Prescription medicine
Etodolac First approved as Lodine
Etodolac (Lodine) is a prescription medicine with an FDA approval on record since 1991. FDA's NDC Directory lists it from 30 generic labelers, and pharmacies paid $0.262 per etodolac 400 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the etodolac FDA label on DailyMed (effective July 16, 2026, Aurobindo Pharma Limited); the NDA 18922 record on Drugs@FDA; every etodolac label on DailyMed.
Highlights of the record
FDA label of July 16, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
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 [see Warnings and Precautions ]. Etodolac tablets, 400 mg and 500 mg are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications and Warnings ]. Gastrointestinal Risk NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal (GI) events. (See WARNINGS ).
Used for
From the label: indications and usageCarefully consider the potential benefits and risks of etodolac tablets and other treatment options before deciding to use etodolac tablets.
Forms and strengths
- 200 mg
- 300 mg
- 400 mg
- 500 mg
- 600 mg
Film-coated tablet; capsule; film-coated extended-release tablet; extended-release tablet; tablet.
On the market
- Earliest approval on file
- January 31, 1991 Lodine, Wyeth Pharms Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 40 first February 28, 1997; 15 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 30 of which 30 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.262 per tablet Etodolac 400 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2013 0 Class I among all firms' recalls; 1 more by firms not listed as its makers
- FAERS reports
- 5,958 through July 30, 2026
What is etodolac used for?
From the label: indications and usageCarefully consider the potential benefits and risks of etodolac tablets and other treatment options before deciding to use etodolac tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Etodolac tablets 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
Conditions named in the indications of etodolac's FDA labels, with every medicine labeled for each:
From other etodolac labelsOsteoarthritis: Osteoarthritis 2.
FDA pharmacologic class: Nonsteroidal Anti-inflammatory Drug.
Source: FDA drug label (Etodolac), Aurobindo Pharma Limited, effective July 16, 2026 (SPL set c74c3c56-a5ac-40b4-974b-c4f4b05c5df9), via openFDA; the full label on DailyMed
What does the patient leaflet for etodolac say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?NSAIDs can cause serious side effects, including: Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase: with increasing doses of NSAIDs with longer use of NSAIDs Do not take NSAIDs right before or after a heart surgery called a "coronary artery bypass graft (CABG)." Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: anytime during use without warning symptoms that may cause death The risk of getting an ulcer or bleeding increases with: past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs taking medicines called "corticosteroids", "anticoagulants", "SSRIs", or "SNRIs" increasing doses of NSAIDs longer use of NSAIDs smoking drinking alcohol older age poor health advanced liver disease bleeding problems NSAIDs should only be used: exactly as prescribed at the lowest dose possible for your treatment for the shortest time needed
Source: FDA drug label (Etodolac), Aurobindo Pharma Limited, effective July 16, 2026 (SPL set c74c3c56-a5ac-40b4-974b-c4f4b05c5df9), via openFDA; the full label on DailyMed
Is there a generic for etodolac (Lodine)?
The FDA approved the first generic etodolac on February 28, 1997. 40 generic applications are approved; 15 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 etodolac from 30 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1991 earliest approval on file
- 1997 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for etodolac (Lodine)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.262 per Etodolac 400 mg tablet, about the same as a year earlier. 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.
- Etodolac 400 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Etodolac 200 mg capsule | Generic | $0.296 per capsule | $8.89 | -28% |
| Etodolac 300 mg capsule | Generic | $0.416 per capsule | $12.47 | +3% |
| Etodolac 400 mg tablet | Generic | $0.262 per tablet | $7.87 | +0.9% |
| Etodolac 500 mg tablet | Generic | $0.285 per tablet | $8.56 | -2% |
| Etodolac ER 400 mg tablet | Generic | $0.616 per tablet | $18.48 | -41% |
| Etodolac ER 500 mg tablet | Generic | $0.718 per tablet | $21.53 | -23% |
| Etodolac ER 600 mg tablet | Generic | $1.07 per tablet | $32.18 | -9% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has etodolac been recalled?
