FDA-filed SPL labeling · retrieved through openFDA

Meclofenamate

Meclofenamate is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve pain, reduce fever, treat arthritis, and manage menstrual symptoms in adults.

Brand names MeclodiumMeclomen
Rx Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveApr 15, 2026
AvailabilityRx
Earliest approval/marketing year 1980
FDA-listed product records 7
Boxed warningYes
How we combine label and product data →
No current FDA shortage listed · checked Sep 24, 2026
Meclofenamate at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Meclofenamate is an effective NSAID for pain, fever, arthritis, and menstrual conditions, but it comes with important heart, stomach, and kidney risks that require careful use. Always take the lowest dose that controls your symptoms for the shortest time possible, and stay alert for warning signs like chest pain, stomach bleeding, or significant swelling. Talk to your pharmacist or doctor before starting it if you have heart disease, kidney disease, a history of ulcers, or are pregnant.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert

Meclofenamate sodium capsules carry two serious FDA boxed warnings that every patient should know.

Heart and stroke risk: NSAIDs like meclofenamate increase the chance of serious — sometimes fatal — cardiovascular events such as heart attack and stroke. This risk can appear early in treatment and may grow with longer use. Meclofenamate must NOT be used by anyone who has just had coronary artery bypass graft (CABG) heart surgery.

Stomach and intestinal risk: These capsules can cause serious bleeding, ulcers, or tears in the stomach or intestines at any point during treatment — sometimes with no warning signs at all. Older adults are at the greatest risk. Seek medical help immediately if you notice bloody or black stools, vomit that looks like coffee grounds, or severe stomach pain.

Read the full warning on DailyMed →

📖 Meclofenamate: Patient Information Guide

A plain-language walkthrough of Meclofenamate — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Meclofenamate sodium capsules are approved for a range of pain, inflammation, and menstrual conditions in adults. Supported uses include:

  • Relief of mild to moderate pain
  • Reduction of fever
  • Relief of signs and symptoms of rheumatoid arthritis
  • Relief of signs and symptoms of osteoarthritis (including acute flares)
  • Relief of signs and symptoms of juvenile arthritis
  • Treatment of primary dysmenorrhea (painful menstrual periods)
  • Treatment of idiopathic heavy menstrual blood loss
  • Relief of signs and symptoms of ankylosing spondylitis
  • Relief of acute painful shoulder (acute subacromial bursitis or supraspinatus tendinitis)
  • Relief of acute gouty arthritis

Meclofenamate sodium capsules are not recommended for children due to insufficient safety and efficacy data.

⚙️How it works

Meclofenamate works mainly by blocking the body's production of prostaglandins — chemical messengers that trigger pain, swelling, and fever. It does this by inhibiting cyclooxygenase (an enzyme needed to make prostaglandins) and by competing directly at prostaglandin receptor sites. It also inhibits an enzyme called 5-lipoxygenase, which may add to its anti-inflammatory effect. Importantly, it treats symptoms but does not alter the underlying course of conditions like arthritis.

💊How it's taken

Meclofenamate sodium is taken orally as a capsule, typically several times a day. Dosing frequency and duration vary depending on the condition — for example, menstrual conditions are treated for a short course starting at the onset of flow, while arthritis may require ongoing daily use. Food significantly reduces the absorption of meclofenamate sodium, so it is generally best taken on an empty stomach; however, if GI upset occurs, it may be taken with food or milk.

  • Always follow your prescriber's specific instructions for your condition
  • Use the lowest effective dose for the shortest time needed
  • Do not exceed the daily maximum your prescriber has set
  • If you miss a dose, follow the guidance on your prescription label or ask your pharmacist
🤒Side effects — in detail

The most common side effects of meclofenamate involve the digestive system:

  • Diarrhea — the most frequently reported side effect; often improves with a lower dose
  • Nausea with or without vomiting
  • Stomach pain or cramps
  • Heartburn, gas, or indigestion
  • Loss of appetite
  • Headache and dizziness
  • Skin rash, hives, or itching
  • Ringing in the ears (tinnitus)

More serious reactions — including stomach bleeding, kidney problems, severe skin reactions, and cardiovascular events like heart attack or stroke — are less common but require immediate medical attention. Stop taking meclofenamate and seek help right away if you experience any of those warning signs.

