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Meclofenamate Side Effects

In Summary

Commonly reported side effects of meclofenamate include: behavioral changes, diarrhea, and nausea. Other side effects include: dizziness, headache, nausea and vomiting, dyspepsia, skin rash, abdominal distention, and abdominal pain. See below for a comprehensive list of adverse effects.

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; difficult breathing; swelling of your face, lips, tongue, or throat.

Get emergency medical help if you have:

  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating; or

  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.

Stop using meclofenamate and call your doctor at once if you have:

  • swelling, rapid weight gain, little or no urinating;

  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness;

  • symptoms of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  • severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Older adults may be more likely to have symptoms of stomach bleeding.

Common side effects may include:

  • nausea, stomach pain; or

  • diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to meclofenamate: compounding powder, oral capsule

Cardiovascular

Cardiovascular side effects have included edema and palpitations.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

Hepatic

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

Nervous system

Nervous system side effects have included headache and dizziness.[Ref]

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.[Ref]

Renal

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

References

1. "Product Information. Meclofenamate Sodium (meclofenamate)." Sandoz Inc, Broomfield, CO.

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

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