ARTHROTEC (diclofenac sodium)
ARTHROTEC is indicated for the treatment of Osteoarthritis; Rheumatoid Arthritis; Gastric Ulcer; Duodenal Ulcer.
How ARTHROTEC Works
Arthrotec utilizes a dual mechanism of action. Diclofenac sodium inhibits cyclooxygenase (COX-1 and COX-2) enzymes, leading to decreased synthesis of prostaglandins involved in pain, fever, and inflammation. To counteract the gastrointestinal toxicity associated with NSAIDs, the misoprostol component acts as a synthetic PGE1 analog. Misoprostol exerts both antisecretory effects (inhibiting basal and stimulated gastric acid secretion) and mucosal protective effects (increasing bicarbonate and mucus production). This replaces the protective prostaglandins typically depleted during NSAID therapy, thereby reducing the risk of ulceration.
Details
- Status
- Prescription
- First Approved
- 1997-12-24
- Routes
- ORAL
- Dosage Forms
- TABLET, DELAYED RELEASE
ARTHROTEC Approval History
What ARTHROTEC Treats
4 indicationsARTHROTEC is approved for 4 conditions since its original approval in 1997. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Osteoarthritis
- Rheumatoid Arthritis
- Gastric Ulcer
- Duodenal Ulcer
ARTHROTEC Boxed Warning
RISK OF UTERINE RUPTURE, ABORTION, PREMATURE BIRTH, BIRTH DEFECTS; SERIOUS CARDIOVASCULAR EVENTS; AND SERIOUS GASTROINTESTINAL EVENTS WARNING: RISK OF UTERINE RUPTURE, ABORTION, PREMATURE BIRTH, BIRTH DEFECTS; SERIOUS CARDIOVASCULAR EVENTS; AND SERIOUS GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. • Administration of misoprostol, a component of ARTHROTEC, to pregnant women can cause uterine rupture, abortion, premature birth, or birth defects. Uterine ruptu...
WARNING: RISK OF UTERINE RUPTURE, ABORTION, PREMATURE BIRTH, BIRTH DEFECTS; SERIOUS CARDIOVASCULAR EVENTS; AND SERIOUS GASTROINTESTINAL EVENTS WARNING: RISK OF UTERINE RUPTURE, ABORTION, PREMATURE BIRTH, BIRTH DEFECTS; SERIOUS CARDIOVASCULAR EVENTS; AND SERIOUS GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. • Administration of misoprostol, a component of ARTHROTEC, to pregnant women can cause uterine rupture, abortion, premature birth, or birth defects. Uterine rupture has occurred when misoprostol was administered in pregnant women to induce labor or an abortion. ( 4 , 5.1 , 8.1 ) • ARTHROTEC is contraindicated in pregnancy and is not recommended in women of childbearing potential. Patients must be advised of the abortifacient property and warned not to give the drug to others. ( 5.1 , 8.3 ) • Increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. ( 5.2 ) • ARTHROTEC is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. ( 4 , 5.2 ) • Increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal and can occur at any time and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk. ( 5.3 ) Uterine Rupture, Abortion, Premature Birth, and Birth Defects • Administration of misoprostol, a component of ARTHROTEC, to pregnant women can cause uterine rupture, abortion, premature birth, or birth defects. Uterine rupture has occurred when misoprostol was administered in pregnant women to induce labor or an abortion [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] . • ARTHROTEC is contraindicated in pregnancy [see Contraindications (4) ] and not recommended in women of childbearing potential. Patients must be advised of the abortifacient p
ARTHROTEC Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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 ARTHROTEC's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ARTHROTEC treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ARTHROTEC
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
