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Diflunisal Side Effects

Medically reviewed by Drugs.com. Last updated on Dec 19, 2023.

Applies to diflunisal: oral tablet.

Warning

Oral route (Tablet)

Cardiovascular Thrombotic EventsNonsteroidal 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. Diflunisal tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery Gastrointestinal RiskNSAIDs 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.

Serious side effects of Diflunisal

Along with its needed effects, diflunisal may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking diflunisal:

More common

Less common

Symptoms of overdose

Other side effects of Diflunisal

Some side effects of diflunisal may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Less common

For Healthcare Professionals

Applies to diflunisal: compounding powder, oral tablet.

General

The most frequently reported side effects were gastrointestinal in nature and included nausea, vomiting, dyspepsia, gastrointestinal pain, diarrhea, constipation, and flatulence.[Ref]

Gastrointestinal

Common (1% to 10%): Gastrointestinal (GI) pain, dyspepsia, diarrhea, nausea, vomiting, constipation, flatulence

Frequency not reported: Peptic ulcer, GI perforation, GI bleeding, gastritis, hematemesis, melena, ulcerative stomatitis, colitis exacerbated, Crohn's disease exacerbated, eructation, GI perforation[Ref]

Cardiovascular

Frequency not reported: Palpitation, hypertension, cardiac failure, flushing, myocardial infarction[Ref]

Dermatologic

Common (1% to 10%): Rash

Frequency not reported: Pruritus, sweating, dry mucous membranes, stomatitis, photosensitivity, urticaria, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, angioedema, sweating, dry mucous membranes, stomatitis, photosensitivity[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness, somnolence

Frequency not reported: Lightheadedness, paresthesia, syncope, stroke

Hematologic

Frequency not reported: Thrombocytopenia, neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia

Hepatic

Frequency not reported: Jaundice, cholestasis, liver function abnormal, hepatitis

Renal

Frequency not reported: Renal impairment, renal failure, interstitial nephritis, nephritic syndrome

Hypersensitivity

Frequency not reported: Hypersensitivity vasculitis, hypersensitivity syndrome[Ref]

Other

Common (1% to 10%): Tinnitus, fatigue

Frequency not reported: Vertigo, asthenia, edema, chest pain, fulminant necrotizing fasciitis, hearing loss[Ref]

Metabolic

Frequency not reported: Anorexia[Ref]

Psychiatric

Common (1% to 10%): Insomnia

Frequency not reported: Nervousness, depression, hallucination, confusion, disorientation[Ref]

Musculoskeletal

Frequency not reported: Muscle cramp[Ref]

Ocular

Frequency not reported: Blurred vision, transient visual disturbance[Ref]

Respiratory

Frequency not reported: Bronchospasm, dyspnea

Genitourinary

Frequency not reported: Dysuria, hematuria, proteinuria[Ref]

Immunologic

Frequency not reported: Acute anaphylaxis[Ref]

References

1. Product Information. Dolobid (diflunisal). Merck & Co., Inc. 2001;PROD.

2. MHRA. Medicines and Health Regulatory Agency. MHRA Drug Safety Update. http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate 2013.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.