Etodolac
Etodolac is a prescription NSAID (nonsteroidal anti-inflammatory drug) used to relieve the pain and inflammation of osteoarthritis, rheumatoid arthritis and, in some products, juvenile arthritis and short-term pain.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 77 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Etodolac is a prescription NSAID (nonsteroidal anti-inflammatory drug), thought to block an enzyme that makes prostaglandins, the chemicals behind pain and swelling, used for osteoarthritis, rheumatoid arthritis and, in some forms, juvenile arthritis or short-term pain; it is an older, familiar alternative to ibuprofen and naproxen, on the market since about 1991 and available generically. Most people tolerate it reasonably well, though indigestion, nausea and some ankle swelling are common. Its boxed warning covers heart attack, stroke and serious stomach bleeding, so black or bloody stools, chest pain or one-sided weakness need urgent care. Use the lowest dose for the shortest time.
Clinical pearls
- If you take warfarin or daily aspirin, check with your prescriber first, since either combination raises the risk of stomach bleeding.
- It can weaken ACE inhibitors and water pills like furosemide, so recheck blood pressure and watch for new swelling.
- Lithium, methotrexate, cyclosporine and digoxin levels can rise with etodolac, so those prescribers may want blood levels rechecked.
- Avoid it from about 30 weeks of pregnancy, and between 20 and 30 weeks use only the lowest dose briefly.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
NSAIDs like etodolac can raise your risk of serious, even fatal, heart attack and stroke, and of serious stomach or intestinal bleeding, ulcers and tears.
The heart risk can start early in treatment and may grow the longer you take it. Etodolac must not be used around coronary artery bypass graft (CABG) surgery.
Stomach problems can happen at any time and without warning symptoms. Older adults are at higher risk. Watch for chest pain, shortness of breath, weakness on one side, black or bloody stools, or vomiting blood, and get help right away.
Patient information guide A plain-language walkthrough of Etodolac, written from its FDA label.
What Etodolac is used for
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Etodolac is used for several types of pain and inflammation, depending on the product.
- Osteoarthritis: all Etodolac products.
- Rheumatoid arthritis: all Etodolac products.
- Acute pain: Etodolac capsules and tablets.
- Juvenile arthritis: Etodolac extended-release tablets.
How Etodolac works
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Etodolac is an NSAID. It reduces inflammation, pain and fever in animal studies. Like other NSAIDs, it may work by blocking prostaglandin synthetase, which helps make prostaglandins.
The exact mechanism is not completely understood. Etodolac is a mix of two mirror-image forms, and the S-form is the active one.
Etodolac dosage
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Etodolac is taken by mouth. Capsules and regular tablets are generally taken a few times a day. Extended-release tablets are taken once a day.
- Your prescriber will adjust the dose to your response.
- The goal is the lowest effective dose for the shortest time.
- Relief in chronic conditions is sometimes seen within a week, but most often by two weeks.
- Food does not significantly change how much extended-release etodolac is absorbed, though it raised peak levels.
Follow your prescriber and the label.
