodolac for acute pain is up to 1,000 mg, given as 200 to 400 mg every 6 to 8 hours.
Source: US FDA prescribing information
Etodolac is contraindicated in patients with known hypersensitivity to etodolac or other ingredients in etodolac capsules. Etodolac should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients. In the setting of coronary artery bypass graft (CABG) surgery
Source: US FDA prescribing information
Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Etodolac is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. Cardiovascular Effects Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs.
Source: US FDA prescribing information
In patients taking etodolac or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1 to 10% of patients are: Gastrointestinal experiences including: abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, GI ulcers (gastric/duodenal), vomiting. Other events including: abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritis, rashes, tinnitus. Adverse-reaction information for etodolac was derived from 2,629 arthritic patients treated with etodolac in double-blind and open-label clinical trials of 4 to 320 weeks in duration and worldwide postmarketing surveillance studies. In clinical trials, most adverse reactions were mild and transient.
Source: US FDA prescribing information
ACE-inhibitors Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors. Antacids The concomitant administration of antacids has no apparent effect on the extent of absorption of etodolac. However, antacids can decrease the peak concentration reached by 15% to 20% but have no detectable effect on the time-to-peak. Aspirin When etodolac is administered with aspirin, its protein binding is reduced, although the clearance of free etodolac is not altered. The clinical significance of this interaction is not known, however, as with other NSAIDs, concomitant administration of etodolac and aspirin is not generally recommended because of the potential of increased adverse effects.
Source: US FDA prescribing information
Store at controlled room temperature 20°C to 25°C (68°F to 77°F), excursions permitted from 15°C to 30°C (59°F to 86°F). Protect from moisture.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
7 presentations of Etodolac, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Etodolac 400 mg tabletOralGeneric name | — | US FDA | Available on request |
| Etodolac 500 mg tabletOralGeneric name | — | US FDA | Available on request |
| Etodolac 400 mg extended-release tabletOralGeneric name | — | US FDA | Available on request |
| Etodolac 600 mg extended-release tabletOralGeneric name | — | US FDA | Available on request |
| Etodolac 200 mg capsuleOralGeneric name | — | US FDA | Available on request |
| Etodolac 500 mg extended-release tabletOralGeneric name | — | US FDA | Available on request |
| Etodolac 300 mg capsuleOralGeneric name | — | US FDA | Available on request |
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 31 January 1991 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Etodolac in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 7 presentations of Etodolac and sources them for licensed hospitals, importers and physicians against valid import documents.
Yes. The US FDA first approved Etodolac on 31 January 1991, according to Drugs@FDA.
No listed presentation of Etodolac is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Etodolac is classified under ATC code M01AB08 (Etodolac).
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