133 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07565012 DIPI-PEP | AFID-OPER-PEP-2025-01 IRB Approval Number | Ph 4 | completed | Comparative Evaluation of Diclofenac Sodium and Ibuprofen for Post-Endodontic Pain Management |
| NCT05322252 MIST results posted | 202202144 | Ph 4 | completed | Simultaneous Mifepristone and Misoprostol Versus Misoprostol Alone for Induction of Labor of Nonviable Second Trimester Pregnancy: a Pilot Randomized Controlled Trial |
| NCT06259097 BLOOM | STUDY-24-00118 | Ph 3 | recruiting | Different Medications to Induce Labor |
| NCT01113229 CYTOCINON | P081104 2009-013177-18 | Ph 4 | terminated | Combined Use of Oxytocin and Misoprostol in the Prevention of Post Partum Haemorrhage |
| NCT04940013 MPP | 20-30048 | Ph 4 | terminated | Missed Period Pill Study |
| NCT06502158 | 2024-15999 | Ph 1 | recruiting | Mifepristone vs Misoprostol |
| NCT06452719 LeMi | 855835 | Ph 2 | recruiting | Letrozole and Misoprostol for Early Pregnancy Loss Management |
| NCT04117243 | 280391 | Ph 2 | completed | Tranexamic Acid Versus Sublingual Misoprostol in Reducing Blood Loss During Elective CS in High Risk Cases |
| NCT06207253 | 23-039 | Ph 2, Ph 3 | recruiting | The Antimicrobial Potential of Diclofenac Sodium as an Intracanal Medicament |
| NCT06946914 Miso/CS | KFSIRB200-244 | Ph 4 | recruiting | Misoprostol Before Caesarean Section |
| NCT06765473 | Pre-vaginal+ Postperative PPH | Ph 3 | not yet recruiting | Comparison Between Preoperative Vaginal and Postoperative Sublingual Misoprostol for Prevention of Postpartum Hemorrhage During Cesarean Section |
| NCT02573051 | ANP | Ph 2 | withdrawn | Termination Of Anembryonic Pregnancy |
| NCT05097326 MiLI results posted | 62448 | Ph 3 | completed | Mifepristone for Labor Induction |
| NCT03670836 COMRED results posted | AAAR8566 | Ph 4 | completed | Comparison of Misoprostol Ripening Efficacy With Dilapan |
| NCT04028765 POM PROM results posted | 833536 | Ph 4 | completed | Pitocin or Oral Misoprostol for PROM IOL |
| NCT06364098 | prevention of PPH | Ph 1 | completed | Comparative Study Between the Roles of Intrauterine Misoprostol Versus the Sublingual Route for Prevention of Postpartum Blood Loss in Elective Cesarean Sections |
| NCT06111573 | YYU-10/31.05.2023 | Ph 4 | completed | Comparative Evaluation of the Effectiveness of Diclofenac Sodium Versus Vitamin D on Myofascial Pain |
| NCT02209545 results posted | STU00091259 | Ph 4 | terminated | Misoprostol for Reduction of Blood Loss During Fibroid Surgery |
| NCT05424445 | EudraCT 2020-000663-23 | Ph 3 | completed | MISOBEST - Orally Misoprostol Solution (Cytotec®) Versus Orally Misoprostol as a Tablet (Angusta®) for Induction of Labor |
| NCT03680339 | 42 | Ph 4 | completed | The Effect of Preoperative and Post Operative Misoprostol Administration on Intraoperative Blood Loss and Postpartum Hemorrhage in CS |
| NCT05829707 | OsijekUH21 | Ph 4 | completed | Long-term Outcomes of Breast Cancer Patients After Wound Infiltration Analgesia |
| NCT05804305 | 3280221MSGE | Ph 2 | completed | Misoprostol for NASH |
| NCT05761418 | REC-H-PhBSU-22021 | Ph 3 | completed | Preoperative Vaginal Dinoprostone Versus Misoprostone in Abdominal Myomectomy |
| NCT05340205 | Placenta previa disorders | Ph 4 | completed | Blood Loss During Cesarean Delivery in Placenta Previa Patients |
| NCT05626140 EDCLAS | PIMS-05-002 | Ph 3 | completed | COMPARISON OF EFFICACY OF DIFFERENT DRUG COMBINATIONS IN ACUTE SCIATICA |
| NCT02777190 results posted | 00005107 | Ph 4 | terminated | A Comparison of Oral Misoprostol and Vaginal Misoprostol for Cervical Ripening and Induction of Labor |
| NCT02680314 results posted | 2015-5341 | Ph 2 | completed | Is More Than One Dose of Misoprostol Needed to Expedite Vaginal Delivery in a Patient With an Unripe Cervix? |