Dosing details from the FDA-approved label
From the Etodolac prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Analgesia (acute pain)
- 200-400 mg every 6 to 8 hours
- Maximum: total daily dose up to 1000 mg; doses greater than 1000 mg/day have not been adequately evaluated in well-controlled trials
- Osteoarthritis and Rheumatoid Arthritis (capsules and tablets)
- Recommended starting dose: 300 mg b.i.d., t.i.d., or 400 mg b.i.d., or 500 mg b.i.d
- A lower dose of 600 mg/day may suffice for long-term administration
- Maximum: doses above 1000 mg/day have not been adequately evaluated in well-controlled clinical trials
- Dosage adjustment generally not required in mild to moderate renal impairment; use with caution
- Osteoarthritis and Rheumatoid Arthritis (extended-release tablets)
- Recommended starting dose 400 to 1000 mg given orally once per day
- Lowest effective dose should be sought for each patient
- Juvenile Rheumatoid Arthritis, patients 6 to 16 years (extended-release tablets), body weight 20 to 30 kg
- 400 mg Tablet x 1 orally once per day
- Dose based on body weight
- Juvenile Rheumatoid Arthritis, patients 6 to 16 years (extended-release tablets), body weight 31 to 45 kg
- 600 mg Tablet x 1 orally once per day
- Dose based on body weight
- Juvenile Rheumatoid Arthritis, patients 6 to 16 years (extended-release tablets), body weight 46 to 60 kg
- 400 mg Tablet x 2 orally once per day
- Dose based on body weight
- Juvenile Rheumatoid Arthritis, patients 6 to 16 years (extended-release tablets), body weight >60 kg
- 500 mg Tablet x 2 orally once per day
- Dose based on body weight
Read the label’s full dosing text
DOSAGE AND ADMINISTRATION Carefully consider the potential benefits and risks of etodolac capsules and tablets and other treatment options before deciding to use etodolac capsules and tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). After observing the response to initial therapy with etodolac capsules and tablets, the dose and frequency should be adjusted to suit an individual patient's needs. Dosage adjustment of etodolac capsules and tablets 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 (see WARNINGS, Renal Effects ). Analgesia The recommended total daily dose of etodolac for acute pain is up to 1000 mg, given as 200-400 mg every 6 to 8 hours. Doses of etodolac greater than 1000 mg/day have not been adequately evaluated in well-controlled trials. Osteoarthritis and Rheumatoid Arthritis The recommended starting dose of etodolac for the management of the signs and symptoms of osteoarthritis or rheumatoid arthritis is: 300 mg b.i.d., t.i.d., or 400 mg b.i.d., or 500 mg b.i.d. A lower dose of 600 mg/day may suffice for long-term administration. Physicians should be aware that doses above 1000 mg/day have not been adequately evaluated in well-controlled clinical trials. In chronic conditions, a therapeutic response to therapy with etodolac is sometimes seen within one week of therapy, but most often is observed by two weeks. After a satisfactory response has been achieved, the patient's dose should be reviewed and adjusted as required.
Read the full Dosage and Administration section on DailyMed →
Etodolac side effects
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Most side effects were mild and temporary in clinical trials. Common ones include:
Common side effects
- Stomach pain or upset (dyspepsia)
- Nausea, vomiting
- Diarrhea, constipation or gas
- Dizziness
- Headache
- Rash or itching
- Ringing in the ears (tinnitus)
- Swelling (edema)
When to get medical help
- Chest pain, shortness of breath, weakness on one side, or slurred speech can signal a heart attack or stroke. Get emergency help.
- Black or bloody stools, vomiting blood, or severe stomach pain can signal stomach or intestinal bleeding or ulcers. Get medical help right away.
- Stop the medicine and call your doctor at the first sign of a skin rash, blistering, or other allergic signs.
- Fever, rash, swollen glands or facial swelling can signal a severe reaction called DRESS. Seek immediate care.
- Swelling of the face or throat, wheezing, or trouble breathing can signal a serious allergic reaction. Get emergency help.
- Worsening swelling, weight gain or shortness of breath can mean heart failure is getting worse.
- Signs of kidney or liver problems, such as yellowing skin or eyes, need prompt medical attention.
Etodolac warnings and precautions
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- Heart attack and stroke: risk can start early and rises with higher doses and longer use.
- Stomach bleeding and ulcers: can happen without warning, especially in older adults and people with ulcer history.
- Blood pressure and heart failure: NSAIDs can raise blood pressure and cause fluid retention.
- Kidney harm: higher risk with kidney disease, heart failure, liver problems, diuretics, ACE inhibitors, and older age.
- Serious allergic and skin reactions: including Stevens-Johnson syndrome and DRESS.
- Pregnancy: avoid at about 30 weeks or later.
Etodolac interactions
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Several medicines can clash with etodolac.
- Aspirin: more side effects, not generally recommended together.
- Warfarin: higher risk of serious stomach bleeding.
- ACE inhibitors and water pills: weaker blood pressure control.
- Lithium: levels can rise.
