What the label lists and what reports show
Naproxen and sumatriptan side effects
Naproxen and sumatriptan's FDA label: “The most common adverse reactions (incidence ≥2%) were: Adults: Dizziness, somnolence, nausea, chest discomfort/chest pain, neck/throat/jaw pain/tightness/pressure, paresthesia, dyspepsia, dry mouth.” FAERS holds 1,443 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (146 reports).
- 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 FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of TREXIMET?TREXIMET may cause serious side effects. See " What is the most important information I should know about TREXIMET? " These serious side effects include: changes in color or sensation in your fingers and toes (Raynaud's syndrome) new or worse high blood pressure heart failure from body swelling (fluid retention) kidney problems including kidney failure low red blood cells (anemia) liver problems including liver failure asthma attacks in people who have asthma stomach and intestinal problems (gastrointestinal and colonic ischemic events). Symptoms of gastrointestinal and colonic ischemic events include: sudden or severe stomach pain weight loss constipation or diarrhea fever stomach pain after meals nausea or vomiting bloody diarrhea problems with blood circulation to your legs and feet (peripheral vascular ischemia). […]
Source: FDA drug label, 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 label list?
From the label: adverse reactionsThe most common adverse reactions (incidence ≥2%) were: Adults: Dizziness, somnolence, nausea, chest discomfort/chest pain, neck/throat/jaw pain/tightness/pressure, paresthesia, dyspepsia, dry mouth.
Table 1. Adverse Reactions in Pooled Placebo-Controlled Trials in Adult Patients with Migraine
| Adverse Reactions | TREXIMET 85/500 mg % (n = 737) | Placebo % (n = 752) | Sumatriptan 85 mg % (n = 735) | Naproxen Sodium 500 mg % (n = 732) |
|---|---|---|---|---|
| Dizziness | 4 | 2 | 2 | 2 |
| Somnolence | 3 | 2 | 2 | 2 |
| Paresthesia | 2 | <1 | 2 | <1 |
| Nausea | 3 | 1 | 3 | <1 |
| Dyspepsia | 2 | 1 | 2 | 1 |
| Dry mouth | 2 | 1 | 2 | <1 |
| Chest discomfort/chest pain | 3 | <1 | 2 | 1 |
| Neck/throat/jaw pain/tightness/pressure | 3 | 1 | 3 | 1 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are described below and elsewhere in labeling: Cardiovascular Thrombotic Events [see Warnings and Precautions (5.1) ] GI Bleeding, Ulceration and Perforation [see Warnings and Precautions (5.2) ] Arrhythmias [see Warnings and Precautions (5.3) ] Chest, Throat, Neck, and/or Jaw Pain/Tightness/Pressure [see Warnings and Precautions (5.4) ] Cerebrovascular Events [see Warnings and Precautions (5.5) ] Other Vasospasm Reactions [see Warnings and Precautions (5.6) ] Hepatotoxicity [see Warnings and Precautions (5.7) ] Hypertension [see Warnings and Precautions (5.8) ] Heart Failure and Edema [see Warnings and Precautions (5.9) ] Medication Overuse Headache [see Warnings and Precautions (5.10) ] Serotonin Syndrome [see Warnings and Precautions (5.11) ] Renal Toxicity and Hyperkalemia [see Warnings and Precautions (5.12) ] Anaphylactic Reactions [see Warnings and Precautions (5.13) ] Serious Skin Reactions [see Warnings and Precautions (5.14) ] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions (5.15) ] Hematological Toxicity [see Warnings and Precautions (5.17) ] Exacerbation Asthma Related to Aspirin Sensitivity [see Warnings and Precautions (5.18) ] Seizures [see Warnings and Precautions (5.19) ] The most common adverse reactions (incidence ≥2%) were: Adults: Dizziness, somnolence, nausea, chest …
Source: FDA drug label, 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?
1,443 reports list naproxen and sumatriptan among the medicines taken, 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. Of the 22 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Naproxen and sumatriptan: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions