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Dolobid (DIFLUNISAL)
Dolobid (generic name: DIFLUNISAL) is a Nonsteroidal Anti-inflammatory Drug [EPC] Small molecule drug developed by Merck. It is currently FDA-approved (first approved 1982) for Chronic pain, Osteoarthritis, Pain.
Dolobid is a small molecule that inhibits cyclooxygenase, a type of enzyme. It has been studied in clinical trials for various conditions, including Type 2 Diabetes, Amyloidosis, and Amyloid Neuropathies, and has been used in combination with other medications such as bezafibrate.
At a glance
| Generic name | DIFLUNISAL |
|---|---|
| Sponsor | Merck |
| Drug class | Nonsteroidal Anti-inflammatory Drug [EPC] |
| Target | Prostaglandin G/H synthase 2 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 1982 |
Approved indications
- Chronic pain
- Osteoarthritis
- Pain
- Rheumatoid arthritis
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 ). 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 ).
Common side effects
- Gastrointestinal bleeding
- Liver function abnormalities
- Jaundice
- Cholestasis
- Hepatitis
- Gastrointestinal perforation
- Peptic ulcer
- Renal failure
- Renal impairment
- Thrombocytopenia
- Agranulocytosis
- Hemolytic anemia
Drug interactions
- lithium
- phenprocoumon
- probenecid
- warfarin
Key clinical trials
- Monitoring of Early Disease Progression in Hereditary Transthyretin Amyloidosis
- Evuzamitide in PET/CT to Measure Potential Therapeutic Response in ATTR (PHASE2)
- The Effects Diflunisal on the Levels of BMS-986165 in Healthy Participants (PHASE1)
- Pilot Study of Diflunisal in HIV-infected Adults (PHASE4)
- The Effect of Diflunisal on Familial Amyloidosis (PHASE2,PHASE3)
- The Effect of Diflunisal on Familial Transthyretin Amyloidosis
- Study of CRx-401 on Glucose Levels in Subjects With Type II Diabetes (PHASE2)
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 |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Dolobid CI brief — competitive landscape report
- Dolobid updates RSS · CI watch RSS
Frequently asked questions about Dolobid
What is Dolobid?
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Who makes Dolobid?
What is the generic name of Dolobid?
What drug class is Dolobid in?
When was Dolobid approved?
What development phase is Dolobid in?
What are the side effects of Dolobid?
What does Dolobid target?
Related
- Drug class: All Nonsteroidal Anti-inflammatory Drug [EPC] drugs
- Target: All drugs targeting Prostaglandin G/H synthase 2
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Chronic pain
- Indication: Drugs for Osteoarthritis
- Indication: Drugs for Pain
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing