Applies to naproxen / sumatriptan: oral tablet.

Serious side effects

Along with its needed effects, naproxen / sumatriptan may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking naproxen / sumatriptan:

Less common

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest discomfort or pain
• fast, irregular, pounding, or racing heartbeat or pulse
• jaw, neck, or throat pain

Other side effects

Some side effects of naproxen / sumatriptan may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Acid or sour stomach
• belching
• dizziness
• dry mouth
• feeling hot
• feeling of warmth
• heartburn
• indigestion
• lack or loss of strength
• muscle tightness
• nausea
• redness of the face, neck, arms, and occasionally, upper chest
• sleepiness or unusual drowsiness
• stomach discomfort, upset, or pain
• sudden sweating

For Healthcare Professionals

Applies to naproxen / sumatriptan: oral tablet.

General

The most common adverse reactions occurring in adult patients included dizziness, somnolence, nausea, chest discomfort/chest pain, neck/throat/jaw pain/tightness/pressure, paresthesia, dyspepsia, dry mouth. In pediatric patients, hot flush and muscle tightness were the most commonly reported adverse reactions.^[Ref]

Cardiovascular

Sumatriptan-naproxen:

Common (1% to 10%): Chest discomfort/chest pain, hot flush

Very rare (less than 0.01%): Acute coronary syndrome

5-HT1 agonists:

Rare (less than 0.1%): Serious cardiac events including acute myocardial infarction

Frequency not reported: Coronary artery vasospasm (Prinzmetal's angina), peripheral vascular ischemia, Raynaud's syndrome, arrhythmias including ventricular tachycardia and ventricular fibrillation

NSAIDs:

Frequency not reported: Hypertension, new onset or worsening; increased risk of serious cardiovascular thrombotic events, myocardial infarction, heart failure, edema^[Ref]

During clinical trials in 3302 adult patients, 1 patient, a 47-year old female patient with cardiac risk factors experienced acute coronary syndrome approximately 2 hours after taking sumatriptan-naproxen.^[Ref]

Nervous system

Sumatriptan-naproxen:

Common (1% to 10%): Dizziness, somnolence, paresthesia

5-HT1 agonists:

Frequency not reported: Seizures, cerebrovascular events including cerebral hemorrhage, subarachnoid hemorrhage, stroke, serotonin syndrome^[Ref]

Gastrointestinal

Sumatriptan-naproxen:

Common (1% to 10%): Nausea, dyspepsia, dry mouth, neck/throat/jaw pain/tightness/pressure

Very rare (less than 0.01%): Recurrence of gastric ulcer, gastric ulcer

5-HT-1 agonists:

Frequency not reported: Gastrointestinal vascular ischemia and infarction (presenting with abdominal pain and bloody diarrhea), splenic infarction

NSAIDs:

Frequency not reported: Gastrointestinal bleeding, ulceration, perforation^[Ref]

During clinical trials in 3302 adult patients, 1 patient experienced recurrence of a gastric ulcer after taking 8 doses of sumatriptan-naproxen over 3 weeks and 1 patient developed a gastric ulcer after treating an average of 8 attacks over a 7 month period.^[Ref]

Ocular

5-HT1 agonists:

Frequency not reported: Transient and permanent blindness and significant partial vision loss^[Ref]

Renal

US FDA Drug Safety Communication (10-2020): The FDA is requiring a new warning be added to NSAID labeling describing the risk of fetal kidney problems that may result in low amniotic fluid. The FDA is recommending pregnant women avoid NSAID use at 20 weeks gestation or later. Through 2017, the FDA has received 35 reports of low amniotic fluid levels or kidney problems in mothers who took NSAIDs while pregnant. Five newborns died; 2 had kidney failure and confirmed low amniotic fluid, 3 had kidney failure without confirmed low amniotic fluid. The low amniotic fluid started as early as 20 weeks of pregnancy. There were 11 reports of low amniotic fluid levels during pregnancy and the fluid volume returned to normal after the NSAID was stopped. The medical literature has reported low amniotic fluid levels with use of NSAIDs for varying amounts of time, ranging from 48 hours to multiple weeks. Complications of prolonged oligohydramnios may include limb contractures and delayed lung maturation. In some postmarketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required. In other cases, the condition was reversible within 3 to 6 days of stopping the NSAID and in these cases reappeared when the same NSAID was restarted.^[Ref]

NSAIDs:

-Frequency not reported: renal papillary necrosis, renal toxicity

-Postmarketing reports: Fetal kidney problems resulting in low amniotic fluid^[Ref]

Dermatologic

NSAIDs:

Frequency not reported: Exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis

Endocrine

NSAIDs

Frequency not reported: Premature closure of ductus arteriosus^[Ref]

Hepatic

NSAIDs:

Common (1% to 10%): Elevated liver tests

Frequency not reported: Severe hepatic reactions including jaundice, fatal fulminant hepatitis, liver necrosis, and hepatic failure^[Ref]

Hematologic

NSAIDs

Frequency not reported: Anemia^[Ref]