💊 Diclofenac (Diclofenac Sodium/misoprostol Diclofenac-sodium-misoprostol)
A combination delayed-release tablet containing diclofenac (a non-steroidal anti-inflammatory drug) and misoprostol (a prostaglandin E1 analog that protects the GI mucosa). It treats signs and symptoms of osteoarthritis and rheumatoid arthritis in adults at high risk of NSAID-induced gastric and duodenal ulcers. It is contraindicated in pregnancy.
In Arabic: ديكلوفيناك الصوديوم / ميزوبروستول
🏷️ Brand names & manufacturers
Diclofenac Sodium🏭 Amneal Pharmaceuticals NY LLCDailyMed✅ What it is used for
- Treatment of signs and symptoms of osteoarthritis in adults at high risk of NSAID-induced gastric and duodenal ulcers and their complications
- Treatment of signs and symptoms of rheumatoid arthritis in adults at high risk of NSAID-induced gastric and duodenal ulcers and their complications
🧪 Active ingredient
Diclofenac sodium: an NSAID with analgesic, anti-inflammatory and antipyretic properties that inhibits cyclooxygenase (COX-1 and COX-2), reducing prostaglandins that cause pain and inflammation. Misoprostol: a synthetic PGE1 analog with gastric antisecretory and mucosal protective properties that reduces the risk of NSAID-induced gastric and duodenal ulcers.
🌿 Benefits
- Relief of signs and symptoms of osteoarthritis and rheumatoid arthritis
- Reduced risk of NSAID-induced gastric and duodenal ulcers in patients at high risk
📝 How to use
- Taken by mouth, by prescription only; your doctor or pharmacist sets the dose based on your condition.
- The lowest effective dose for the shortest duration consistent with treatment goals is used.
- The label notes that taking it with food and avoiding magnesium-containing antacids can reduce diarrhea.
- Do not change the dose or stop without consulting your doctor, and never give the medicine to anyone else.
💊 Dosage forms
- Delayed-release uncoated tablets: 50 mg diclofenac sodium / 200 mcg misoprostol
- Delayed-release tablets: 75 mg diclofenac sodium / 200 mcg misoprostol (white to off-white, round, biconvex, debossed "D 75 M")
⚠️ Common side effects
- Abdominal pain
- Diarrhea
- Dyspepsia
- Nausea
- Flatulence
- Gastritis
- Vomiting
- Constipation
- Headache
- Dizziness
- Increased ALT
- Decreased hematocrit
🚨 Serious — seek medical help
- GI bleeding, ulceration, and perforation (can occur without warning and may be fatal)
- Cardiovascular thrombotic events such as myocardial infarction and stroke
- Hepatotoxicity
- Hypertension
- Heart failure and edema
- Renal toxicity and hyperkalemia
- Anaphylactic reactions
- Serious skin reactions, including DRESS
- Hematologic toxicity (anemia)
- Severe dehydration from profound diarrhea
- Postmenopausal vaginal bleeding
⛔ Do not use if
- Pregnancy
- In the setting of coronary artery bypass graft (CABG) surgery
- Active gastrointestinal bleeding
- History of asthma, urticaria, or other allergic-type reactions after aspirin or other NSAIDs
- Known hypersensitivity to diclofenac, misoprostol, other prostaglandins, or any component of the product
❗ Warnings & precautions
- Boxed warning: misoprostol can cause uterine rupture, abortion, premature birth, or birth defects; not recommended in women of childbearing potential.
- Verify pregnancy status within 2 weeks before starting, use effective contraception during treatment, and start only on the second or third day of the next normal menstrual period.
- Boxed warning: NSAIDs increase the risk of serious cardiovascular thrombotic events (MI, stroke); risk may occur early and increase with duration of use.
- Boxed warning: risk of GI bleeding, ulceration, and perforation; elderly patients and those with prior peptic ulcer disease or GI bleeding are at greater risk.
- Hepatotoxicity: discontinue if abnormal liver tests persist or worsen or signs of liver disease develop.
- May impair response to some antihypertensive medications; monitor blood pressure.
- Avoid in severe heart failure unless benefits outweigh risks; monitor renal function in renal or hepatic impairment, heart failure, dehydration, or hypovolemia.
