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Arthrotec (Diclofenac Sodium)
Arthrotec, a combination medication by Pfizer Inc., is a fixed-dose combination of diclofenac sodium and misoprostol. It works by inhibiting prostaglandin synthesis and increasing bicarbonate and mucus production. The medication is used to treat actinic keratosis, adhesive capsulitis of the shoulder, analgesia in various types of cancer, ankylosing spondylitis, and dysmenorrhea. Arthrotec's unique combination of diclofenac and misoprostol provides clinical differentiation by reducing the risk of gastric and duodenal ulcers. This makes it a commercially significant medication in the market. There are no notable pipeline developments for Arthrotec.
At a glance
| Generic name | Diclofenac Sodium |
|---|---|
| Sponsor | Pfizer |
| Drug class | diclofenac |
| Target | Acid-sensing ion channel 3 |
| 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
- Nausea
- Dyspepsia
- Diarrhea
- Heartburn
- Headaches
- Edema
- Dizziness
- Constipation
- Vomiting
- Rashes
- Elevated liver enzymes
Serious adverse events
- Anaphylactic reactions
- Stevens-Johnson syndrome
- Toxic epidermal necrolysis
- Liver failure
- Fulminant hepatitis
- Myocardial infarction
- Renal failure
- Interstitial nephritis
- 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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Arthrotec CI brief — competitive landscape report
- Arthrotec updates RSS · CI watch RSS
- Pfizer portfolio CI