Naproxeno

ATC code

M01AE02

Therapeutic class

Non-Steroidal Anti-Inflammatory Drug (NSAID) · Propionic acid derivative

Forms

oral tablet, modified-release tablet, oral suspension

Brand names

Actromadol (ES) · Flanax (MX) · Aleve (US) · Naprosyn (US)

Overall confidence

medium

Regulatory sources consulted

AEMPS CIMA: 83348
CredibleMeds.org
Flockhart Table
General Clinical Knowledge
AEMPS CIMA · nº registro 83348 ↗
RxNorm rxcui 7258 ↗

Approved indications

Symptomatic relief of occasional mild to moderate pain, such as headaches, dental pain, menstrual pain, muscle pain (contractures) or back pain (lumbago), as well as in febrile states.
Treatment of rheumatic diseases such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, and for the management of acute gout.

Contraindications

Absolute

Hypersensitivity to naproxen or other NSAIDs.
Active peptic ulcer, history of gastrointestinal bleeding or perforation related to NSAIDs.
Severe heart, hepatic, or renal failure.
Third trimester of pregnancy.

Clinical warnings

Boxed warning · Risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke. — FDA
Boxed warning · Risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines. — FDA

Drug interactions

HighMethotrexateL01BA01
Mechanism: Decreased renal clearance of methotrexate, which can lead to increased plasma concentrations and hematologic toxicity.
Recommendation: Avoid concomitant use with high-dose methotrexate. With low doses, use with extreme caution and monitor renal function and blood counts.
AEMPS CIMA
HighWarfarinB01AA03
Mechanism: Increased risk of bleeding due to naproxen's antiplatelet effect and potential displacement of warfarin from plasma protein binding.
Recommendation: Closely monitor INR and signs and symptoms of bleeding. Consider using an alternative analgesic.
AEMPS CIMA
ModerateACE Inhibitors / ARBsC09
Mechanism: NSAIDs can diminish the antihypertensive effect and increase the risk of renal impairment, especially in elderly or dehydrated patients.
Recommendation: Monitor blood pressure and renal function when starting or changing the naproxen dose. Ensure adequate hydration.
AEMPS CIMA

Adverse events

Common (≥1%)

dyspepsia · nausea · abdominal pain · headache · dizziness · edema

Rare but serious

gastrointestinal bleeding · gastrointestinal perforation · myocardial infarction · stroke · acute renal failure · anaphylactic reactions · Stevens-Johnson syndrome

Pregnancy and lactation

FDA category: D (en 3er trimestre)

Contraindicated in the third trimester of pregnancy due to risk of premature closure of the ductus arteriosus. Avoid use during the first and second trimesters unless strictly necessary. It is excreted in breast milk in small amounts; use during lactation is not recommended.