Meclofenamate

Mechanism-of-action class: Cyclooxygenase Inhibitors.

• Carefully consider the potential benefits and risks of meclofenamate sodium capsules and other treatment options before deciding to use meclofenamate sodium capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ).

• Meclofenamate sodium capsules are contraindicated in patients with known hypersensitivity to meclofenamate sodium. Meclofenamate sodium capsules should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.contraindicated

Carefully consider the potential benefits and risks of meclofenamate sodium capsules and other treatment options before deciding to use meclofenamate sodium capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). After observing the response to initial therapy with meclofenamate sodium capsules, the dose and frequency should be adjusted to suit an individual patient's needs. Usual Dosage For Mild to Moderate Pain The recommended dose is 50 mg every 4 to 6 hours. Doses of 100 mg may be needed in some patients for optimal pain relief (see CLINICAL PHARMACOLOGY ). However, the daily dose should not exceed 400 mg (see ADVERSE REACTIONS ). For excessive menstrual blood loss and primary dysmenorrheal The recommended dose of meclofenamate sodium is 100 mg 3 times a day, for up to 6 days, starting at the onset of menstrual flow. For rheumatoid arthritis and osteoarthritis (including acute exacerbations of chronic disease) The dosage is 200 mg to 400 mg per day, administered in three or four equal doses. Therapy should be initiated at the lower dosage, then increased as necessary to improve clinical response. The dosage should be individually adjusted for each patient, depending on the severity of the symptoms and the clinical response. The daily dosage should not exceed 400 mg per day. The smallest dosage of meclofenamate sodium that yields clinical control should be employed.

Cardiovascular Effects Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to 3 years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses. To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur. There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use.

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 2 years. Gastrointestinal The most frequently reported adverse reactions associated with meclofenamate sodium involve the gastrointestinal system. In controlled studies of up to 6 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 pain * . In long-term uncontrolled studies of up to 4 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 pyrosis * , flatulence * , 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.

Pregnancy Risk Summary Use of NSAIDs, including meclofenamate sodium capsules, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of meclofenamate sodium capsules use between about 20 and 30 weeks of gestation, and avoid meclofenamate sodium capsules use at about 30 weeks of gestation and later in pregnancy (see WARNINGS: Fetal Toxicity ). Premature Closure of Fetal Ductus Arteriosus Use of NSAIDs, including meclofenamate sodium capsules, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Oligohydramnios/Neonatal Renal Impairment Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. Data from observational studies regarding other potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. Animal reproductive studies conducted in rats and rabbits have not demonstrated evidence of developmental abnormalities. However, animal reproduction studies are not always predictive of human response.

Metabolism

Meclofenamate sodium is rapidly absorbed in man following single and multiple oral doses with peak plasma concentrations occurring in 0.5 to 2 hours. Based on a comparison to a suspension of meclofenamic acid, meclofenamate sodium is completely bioavailable.

The following is based on the little information available concerning overdosage with meclofenamate sodium and related compounds. After a massive overdose, CNS stimulation may be manifested by irrational behavior, marked agitation and generalized seizures. Following this phase, renal toxicity (falling urine output, rising creatinine, abnormal urinary cellular elements) may be noted with possible oliguria or anuria and azotemia. A 24 year-old male was anuric for approximately one week after ingesting an overdose of 6 to 7 grams of meclofenamate sodium. Spontaneous diuresis and recovery subsequently occurred. Management consists of emptying the stomach by emesis or lavage and instilling an ample dose of activated charcoal into the stomach. There is some evidence that charcoal will actively absorb meclofenamate sodium, but dialysis or hemoperfusion may be less effective because of plasma protein binding. The seizures should be controlled by an appropriate anticonvulsant regimen. Attention should be directed throughout, by careful monitoring, to the preservation of vital functions and fluid-electrolyte balance.