- Discontinue at first sign of skin rash or hypersensitivity; seek emergency help for anaphylactic reactions.
- Patients with inflammatory bowel disease or those at risk from dehydration should be monitored carefully because of diarrhea risk.
- May be associated with reversible infertility in some women; consider withdrawal in women who have difficulty conceiving.
🔄 Drug interactions
- Anticoagulants (e.g., warfarin), antiplatelet drugs (e.g., aspirin), SSRIs and SNRIs: increased risk of bleeding.
- Aspirin at analgesic doses: not generally recommended together due to increased bleeding and GI adverse reactions; this product is not a substitute for low-dose aspirin for cardiovascular protection.
- ACE inhibitors, ARBs, and beta-blockers: antihypertensive effect may be diminished; renal function may deteriorate in elderly, volume-depleted, or renally impaired patients.
- Magnesium-containing antacids: may increase diarrhea.
🤰 Pregnancy
Contraindicated in pregnancy. Misoprostol can cause uterine rupture, abortion, premature birth, or birth defects, and NSAIDs at about 20 weeks gestation or later may cause oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus. If pregnancy occurs during treatment, discontinue the drug and inform your doctor immediately.
🍼 Breastfeeding
The label text provided does not include specific lactation guidance; consult your doctor before use.
🧒 Children
Safety and effectiveness in pediatric patients have not been established.
👴 Older adults
Patients 65 and older are at greater risk of NSAID-associated cardiovascular, gastrointestinal, and renal adverse reactions. Avoid use in those with cardiovascular and/or renal risk factors; if unavoidable, use the lowest recommended dose for the shortest duration and monitor cardiac and renal function.
🌡️ Storage
Store at 20° to 25°C (68° to 77°F), USP controlled room temperature.
⏰ Missed dose
The label text provided does not include missed-dose instructions; ask your doctor or pharmacist and do not double the dose.
🆘 Overdose
There is no specific antidote. Symptoms may include lethargy, drowsiness, nausea, vomiting, epigastric pain, and GI bleeding; rarely hypertension, acute renal failure, respiratory depression, or coma. Misoprostol overdose signs include sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhea, fever, palpitations, hypotension, or bradycardia. Contact a poison control center (1-800-222-1222) or emergency services; management is supportive and symptomatic.
💰 Price & brands in your area
🏛️ Official price in Palestine — Ministry of Health price list:
| Product | Company | Pack | Price |
|---|---|---|---|
| RUFENAL 12.5 MG 6 SUPP. DICLOFENAC SODIUM | BPC | 6 supp | 11 ₪ |
| TOLERAN 50 MG TAB DICLOFENAC POTASSIUM 50 MG | BPC | 10 Tab | 12 ₪ |
| ABITRENE 50MG SUPP Diclofenac sodium | Teva | 10 SUPP | 14 ₪ |
| RUFENAL 3 ML AMP 5 AMP DICLOFENAC SODIUM | BPC | 5 amp | 15 ₪ |
| DICLO -SAMA GEL 50GM Diclofenacdiethylamine | Sama Pharmaceutical. Co. | 50 GM | 18 ₪ |
| VORYN 50 G GEL Diclofenac diethylammonium | Pharmacare Company | ONE TUBE OF 50 G / BOX | 18 ₪ |
| ANAFLAM 50mg Diclofenac Potassium 50mg/tablet | Beit Jala | 20 tab | 21 ₪ |
| RUFENAL D.S EMULGEL 30 G DICLOFENAC DIETHYL AMMONIUM | BPC | 30g | 22 ₪ |
| DICLO SAMA 50MG Diclofenac Na | Sama Pharmaceutical. Co. | 30 Tab | 22 ₪ |
| VORYN 50 MG TABLETS (30 TAB) Diclofenac sodium50MG | Pharmacare Company | 30 TABLETS / BOX | 22 ₪ |
| DICLOFEN 75MG SUPPOSITORIES. DICLOFENAC SOD. 75MG | Jepharm Co. | 10 SUPP | 23 ₪ |
| TOLERAN 25MG SOFT GELATIN CAPS- 20 CAPS Diclofenac Potassium | BPC | 20 Cap | 25 ₪ |
| RUFENAL 100 MG 12 SUPP. DICLOFENAC SODIUM | BPC | 12 supp | 27 ₪ |
| DICLOFEN 100MG SUPPOSITORIES DICLOFENAC SOD. 100MG | Jepharm Co. | 12 SUPP | 28 ₪ |
