Last reviewed 2026-04-20 · How we verify

FENOPROFEN CALCIUM

FDA-approved approved Small molecule Quality 35/100

FENOPROFEN CALCIUM is a drug. It is currently FDA-approved (first approved 1976) for Mild to Moderate Pain Relief, Rheumatoid Arthritis Symptoms, Osteoarthritis Symptoms.

Fenoprofen calcium is a marketed drug primarily indicated for mild to moderate pain relief, positioning it in a competitive segment of the analgesic market. The key composition patent is set to expire in 2028, providing a clear timeline for potential generic competition. The primary risk is the loss of exclusivity post-2028, which could significantly impact revenue.

At a glance

Generic name	FENOPROFEN CALCIUM
Modality	Small molecule
Phase	FDA-approved
First approval	1976

Approved indications

Mild to Moderate Pain Relief
Rheumatoid Arthritis Symptoms
Osteoarthritis Symptoms

Boxed warnings

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 ). • Fenoprofen calcium tablets 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 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 ).

Common side effects

dyspepsia
nausea
constipation
vomiting
abdominal pain
diarrhea
headache
somnolence
dizziness
tremor
confusion
increased sweating

Drug interactions

ACE Inhibitors
Aspirin
Diuretics (furosemide, thiazides)
Lithium
Methotrexate
Warfarin
Phenobarbital

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
FDA label	Mechanism, indications, dosing, boxed warnings, drug interactions

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

FENOPROFEN CALCIUM CI brief — competitive landscape report
FENOPROFEN CALCIUM updates RSS · CI watch RSS

Frequently asked questions about FENOPROFEN CALCIUM

What is FENOPROFEN CALCIUM?

FENOPROFEN CALCIUM is a Small molecule drug, indicated for Mild to Moderate Pain Relief, Rheumatoid Arthritis Symptoms, Osteoarthritis Symptoms.

What is FENOPROFEN CALCIUM used for?

FENOPROFEN CALCIUM is indicated for Mild to Moderate Pain Relief, Rheumatoid Arthritis Symptoms, Osteoarthritis Symptoms.

When was FENOPROFEN CALCIUM approved?

FENOPROFEN CALCIUM was first approved on 1976.

What development phase is FENOPROFEN CALCIUM in?

FENOPROFEN CALCIUM is FDA-approved (marketed).

What are the side effects of FENOPROFEN CALCIUM?

Common side effects of FENOPROFEN CALCIUM include dyspepsia, nausea, constipation, vomiting, abdominal pain, diarrhea.

Indication: Drugs for Mild to Moderate Pain Relief
Indication: Drugs for Rheumatoid Arthritis Symptoms
Indication: Drugs for Osteoarthritis Symptoms

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing