Does Meclofenamate sodium cause side effects?

Meclofenamate sodium is a non-steroidal anti-inflammatory drug (NSAID) used to relieve mild to moderate pain. Meclofenamate sodium is also indicated to treat primary dysmenorrhea (menopause), to treat idiopathic heavy menstrual blood loss, and for relief of the signs and symptoms of acute and chronic rheumatoid arthritis and osteoarthritis

NSAIDs work by reducing the levels of prostaglandins, chemicals that are responsible for pain, fever, and inflammation. Meclofenamate blocks the enzymes that make prostaglandins (cyclooxygenases), resulting in lower concentrations of prostaglandins. As a consequence, inflammation, pain, and fever are reduced. 

Common side effects of meclofenamate sodium include

Serious side effects of meclofenamate sodium include

Drug interactions of meclofenamate sodium include warfarin, a blood thinner, because this may cause excessive bleeding as meclofenamate enhances the effect of warfarin. 

Meclofenamate, as other NSAIDs, may reduce the effects of blood pressure-lowering medications. 

Concurrent use of meclofenamate and cyclosporine, an immunosuppressant, can increase the risk of kidney damage (nephrotoxicity), as meclofenamate tends to increase cyclosporine-induced kidney damage by blocking certain prostaglandins that are important in preventing toxic effects on the kidney. 

Persons who have more than three alcoholic beverages per day may be at increased risk of developing stomach ulcers when taking meclofenamate or other NSAIDs. 

During pregnancy, meclofenamate should be used only when clearly needed. It is not recommended for use during the first and last trimesters of pregnancy due to possible harm to the fetus and interference with normal labor/delivery. 

Meclofenamate passes into breast milk. Consult your doctor before breastfeeding

What are the important side effects of Meclofenamate sodium?

The most common side effects are:

It is important to note that people who take NSAIDs such as meclofenamate may have a higher risk of having a heart attack or a stroke than people who do not take these medications. Meclofenamate may cause ulcers, bleeding, or holes in the stomach or intestine. The risk may be higher for people who take NSAIDs for a longer period of time, are older in age, have poor health, or drink large amounts of alcohol.

If patients experience any of the following symptoms they should stop taking meclofenamate and call their doctor:

  • stomach pain,
  • heartburn,
  • vomiting a substance that is bloody or looks like coffee grounds,
  • blood in the stool, or
  • black and tarry stools.

Nonsteroidal antiinflammatory drugs (NSAIDs) used to treat pain and inflammation. Other NSAIDS include:

(Relafen) and several others. These drugs are used for the management of mild to moderate pain, fever, and inflammation. They work by reducing the levels of prostaglandins, chemicals that are responsible for pain, fever, and inflammation.

Meclofenamate blocks the enzymes that make prostaglandins (cyclooxygenases), resulting in lower concentrations of prostaglandins. As a consequence, inflammation, pain, and fever are reduced. Meclofenamate was approved by the FDA in June 1980.

Meclofenamate sodium side effects list for healthcare professionals

Incidence Greater Than 1%

The following adverse reactions were observed in clinical trials and included observations from more than 2,700 patients, 594 of whom were treated for one year and 248 for at least two years.

Gastrointestinal: The most frequently reported adverse reactions associated with meclofenamate sodium involve the gastrointestinal system. In controlled studies of up to six months duration, these disturbances occurred in the following decreasing order of frequency with the approximate incidences in parentheses:

  • diarrhea (10% to 33%),
  • nausea with or without vomiting (11%),
  • other gastrointestinal disorders (10%), and
  • abdominal pain1.

In long-term uncontrolled studies of up to four years duration, one third of the patients had at least one episode of diarrhea some time during meclofenamate sodium therapy.

In approximately 4% of the patients in controlled studies, diarrhea was severe enough to require discontinuation of meclofenamate sodium. The occurrence of diarrhea is dose related, generally subsides with dose reduction, and clears with termination of therapy. The incidence of diarrhea in patients with osteoarthritis is generally lower than that reported in patients with rheumatoid arthritis.

Other reactions less frequently reported were

The majority of the patients with peptic ulcer had either a history of ulcer disease or were receiving concomitant anti-inflammatory drugs, including corticosteroids which are known to produce peptic ulceration.

