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Voltaren (DICLOFENAC)
Voltaren (Diclofenac) is a nonsteroidal anti-inflammatory drug (NSAID) developed by Hisamitsu Pharmaceutical Co., Inc. and currently owned by Zyla. It targets prostaglandin G/H synthase 2 to provide analgesic and anti-inflammatory effects. Voltaren is approved for various indications, including osteoarthritis, ankylosing spondylitis, and dysmenorrhea. The drug has a half-life of 1.4 hours and bioavailability of 54%. It is a small molecule modality that has been FDA-approved since 1988.
At a glance
| Generic name | DICLOFENAC |
|---|---|
| Sponsor | Hisamitsu Pharmaceutical Co., Inc |
| Drug class | Nonsteroidal Anti-inflammatory Drug |
| Target | Prostaglandin G/H synthase 2 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1988 |
Approved indications
- Actinic keratosis
- Adhesive capsulitis of shoulder
- Analgesia in various types of cancer
- Ankylosing spondylitis
- Dysmenorrhea
- Lumbago
- Neckshoulderarm syndrome
- Osteoarthritis
- Osteoarthritis in Patients at High Ulcer Risk
- Osteoarthrosis of the Knee
- Pain
- Post-Op Ocular Inflammation
- Post-Op Photophobia
- Postoperative Ocular Pain
- Rheumatoid Arthritis in Patient at High Ulcer Risk
- Rheumatoid arthritis
- Sprains and Strains
- Tenosynovitis
Common side effects
- Abdominal pain
- Dyspepsia
- Nausea
- Diarrhea
- Constipation
- Heartburn
- Headaches
- Dizziness
- Elevated liver enzymes
- Edema
- Rashes
- Pruritus
Serious adverse events
- Fulminant hepatitis
- Liver failure
- Liver necrosis
- Stevens-Johnson syndrome
- Toxic epidermal necrolysis
- Myocardial infarction
- Anaphylactic reactions
- Renal failure
- Aplastic anemia
- Agranulocytosis
Drug interactions
- dicoumarol
- fluconazole
- lithium
- methotrexate
- phenprocoumon
- voriconazole
- warfarin
Key clinical trials
- Diclofenac as a KMO Inhibitor (EARLY_PHASE1)
- Efficacy of Chemically Distinct Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) and Pain Phenotypes in Adhesive Capsulitis (NA)
- Comparative Clinical Study to Evaluate the Possible Efficacy and Safety of Oral N-Acetyl Cysteine Versus Rectal Diclofenac in the Prevention of Post Endoscopic Retrograde Cholangiopancreatography Pancreatitis (PHASE1,PHASE2)
- Pain Control After Open Radical Nephrectomy: Thoracic Paravertebral Block Versus External Oblique Intercostal Block (NA)
- Counterpain PXM Versus Diclofenac Versus Piroxicam (PHASE3)
- KF2022#4-trial: Effects of a Beta Blocker and NSAID on CYP Mediated Drug Metabolism (NA)
- Comparison of the Effectiveness of Therapeutic Ultrasound and Phonophoresis in Chronic Low Back Pain (NA)
- Helping Osteoarthritis Patients to Walk With NSAID (PHASE4)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
| FDA Orange Book | Patents + exclusivity |