⚠️Warnings & precautions
  • Heart attack and stroke: Like all NSAIDs, meclofenamate increases the risk of serious — potentially fatal — cardiovascular events. Risk starts early and grows with dose and duration. People with existing heart disease or risk factors are most vulnerable. Avoid use after CABG surgery — it is contraindicated.
  • Stomach and intestinal bleeding: Serious GI bleeding, ulcers, or perforation can occur at any time without warning, even in short-term use. Older adults and those with a history of ulcers are at greatest risk.
  • Kidney damage: Long-term use can cause kidney injury. People with kidney disease, heart failure, liver dysfunction, or those taking diuretics and ACE inhibitors are at highest risk.
  • Serious skin reactions: Rare but potentially fatal skin reactions — including Stevens-Johnson Syndrome and toxic epidermal necrolysis — can occur. Stop the medication at the first sign of a rash or skin reaction.
  • DRESS syndrome: A rare but serious drug reaction causing fever, rash, swollen lymph nodes, and organ involvement — can be life-threatening. Seek care immediately if these symptoms appear.
  • Pregnancy risk: Avoid use at around 20 weeks of pregnancy or later due to risk of fetal kidney damage; avoid at 30 weeks or later due to risk of premature closure of a critical fetal blood vessel.
  • Blood pressure and heart failure: Meclofenamate can raise blood pressure and worsen heart failure. It may also blunt the effects of diuretics, ACE inhibitors, and ARBs.
🔀What it interacts with

Meclofenamate sodium can interact with several common medications — tell your prescriber and pharmacist about everything you take:

  • Aspirin: Taking both together increases the risk of serious stomach bleeding and reduces meclofenamate's protein binding; not generally recommended
  • Warfarin: The combination greatly amplifies the risk of serious GI bleeding
  • ACE inhibitors: Meclofenamate may weaken their blood pressure-lowering effect
  • Furosemide and thiazide diuretics: Meclofenamate can reduce their diuretic effect and raise the risk of kidney problems
  • Lithium: Meclofenamate can raise lithium levels in the blood, increasing the risk of lithium toxicity
  • Methotrexate: Meclofenamate may increase methotrexate's toxic effects; use together with caution

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Do not take if you are allergic to meclofenamate sodium or have had asthma, hives, or a serious allergic reaction to aspirin or any other NSAID
  • Do not take if you have recently had coronary artery bypass graft (CABG) heart surgery
  • Tell your doctor if you have heart disease, a history of heart attack, or high blood pressure
  • Tell your doctor if you have a history of stomach ulcers or gastrointestinal bleeding
  • Use with caution if you have kidney or liver disease — your doctor may need to monitor you closely
  • Tell your doctor if you have asthma, nasal polyps, or the "aspirin triad" (asthma + nasal polyps + aspirin sensitivity)
  • Pregnant women should avoid use at around 20 weeks or later; use is particularly dangerous at 30 weeks or later
  • Trace amounts pass into breast milk — discuss with your doctor before breastfeeding
  • Not recommended in children — safety has not been established
  • Older adults should be especially cautious due to higher risk of serious GI and cardiovascular events
🚑If you take too much

Taking too much meclofenamate can cause agitation, irrational behavior, and seizures, followed by serious kidney problems including very low or no urine output. If an overdose is suspected, seek emergency medical help immediately. Treatment focuses on removing the drug from the stomach, controlling seizures, and carefully monitoring kidney function and fluid balance.

📡Pharmacodynamics — effects in the body

Meclofenamate has anti-inflammatory, pain-relieving (analgesic), and fever-reducing (antipyretic) effects. It works by inhibiting prostaglandin synthesis and blocking prostaglandin receptor sites, which reduces the chemical signals that cause swelling, pain, and fever. Unlike aspirin, meclofenamate has little to no effect on platelet aggregation (blood clotting activity) or bleeding time at typical doses. It does cause a small amount of gastrointestinal blood loss, though significantly less than aspirin at comparable anti-inflammatory doses.