The FDA's Enforcement Report lists 1 recall naming etodolac since 2013: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of etodolac and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup; ETODOLAC, Tablet, 400 mg may be potentially mislabeled as PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units, NDC 00032121201 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the etodolac label say about other medicines?
The etodolac label names 10 other medicines in its interaction, contraindication or warning sections. 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 |
|---|---|---|
| Aspirin | contraindications | Etodolac tablets should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. |
| Cyclosporine | drug interactions | Cyclosporine, Digoxin, Methotrexate Etodolac, like other NSAIDs, through effects on renal prostaglandins, may cause changes in the elimination of these drugs leading to elevated serum levels of cyclosporine, digoxin, methotrexate, and increased toxicity. |
| Digoxin | drug interactions | Cyclosporine, Digoxin, Methotrexate Etodolac, like other NSAIDs, through effects on renal prostaglandins, may cause changes in the elimination of these drugs leading to elevated serum levels of cyclosporine, digoxin, methotrexate, and increased toxicity. |
| Furosemide | drug interactions | Nevertheless, clinical studies, as well as postmarketing observations have shown that etodolac can reduce the natriuretic effect of furosemide and thiazides in some patients with possible loss of blood pressure control. |
| Glyburide | drug interactions | Glyburide Etodolac has no apparent pharmacokinetic interaction when administered with glyburide. |
| Hydrochlorothiazide | drug interactions | Diuretics Etodolac has no apparent pharmacokinetic interaction when administered with furosemide or hydrochlorothiazide. |
| Lithium | drug interactions | Lithium NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. |
| Methotrexate | drug interactions | Cyclosporine, Digoxin, Methotrexate Etodolac, like other NSAIDs, through effects on renal prostaglandins, may cause changes in the elimination of these drugs leading to elevated serum levels of cyclosporine, digoxin, methotrexate, and increased toxicity. |
| Phenytoin | drug interactions | Phenytoin Etodolac has no apparent pharmacokinetic interaction when administered with phenytoin. |
| Warfarin | drug interactions | Warfarin The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than that of users of either drug alone. |
Source: FDA drug label (Etodolac), Aurobindo Pharma Limited, effective July 16, 2026 (SPL set c74c3c56-a5ac-40b4-974b-c4f4b05c5df9), via openFDA; the full label on DailyMed
What do FAERS reports show for etodolac?
The FDA Adverse Event Reporting System holds 5,958 reports that list etodolac among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 461 are coded as a death and 1,961 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 etodolac?
52 other medicines are given the same way (oral) and in the same FDA class as etodolac or labeled mainly for the same use (pain), the same class first. Pain lists all 80 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 |
|---|---|---|---|---|
| Ibuprofen | Pain, Osteoarthritis, Rheumatoid arthritis | 273 labelers | $0.0573 per tablet 800 mg tablet | No current entry |
| Naproxen | Pain, Osteoarthritis, Rheumatoid arthritis | 146 labelers | $0.0565 per tablet 500 mg tablet | No current entry |
| Celecoxib | Pain, Osteoarthritis, Rheumatoid arthritis | 65 labelers | $0.0762 per capsule 200 mg capsule | No current entry |
| Diclofenac | Pain, Osteoarthritis, Rheumatoid arthritis | 67 labelers | $0.0619 per tablet 75 mg tablet | A presentation being discontinued |
| Acetaminophen and aspirin and caffeine | Pain | 39 labelers | $0.0648 per unit 250-250-65 mg cplt | No current entry |
| Meloxicam | Pain, Osteoarthritis, Rheumatoid arthritis | 43 labelers | $0.0166 per tablet 7.5 mg tablet | No current entry |
| Acetaminophen and ibuprofen | Pain | 51 labelers | $0.107 per unit 250-125 mg | No current entry |
| Indomethacin | Osteoarthritis, Rheumatoid arthritis | 25 labelers | $0.210 per capsule 75 mg capsule | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does etodolac compare with medicines for the same use?
8 side-by-side pages set etodolac beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to etodolac
- 52 medicines for the same use
- Other NSAIDs
- the pharmacologic class, with prices and generics
- Etodolac side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other