- Methotrexate, cyclosporine, digoxin: levels and toxicity can rise.
- Phenylbutazone: not recommended together.
- Antacids: lower peak levels by about 15 to 20% but do not change total absorption.
Interactions listed in the FDA-approved label
From the Etodolac prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- ACE-inhibitors: NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. Give this interaction consideration in patients taking NSAIDs with ACE-inhibitors.
- Antacids: No apparent effect on the extent of absorption of etodolac, but antacids can decrease the peak concentration reached by 15% to 20% with no detectable effect on time-to-peak.
- Aspirin: Etodolac's protein binding is reduced, although clearance of free etodolac is not altered; clinical significance is not known. Concomitant administration is not generally recommended because of the potential of increased adverse effects.
- Cyclosporine, Digoxin, Methotrexate: Etodolac, like other NSAIDs, may change elimination of these drugs, leading to elevated serum levels and increased toxicity; cyclosporine nephrotoxicity may also be enhanced. Observe patients, particularly those with altered renal function, for specific toxicities; do not give NSAIDs prior to or with high doses of methotrexate; use caution with methotrexate in general.
- Diuretics (furosemide, thiazides): No apparent pharmacokinetic interaction with furosemide or hydrochlorothiazide, but etodolac can reduce the natriuretic effect of furosemide and thiazides in some patients with possible loss of blood pressure control. Observe closely for signs of renal insufficiency or failure and to assure diuretic efficacy.
- Glyburide: No apparent pharmacokinetic interaction.
- Lithium: NSAIDs have produced elevated plasma lithium levels and reduced renal lithium clearance; mean minimum lithium concentration increased 15% and renal clearance decreased by approximately 20%. Observe carefully for signs of lithium toxicity; monitor lithium levels carefully if NSAID dosage adjustments are required.
- Phenylbutazone: Phenylbutazone increases the free fraction of etodolac by about 80%. Coadministration is not recommended.
- Phenytoin: No apparent pharmacokinetic interaction.
- Warfarin: Warfarin and NSAIDs have synergistic effects on GI bleeding; etodolac reduces warfarin protein binding without changing free warfarin clearance or prothrombin time, but there have been a few reports of prolonged prothrombin times, with or without bleeding. Concomitant therapy should not require dosage adjustment of either drug, but exercise caution and monitor such patients closely.
Read the label’s full interactions text
Drug Interactions 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 (see WARNINGS ). Antacids The concomitant administration of antacids has no apparent effect on the extent of absorption of etodolac capsules and tablets. 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 capsules and tablets are 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. 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. Nephrotoxicity associated with cyclosporine may also be enhanced. Patients receiving these drugs who are given etodolac, or any other NSAID, and particularly those patients with altered renal function, should be observed for the development of the specific toxicities of these drugs. NSAIDs, such as etodolac, should not be administered prior to or concomitantly with high doses of methotrexate. NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. In general, caution should be used when NSAIDs are administered concomitantly with methotrexate. Diuretics Etodolac has no apparent pharmacokinetic interaction when administered with furosemide or hydrochlorothiazide.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Etodolac
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- Do not use if allergic to etodolac, or if aspirin or NSAIDs caused asthma, hives or allergic reactions.
- Not for use around CABG surgery.
- Use caution after a recent heart attack or with severe heart failure.
- Use caution with high blood pressure, ulcers or bleeding history.
- Use caution with kidney disease. Not recommended in advanced kidney disease.
- Avoid at about 30 weeks of pregnancy or later.
- Older adults are at higher risk of serious stomach problems.
Etodolac overdose
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NSAID overdose can cause lethargy, drowsiness, nausea, vomiting and stomach pain. Stomach bleeding can occur. Rarely, high blood pressure, kidney failure or slowed breathing can occur. There is no specific antidote, so treatment is supportive care, and emergency help is needed.
What Etodolac does in the body
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Etodolac shows anti-inflammatory, pain-relieving and fever-reducing effects in animal models. It is a mix of two forms, and the S-form is the biologically active one. There is no conversion of the R-form to the S-form in the body.