🔬Pharmacokinetics — how your body processes it

Meclofenamate sodium is rapidly and completely absorbed after oral doses, with peak blood levels reached within about 30 minutes to 2 hours. Food significantly reduces the speed and extent of absorption, so taking it on an empty stomach is generally preferred when tolerated. The drug is more than 99% bound to proteins in the blood and is broken down in the body into several metabolites, with about 70% of the dose eventually eliminated through the kidneys and about 30% through the stool. The main active form clears the body relatively quickly, but one metabolite takes longer — though its buildup is considered unlikely to be clinically significant at standard doses.

📦How to store it

Store at 20° to 25°C (68° to 77°F). Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

📄 Written from Meclofenamate’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

32

Supplements & herbs that interact with Meclofenamate

32 supplements and herbal products have documented interactions with Meclofenamate in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 5
  • Moderate · 16
  • Minor · 11
Every supplement checked against Meclofenamate — ranked by severity The full interaction hub: 5 major · 16 moderate · 11 minor · every one linked to its full report. Check Meclofenamate against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

1

Nutrient depletion considerations

Meclofenamate has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

See the full Meclofenamate nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Meclofenamate — the kind of thing our pharmacy team would talk through with you at the counter.

What is meclofenamate actually used for?
Meclofenamate is used to treat a number of conditions in adults — including pain, fever, rheumatoid arthritis, osteoarthritis, and painful or heavy menstrual periods. It's also approved for ankylosing spondylitis, gout flares, and acute shoulder pain. It's a prescription NSAID, similar in family to ibuprofen or naproxen, but it's not approved for use in children.
Should I take this with food or on an empty stomach?
For the best absorption, it's generally taken on an empty stomach. Food — even taken half an hour before your dose — can significantly reduce how much of the medication your body absorbs and slow it down considerably. That said, if it upsets your stomach, your doctor may tell you to take it with food or a glass of milk. Just know there's a real trade-off in how well it works when taken with meals.
What side effects should I expect, and which ones mean I should call my doctor?
The most common side effect is diarrhea — it affects a notable number of people and is often related to the dose, so it may improve if your dose is lowered. Nausea, stomach pain, heartburn, headache, and dizziness are also fairly common. Call your doctor right away — or go to the ER — if you notice black or tarry stools, vomit that looks like coffee grounds, chest pain, sudden weakness, severe skin reactions like blistering or peeling, or a big drop in how much you're urinating. Those are serious warning signs.
Is it safe to take this with my other medications, like blood thinners or blood pressure pills?
That's a really important question. Meclofenamate can interact with several common drugs. If you take warfarin (a blood thinner), the combination significantly raises your risk of serious stomach bleeding. It can also reduce how well ACE inhibitors and diuretics (water pills) work, and it can raise lithium levels in your blood to potentially dangerous amounts. Always give your pharmacist and doctor a full list of everything you take — including over-the-counter drugs — before starting this medication.
Can I take this if I'm pregnant or trying to become pregnant?
Pregnancy is a major concern with this medication. Avoid it at around 20 weeks of pregnancy or later because it can harm your baby's kidneys and reduce amniotic fluid. At around 30 weeks or later, it can also cause a critical blood vessel in your baby's heart to close too early, which is very dangerous. If you are pregnant, planning to become pregnant, or breastfeeding, talk to your doctor before taking this medication — there may be safer options.
I have a history of stomach ulcers. Is this safe for me?
You'd need to have a careful conversation with your doctor before taking meclofenamate. People with a history of peptic ulcer disease or stomach bleeding have a much higher risk — more than ten times greater — of developing a GI bleed while on an NSAID like this one. Your doctor may recommend a different type of pain reliever or add a stomach-protecting medication if they decide the benefits outweigh the risks in your case.
Is Meclofenamate available over the counter?
Meclofenamate is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Meclofenamate first available?
Meclofenamate has been available in the United States since at least 1980, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Meclofenamate?
Meclofenamate is supplied by 4 manufacturers listed in the FDA NDC Directory, including Mylan Pharmaceuticals Inc., Spectrum Laboratory Products, Inc., W. R. Grace & Co.-Conn..

