Prescription medicine

Diflunisal Brand names: Dolobid

Diflunisal (Dolobid) is a prescription medicine with an FDA approval on record since 1982. FDA's NDC Directory lists it from 6 generic labelers, and pharmacies paid $1.06 per diflunisal 500 mg tablet in the October 7, 2026 NADAC survey.

Generic listed
Boxed warning

Check it at the source: the diflunisal FDA label on DailyMed (effective August 4, 2026, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.); the NDA 18445 record on Drugs@FDA; every diflunisal label on DailyMed.

Highlights of the record

FDA label of August 4, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Boxed warning

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 ). Diflunisal tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATION 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 events (see WARNINGS ).

Used for

From the label: indications and usage
Carefully consider the potential benefits and risks of diflunisal tablets and other treatment options before deciding to use diflunisal tablets.

Forms and strengths

250 mg
375 mg
500 mg

Film-coated tablet; tablet.

On the market

Earliest approval on file: April 19, 1982 Dolobid, Merck; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 9 first July 31, 1992; 3 with a marketed status in Drugs@FDA
Labelers listed (NDC): 6 of which 6 under generic applications, 0 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC): $1.06 per tablet Diflunisal 500 mg tablet
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded
FAERS reports: 806 through July 30, 2026

What is diflunisal used for?

From the label: indications and usage
Carefully consider the potential benefits and risks of diflunisal tablets and other treatment options before deciding to use diflunisal tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Diflunisal tablets are indicated for acute or long-term use for symptomatic treatment of the following: Mild to moderate pain Osteoarthritis Rheumatoid arthritis

Conditions named in the indications of diflunisal's FDA labels, with every medicine labeled for each:

FDA pharmacologic class: Nonsteroidal Anti-inflammatory Drug.

Source: FDA drug label (diflunisal), Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., effective August 4, 2026 (SPL set 666f89b4-fd81-420a-a390-eb1cd4014f61), via openFDA; the full label on DailyMed

What does the patient leaflet for diflunisal 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: o with increasing doses of NSAIDs o 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: o anytime during use o without warning symptoms o that may cause death The risk of getting an ulcer or bleeding increases with: o past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs o taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs” o increasing doses of NSAIDs o longer use of NSAIDs o smoking o drinking alcohol o older age o poor health o advanced liver disease o bleeding problems NSAIDs should only be used: o exactly as prescribed o at the lowest dose possible for your treatment o for the shortest time needed

Is there a generic for diflunisal (Dolobid)?

The FDA approved the first generic diflunisal on July 31, 1992. 9 generic applications are approved; 3 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 diflunisal from 6 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.

1982 earliest approval on file
1992 first generic approved

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for diflunisal (Dolobid)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.06 per Diflunisal 500 mg tablet, down 4% from $1.10 on October 8, 2025. 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.

Diflunisal 500 mg tablet (generic)

$1.25

$0.839

January 2024October 2026

NADAC per unit, October 7, 2026
Strength and form	Brand or generic	Pharmacy cost	30 tablets, or one pen or vial	12-month change
Diflunisal 500 mg tablet	Generic	$1.06 per tablet	$31.94	-4%

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

What does the diflunisal label say about other medicines?

The diflunisal label names 10 other medicines in its interaction, contraindication or warning sections. The labels of 21 other medicines name diflunisal. 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
Acetaminophen	drug interactions	Acetaminophen In normal volunteers, concomitant administration of diflunisal and acetaminophen resulted in an approximate 50% increase in plasma levels of acetaminophen.
Aspirin	contraindications	Diflunisal tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
Cyclosporine	drug interactions	Cyclosporine Administration of non-steroidal anti-inflammatory drugs concomitantly with cyclosporine has been associated with an increase in cyclosporine-induced toxicity, possibly due to decreased synthesis of renal prostacyclin.
Furosemide	drug interactions	Diuretics Clinical studies, as well as postmarketing observations, have shown that diflunisal can reduce the natriuretic effect of furosemide and thiazides in some patients.
Hydrochlorothiazide	drug interactions	In normal volunteers, concomitant administration of diflunisal and hydrochlorothiazide resulted in significantly increased plasma levels of hydrochlorothiazide.
Indomethacin	drug interactions	NSAIDs The administration of diflunisal to normal volunteers receiving indomethacin decreased the renal clearance and significantly increased the plasma levels of indomethacin.
Lithium	drug interactions	Lithium NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance.
Methotrexate	drug interactions	Methotrexate NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices.
Naproxen	drug interactions	Naproxen The concomitant administration of diflunisal and naproxen in normal volunteers had no effect on the plasma levels of naproxen, but significantly decreased the urinary excretion of naproxen and its glucuronide metabolite.
Sulindac	drug interactions	Sulindac The concomitant administration of diflunisal and sulindac in normal volunteers resulted in lowering of the plasma levels of the active sulindac sulfide metabolite by approximately one-third.

Other labels that name diflunisal

Check diflunisal against other medicines

What do FAERS reports show for diflunisal?

The FDA Adverse Event Reporting System holds 806 reports that list diflunisal among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 66 are coded as a death and 239 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

Nausea (named in the label)66
Fatigue (named in the label)58
Pain (a use or a product term, not a reaction)51
Drug Hypersensitivity47
Headache (named in the label)45
Drug Ineffective (a use or a product term, not a reaction)44
Arthralgia (named in the label)43
Diarrhoea (named in the label)43

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as diflunisal?

52 other medicines are given the same way (oral) and in the same FDA class as diflunisal 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
Etodolac	Pain, Osteoarthritis, Rheumatoid arthritis	30 labelers	$0.262 per tablet 400 mg tablet	No current entry
Acetaminophen and ibuprofen	Pain	51 labelers	$0.107 per unit 250-125 mg	No current entry

Every medicine labeled for the same conditions as diflunisal

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

How does diflunisal compare with medicines for the same use?

2 side-by-side pages set diflunisal beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.

What next?

Alternatives to diflunisal: 52 medicines for the same use
Other NSAIDs: the pharmacologic class, with prices and generics
Diflunisal side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other