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Arthrotec Side Effects

Generic Name: diclofenac / misoprostol

Note: This page contains information about the side effects of diclofenac / misoprostol. Some of the dosage forms included on this document may not apply to the brand name Arthrotec.

Not all side effects for Arthrotec may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to diclofenac / misoprostol: oral tablet, oral tablet enteric coated

In addition to its needed effects, some unwanted effects may be caused by diclofenac / misoprostol. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when 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

If any of the following symptoms of overdose occur while taking diclofenac / misoprostol, get emergency help immediately:

Symptoms of overdose
  • Diarrhea
  • fever
  • slow heartbeat
  • stomach pain
  • trembling or shaking

Some of the side effects that can occur with diclofenac / misoprostol may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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.[Ref]

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.[Ref]

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]

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]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. "Product Information. Arthrotec (diclofenac-misoprostol)." Searle, Skokie, IL.

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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