Prescription medicine
Naproxen and sumatriptan Brand names: Treximet
Naproxen and sumatriptan (Treximet) is a prescription medicine with an FDA approval on record since 2008. FDA's NDC Directory lists it from 3 generic labelers, and pharmacies paid $10.46 per unit (Sumatriptan-naproxen 85-500 mg) in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the naproxen and sumatriptan FDA label on DailyMed (effective December 23, 2024, Currax Pharmaceuticals LLC); the NDA 21926 record on Drugs@FDA; every naproxen and sumatriptan label on DailyMed.
Highlights of the record
FDA label of December 23, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS.
See full prescribing information for complete boxed warning. Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. ( 5.1 ) TREXIMET is contraindicated in the setting of coronary artery bypass graft (CABG) surgery ( 4 , 5.1 ) NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events. ( 5.2 ) Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnings and Precautions (5.1) ]. […]
Used for
From the label: indications and usageTREXIMET is indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older.
Forms and strengths
- 85 mg / 500 mg
Film-coated tablet; tablet.
On the market
- Earliest approval on file
- April 15, 2008 Treximet, Azurity; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first February 15, 2018; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 5 of which 3 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- April 2, 2026 Treximet tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $10.46 per unit Sumatriptan-naproxen 85-500 mg
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,443 through July 30, 2026
What is naproxen and sumatriptan used for?
From the label: indications and usageTREXIMET is indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older. TREXIMET is a combination of sumatriptan, a serotonin (5-HT) 1b/1d receptor agonist (triptan), and naproxen sodium, a non-steroidal anti-inflammatory drug, indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older. ( 1 ) Limitations of Use: Use only if a clear diagnosis of migraine headache has been established. ( 1 ) Not indicated for the prophylactic therapy of migraine attacks. ( 1 ) Not indicated for the treatment of cluster headache. […]
Conditions named in the indications of naproxen and sumatriptan's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Nonsteroidal Anti-inflammatory Drug and Serotonin-1b and Serotonin-1d Receptor Agonist.
Source: FDA drug label (Treximet), NDA021926 (Azurity), as published by Currax Pharmaceuticals LLC, effective December 23, 2024 (SPL set 42ddf376-8dc0-4236-be2a-0c6ae92ece04), via openFDA; the full label on DailyMed
What does the patient leaflet for naproxen and sumatriptan say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about TREXIMET?TREXIMET may increase your chance of a heart attack or stroke that can lead to death. TREXIMET contains 2 medicines: sumatriptan and naproxen sodium (a nonsteroidal anti-inflammatory drug [NSAID]). This risk may happen early in treatment and may increase: with increasing doses of NSAIDs with longer use of NSAIDs Do not take TREXIMET right before or after a heart surgery called a "coronary artery bypass graft (CABG)." Avoid taking TREXIMET after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. Stop taking TREXIMET and get emergency help right away if you have any of the following symptoms of a heart attack or stroke: discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw pain or discomfort in your arms, back, neck, jaw, or stomach shortness of breath with or without chest discomfort breaking out in a cold sweat nausea or vomiting feeling lightheaded weakness in one part or on one side of your body slurred speech TREXIMET is not for people with risk factors for heart disease unless a heart exam is done and shows no problem. You have a higher risk for heart disease if you: have high blood pressure smoke have diabetes have high cholesterol levels are overweight have a family history of heart disease TREXIMET can cause ulcers and bleeding in the stomach and intestines at any time during your treatment. Ulcers and bleeding can happen without warning symptoms and may cause death. […]
From the patient leaflet: What should I avoid while taking TREXIMET?TREXIMET can cause dizziness, weakness, or drowsiness. If you have these symptoms, do not drive a car, use machinery, or do anything where you need to be alert.
From the patient leaflet: How should I store TREXIMET?Store TREXIMET at room temperature between 68°F to 77°F (20°C to 25°C). Keep TREXIMET and all medicines out of the reach of children.
Source: FDA drug label (Treximet), NDA021926 (Azurity), as published by Currax Pharmaceuticals LLC, effective December 23, 2024 (SPL set 42ddf376-8dc0-4236-be2a-0c6ae92ece04), via openFDA; the full label on DailyMed
Is there a generic for naproxen and sumatriptan (Treximet)?
The FDA approved the first generic naproxen and sumatriptan on February 15, 2018. 3 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists naproxen and sumatriptan from 3 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 1 patent for Treximet tablets, the last expiring on April 2, 2026. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2008 earliest approval on file
- 2018 first generic approved
- 2026 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for naproxen and sumatriptan (Treximet)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $10.46 per unit (Sumatriptan-naproxen 85-500 mg), down 46% from $19.34 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Sumatriptan-naproxen 85-500 mg (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Sumatriptan-naproxen 85-500 mg | Generic | $10.46 per unit | n/a | -46% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the naproxen and sumatriptan label say about other medicines?
