DICLOFENAC SODIUM AND MISOPROSTOL (diclofenac sodium)
DICLOFENAC SODIUM AND MISOPROSTOL is indicated for the treatment of Osteoarthritis; Rheumatoid Arthritis; Gastric Ulcer; Duodenal Ulcer.
How DICLOFENAC SODIUM AND MISOPROSTOL Works
Diclofenac functions by inhibiting cyclooxygenase (COX-1 and COX-2) enzymes, leading to decreased synthesis of prostaglandins involved in pain and inflammation. Misoprostol, a synthetic prostaglandin E1 analog, compensates for NSAID-induced prostaglandin deficiency in the GI tract by increasing bicarbonate and mucus production and exerting antisecretory effects on gastric acid, thereby protecting the gastric and duodenal mucosa.
Details
- Status
- Discontinued
- First Approved
- 2012-07-09
- Routes
- ORAL
- Dosage Forms
- TABLET, DELAYED RELEASE
Companies
DICLOFENAC SODIUM AND MISOPROSTOL Approval History
What DICLOFENAC SODIUM AND MISOPROSTOL Treats
4 indicationsDICLOFENAC SODIUM AND MISOPROSTOL is approved for 4 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Osteoarthritis
- Rheumatoid Arthritis
- Gastric Ulcer
- Duodenal Ulcer
DICLOFENAC SODIUM AND MISOPROSTOL Boxed Warning
RISK OF UTERINE RUPTURE, ABORTION, PREMATURE BIRTH, BIRTH DEFECTS; AND SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS WARNING: RISK OF UTERINE RUPTURE, ABORTION, PREMATURE BIRTH, BIRTH DEFECTS; SERIOUS CARDIOVASCULAR EVENTS; AND SERIOUS GASTROINTESTINAL EVENTS Uterine Rupture, Abortion, Premature Birth, and Birth Defects • Administration of misoprostol, a component of diclofenac sodium and misoprostol delayed-release tablets, to pregnant women can cause uterine rupture, abortion, premature b...
WARNING: RISK OF UTERINE RUPTURE, ABORTION, PREMATURE BIRTH, BIRTH DEFECTS; AND SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS WARNING: RISK OF UTERINE RUPTURE, ABORTION, PREMATURE BIRTH, BIRTH DEFECTS; SERIOUS CARDIOVASCULAR EVENTS; AND SERIOUS GASTROINTESTINAL EVENTS Uterine Rupture, Abortion, Premature Birth, and Birth Defects • Administration of misoprostol, a component of diclofenac sodium and misoprostol delayed-release tablets, 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)]. • Diclofenac sodium and misoprostol delayed-release tablets are contraindicated in pregnancy [see Contraindications (4)] and not recommended in women of childbearing potential. Patients must be advised of the abortifacient property and warned not to give the drug to others [see Warnings and Precautions (5.1)]. • If diclofenac sodium and misoprostol delayed-release tablets are prescribed, verify the pregnancy status of females of reproductive potential prior to initiation of treatment and advise them to use effective contraception during treatment [see Use in Specific Populations (8.3)]. Cardiovascular Thrombotic Events • 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 (5.2)]. • Diclofenac sodium and misoprostol delayed-release tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4) and Warnings and Precautions (5.2)]. Gastrointestinal Bleeding, Ulceration, and Perforation • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of th
DICLOFENAC SODIUM AND MISOPROSTOL 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 DICLOFENAC SODIUM AND MISOPROSTOL's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications DICLOFENAC SODIUM AND MISOPROSTOL treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to DICLOFENAC SODIUM AND MISOPROSTOL
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
26 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 |
| NCT06207253 | 23-039 | Ph 2, Ph 3 | recruiting | The Antimicrobial Potential of Diclofenac Sodium as an Intracanal Medicament |
| NCT06111573 | YYU-10/31.05.2023 | Ph 4 | completed | Comparative Evaluation of the Effectiveness of Diclofenac Sodium Versus Vitamin D on Myofascial Pain |
| NCT05829707 | OsijekUH21 | Ph 4 | completed | Long-term Outcomes of Breast Cancer Patients After Wound Infiltration Analgesia |
| NCT05626140 EDCLAS | PIMS-05-002 | Ph 3 | completed | COMPARISON OF EFFICACY OF DIFFERENT DRUG COMBINATIONS IN ACUTE SCIATICA |