How your body processes Etodolac
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Etodolac is well absorbed, with over 80% reaching the bloodstream. Regular tablets peak in about 1.4 hours, and extended-release tablets in about 6.7 hours. Half-life is about 6.4 hours for regular tablets and 8.4 hours for extended-release tablets.
It is more than 99% bound to proteins in the blood. It is broken down into metabolites and eliminated mostly in urine, with some in stool.
How to store Etodolac
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Store at 20°-25°C (68°-77°F) protected from moisture . Store at 20°-25°C (68°-77°F) . Store tablets in original container until ready to use.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Etodolac
52 supplements and herbal products have documented interactions with Etodolac in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 5
- Moderate · 35
- Minor · 12
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Etodolac: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Etodolac — the kind of thing our pharmacy team would talk through with you at the counter.
What is etodolac for?
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How should I take it?
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What side effects are common?
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When should I get help right away?
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Can I take it with aspirin or other medicines?
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Is it safe in pregnancy?
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Is Etodolac available over the counter?
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When was Etodolac first available?
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Who makes Etodolac?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Etodolac on HelloPharmacist
Etodolac forms and strengths (how it comes)
Etodolac is available in 3 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Etodolac inactive ingredients by manufacturer.
Tablet
How this form is used
- Etodolac tablets are used for osteoarthritis and rheumatoid arthritis, both acute and long-term.
- Etodolac tablets are also used to manage acute pain.
- Etodolac tablets are taken by mouth, with the dose and frequency adjusted to your response.
- Etodolac tablets should be used at the lowest effective dose for the shortest time.
Extended-release tablet
How this form is used
- Etodolac extended-release tablets are used for osteoarthritis and rheumatoid arthritis.
- Etodolac extended-release tablets are also used for juvenile arthritis.
- Etodolac extended-release tablets are taken by mouth once per day.
- For juvenile rheumatoid arthritis in ages 6 to 16, the Etodolac extended-release tablet dose is based on body weight.
Capsule
How this form is used
- Etodolac capsules are used for osteoarthritis and rheumatoid arthritis, both acute and long-term.
- Etodolac capsules are also used to manage acute pain.
- Etodolac capsules are taken by mouth, with the dose and frequency adjusted to your response.
- Etodolac capsules should be used at the lowest effective dose for the shortest time.
Etodolac on the U.S. market: products, makers and brands
How Etodolac appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
28 companies list 103 Etodolac product records with the FDA, mostly as tablet, extended-release tablet, capsule; the earliest marketing or approval year on record is 1991. Brand names on the directory include Lodine, Lodine XL; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (10) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Etodolac is used (Medicaid data)
A general measure of how commonly Etodolac is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Etodolac is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Etodolac prescribed? Of the 1,601 medications we measure, Etodolac ranks #659 by Medicaid prescriptions — more than 59% of them.
Utilization by Etodolac product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
etodolac 400 MG Oral Tablet Most dispensed
Summed across the 4 of 161 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197686
etodolac 500 MG Oral Tablet
Summed across the 4 of 68 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 199390
etodolac 300 MG Oral Capsule
Summed across the 3 of 43 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197685
etodolac 200 MG Oral Capsule
Summed across the 3 of 25 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197684
24 HR etodolac 400 MG Extended Release Oral Tablet
Summed across the 2 of 36 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 310245
24 HR etodolac 500 MG Extended Release Oral Tablet
Summed across the 3 of 35 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 359500
24 HR etodolac 600 MG Extended Release Oral Tablet
Summed across the 2 of 32 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 310247
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Etodolac, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 21 of 400 listed Etodolac NDCs with Medicaid activity.
