DIFLUNISAL
DIFLUNISAL is indicated for the treatment of Pain; Osteoarthritis; Rheumatoid Arthritis.
Details
- Status
- Prescription
- First Approved
- 1992-07-31
- Routes
- ORAL
- Dosage Forms
- TABLET
DIFLUNISAL Approval History
What DIFLUNISAL Treats
3 indicationsDIFLUNISAL is approved for 3 conditions since its original approval in 1992. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pain
- Osteoarthritis
- Rheumatoid Arthritis
DIFLUNISAL 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 i...
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 ).
DIFLUNISAL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in DIFLUNISAL's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications DIFLUNISAL treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to DIFLUNISAL
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04113668 | IM011-101 | Ph 1 | completed | The Effects Diflunisal on the Levels of BMS-986165 in Healthy Participants |
| NCT01676363 | H11-03547 H11-03547 | Ph 4 | terminated | Pilot Study of Diflunisal in HIV-infected Adults |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DIFLUNISAL FDA Label Details
Indications & Usage
DIFLUNISAL is indicated for the treatment of Pain; Osteoarthritis; Rheumatoid Arthritis.
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 WARNIN...
Looking for the branded version?
DOLOBID
Full clinical data, patents, trials, and competitive landscape for diflunisal.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.