The naproxen and sumatriptan label names 17 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aspirin | contraindications | … History of asthma, urticaria, other allergic type reactions, rhinitis, or nasal polyps syndrome after taking aspirin or other NSAID/analgesic drugs. ( 4 ) Known hypersensitivity to sumatriptan, naproxen, or any components of TREXIMET (angioedema and anaphylaxis seen). ( 4 ) Severe hepatic impairment. |
| Cyclosporine | drug interactions | Clinical Impact: Concomitant use of NSAIDs and cyclosporine may increase cyclosporine's nephrotoxicity. Intervention: During concomitant use of TREXIMET and cyclosporine, monitor patients for signs of worsening renal function. NSAIDs and Salicylates |
| Diclofenac | drug interactions | NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed. |
| Diflunisal | drug interactions | NSAIDs and Salicylates Clinical Impact: Concomitant use of naproxen with other NSAIDs or salicylates (…) increases the risk of GI toxicity, with little or no increase in efficacy. Intervention: The concomitant use of naproxen with other NSAIDs or salicylates is not recommended. |
| Digoxin | drug interactions | Concomitant use with TREXIMET can increase serum concentration and prolong half-life of digoxin. |
| Dihydroergotamine | contraindications | Recent use (i.e., within 24 hours) of ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine 1 (5-HT 1 ) agonist [see Drug Interactions (7) ]. |
| Ergotamine | warnings and precautions | Overuse of acute migraine drugs (e.g., ergotamine, triptans, opioids, or a combination of these drugs for 10 or more days per month) may lead to exacerbation of headache (medication overuse headache). |
| Furosemide | drug interactions | Diuretics Clinical Impact: Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. … Intervention: During concomitant use of TREXIMET with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects [see, ]. |
| Indomethacin | drug interactions | NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed. |
| Lithium | drug interactions | Monitor serum digoxin levels. ( 7.1 ) Lithium: Increases lithium plasma levels. |
| Meloxicam | drug interactions | Pemetrexed Clinical Impact: Concomitant use of NSAIDs and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (…). … potential interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days … |
| Methotrexate | drug interactions | Increases methotrexate plasma levels. |
| Nabumetone | drug interactions | Pemetrexed Clinical Impact: Concomitant use of NSAIDs and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (…). … interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following … |
| Pemetrexed | drug interactions | Pemetrexed Clinical Impact: Concomitant use of NSAIDs and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (…). Intervention: During concomitant use of TREXIMET and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity. … |
Every other medicine the naproxen and sumatriptan label names
| Medicine named | Section | What the label says |
|---|---|---|
| Probenecid | drug interactions | Clinical Impact: Probenecid given concurrently increases naproxen anion plasma levels and extends its plasma half-life significantly. The clinical significance of this is unknown. Intervention: Reduce the frequency of administration of Treximet when given concurrently with probenecid. Naproxen may decrease platelet aggregation and prolong bleeding time. … |
| Propranolol | drug interactions | ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-blockers Clinical Impact: NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol). … Intervention: During concomitant use of TREXIMET and ACE-inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained [see ]. … |
| Warfarin | drug interactions | Clinical Impact: Naproxen and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of naproxen and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. … Intervention: Monitor patients with concomitant use of TREXIMET with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine … |
Source: FDA drug label (Treximet), NDA021926 (Azurity), as published by Currax Pharmaceuticals LLC, effective December 23, 2024 (SPL set 42ddf376-8dc0-4236-be2a-0c6ae92ece04), via openFDA; the full label on DailyMed
What do FAERS reports show for naproxen and sumatriptan?
The FDA Adverse Event Reporting System holds 1,443 reports that list naproxen and sumatriptan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 24 are coded as a death and 151 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as naproxen and sumatriptan?
13 other medicines are given the same way (oral) and in the same FDA class as naproxen and sumatriptan or labeled mainly for the same use (migraine), the same class first. Migraine lists all 27 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Celecoxib | Migraine | 65 labelers | $0.0762 per capsule 200 mg capsule | No current entry |
| Diclofenac | Migraine | 67 labelers | $0.0619 per tablet 75 mg tablet | A presentation being discontinued |
| Rizatriptan | Migraine | 25 labelers | $0.335 per tablet 10 mg tablet | No current entry |
| Zolmitriptan | Migraine | 18 labelers | $1.02 per tablet 2.5 mg tablet | No current entry |
| Eletriptan | Migraine | 10 labelers | $1.75 per tablet 40 mg tablet | No current entry |
| Naratriptan | Migraine | 4 labelers | $1.08 per tablet 2.5 mg tablet | No current entry |
| Almotriptan | Migraine | 3 labelers | $16.86 per tablet 12.5 mg tablet | No current entry |
| Frovatriptan | Migraine | 4 labelers | $2.72 per tablet 2.5 mg tablet | A presentation being discontinued |
Every medicine labeled for the same conditions as naproxen and sumatriptan
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to naproxen and sumatriptan
- 13 medicines for the same use
- Other NSAIDs
- the pharmacologic class, with prices and generics
- Naproxen and sumatriptan side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other