Cardiovascular: edema

Dermatologic: rash1, urticaria, pruritus

Central Nervous System: headache1, dizziness1

Special Senses: tinnitus

Incidence Less Than 1%—Probably Causally Related

The following adverse reactions were reported less frequently than 1% during controlled clinical trials and through voluntary reports since marketing. The probability of a causal relationship exists between the drug and these adverse reactions.

Gastrointestinal: bleeding and/or perforation with or without obvious ulcer formation, colitis, cholestatic jaundice

Renal: renal failure

Hematologic: neutropenia, thrombocytopenic purpura, leukopenia, agranulocytosis, hemolytic anemia, eosinophilia, decrease in hemoglobin and/or hematocrit

Dermatologic: erythema multiforme, Stevens-Johnson Syndrome, exfoliative dermatitis

Hepatic: alteration of liver function tests

Allergic: lupus and serum sickness-like symptoms

Incidence Less Than 1%—Causal Relationship Unknown

Other reactions have been reported but under conditions where a causal relationship could not be established. However, in these rarely reported events, that possibility cannot be excluded. Therefore, these observations are listed to alert physicians.

Cardiovascular: palpitations

Central Nervous System: malaise, fatigue, paresthesia, insomnia, depression

Special Senses: 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, iritis

Renal: nocturia

Gastrointestinal: paralytic ileus

Dermatologic: erythema nodosum, hair loss

What drugs interact with Meclofenamate sodium?

Warfarin
  • Meclofenamate sodium enhances the effect of warfarin. Therefore, when meclofenamate sodium is given to a patient receiving warfarin, the dosage of warfarin should be reduced to prevent excessive prolongation of the prothrombin time.
Aspirin
  • Concurrent administration of aspirin may lower meclofenamate sodium plasma levels, possibly by competing for protein binding sites.
  • The urinary excretion of meclofenamate sodium is unaffected by aspirin, indicating no change in meclofenamate sodium absorption.
  • Meclofenamate sodium does not affect serum salicylate levels.
  • Greater fecal blood loss results from concomitant administration of both drugs than from either drug alone.
Propoxyphene
  • The concurrent administration of propoxyphene hydrochloride does not affect the bioavailability of meclofenamate sodium.
Antacids
  • Concomitant administration of aluminum and magnesium hydroxides does not interfere with absorption of meclofenamate sodium.

Carcinogenesis

  • An 18-month study in rats revealed no evidence of carcinogenicity.

Pregnancy

  • Meclofenamate sodium, like aspirin and other non-steroidal anti-inflammatory drugs, causes fetotoxicity, minor skeletal malformations, e.g., supernumerary ribs, and delayed ossification in rodent reproduction trials, but no major teratogenicity.
  • Similarly, it prolongs gestation and interferes with parturition and with normal development of young before weaning.
  • Meclofenamate sodium is not recommended for use during pregnancy, particularly in the 1st and 3rd trimesters based on these animal findings.
  • There are, however, no adequate and well controlled studies in pregnant women.

Nursing Mothers

  • Trace amounts of meclofenamic acid are excreted in human milk. Because of the possible adverse effects of prostaglandin-inhibiting drugs on neonates, meclofenamate sodium is not recommended for nursing women.

Pediatric Use

  • Safety and effectiveness in children below the age of 14 have not been established.

1 Incidence between 3% and 9%. Those reactions occurring in 1% to 3% of patients are not marked with an asterisk.

Summary

Meclofenamate sodium is a non-steroidal anti-inflammatory drug (NSAID) used to relieve mild to moderate pain. It is also indicated to treat primary dysmenorrhea (menopause), to treat idiopathic heavy menstrual blood loss, and for relief of the signs and symptoms of acute and chronic rheumatoid arthritis and osteoarthritis. Common side effects of meclofenamate sodium include abdominal pain with cramps, allergic reactions, diarrhea, dizziness, headache, heartburn, nausea, and skin rash. During pregnancy, meclofenamate should be used only when clearly needed. Meclofenamate passes into breast milk.

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Medically Reviewed on 9/23/2020
References
FDA Prescribing Information

Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.