Tolmetin
Tolmetin is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve the signs and symptoms of rheumatoid arthritis, osteoarthritis, and juvenile rheumatoid arthritis.
🧬 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 6 clinical label sets 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 →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Tolmetin carries two serious FDA boxed warnings that every patient should know about.
Heart attack and stroke risk: NSAIDs like tolmetin increase the chance of a serious — and potentially fatal — heart attack or stroke. This risk can begin early in treatment and may grow the longer you take it. People with existing heart disease or risk factors are at the highest risk, but even those without known heart problems can be affected. Tolectin tablets must NOT be taken around the time of coronary artery bypass graft (CABG) heart surgery. Watch for chest pain, sudden weakness, or difficulty speaking, and seek emergency care immediately.
Serious stomach and intestinal bleeding: Tolmetin can cause dangerous bleeding, ulcers, or holes (perforation) in the stomach or intestines — which can be fatal. These events can happen at any time and often without any warning signs. Older adults are at the greatest risk. Seek medical help right away if you notice blood in your stool, black or tarry stools, or vomiting blood.
📖 Tolmetin: Patient Information Guide
A plain-language walkthrough of Tolmetin — 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▾
Tolmetin is an NSAID approved to treat several forms of arthritis in both adults and children.
- Tolmetin Sodium capsules and tablets, and Tolectin tablets, are all indicated to relieve signs and symptoms of rheumatoid arthritis in adults — during acute flares and for long-term management
- Tolmetin Sodium capsules and tablets, and Tolectin tablets, are all indicated to relieve signs and symptoms of osteoarthritis in adults — during acute flares and for long-term management
- Tolmetin Sodium capsules and tablets, and Tolectin tablets, are indicated for juvenile rheumatoid arthritis in children 2 years of age and older
- Tolmetin has not been established as safe or effective in children under 2 years of age
⚙️How it works▾
Tolmetin blocks an enzyme called prostaglandin synthetase, which the body uses to make prostaglandins — chemicals that promote inflammation, pain, and fever. By reducing prostaglandin levels, tolmetin helps ease joint swelling, stiffness, and pain. Its anti-inflammatory effects do not appear to involve stimulation of the body's stress hormone (pituitary-adrenal) system, and it does not appear to change the underlying course of arthritis itself.
💊How it's taken▾
Tolmetin is taken by mouth, typically several times a day (often three times daily), including on waking and at bedtime. Your prescriber will adjust your dose based on how you respond over the first one to two weeks of treatment. Food and milk can affect how much of the medication your body absorbs — follow your prescriber's specific instructions on whether to take it with or without food. If stomach upset occurs, it may be taken with antacids other than sodium bicarbonate.
- A response is usually seen within a few days to a week; improvement may continue over following weeks
- Always use the lowest effective dose for the shortest duration that meets your treatment goals
- For children 2 years and older with juvenile rheumatoid arthritis, dosing is based on body weight — your prescriber will determine the right amount
🤒Side effects — in detail▾
The most common side effects with tolmetin involve the stomach and digestive tract. Other effects can also occur:
- Nausea (the most frequently reported, in about 1 in 10 patients)
- Upset stomach, abdominal pain, diarrhea, gas, or vomiting
- Constipation or gastritis (stomach lining irritation)
- Headache, dizziness, or drowsiness
- Elevated blood pressure or swelling (edema)
- Ringing in the ears (tinnitus) or visual disturbance
- Weight gain or weight loss
- Small, temporary drops in red blood cell levels (hemoglobin and hematocrit)
Serious reactions — including stomach ulcers with bleeding, kidney problems, severe skin reactions, and heart or blood vessel events — can occur and require immediate medical attention. See the warnings section for details.
⚠️Warnings & precautions▾
- Heart attack and stroke: Tolmetin raises the risk of serious cardiovascular events, including fatal heart attack and stroke. This risk can begin in the first weeks and increases with higher doses and longer use. Tolmetin is contraindicated around CABG (coronary artery bypass graft) surgery.
- Serious stomach and gut bleeding: Ulcers, bleeding, and perforation of the stomach or intestines can occur at any time — often without warning symptoms. Older adults, people with a prior history of ulcers, and those taking corticosteroids or blood thinners face the highest risk.
- Kidney damage: Long-term use can cause serious kidney injury. People with impaired kidney function, heart failure, liver problems, or those taking diuretics and ACE inhibitors are at greatest risk.
