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Arthrotec (Diclofenac Sodium)
Arthrotec (generic name: Diclofenac Sodium) is a diclofenac Small molecule drug developed by Pfizer. It is currently FDA-approved (first approved 1988) for Arthritis pain relief (upper body), Arthritis pain relief (lower body).
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
- Arthritis pain relief (upper body)
- Arthritis pain relief (lower body)
Common side effects
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
- Efficacy of Low-Intensity Shockwave Therapy in Treating Radiation Cystitis (EARLY_PHASE1)
- Analgesic Equivalence of NSAIDs and Tramadol in Acute Postoperative Pain Following Minimally Invasive Surgery (NA)
- Efficacy of Chemically Distinct Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) and Pain Phenotypes in Adhesive Capsulitis (NA)
- Impact of the Helfer Skin Tap Technique on Pain and Comfort Levels During Ventrogluteal Injection: A Randomized Controlled Trial (NA)
- Efficacy of Genicular Block on Total Knee Arthroplasty Surgery (NA)
- A Study to Evaluate Efficacy and Safety of AMZ001 for the Treatment of Knee Osteoarthritis Symptoms (PHASE3)
- Comparative Evaluation of Diclofenac Sodium and Ibuprofen for Post-Endodontic Pain Management (PHASE4)
- Methocarbamol vs Oxybutynin for Management of Pain and Discomfort S/P Ureteroscopy Procedure (NA)
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
Frequently asked questions about Arthrotec
What is Arthrotec?
What is Arthrotec used for?
Who makes Arthrotec?
What is the generic name of Arthrotec?
What drug class is Arthrotec in?
When was Arthrotec approved?
What development phase is Arthrotec in?
What does Arthrotec target?
Related
- Drug class: All diclofenac drugs
- Target: All drugs targeting Acid-sensing ion channel 3
- Manufacturer: Pfizer — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Arthritis pain relief (upper body)
- Indication: Drugs for Arthritis pain relief (lower body)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing