Note: This document contains side effect information about diclofenac / misoprostol. Some of the dosage forms listed on this page may not apply to the brand name Arthrotec.
Applies to diclofenac / misoprostol: oral tablet enteric coated
Oral route (Tablet, Enteric Coated)
Diclofenac sodium/misoprostol should not be administered during pregnancy as abortion, premature birth, or birth defects can occur. Avoid use in women of childbearing potential unless the patient requires NSAID therapy and is at high risk of developing complications from gastric or duodenal ulcers and meets the following criteria: has a negative serum pregnancy test within 2 weeks of treatment initiation, uses effective contraception, receives oral and written warnings of the hazards of misoprostol, and initiates therapy only on the second or third day of her next normal menstrual period. 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. Diclofenac sodium/misoprostol is contraindicated in the setting of CABG surgery. NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
Along with its needed effects, diclofenac / misoprostol may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking diclofenac / misoprostol:
Get emergency help immediately if any of the following symptoms of overdose occur while taking diclofenac / misoprostol:
Symptoms of overdose
Some side effects of diclofenac / misoprostol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Applies to diclofenac / misoprostol: oral tablet
The highest reported incidences of adverse events for this drug were gastrointestinal and included abdominal pain, diarrhea, dyspepsia, nausea, and flatulence.
NSAIDs including this drug, can cause serious gastrointestinal (GI) events which can occur at any time, with or without warning. For patients who develop a serious upper GI event, only about 20% were symptomatic. Upper GI ulcers, gross bleeding, or perforation occurred in approximately 1% of patients treated with NSAIDs for 3 to 6 months and 2% to 4% of patients treated for 1 year. Patients with a prior history of peptic ulcer disease and/or GI bleeding had a greater than 10-fold increased risk for developing a GI bleed than patients with neither of these risk factors.
Very common (10% or more): Abdominal pain (21%), diarrhea (19%), dyspepsia (14%), nausea (11%)
Common (1% to 10%): Flatulence, gastritis, vomiting, eructation, constipation, peptic ulcer
Uncommon (0.1% to 1%): Stomatitis
Rare (less than 0.1%): Esophageal ulceration, esophagitis, gastroesophageal reflux, heartburn, hematemesis, melena, gall bladder disorder
Frequency not reported: Pancreatitis
Postmarketing reports: Gastrointestinal (GI) perforation, GI bleeding, melena, colitis, Crohn's disease, esophageal disorder, mouth ulceration, tongue edema, dry mouth
Very common (10% or more): Abdominal pain (15%), diarrhea (11%), dyspepsia (11%), nausea (11%)
Common (1% to 10%): Flatulence, nausea
Uncommon (0.1% to 1%): Hypertension, chest pain, edema, palpitation, syncope
Rare (less than 0.1%): Arrhythmia, atrial fibrillation, hypotension, myocardial infarction, premature ventricular contractions, tachycardia, vasculitis, phlebitis
Frequency not reported: Cardiac failure, palpitations
Clinical trials of several cyclooxygenase (COX)-2 selective and nonselective NSAIDs of up to 3 years duration have shown an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs appear to have a similar risk. There is no consistent evidence that concurrent use of aspirin mitigates this increased risk and may be associated with an increased risk of serious gastrointestinal events.
Common (1% to 10%): Alanine aminotransferase increased, aspartate aminotransferase increased
Rare (less than 0.1%): Hepatitis, jaundice, abnormal hepatic function
Frequency not reported: Liver failure
Postmarketing reports: Hepatitis fulminant, blood bilirubin increased
Elevations to greater than 3 x ULN of ALT occurred in about 1.6% (n=2184) of patients receiving diclofenac-misoprostol at some point during treatment. These increases were generally transient and returned to within normal range upon discontinuation of therapy. In an open-labeled trial among patients receiving NSAIDs, a higher incidence of transaminase elevations were observed in patients receiving diclofenac compared with other NSAIDs.
Rare (less than 0.1%): Allergic reactions
Frequency not reported: Angioedema, laryngeal/pharyngeal edema, urticaria
Postmarketing reports: Anaphylaxis
Common (1% to 10%): Erythema multiforme, rash, pruritus
Uncommon (0.1% to 1%): Purpura, urticaria
Rare (less than 0.1%): Angioedema, increased sweating, acne
Postmarketing reports: Toxic epidermal necrolysis, Stevens-Johnson syndrome, dermatitis exfoliative, dermatitis bullous, Henoch Schonlein purpura, mucocutaneous rash, rash vesicular, photosensitivity reaction, alopecia
Frequency not reported: Renal failure, glomerulonephritis membranous, glomerulonephritis minimal lesion
Postmarketing reports: Acute renal failure, renal papillary necrosis, nephritis, interstitial nephrotic syndrome, proteinuria
Uncommon (0.1% to 1%): Thrombocytopenia
Rare (less than 0.1%): Agranulocytosis, anemia, aplastic anemia, coagulation time increased, ecchymosis, eosinophilia, hemolytic anemia, leukocytosis, leukopenia, lymphadenopathy, pancytopenia, decreased hematocrit
NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Unlike aspirin, the NSAID effect on platelet function is quantitatively less, of shorter duration, and reversible.
Rare (less than 0.1%): Anorexia, appetite changes, dehydration, hyperglycemia, hypoglycemia, hyponatremia, weight changes, gout, hypercholesterolemia, porphyria
Common (1% to 10%): Headache, dizziness
Rare (less than 0.1%): Drowsiness, headache, hyperesthesia, hypertonia, hypoesthesia, insomnia, meningitis, migraine, neuralgia, paresthesia, somnolence, stroke, tremor, confusion
Frequency not reported: Coma
Postmarketing reports: Convulsions, memory disturbance, taste disturbance
Common (1% to 10%): Insomnia
Rare (less than 0.1%): Anxiety, impaired concentration, depression, dream abnormalities, hallucinations, irritability, nervousness, paranoia, psychotic reaction
Postmarketing reports: Mood changes, nightmares
Rare (less than 0.1%): Asthenia, fatigue, fever, malaise, chills, hearing impairment, tinnitus, speech disorder
Rare (less than 0.1%): Vaginitis, menstrual disorder, menorrhagia, dysmenorrhea, intermenstrual bleeding, cystitis, dysuria, nocturia
Frequency not reported: Impotence, perineal pain
Postmarketing reports: Intrauterine death, uterine rupture, incomplete abortion, abnormal uterine contractions, retained placenta, dysuria, urine abnormal
Frequency not reported: Hyperstimulation of the uterus, amniotic fluid embolism resulting in maternal and fetal death, severe vaginal bleeding, retained placenta, pelvic pain, uterine rupture
Misoprostol may cause abortion. It has been used outside of its approved indications to ripen the cervix, to induce labor, and to treat postpartum hemorrhage, however a major adverse effect of these uses is hyperstimulation of the uterus. Uterine rupture, amniotic fluid embolism, and severe genital bleeding have been reported.
Rare (less than 0.1%): Amblyopia, blurred vision, conjunctivitis, diplopia, glaucoma, iritis, lacrimation abnormal, night blindness, abnormal vision, eye pain
Rare (less than 0.1%): Coughing, dyspnea, hyperventilation, pneumonia, respiratory depression, pharyngitis, increased sputum
Postmarketing reports: Asthma, pneumonitis, dyspnea
Frequency not reported: Infection, sepsis
Postmarketing reports: Aseptic meningitis
Rare (less than 0.1%): Arthralgia, myalgia, leg cramps
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Arthrotec 50 (www.drugs.com/arthrotec.html).
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