- Serious skin reactions: Rare but potentially fatal skin reactions — including Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and generalized bullous fixed drug eruption — can occur. Stop tolmetin and seek care immediately if a rash or skin blistering develops.
- DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms): A rare but serious and sometimes fatal reaction presenting with fever, rash, swollen lymph nodes, and organ involvement. Discontinue tolmetin immediately if suspected.
- Pregnancy risk: Tolmetin can harm an unborn baby. Avoid use from about 20 weeks of pregnancy onward; use around 30 weeks or later risks premature closure of a vital blood vessel in the fetal heart.
- High blood pressure and heart failure: Tolmetin can worsen high blood pressure and heart failure, and may reduce the effectiveness of blood pressure and diuretic medications.
🔀What it interacts with▾
Tolmetin can interact with several common medications and can affect how well they work or increase the risk of side effects:
- Aspirin: Combining is generally not recommended — it increases the risk of serious GI bleeding without added anti-inflammatory benefit
- Warfarin (blood thinner): Together they significantly raise the risk of serious bleeding; careful monitoring is needed
- ACE inhibitors: Tolmetin may reduce the blood-pressure-lowering effect of these medications
- Diuretics (water pills, such as furosemide or thiazides): Tolmetin can reduce their effectiveness and increase kidney stress when used together
- Lithium: Tolmetin can raise lithium blood levels and reduce its clearance, increasing the risk of lithium toxicity
- Methotrexate: Tolmetin may increase methotrexate's toxicity in the kidneys; use with caution
- Corticosteroids: Using both together raises the risk of stomach ulcers and GI bleeding
- Food and milk: These affect absorption of tolmetin; follow your prescriber's specific timing instructions
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 tolmetin if you have had an allergic reaction (hives, rash, breathing problems) to aspirin or any other NSAID
- Do not take tolmetin if you have aspirin-sensitive asthma, especially with nasal polyps — severe breathing reactions are possible
- Tell your doctor if you have a history of stomach ulcers or GI bleeding — your risk of a serious GI event is much higher
- Tell your doctor if you have heart disease, high blood pressure, or heart failure — tolmetin can worsen these conditions
- Tell your doctor if you have kidney disease — tolmetin is not recommended in advanced kidney disease and requires close monitoring in milder impairment
- Tell your doctor if you have liver problems
- Older adults are at increased risk for serious stomach bleeding and kidney complications
- Avoid tolmetin starting at about 20 weeks of pregnancy; it is especially harmful at 30 weeks or later
- Tolmetin is not for use in children under 2 years of age
- Do not use tolmetin in the setting of coronary artery bypass graft (CABG) surgery
🚑If you take too much▾
If someone takes too much tolmetin, the stomach should be emptied — either by inducing vomiting or by gastric lavage (stomach pumping) — followed by activated charcoal to limit further absorption. If you suspect an overdose, contact emergency services or a poison control center immediately.
📡Pharmacodynamics — effects in the body▾
Tolmetin has anti-inflammatory, analgesic (pain-relieving), and antipyretic (fever-reducing) effects. It works by inhibiting prostaglandin synthesis, which lowers prostaglandin E levels in the blood. In clinical studies, tolmetin was as effective as aspirin and indomethacin at controlling disease activity in rheumatoid arthritis and osteoarthritis, but with a lower rate of some gastrointestinal side effects and less central nervous system effects than indomethacin. Tolmetin does not appear to alter the underlying course of arthritis disease in humans.
🔬Pharmacokinetics — how your body processes it▾
After a standard oral dose, tolmetin is rapidly and almost completely absorbed, with peak blood levels reached within 30 to 60 minutes. It follows a two-stage elimination: a fast initial phase with a half-life of 1 to 2 hours, then a slower phase with a half-life of about 5 hours. Essentially all of the drug is cleared through the urine within 24 hours — either as an inactive metabolite or as conjugates. Tolmetin does not accumulate in the body with regular dosing. Food and milk can affect how much is absorbed, so timing of doses relative to meals matters.
📦How to store it▾
Store at 20° to 25°C (68° to 77°F). Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
📄 Written from Tolmetin’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 →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Tolmetin — the kind of thing our pharmacy team would talk through with you at the counter.
