Meclofenamate Side Effects

Some side effects of meclofenamate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to meclofenamate: oral capsule

Get emergency medical help if you have any of these signs of an allergic reaction while taking meclofenamate: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking meclofenamate and call your doctor at once if you have any of these serious side effects:

• chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;

• black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• urinating less than usual or not at all;

• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or

• bruising, severe tingling, numbness, pain, muscle weakness.

Less serious side effects of meclofenamate may include:

• upset stomach, mild heartburn or stomach pain, diarrhea, constipation; bloating, gas;

• dizziness, headache, nervousness;

• skin itching or rash;

• dry mouth;

• increased sweating, runny nose;

• blurred vision; or

• ringing in your ears.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to meclofenamate: compounding powder, oral capsule

Cardiovascular

Cardiovascular side effects have included edema and palpitations.

Dermatologic

Dermatologic side effects have included rash, urticaria, and pruritus. Dermatologic side effects reported in less than 1% of test subjects have included erythema multiforme, Stevens-Johnson Syndrome, and exfoliative dermatitis.

Gastrointestinal

Gastrointestinal side effects have included diarrhea (10 to 33%), nausea with or without vomiting (11%), other gastrointestinal disorders (10%), and abdominal pain. Less frequently reported gastrointestinal side effects have included pyrosis, flatulence, anorexia, constipation, stomatitis, and peptic ulcer (most patients with peptic ulcer had either a history of ulcer disease or were receiving concomitant anti-inflammatory drugs). Gastrointestinal side effects reported in less than 1% of patients have included bleeding and/or perforation with or without obvious ulcer formation, colitis, cholestatic jaundice, and gastric ileus.

General

General side effects with an unknown causal relationship have included malaise, fatigue, paresthesia, insomnia, depression, blurred vision, taste disturbances, decreased visual acuity, temporary loss of vision, reversible loss of color vision, retinal changes including macular fibrosis, macular and perimacular edema, conjunctivitis, and iritis.

Hematologic

Hematologic side effects were reported in less than 1% of test subjects and have included neutropenia, thrombocytopenic purpura, leukopenia, agranulocytosis, hemolytic anemia, eosinophilia, and decrease in hemoglobin and/or hematocrit.

Hepatic

Hepatic side effects have included alteration of lever function tests (less than 1%).

Nervous system

Nervous system side effects have included headache and dizziness.

Other

Other side effects have included tinnitus (3 to 9%). Other side effects occurring in less than 1% of test subjects have included lupus and serum sickness-like symptoms.

Renal

Renal side effects have included renal failure (less than 1%) and nocturia (less than 1%).

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