Compare Etodolac products
A representative set of FDA-listed product records for Etodolac — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 300 mg | Oral | A-S Medication Solutions × 2 listings | ANDA | View NDC → |
| 200 mg | Oral | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 300 mg | Oral | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 200 mg | Oral | Apotex Corp. | ANDA | View NDC → |
| 300 mg | Oral | Apotex Corp. | ANDA | View NDC → |
| 200 mg | Oral | Bryant Ranch Prepack × 4 listings | ANDA | View NDC → |
| 300 mg | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 200 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 300 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 200 mg | Oral | Ipca Laboratories Limited | ANDA | View NDC → |
| 300 mg | Oral | Ipca Laboratories Limited | ANDA | View NDC → |
| 300 mg | Oral | Northwind Health Company, LLC | ANDA | View NDC → |
| 200 mg | Oral | Proficient Rx LP | ANDA | View NDC → |
| 200 mg | Oral | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 300 mg | Oral | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 💊Extended-release tablet | ||||
| 600 mg | Oral | Advanced Rx Pharmacy of Tennessee, LLC × 3 listings | ANDA | View NDC → |
| 600 mg | Oral | Bryant Ranch Prepack | ANDA | View NDC → |
| 400 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 500 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 400 mg | Oral | Northstar Rx Llc | ANDA | View NDC → |
| 500 mg | Oral | Northstar Rx Llc | ANDA | View NDC → |
| 600 mg | Oral | Northstar Rx Llc | ANDA | View NDC → |
| 400 mg | Oral | NuCare Pharmaceuticals, Inc. | ANDA | View NDC → |
| 400 mg | Oral | Proficient Rx LP × 3 listings | ANDA | View NDC → |
| 500 mg | Oral | St. Mary's Medical Park Pharmacy | ANDA | View NDC → |
| 400 mg | Oral | Taro Pharmaceuticals U.S.A., Inc. | ANDA | View NDC → |
| 500 mg | Oral | Taro Pharmaceuticals U.S.A., Inc. | ANDA | View NDC → |
| 600 mg | Oral | Taro Pharmaceuticals U.S.A., Inc. | ANDA | View NDC → |
| 400 mg | Oral | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| 500 mg | Oral | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| 600 mg | Oral | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| 400 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 500 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 600 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 400 mg | Oral | Zydus Pharmaceuticals USA Inc. | ANDA | View NDC → |
| 500 mg | Oral | Zydus Pharmaceuticals USA Inc. | ANDA | View NDC → |
| 600 mg | Oral | Zydus Pharmaceuticals USA Inc. | ANDA | View NDC → |
| 💊Tablet | ||||
| 400 mg | Oral | A-S Medication Solutions × 3 listings | ANDA | View NDC → |
| 500 mg | Oral | A-S Medication Solutions × 3 listings | ANDA | View NDC → |
| 400 mg | Oral | Advanced Rx of Tennessee, LLC | ANDA | View NDC → |
| 400 mg | Oral | Advanced Rx Pharmacy of Tennessee, LLC × 2 listings | ANDA | View NDC → |
| 400 mg | Oral | Amneal Pharmaceuticals NY LLC | ANDA | View NDC → |
| 500 mg | Oral | Amneal Pharmaceuticals NY LLC | ANDA | View NDC → |
| 400 mg | Oral | Aphena Pharma Solutions - Tennessee, LLC × 4 listings | ANDA | View NDC → |
| 500 mg | Oral | Aphena Pharma Solutions - Tennessee, LLC × 2 listings | ANDA | View NDC → |
| 400 mg | Oral | Apotex Corp. | ANDA | View NDC → |
| 500 mg | Oral | Apotex Corp. | ANDA | View NDC → |
| 400 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 500 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 400 mg | Oral | Bryant Ranch Prepack × 5 listings | ANDA | View NDC → |
| 500 mg | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 400 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 500 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 400 mg | Oral | Doc Rx | ANDA | View NDC → |
| 400 mg | Oral | Edenbridge Pharmaceuticals LLC. | ANDA | View NDC → |
| 500 mg | Oral | Edenbridge Pharmaceuticals LLC. | ANDA | View NDC → |
| 400 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 500 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 400 mg | Oral | Ipca Laboratories Limited | ANDA | View NDC → |
| 500 mg | Oral | Ipca Laboratories Limited | ANDA | View NDC → |
| 500 mg | Oral | Medsource Pharmaceuticals | ANDA | View NDC → |