💬 Answers drafted from Meclofenamate’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Meclofenamate comes

Meclofenamate is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Capsule

By mouth
How this form is used
What it may be used for
  • Meclofenamate Sodium capsules are used to relieve mild to moderate pain and reduce fever in adults
  • Meclofenamate Sodium capsules treat signs and symptoms of rheumatoid arthritis, osteoarthritis, juvenile arthritis, and ankylosing spondylitis
  • Meclofenamate Sodium capsules are used for primary dysmenorrhea (painful periods) and idiopathic heavy menstrual bleeding
  • Meclofenamate Sodium capsules treat acute painful shoulder and acute gouty arthritis
Important instructions
  • Meclofenamate Sodium capsules are taken by mouth multiple times daily — frequency depends on the condition being treated; follow your prescriber's directions
  • Meclofenamate Sodium capsules are best absorbed on an empty stomach, but may be taken with food or milk if stomach upset occurs
  • Meclofenamate Sodium capsules for menstrual conditions are typically started at the onset of menstrual flow and taken for a short course only
  • Use the lowest effective dose for the shortest duration; do not exceed the daily maximum set by your prescriber
Available strengths 2 strengths
4 FDA-listed product records

📊 Meclofenamate across the U.S. market

How Meclofenamate appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms
4
Manufacturers
1
Brand names
7
FDA-listed product records
1980
First marketed

Also listed with the FDA, not a patient dose form: Powder (3) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Mylan Pharmaceuticals Inc.57%
Spectrum Laboratory Products, Inc.14%
W. R. Grace & Co.-Conn.14%
Yung Shin Pharmaceutical Ind. Co., Ltd.14%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Meclofenamate is used

A general measure of how commonly Meclofenamate is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Meclofenamate is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

85
Medicaid prescriptions filled (Q1–Q4 2025)
$24,405 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Meclofenamate prescribed? Of the 1,596 medications we measure, Meclofenamate ranks #1,515 by Medicaid prescriptions — more than 5% of them.

Where Meclofenamate ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Meclofenamate product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

meclofenamate 100 MG Oral Capsule

85 Medicaid prescriptions (Q1–Q4 2025) 100% of Meclofenamate prescriptions shown $24,405 gross reimbursement (before rebates) ≈ $287 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 618552

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Meclofenamate, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 3 listed Meclofenamate NDCs with Medicaid activity.

🔍 Compare Meclofenamate products

A representative set of FDA-listed product records for Meclofenamate — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category Details
💊Capsule
50 mg Oral Mylan Pharmaceuticals Inc. × 2 listings ANDA View NDC →
100 mg Oral Mylan Pharmaceuticals Inc. × 2 listings ANDA View NDC →
💊Bulk drug substance
1 g/g Spectrum Laboratory Products, Inc. BULK INGREDIENT View NDC →
1 kg/kg W. R. Grace & Co.-Conn. BULK INGREDIENT View NDC →
1 kg/kg Yung Shin Pharmaceutical Ind. Co., Ltd. BULK INGREDIENT View NDC →

Showing 7 of 7 products — FDA National Drug Code Directory. See every product, package size and price: browse all 7 Meclofenamate NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Meclofenamate RxCUI 588003 1 dose form · 2 strengths
  1. Dose form (SCDF) Oral Capsule RxCUI 618551 In current FDA listings
    Clinical drug / strength (SCD) 50 MG RxCUI 618557 100 MG RxCUI 618552

Look up RxCUI 588003 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Meclodium Meclomen

🏭 Manufacturers & labelers

Mylan Pharmaceuticals Inc. 4 Spectrum Laboratory Products, Inc. 1 W. R. Grace & Co.-Conn. 1 Yung Shin Pharmaceutical Ind. Co., Ltd. 1

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Apr 15, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Meclofenamate.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Meclofenamate after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
7
Distinct labelers/manufacturers represented
4
Linked representative label
Mylan Pharmaceuticals Inc.
Linked label effective
Apr 15, 2026
Composite sections available
20
Linked SPL Set ID
96f19af4-de8f-4fd7-90d8-55fe6ebdd81d
Linked SPL Document ID
4be1c27e-b52c-472c-8795-16af910fa26e
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Mylan Pharmaceuticals Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.