Medical Editor: John P. Cunha, DO, FACOEP
Meclofenamate sodium is a nonsteroidal anti-inflammatory drug (NSAID) used for the treatment of mild to moderate pain from various conditions (e.g., dental pain, osteoarthritis) and to decrease pain and blood loss from menstrual periods. Meclofenamate sodium is also used alone or with other treatments to reduce pain, swelling, and joint stiffness from rheumatoid arthritis. Common side effects of meclofenamate sodium include:
The recommended dose of meclofenamate sodium is 50 mg every 4 to 6 hours. Meclofenamate sodium may interact with cidofovir, ketorolac, aliskiren, ACE inhibitors, angiotensin II receptor blockers, anti-platelet drugs, bisphosphonates taken by mouth, blood thinners, corticosteroids, cyclosporine, desmopressin, lithium, methotrexate, pemetrexed, probenecid, antidepressants, tenofovir, or medications that contain aspirin or other NSAIDs . Tell your doctor all medications and supplements you use. Before using this drug, women should talk with their doctor about the benefits and risks (such as miscarriage). Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when prescribed. 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. This drug passes into breast milk. Consult your doctor before breastfeeding.
Our Meclofenamate Sodium Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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Nausea, vomiting, heartburn, dizziness, drowsiness, diarrhea, and headache may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. If you are taking this medication for heavy/painful periods, tell your doctor if you have spotting/bleeding between cycles or an unusually heavy menstrual flow.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, persistent/severe headache, fast/pounding heartbeat, hearing changes (e.g., ringing in the ears), mental/mood changes, stomach pain, difficult/painful swallowing, swelling of the ankles/feet/hands, sudden/unexplained weight gain, unusual tiredness.
Stop taking meclofenamate and tell your doctor immediately if any of these rare but very serious side effects occur: easy bruising/bleeding, signs of infection (e.g., fever, persistent sore throat), unexplained stiff neck, change in the amount/color of urine, vision changes.
This drug may rarely cause serious, possibly fatal liver disease. If you notice any of the following rare but very serious side effects, stop taking meclofenamate and consult your doctor or pharmacist immediately: persistent nausea/vomiting, severe stomach/abdominal pain, weakness, dark urine, yellowing eyes/skin.
A very serious allergic reaction to this drug is rare. However, stop taking meclofenamate and immediately seek medical attention if you notice any of the following symptoms of a serious allergic reaction: rash/blisters, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Meclofenamate (Meclofenamate)
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 pyrosis1, flatulence1, anorexia, constipation, stomatitis, and peptic ulcer. 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.
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
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.
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
Gastrointestinal: paralytic ileus
Read the entire FDA prescribing information for Meclofenamate (Meclofenamate)
© Meclofenamate Patient Information is supplied by Cerner Multum, Inc. and Meclofenamate Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.