• Sep 3, 1986ANDAANDA071081Mylan

1. 1Pain611%
2. 2Hypertension59.3%
3. 3Drug Ineffective47.4%
4. 4Dyspnoea47.4%
5. 5Fatigue47.4%
6. 6Nausea47.4%
7. 7Arthralgia35.6%
8. 8Coronary Artery Disease35.6%
9. 9Death35.6%
10. 10Dehydration35.6%
11. 11Injury35.6%
12. 12Intestinal Diaphragm Disease35.6%
13. 13Joint Swelling35.6%
14. 14Malaise35.6%
15. 15Oedema Peripheral35.6%

Recent PubMed references pinned to Meclofenamate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Inhibition of Ca(2+)-activated chloride channels by the NSAID meclofenamate for anti-diarrhea.
  Biochemical pharmacology · 2026 · Li Q, Shi H, Zhou P, et al.
  PMID 41544862DOI 10.1016/j.bcp.2026.117710
• Repurposing auranofin and meclofenamic acid as energy-metabolism inhibitors and anti-cancer drugs.
  PloS one · 2024 · Rodríguez-Enríquez S, Robledo-Cadena DX, Pacheco-Velázquez SC, et al.
  PMID 39288141DOI 10.1371/journal.pone.0309331
• Neuroprotection of the Inner Retina Also Prevents Secondary Outer Retinal Pathology in a Mouse Model of Glaucoma.
  Investigative ophthalmology & visual science · 2021 · Kumar S, Ramakrishnan H, Viswanathan S, et al.
  PMID 34297802DOI 10.1167/iovs.62.9.35
• Nickel(II)-meclofenamate complexes: Structure, in vitro and in silico DNA- and albumin-binding studies, antioxidant and anticholinergic activity.
  Journal of inorganic biochemistry · 2021 · Barmpa A, Geromichalos GD, Hatzidimitriou AG, et al.
  PMID 34139455DOI 10.1016/j.jinorgbio.2021.111507
• Meclofenamate causes loss of cellular tethering and decoupling of functional networks in glioblastoma.
  Neuro-oncology · 2021 · Schneider M, Vollmer L, Potthoff AL, et al.
  PMID 33864086DOI 10.1093/neuonc/noab092
• Effect of Pharmacological Inhibition of Fat-Mass and Obesity-Associated Protein on Nerve Trauma-Induced Pain Hypersensitivities.
  Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2021 · Zheng BX, Guo X, Albik S, et al.
  PMID 33829413DOI 10.1007/s13311-021-01053-2
• Copper(II) complexes with meclofenamate ligands: Structure, interaction with DNA and albumins, antioxidant and anticholinergic activity.
  Journal of inorganic biochemistry · 2021 · Barmpa A, Hatzidimitriou AG, Psomas G, et al.
  PMID 33556771DOI 10.1016/j.jinorgbio.2021.111357
• Significance of Multiple Bioactivation Pathways for Meclofenamate as Revealed through Modeling and Reaction Kinetics.
  Drug metabolism and disposition: the biological fate of chemicals · 2021 · Schleiff MA, Flynn NR, Payakachat S, et al.
  PMID 33239334DOI 10.1124/dmd.120.000254

The 2 most recently updated of 2 ClinicalTrials.gov registrations naming Meclofenamate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Meclofenamate in Subjects With Recurrent or Progressive Brain Metastasis From Solid Tumor Primary
  Active not recruiting · Interventional · 30 enrolled · Memorial Sloan Kettering Cancer Center
  NCT02429570updated 2026-05-29
• Pentosan Polysulfate Sodium and Meclofenamic Acid as Treatments in Patients With Psychotic Disorders
  Completed · Phase 2 · Interventional · 8 enrolled · The University of Texas Health Science Center, Houston
  NCT02930005updated 2019-03-26

Frequently asked questions

How does Meclofenamate work?

Mechanism-of-action class: Cyclooxygenase Inhibitors.

What is Meclofenamate used for?

According to FDA labeling, Meclofenamate carries indications including: Carefully consider the potential benefits and risks of meclofenamate sodium capsules and other treatment options before deciding to use meclofenamate sodium capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Meclofenamate?

Meclofenamate is classified as Cyclooxygenase Inhibitors, Analgesia, Decreased Prostaglandin Production.

What are the contraindications for Meclofenamate?

Meclofenamate labeling lists contraindications including: Meclofenamate sodium capsules are contraindicated in patients with known hypersensitivity to meclofenamate sodium. Meclofenamate sodium capsules should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.. Always consult the full prescribing information and a clinician.