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Meclofenamate Side Effects Center
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.
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Meclofenamate Overview - Patient Information: Side Effects
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)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Meclofenamate FDA Prescribing Information: Side Effects
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.
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) »
Additional Meclofenamate Information
Meclofenamate - User Reviews
Meclofenamate User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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