Arthrotec Side Effects

Generic name: diclofenac / misoprostol

Medically reviewed by Drugs.com. Last updated on Jun 13, 2023.

Note: This document provides detailed information about Arthrotec Side Effects associated with diclofenac / misoprostol. Some dosage forms listed on this page may not apply specifically to the brand name Arthrotec.

Applies to diclofenac / misoprostol: oral tablet enteric coated.

Precautions

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant, especially during the later part of pregnancy can cause miscarriage, premature birth, very serious birth defects, or tearing of the uterus. If you are a woman who can bear children, your doctor may give you a pregnancy test within 2 weeks before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control to keep from getting pregnant while you are using this medicine and after the last dose. The most effective forms of birth control are hormone birth control pills, patches, shots, vaginal rings, or implants, an IUD, or a vasectomy (for men). One of these forms of birth control should be combined with a condom, a diaphragm, or a cervical cap. You must have a negative pregnancy test before you will be allowed to take this medicine. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may increase your risk of having blood clots, heart attack, or stroke. This is more likely in people who already have heart or blood vessel disease. People who use this medicine for a long time might also have a higher risk. Check with your doctor right away if you have swelling and pain in your arms, legs, or stomach, chest pain, trouble breathing, loss of sensation, confusion, or problems with muscle control or speech.

This medicine may cause bleeding, perforation, or ulcers in your stomach or bowels. These problems can happen without warning signs and are more likely to occur if you have had a stomach ulcer, if you smoke or drink alcohol regularly, are over 60 years of age, in poor health, or using certain medicines (eg, steroid medicine, blood thinner).

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Your blood pressure might get too high while you are using this medicine. This may cause headaches, dizziness, or blurred vision. You might need to measure your blood pressure at home. If you think your blood pressure is too high, call your doctor right away.

This medicine may cause a serious type of allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing or swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Serious skin reactions including Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) can occur during treatment with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, painful or difficult urination, red skin lesions, sore throat, sores ulcers, white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness. .

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have stomach pain, confusion, difficulty with breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, or weakness or heaviness of the legs.

This medicine can cause worsening of your heart failure. Check with your doctor right away if you have chest pain, decreased urine output, dilated neck veins, extreme fatigue, irregular breathing, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, tightness in the chest, trouble breathing, or weight gain.

This medicine may cause diarrhea in some people. The diarrhea will usually disappear within a few days as your body adjusts to the medicine. However, check with your doctor right away if the diarrhea is severe or does not stop after a week.

Stomach problems may be more likely to occur if you drink alcoholic beverages while being treated with this medicine. Therefore, do not regularly drink alcoholic beverages while taking this medicine, unless otherwise directed by your doctor.

This medicine may cause a delay in ovulation for women and may affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.

Taking nonsteroidal anti-inflammatory drugs (eg, acetaminophen, aspirin or other salicylates, or ketorolac, Toradol®) together with this medicine on a regular basis may increase the chance of unwanted effects. The risk will depend on how much of each medicine you take everyday, and on how long you take these medicines together. If your doctor directs you to take these medicines together on a regular basis, follow his or her directions carefully. However, do not take acetaminophen or aspirin or other salicylates together with this medicine for more than a few days, and do not take any ketorolac (eg, Toradol®) while you are taking this medicine, unless your doctor has directed you to do so and is following your progress.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or non-prescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Arthrotec

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:

Other side effects of Arthrotec

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:

For healthcare professionals

Applies to diclofenac / misoprostol: oral delayed release tablet, oral tablet.

General adverse events

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

Gastrointestinal

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^[Ref]

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.^[Ref]

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^[Ref]

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.^[Ref]

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^[Ref]

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.^[Ref]

Hypersensitivity

• Rare (less than 0.1%): Allergic reactions
• Frequency not reported: Angioedema, laryngeal/pharyngeal edema, urticaria
• Postmarketing reports: Anaphylaxis^[Ref]

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^[Ref]

Renal

• Frequency not reported: Renal failure, glomerulonephritis membranous, glomerulonephritis minimal lesion
• Postmarketing reports: Acute renal failure, renal papillary necrosis, nephritis, interstitial nephrotic syndrome, proteinuria^[Ref]

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^[Ref]

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.^[Ref]

Metabolic

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

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^[Ref]

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^[Ref]

Other

• Rare (less than 0.1%): Asthenia, fatigue, fever, malaise, chills, hearing impairment, tinnitus, speech disorder^[Ref]

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^[Ref]

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.^[Ref]

Ocular

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

Respiratory

• Rare (less than 0.1%): Coughing, dyspnea, hyperventilation, pneumonia, respiratory depression, pharyngitis, increased sputum
• Postmarketing reports: Asthma, pneumonitis, dyspnea^[Ref]

Immunologic

• Frequency not reported: Infection, sepsis
• Postmarketing reports: Aseptic meningitis^[Ref]

Musculoskeletal

• Rare (less than 0.1%): Arthralgia, myalgia, leg cramps^[Ref]

See also:

Further information

Arthrotec side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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