| 400 mg | Oral | Northwind Health Company, LLC | ANDA | View NDC → |
| 500 mg | Oral | Northwind Health Company, LLC | ANDA | View NDC → |
| 400 mg | Oral | PD-Rx Pharmaceuticals, Inc. × 3 listings | ANDA | View NDC → |
| 500 mg | Oral | PD-Rx Pharmaceuticals, Inc. | ANDA | View NDC → |
| 400 mg | Oral | Preferred Pharmaceuticals Inc. × 3 listings | ANDA | View NDC → |
| 400 mg | Oral | Proficient Rx LP | ANDA | View NDC → |
| 500 mg | Oral | Proficient Rx LP | ANDA | View NDC → |
| 400 mg | Oral | Remedyrepack Inc. | ANDA | View NDC → |
| 500 mg | Oral | Remedyrepack Inc. × 2 listings | ANDA | View NDC → |
| 400 mg | Oral | St. Marys Medical Park Pharmacy | ANDA | View NDC → |
| 400 mg | Oral | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 500 mg | Oral | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 400 mg | Oral | Unichem Pharmaceuticals (USA), Inc. | ANDA | View NDC → |
| 500 mg | Oral | Unichem Pharmaceuticals (USA), Inc. | ANDA | View NDC → |
Showing 103 of 103 products — FDA National Drug Code Directory. See every product, package size and price: browse all 103 Etodolac NDCs →
Etodolac side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Etodolac — a signal of what to watch for, not proof the drug caused it.
The effects most often named in FDA reports that mention Etodolac are pain, nausea, arthralgia; about 65% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Etodolac in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Etodolac FDA approval history
How Etodolac went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Etodolac was first approved by the FDA in 1991 (Brand: LODINE · Wyeth Pharms Inc); the first generic version was approved in 1997. It remains available in U.S. pharmacies today.
Source: Drugs@FDA.
Etodolac recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Etodolac recalls since July 2021.
✅No Etodolac recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 24605 3 dose forms · 7 strengths
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Dose form (SCDF) Extended Release Oral Tablet RxCUI 379169In current FDA listingsClinical drug / strength (SCD) 24 HR etodolac 400 MGRxCUI 31024524 HR etodolac 500 MGRxCUI 35950024 HR etodolac 600 MGRxCUI 310247 -
Dose form (SCDF) Oral Capsule RxCUI 372125In current FDA listings -
Dose form (SCDF) Oral Tablet RxCUI 372126In current FDA listings
Look up RxCUI 24605 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Etodolac supply and shortage status
Whether Etodolac is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Etodolac costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet, Film Coated · Oral | 400 mg | $0.262 per tablet | NDC details & price history |
| Tablet, Film Coated · Oral | 500 mg | $0.285 per tablet | NDC details & price history |
| Capsule · Oral | 200 mg | $0.296 per capsule | NDC details & price history |
| Tablet, Film Coated, Extended Release · Oral | 600 mg | $1.07 per tablet | NDC details & price history |
| Tablet, Film Coated, Extended Release · Oral | 400 mg | $0.616 per tablet | NDC details & price history |
| Tablet, Film Coated, Extended Release · Oral | 500 mg | $0.718 per tablet | NDC details & price history |
| Tablet, Extended Release · Oral | 400 mg | $0.616 per tablet | NDC details & price history |
| Tablet, Extended Release · Oral | 600 mg | $1.07 per tablet | NDC details & price history |
| Tablet, Extended Release · Oral | 500 mg | $0.718–$1.04 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Etodolac brand names
Etodolac is sold under 2 brand names in the FDA directory — Lodine, Lodine XL. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Etodolac: manufacturers and labelers
28 companies list Etodolac products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, A-S Medication Solutions, Taro Pharmaceuticals U.S.A., Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
…and 4 more on the FDA NDC directory.
Etodolac drug class (RxNorm)
Etodolac belongs to the Nonsteroidal Anti-inflammatory Drug class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Etodolac page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Teva Pharmaceuticals USA, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →