Prescription medicine
Fenoprofen First approved as Nalfon
Fenoprofen (Nalfon) is a prescription medicine with an FDA approval on record since 1976. FDA's NDC Directory lists it from 6 generic labelers.
- Generic listed
- Boxed warning
Check it at the source: the fenoprofen FDA label on DailyMed (effective August 20, 2026, Misemer Pharmaceuticals, Inc.); the NDA 17604 record on Drugs@FDA; every fenoprofen label on DailyMed.
Highlights of the record
FDA label of August 20, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS.
Cardiovascular Thrombic Events Non-Steroidal 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 ( 5.1 )]. FENOPROFEN CALCIUM ® is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [ see Contraindications ( 4 ) and Warnings and precautions ( 5.1 )]. Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs cause an increased risk of serious gastrointestinal (GI) 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [ see Warnings and Precautions ( 5.2 )]. WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning
Non-Steroidal Anti-Inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. […]
Used for
From the label: indications and usageINDICATIONS AND USAGE FENOPROFEN CALCIUM is indicated for:
Relief of mild to moderate pain in adults
Relief of the signs and symptoms of rheumatoid arthritis
Relief of the signs and symptoms of osteoarthritis FENOPROFEN CALCIUM is a nonsteroidal anti-inflammatory drug indicated for: Relief of mild to moderate pain in adults.
Forms and strengths
- 200 mg
- 300 mg
- 400 mg
Capsule.
On the market
- Earliest approval on file
- March 16, 1976 Nalfon, Pharmaco; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 17 first April 20, 1988; 2 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)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 49 through July 30, 2026
What is fenoprofen used for?
From the label: indications and usageINDICATIONS AND USAGE FENOPROFEN CALCIUM is indicated for:
Relief of mild to moderate pain in adults
Relief of the signs and symptoms of rheumatoid arthritis
Relief of the signs and symptoms of osteoarthritis FENOPROFEN CALCIUM is a nonsteroidal anti-inflammatory drug indicated for: Relief of mild to moderate pain in adults. ( 1 ) Relief of the signs and symptoms of rheumatoid arthritis. ( 1 ) Relief of the signs and symptoms of osteoarthritis.
Conditions named in the indications of fenoprofen's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Nonsteroidal Anti-inflammatory Drug.
Source: FDA drug label (Fenoprofen Calcium), Misemer Pharmaceuticals, Inc., effective August 20, 2026 (SPL set d33ad329-1ca6-ac2e-e053-2995a90a15c5), via openFDA; the full label on DailyMed
What does the patient leaflet for fenoprofen 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 o 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 older age longer use of NSAIDs poor health smoking advanced liver disease drinking alcohol bleeding problems NSAIDs should only be used: exactly as prescribed o at the lowest dose possible for your treatment for the shortest time needed
Source: FDA drug label (Fenoprofen Calcium), Misemer Pharmaceuticals, Inc., effective August 20, 2026 (SPL set d33ad329-1ca6-ac2e-e053-2995a90a15c5), via openFDA; the full label on DailyMed
Is there a generic for fenoprofen (Nalfon)?
The FDA approved the first generic fenoprofen on April 20, 1988. 17 generic applications are approved; 2 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 fenoprofen 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.
- 1976 earliest approval on file
- 1988 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the fenoprofen label say about other medicines?
The fenoprofen label names 15 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name fenoprofen. 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 | … and Precautions ( 5.7 , 5.9 ) ] History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. |
| Cyclosporine | drug interactions | Clinical Impact: Concomitant use of FENOPROFEN CALCIUM and cyclosporine may increase cyclosporine’s nephrotoxicity. Intervention: During concomitant use of FENOPROFEN CALCIUM and cyclosporine, monitor patients for signs of worsening renal function. NSAIDs and Salicylates |
| Diclofenac | drug interactions | NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed. |
| Diflunisal | drug interactions | NSAIDs and Salicylates Clinical Impact: Concomitant use of fenoprofen with other NSAIDs or salicylates (…) increases the risk of GI toxicity, with little or no increase in efficacy [ see Warnings and Precautions () ]. Intervention: The concomitant use of fenoprofen with other NSAIDs or salicylates is not recommended. |
| Digoxin | drug interactions | Clinical Impact: The concomitant use of fenoprofen with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin. Intervention: During concomitant use of FENOPROFEN CALCIUM and digoxin, monitor serum digoxin levels. |
| Furosemide | drug interactions | Diuretics Clinical Impact: Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. … Intervention: During concomitant use of FENOPROFEN CALCIUM with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects [ see … |
| Indomethacin | drug interactions | NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed. |
| Lithium | drug interactions | Clinical Impact: NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. … Intervention: During concomitant use of FENOPROFEN CALCIUM and lithium, monitor patients for signs of lithium toxicity. |
| Meloxicam | drug interactions | Pemetrexed Clinical Impact: Concomitant use of FENOPROFEN CALCIUM and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (…). … potential interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days … |
| Methotrexate | drug interactions | Methotrexate Clinical Impact: Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (…). Intervention: During concomitant use of FENOPROFEN CALCIUM and methotrexate, monitor patients for methotrexate toxicity. |
| Nabumetone | drug interactions | Pemetrexed Clinical Impact: Concomitant use of FENOPROFEN CALCIUM and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (…). … interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following … |
| Pemetrexed | drug interactions | Pemetrexed Clinical Impact: Concomitant use of FENOPROFEN CALCIUM and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (…). Intervention: During concomitant use of FENOPROFEN CALCIUM and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity. … |
| Phenobarbital | drug interactions | Phenobarbital Clinical Impact: Chronic administration of phenobarbital, a known enzyme inducer, may be associated with a decrease in the plasma half-life of fenoprofen. Intervention: When phenobarbital is added to or withdrawn from treatment, dosage adjustment of FENOPROFEN CALCIUM may be required. |
| Propranolol | drug interactions | ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers Clinical Impact: NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol). … Intervention: During concomitant use of FENOPROFEN CALCIUM and ACE-inhibitors, ARBs, or betablockers, monitor blood pressure to ensure that the desired blood pressure is obtained. … |
Every other medicine the fenoprofen label names
| Medicine named | Section | What the label says |
|---|---|---|
| Warfarin | drug interactions | Drugs That Interfere with Hemostasis Clinical Impact: Fenoprofen and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of fenoprofen and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. … Intervention: Monitor patients with concomitant use of FENOPROFEN CALCIUM with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin … |
Source: FDA drug label (Fenoprofen Calcium), Misemer Pharmaceuticals, Inc., effective August 20, 2026 (SPL set d33ad329-1ca6-ac2e-e053-2995a90a15c5), via openFDA; the full label on DailyMed
What do FAERS reports show for fenoprofen?
The FDA Adverse Event Reporting System holds 49 reports that list fenoprofen among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6 are coded as a death and 15 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
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as fenoprofen?
52 other medicines are given the same way (oral) and in the same FDA class as fenoprofen 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 fenoprofen
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does fenoprofen compare with medicines for the same use?
2 side-by-side pages set fenoprofen beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to fenoprofen
- 52 medicines for the same use
- Other NSAIDs
- the pharmacologic class, with prices and generics
- Fenoprofen side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other