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Arthrotec 75

Generic Name: diclofenac and misoprostol (dye KLOE fen ak and mye so PROST ole)
Brand Names: Arthrotec
Arthrotec (diclofenac and misoprostol) is used to treat osteoarthritis and rheumatoid arthritis. Includes Arthrotec side effects, interactions and indications.
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Drug Information:
Arthrotec contains a combination of diclofeNac and Misoprostol. DiclofeNac is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing substances in the body that cause pain and inflammation. Misoprostol reduces stomach acid and replaces protective substances in the stomach that are reduced by NSAIDs. Arthrotec is used to treat osteoarthritis and rheumatoid arthritis in people at high risk for developing stomach or intestinal ulcers. Arthrotec may also be used for purposes not listed in this medication guide. Learn more

Arthrotec 75 Side Effects

Arthrotec Side Effects

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.

For the Consumer

Applies to diclofenac / misoprostol: oral tablet enteric coated

Warning

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:

Less common

  • Black, tarry stools
  • bleeding or crusting sores on the lips
  • blood in the urine or stools
  • bruises or red spots on the skin
  • chest pain
  • chills
  • confusion
  • continuing thirst
  • convulsions (seizures)
  • cough or hoarseness
  • disorientation
  • drowsiness
  • fainting
  • fever with or without chills
  • fluid retention
  • general feeling of illness
  • heartburn or indigestion
  • increased heart rate
  • increased weight gain
  • irregular heartbeat
  • itching of the skin
  • large, flat, blue or purplish patches on the skin
  • lightheadedness or dizziness
  • lower back or side pain
  • mental depression
  • muscle cramps
  • nausea
  • painful or difficult urination
  • pounding heartbeat
  • psychotic reaction
  • rectal bleeding
  • seeing, hearing, or feeling things that are not there
  • severe headache
  • severe liver reactions
  • severe stomach pain, cramping, or burning
  • skin rash
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • stiff neck or back
  • sudden decrease in the amount of urine
  • swelling or tenderness in the upper stomach
  • swelling of the face, fingers, feet, or lower legs
  • troubled breathing, tightness in the chest
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting of material that looks like coffee grounds
  • yellow eyes or skin

Rare

  • Changes in facial skin color
  • fast or irregular breathing
  • puffiness or swelling of the eyelids or around the eyes

Get emergency help immediately if any of the following symptoms of overdose occur while taking diclofenac / misoprostol:

Symptoms of overdose

  • Diarrhea
  • fever
  • slow heartbeat
  • stomach pain
  • trembling or shaking

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:

More common

  • Gas

Less common

  • Abnormal vision
  • acne
  • change in sense of taste
  • decreased appetite
  • decrease in sexual ability
  • dry mouth
  • irritability or nervousness
  • loss of hair
  • muscle pain
  • tingling, burning, or prickling sensations
  • trouble with swallowing
  • vaginal bleeding

For Healthcare Professionals

Applies to diclofenac / misoprostol: oral tablet

General

The highest reported incidences of adverse events for this drug were gastrointestinal and included abdominal pain, diarrhea, dyspepsia, nausea, and flatulence.

Gastrointestinal

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.

Diclofenac-misoprostol:

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

Diclofenac:

Very common (10% or more): Abdominal pain (15%), diarrhea (11%), dyspepsia (11%), nausea (11%)

Common (1% to 10%): Flatulence, nausea

Cardiovascular

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.

Hepatic

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.

Hypersensitivity

Rare (less than 0.1%): Allergic reactions

Frequency not reported: Angioedema, laryngeal/pharyngeal edema, urticaria

Postmarketing reports: Anaphylaxis

Dermatologic

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

Renal

Frequency not reported: Renal failure, glomerulonephritis membranous, glomerulonephritis minimal lesion

Postmarketing reports: Acute renal failure, renal papillary necrosis, nephritis, interstitial nephrotic syndrome, proteinuria

Hematologic

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.

Metabolic

Rare (less than 0.1%): Anorexia, appetite changes, dehydration, hyperglycemia, hypoglycemia, hyponatremia, weight changes, gout, hypercholesterolemia, porphyria

Nervous system

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

Psychiatric

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

Other

Rare (less than 0.1%): Asthenia, fatigue, fever, malaise, chills, hearing impairment, tinnitus, speech disorder

Genitourinary

Diclofenac-misoprostol:

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

Misoprostol:

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.

Ocular

Rare (less than 0.1%): Amblyopia, blurred vision, conjunctivitis, diplopia, glaucoma, iritis, lacrimation abnormal, night blindness, abnormal vision, eye pain

Respiratory

Rare (less than 0.1%): Coughing, dyspnea, hyperventilation, pneumonia, respiratory depression, pharyngitis, increased sputum

Postmarketing reports: Asthma, pneumonitis, dyspnea

Immunologic

Frequency not reported: Infection, sepsis

Postmarketing reports: Aseptic meningitis

Musculoskeletal

Rare (less than 0.1%): Arthralgia, myalgia, leg cramps

Editorial References and Review

Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.

Source: Drugs.com Arthrotec 75 (www.drugs.com/arthrotec.html).