What conditions does tolmetin actually treat? ▾
Should I take tolmetin with food or on an empty stomach? ▾
What side effects should I expect, and which ones mean I need to call a doctor? ▾
I've heard NSAIDs can be hard on the heart. Should I be worried? ▾
Can I take tolmetin with aspirin or my other medications? ▾
Is tolmetin safe to take during pregnancy? ▾
Is Tolmetin available over the counter? ▾
When was Tolmetin first available? ▾
Who makes Tolmetin? ▾
💬 Answers drafted from Tolmetin’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 Tolmetin comes
Tolmetin is available in 2 forms. 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.
Tablet
How this form is used
- Tolectin tablets and Tolmetin Sodium tablets are used to relieve signs and symptoms of rheumatoid arthritis in adults
- Tolectin tablets and Tolmetin Sodium tablets are used to relieve signs and symptoms of osteoarthritis in adults
- Tolectin tablets and Tolmetin Sodium tablets are used for acute flares and long-term management of these conditions
- Tolectin tablets and Tolmetin Sodium tablets are used to treat juvenile rheumatoid arthritis in children 2 years and older
- Tolectin tablets and Tolmetin Sodium tablets are taken by mouth multiple times daily, typically three times a day
- Tolectin tablets and Tolmetin Sodium tablets may be taken with antacids (other than sodium bicarbonate) if stomach upset occurs
- Food and milk can affect absorption of Tolectin and Tolmetin Sodium tablets — follow your prescriber's guidance on timing with meals
- Tolectin tablet and Tolmetin Sodium tablet dosing should be adjusted by your prescriber based on your response, using the lowest effective dose
Capsule
How this form is used
- Tolmetin Sodium capsules are used to relieve signs and symptoms of rheumatoid arthritis in adults
- Tolmetin Sodium capsules are used to relieve signs and symptoms of osteoarthritis in adults
- Tolmetin Sodium capsules are used for acute flares and long-term management of these conditions
- Tolmetin Sodium capsules are used to treat juvenile rheumatoid arthritis in children 2 years and older
- Tolmetin Sodium capsules are taken by mouth multiple times daily, typically three times a day
- Tolmetin Sodium capsules may be taken with antacids (other than sodium bicarbonate) if stomach upset occurs
- Food and milk can affect absorption of Tolmetin Sodium capsules — follow your prescriber's guidance on whether to take with or without food
- Tolmetin Sodium capsule dose should be adjusted by your prescriber based on your response, using the lowest effective dose
📊 Tolmetin across the U.S. market
How Tolmetin 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.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Tolmetin is used
A general measure of how commonly Tolmetin 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 Tolmetin 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.
How commonly is Tolmetin prescribed? Of the 1,597 medications we measure, Tolmetin ranks #1,061 by Medicaid prescriptions — more than 34% of them.
Utilization by Tolmetin 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.
tolmetin 600 MG Oral Tablet Most dispensed
Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198297
tolmetin 400 MG Oral Capsule
Summed across the 1 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198296
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 Tolmetin, 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 3 of 14 listed Tolmetin NDCs with Medicaid activity.
🔍 Compare Tolmetin products
A representative set of FDA-listed product records for Tolmetin — 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 | ||||
| 400 mg | Oral | Atland Pharmaceuticals, LLC | ANDA | View NDC → |
| 400 mg | Oral | Galt Pharmaceuticals, LLC | ANDA | View NDC → |
| 400 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
| 💊Tablet | ||||
| 600 mg | Oral | Atland Pharmaceuticals, LLC | ANDA | View NDC → |
| 200 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 200 mg | Oral | Lifsa Drugs LLC | ANDA | View NDC → |
| 600 mg | Oral | Poly Pharmaceuticals, Inc. | ANDA | View NDC → |
| 600 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | Matrix Pharmacorp Private Limited | BULK INGREDIENT | View NDC → |
Showing 9 of 9 products — FDA National Drug Code Directory. See every product, package size and price: browse all 9 Tolmetin NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Tolmetin — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Tolmetin in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Tolmetin went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
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.
RxCUI 10636 2 dose forms · 3 strengths
-
Dose form (SCDF) Oral Capsule RxCUI 374155In current FDA listingsClinical drug / strength (SCD) 400 MGRxCUI 198296 -
Dose form (SCDF) Oral Tablet RxCUI 374157In current FDA listings
Look up RxCUI 10636 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.
📦 Supply & shortage status
Whether Tolmetin is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Tolmetin belongs to the Nonsteroidal Anti-inflammatory Drug class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 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.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 6 FDA-filed SPL label sets 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. Poly 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.