Famotidine and ibuprofen First approved as Duexis

What is famotidine and ibuprofen used for?

From the label: indications and usage

Ibuprofen and famotidine tablet, a combination of the NSAID ibuprofen and the histamine H 2 -receptor antagonist famotidine, is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond 6 months [see Clinical Studies (14), Use in Specific Populations (8.5) ]. […]

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

• Osteoarthritis
• Rheumatoid arthritis

FDA pharmacologic class: Histamine-2 Receptor Antagonist and Nonsteroidal Anti-inflammatory Drug.

What does the patient leaflet for famotidine and ibuprofen 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 ibuprofen and famotidine tablets?

Ibuprofen and famotidine tablets 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 medicine containing NSAIDs with longer use of medicine containing NSAIDs Do not take ibuprofen and famotidine tablets right before or after a heart surgery called a “coronary artery bypass graft (CABG).” Avoid taking ibuprofen and famotidine tablets 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 ibuprofen and famotidine tablets 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 the use of NSAIDs smoking drinking alcohol taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs” older age poor health increasing doses of NSAIDs advanced liver disease longer use of NSAIDs bleeding problems You should take ibuprofen and famotidine tablets exactly as prescribed, at the lowest dose possible and for the shortest time needed. Ibuprofen and famotidine tablet contains a non-steroidal anti-inflammatory drug NSAID (ibuprofen). Do not use ibuprofen and famotidine tablets with other medicines to lessen pain or fever or with other medicines for colds or sleeping problems without talking to your healthcare provider first, because they may contain an NSAID also. […]

Is there a generic for famotidine and ibuprofen (Duexis)?

The FDA approved the first generic famotidine and ibuprofen on August 3, 2021. 7 generic applications are approved; 4 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 famotidine and ibuprofen from 16 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.

The Orange Book lists 5 patents for Duexis tablets, the last expiring on July 18, 2026. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

What do pharmacies pay for famotidine and ibuprofen (Duexis)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.714 per unit (Ibuprofen-famotidin 800-26.6 mg), down 22% from $0.914 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.

Has famotidine and ibuprofen been recalled?

The FDA's Enforcement Report lists 1 recall naming famotidine and ibuprofen since 2023: 0 Class I (the most serious), 1 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.

What does the famotidine and ibuprofen label say about other medicines?

The famotidine and ibuprofen label names 24 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.

Every other medicine the famotidine and ibuprofen label names

Check famotidine and ibuprofen against other medicines

What do FAERS reports show for famotidine and ibuprofen?

The FDA Adverse Event Reporting System holds 10 reports that list famotidine and ibuprofen among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 4 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.

The most reported reactions

• Arthralgia (named in the label)3
• Pain3
• Alopecia2
• Drug Ineffective (a use or a product term, not a reaction)2
• Rash (named in the label)2
• Wheezing2
• Abdominal Discomfort1
• Abdominal Distension1

What else is labeled for the same conditions as famotidine and ibuprofen?

20 other medicines are given the same way (oral) and in the same FDA class as famotidine and ibuprofen or labeled mainly for the same use (osteoarthritis), the same class first. Osteoarthritis lists all 27 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.

Every medicine labeled for the same conditions as famotidine and ibuprofen

What next?

Alternatives to famotidine and ibuprofen

20 medicines for the same use

Other H2 blockers

the pharmacologic class, with prices and generics

Famotidine and ibuprofen side effects

the label's list beside FAERS reports

Check an interaction

what two or more labels say about each other