| NCT04533841 | Ahmed mohamed fathy ismail | Ph 2 | completed | Propranolol and Misoprostol Versus Misoprostol Alone for Induction of Labor in Primigravidas |
| NCT05488925 | BDC/ERB/2021/016 | Ph 4 | completed | Comparison of Preoperative Analgesics on the Efficacy of Inferior Alveolar Nerve Block. |
| NCT05215873 | FMASU MS 733/2020/2021 | Ph 4 | completed | Induction of Labor in Pregnant Women With Prelabor Rupture of Membranes - Oxytocin or Misoprostol |
| NCT04604366 | IslamabadMDC | Ph 2 | completed | Comparison of Vaginal Versus Sublingual Misoprostol in the Treatment of First Trimester Missed Miscarriage |
| NCT04685694 RPOC | 0444-19-TLV | Ph 4 | completed | Management of RPOC After Induced Abortion |
| NCT02412618 MMSAP results posted | 2012-245 | Ph 4 | completed | Same-Day Mifepristone-Misoprostol Compared to Misoprostol Only for Surgical Abortion Cervical Preparation |
| NCT05108597 | 25102021 | Ph 3 | completed | Effect of Rectal Misoprostol in Reducing Intra-operative Blood Loss During Myomectomy |
| NCT03676621 | BMISO | Ph 4 | completed | Buccal Misoprostol Versus IV Oxytocin in Prevention of Postpartum Hemorrhage |
| NCT04989400 | 5181 | Ph 4 | completed | Use of Ulipristal Acetate in Induction of Second Trimester Missed Abortion |
| NCT02704481 | 1035 | Ph 4 | terminated | Non-surgical Alternatives to Treatment of Failed Medical Abortion |
| NCT04063904 | 1044 | Ph 4 | terminated | Pilot Study of an Ambulatory Medical Abortion Service at 13-18 Weeks of Gestation in Colombia |
| NCT03148574 | IUM | Ph 3 | completed | Intrauterine Misoprostol Versus Intravenous Oxytocin Infusion During Cesarean Delivery |
| NCT03682718 | ase36278 | Ph 4 | completed | Vaginal Misoprostol With Intracervical Foley Catheter in Induction of Labor |
| NCT04044079 | dinoprostone misoprostol | Ph 4 | completed | Vaginal Dinoprostone Versus Vaginal Misoprostol Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients |
| NCT02562300 | Utrotonics during CS | Ph 2 | completed | Uterotonics Using to Reduce Bleeding at Cesarean Section |
| NCT01962987 results posted | 71204901 | Ph 3 | completed | A Study Comparing Diclofenac Sodium Gel 3% to Solaraze® (Diclofenac Sodium) Gel 3% in the Treatment of Actinic Keratosis |
| NCT04273984 | Misoprostol Prior to IUCD | Ph 4 | completed | Efficacy and Safety of Different Doses of Vaginal Misoprostol Prior to Intra Uterine Contraceptive Device Insertion |
| NCT02786992 CS | AS1301 | Ph 2, Ph 3 | completed | Misoprostol+Oxytocin vs. Carbetocin in CS |
| NCT04080336 | dinoprostone misoprostol IUD | Ph 4 | completed | Comparison of Vaginal Misoprostol and Dinoprostone Prior to Copper Intrauterine Device Insertion in Nulliparous Women |
| NCT03212352 Triple M | 62449 | Ph 4 | terminated | Comparing Two Medical Treatments for Early Pregnancy Failure. |
| NCT04270994 | MSP_2016 | Ph 2, Ph 3 | completed | Misoprostol as a Treatment for Endometrial Polyps in Infertile Patients |
| NCT03825016 | AS1855 | Ph 2 | completed | Lidocaine Infusion in Hystroscopy |
| NCT01615224 | WMA11 | Ph 2, Ph 3 | terminated | Repeated Doses of Misoprostol for Medical Treatment of Missed Miscarriage |
Showing 50 of 133 trials
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.
ARTHROTEC FDA Label Details
Indications & Usage
FDA Label (PDF)ARTHROTEC is indicated for the treatment of Osteoarthritis; Rheumatoid Arthritis; Gastric Ulcer; Duodenal Ulcer.
WARNING: RISK OF UTERINE RUPTURE, ABORTION, PREMATURE BIRTH, BIRTH DEFECTS; SERIOUS CARDIOVASCULAR EVENTS; AND SERIOUS GASTROINTESTINAL EVENTS WARNING: RISK OF UTERINE RUPTURE, ABORTION, PREMATURE BIRTH, BIRTH DEFECTS; SERIOUS CARDIOVASCULAR EVENTS; AND SERIOUS GASTROINTESTINAL EVENTS See full presc...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.