| NCT05488925 | BDC/ERB/2021/016 | Ph 4 | completed | Comparison of Preoperative Analgesics on the Efficacy of Inferior Alveolar Nerve Block. |
| 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 |
| NCT03825016 | AS1855 | Ph 2 | completed | Lidocaine Infusion in Hystroscopy |
| NCT03074162 results posted | 1358.2 | Ph 1 | completed | Comparison of the Bioavailability of Diclofenac in a Combination Product (Diclofenac 2% + Capsaicin 0.075% Topical Gel) With Two Diclofenac Only Products, Diclofenac Mono Gel 2% and Voltarol® 12 Hour Emulgel 2.32% Gel, in Healthy Volunteers |
| NCT02598102 | INU/RRC/01/2014-15 | Ph 2 | completed | Efficacy of Preprocedural Diclofenac in Males Undergoing Double J Stent Removal Under Local Anesthesia |
| NCT03221946 | PMVIDS&RC/IEC/OMR/PR 0051-15 | Ph 4 | completed | A Comparative Evaluation of Diclofenac Sodium Transdermal Patch, Oral Diclofenac Sodium With Intramuscular Injections of Diclofenac Sodium in Patients Suffering From Oral Pain |
| NCT03090971 | NX101-02-2016 | Ph 2 | completed | Use of Topical Liquid Diclofenac Following Laser Microporation of Cutaneous Neurofibromas in Patients With NF1 |
| NCT02201238 | 202188 RH02175 | Ph 1 | completed | Pharmacokinetics Study Comparing Topical Diclofenac/Menthol Gels With Voltaren Gel and Oral Diclofenac Sodium |
| NCT02611804 | SYM 2015-01 | Ph 3 | completed | A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study Comparing Diclofenac Sodium Gel, 3% to Solaraze® Gel, 3% in the Treatment of Actinic Keratosis on the Face or Bald Scalp |
| NCT00523120 | HP 7-264S | Ph 2 | terminated | Topical Voltaren in Otitis Externa |
| NCT02495831 results posted | Z7219J01 | Ph 1 | completed | Drug Interaction Study of Safinamide and a BCRP Substrate, Diclofenac, Concomitantly Administered to Healthy Volunteers |
| NCT02658721 | IVRA | Ph 3 | completed | Effects of Systemic or Adjunct Tramadol Addition to Lidocaine Used for IVRA in Patients Undergoing Hand Surgery |
| NCT02253446 | MDhayri2014 | Ph 4 | completed | A Comparison of Analgesic İmpacts of Piroxicam and Diclofenac Sodium in the Treatment of Primary Dysmenorrhea |
| NCT01706588 DP4 results posted | 12UK/DCsc04 | Ph 2 | completed | Injectable Diclofenac for the Prevention of Post-operative Dental Pain |
| NCT01858090 | KA08/48 | Ph 3 | completed | Intrathecal Levobupivacaine With Opioids for Caesarean Section |
| NCT01272934 results posted | VOSG-P-318 | Ph 3 | completed | Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Ankle Sprain |
| NCT01272947 results posted | VOSG-P-319 | Ph 3 | completed | Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Blunt Trauma Injuries |
| NCT00931866 | DCF-006 | Ph 3 | completed | Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Soft Tissue Injuries (TAPED) |
| NCT00869180 SUPPORT 2 | DCF-004 | Ph 3 | completed | Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Ankle Sprain |
| NCT00805090 | DFC-PK-009 | Ph 1 | completed | Open-Label, Single-Dose Study to Evaluate the Safety and PK of DIC075V in Subjects With Renal Insufficiency and Hepatic Impairment Compared to Healthy Subjects and Evaluate the Safety and Pharmacokinetics of HPβCD When Administered in DIC075V Compared to Sporanox® in Healthy Subjects |
| NCT00640705 | DCF-002 | Ph 2, Ph 3 | terminated | Diclofenac Patch for Treatment of Mild to Moderate Ankle Sprain |
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.
DICLOFENAC SODIUM AND MISOPROSTOL FDA Label Details
Indications & Usage
DICLOFENAC SODIUM AND MISOPROSTOL is indicated for the treatment of Osteoarthritis; Rheumatoid Arthritis; Gastric Ulcer; Duodenal Ulcer.
WARNING: RISK OF UTERINE RUPTURE, ABORTION, PREMATURE BIRTH, BIRTH DEFECTS; AND SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS WARNING: RISK OF UTERINE RUPTURE, ABORTION, PREMATURE BIRTH, BIRTH DEFECTS; SERIOUS CARDIOVASCULAR EVENTS; AND SERIOUS GASTROINTESTINAL EVENTS Uterine Rupture, Abortion,...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.