| RUFENAL1 MG/ML EYE DROP 10 ML DICLOFENAC DIETHYL AMMONIUM | BPC | EYE DROPS | 28 ₪ |
| VEOXGEL 2.32% EMULGEL Diclofenac Diethylamine 2.32% | Beit Jala | Emulgel 50G TUBE | 30 ₪ |
| Voryn Forte (50 g) Diclofenac Diethylammonium | Pharmacare Company | 50 g gel | 30 ₪ |
| JOFLAM 50MG TABLETS Diclofenac potassium 50 mg | Jepharm Co. | 30 tab | 30 ₪ |
| ABITREN Teva Diclofenac | Teva | 10 AMP | 35 ₪ |
| Diclo-Alison 100 AMP Diclofenac Sodium 75mg/3ml | Alison pharmaceutical company | 100 amp | 250 ₪ |
| Diclo-Lido Alison 100 AMP Diclofenac sodium 75mg/2ml, Lidocaine Hcl 20mg/2ml | Alison pharmaceutical company | 100 Ampoule | 270 ₪ |
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Mechanism of action
Diclofenac inhibits COX-1 and COX-2, reducing prostaglandin synthesis that mediates pain and inflammation. Misoprostol, a PGE1 analog, binds specific prostaglandin receptors, increases bicarbonate and mucus, and is antisecretory, reducing the risk of NSAID-induced gastric and duodenal ulcers.
Labeled dosing
General adult dosing per label: Osteoarthritis: one 50 mg/200 mcg tablet three times daily for maximal GI protection; diclofenac not above 150 mg/day. Rheumatoid arthritis: one 50 mg/200 mcg tablet three or four times daily; diclofenac not above 200 mg/day. If intolerant: 75 mg/200 mcg twice daily or 50 mg/200 mcg twice daily, though less effective in preventing ulcers. The final dose is set by the physician or pharmacist.
- Use the lowest effective dosage for the shortest duration.
- Not recommended for patients who would not receive the appropriate dosage of both active ingredients.
- Verify pregnancy status within 2 weeks before initiation and counsel on effective contraception.
- Monitor hemoglobin/hematocrit, renal and hepatic function, and blood pressure as indicated.
- Diarrhea and abdominal pain usually occur early and resolve in 2 to 7 days; administer with food and avoid magnesium-containing antacids.
- May cause postmenopausal vaginal bleeding.
🎓 Key points for students
- Diclofenac: phenylacetic acid derivative, nonselective COX inhibitor.
- Misoprostol: PGE1 analog providing GI mucosal protection; also an abortifacient.
- The fixed combination reduces gastric/duodenal ulcers compared with diclofenac alone but causes more abdominal pain and diarrhea.
- Key contraindications: pregnancy, CABG surgery, active GI bleeding, aspirin/NSAID-sensitive asthma or allergy.
- Boxed warnings cover three areas: uterine/fetal risk, cardiovascular events, and GI events.
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What is this medicine used for?
It treats signs and symptoms of osteoarthritis and rheumatoid arthritis in adults at high risk of NSAID-induced gastric and duodenal ulcers.
Can pregnant women take it?
No. It is contraindicated in pregnancy because misoprostol can cause abortion, uterine rupture, premature birth, and birth defects. It is also not recommended for women of childbearing potential without effective contraception.
How can diarrhea be reduced?
Per the label, taking it with food and avoiding magnesium-containing antacids can reduce the incidence of diarrhea.
Can I take it with aspirin?
Concomitant use with analgesic doses of aspirin is not generally recommended because of increased bleeding risk, and this product is not a substitute for low-dose aspirin for heart protection. Ask your doctor.
Which symptoms need urgent medical attention?
Chest pain, shortness of breath, weakness on one side of the body, black stools or vomiting blood, skin rash, yellowing of skin or eyes, facial swelling, or severe diarrhea with dehydration.
⚕️ For education only — not a substitute for advice from your doctor or pharmacist. Do not start or stop any medicine without advice. Source: official FDA drug label via openFDA (2026-03), simplified. Updated: 2026-11-10.