naproxen
Brand names: Aleve, Naprosyn
Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). It helps reduce pain, swelling, and stiffness.
Drug Pricing (NADAC)
Generic Price
$0.25/unit
Generic Available
Yes (39 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Naproxen is used to relieve pain and inflammation.
Common side effects
Heartburn, Abdominal pain, Nausea
Key warnings
Naproxen may increase your risk of serious heart problems like heart attack or stroke, which can be fatal.
How It Works
Naproxen works by reducing substances in the body that cause pain and inflammation. It blocks the production of prostaglandins. These substances contribute to the symptoms of pain, swelling, and fever.
How to Take It
Take naproxen exactly as your doctor tells you. Use the lowest dose that works for you, and for the shortest time needed. For arthritis, a common dose is 250 mg to 500 mg twice a day. For pain, you might start with 550 mg, then 275 mg every 6-8 hours as needed.
Pregnancy & Breastfeeding
Using naproxen after 20 weeks of pregnancy can cause kidney problems in the unborn baby, leading to low amniotic fluid. Avoid using naproxen at 30 weeks of pregnancy or later because it can cause the baby's heart to close too early. Talk to your doctor if you are pregnant or plan to become pregnant.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
Storage
Store naproxen at room temperature, away from moisture and heat.
Side Effects (from patient reports)
Based on 66,724 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 75,912 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
75,912
Death-Related Reports
7,527
Hospitalization Reports
25,220
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DRUG INEFFECTIVE | 9,822 |
| 2 | PAIN | 8,756 |
| 3 | FATIGUE | 7,339 |
| 4 | ARTHRALGIA | 7,243 |
| 5 | NAUSEA | 7,062 |
| 6 | OFF LABEL USE | 5,976 |
| 7 | HEADACHE | 5,716 |
| 8 | DIARRHOEA | 5,350 |
| 9 | VOMITING | 4,746 |
| 10 | DIZZINESS | 4,711 |
| 11 | RASH | 4,612 |
| 12 | DYSPNOEA | 4,585 |
| 13 | MALAISE | 4,452 |
| 14 | JOINT SWELLING | 4,358 |
| 15 | PAIN IN EXTREMITY | 4,337 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Naproxen may increase your risk of serious heart problems like heart attack or stroke, which can be fatal. This risk may happen early in treatment and increases with longer use. You should not take naproxen if you are having heart bypass surgery. Naproxen can also increase your risk of serious stomach and intestine problems, including bleeding, ulcers, and holes, which can be fatal. These problems can occur without warning. Elderly people are at higher risk.
Known Drug Interactions
Methotrexate Clinical Impact: Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction). Intervention: During concomitant use of naproxen tablets or naproxen sodium tablets and methotrexate, monitor patients for methotrexate toxicity.
Mechanism: Naproxen can cause methotrexate to stay in your system longer, which increases the risk of harmful side effects like low blood cell counts or kidney problems.
What to do: Your doctor should monitor you closely for signs of toxicity while you are taking both medications. Report any unusual symptoms like bruising or fatigue to your healthcare provider.
Antacids and Sucralfate Clinical Impact: Concomitant administration of some antacids (magnesium oxide or aluminum hydroxide) and sucralfate can delay the absorption of naproxen. Intervention: Concomitant administration of antacids such as magnesium oxide or aluminum hydroxide, and sucralfate with naproxen tablets and naproxen sodium tablets is not recommended.
Mechanism: Magnesium oxide can slow down how quickly your body absorbs naproxen into your bloodstream. This might make the naproxen take longer to start working.
What to do: It is not recommended to take these two medications at the same time. Talk to your doctor or pharmacist about how to space out your doses.
NSAIDs and Salicylates Clinical Impact: Concomitant use of naproxen with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy [ see Warnings and Precautions ( 5.2 ) ].
Mechanism: Taking these two similar pain relievers together increases the risk of stomach and intestinal damage without providing extra relief.
What to do: Avoid using these medications at the same time.
Antacids and Sucralfate Clinical Impact: Concomitant administration of some antacids (magnesium oxide or aluminum hydroxide) and sucralfate can delay the absorption of naproxen. Intervention: Concomitant administration of antacids such as magnesium oxide or aluminum hydroxide, and sucralfate with naproxen tablets and naproxen sodium tablets is not recommended.
Mechanism: Sucralfate can slow down how quickly your body absorbs naproxen, which may delay its effects.
What to do: Taking these two medications together is not recommended.
Cholestyramine Clinical Impact: Concomitant administration of cholestyramine can delay the absorption of naproxen. Intervention: Concomitant administration of cholestyramine with naproxen tablets or naproxen sodium tablets is not recommended.
Mechanism: Cholestyramine can slow down the absorption of naproxen into your system.
What to do: It is not recommended to take these two medications at the same time.
Common Questions
Can I take naproxen with aspirin?
How long does it take for naproxen to work?
Can I drink alcohol while taking naproxen?
Is naproxen safe for my kidneys?
Can naproxen raise my blood pressure?
What should I do if I have a skin rash while taking naproxen?
Can naproxen cause stomach problems?
Can I take naproxen if I am allergic to aspirin?
Does naproxen interact with other medications?
Can naproxen cause weight gain?
What are the common side effects of naproxen?
Does naproxen interact with other medications?
What drug class is naproxen?
Is naproxen safe during pregnancy?
Has naproxen been recalled?
Active Recalls
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC
CGMP Deviations
Glenmark Pharmaceuticals Inc., USA
Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Glenmark Pharmaceuticals Inc., USA
Related Medications in Nonsteroidal Anti-Inflammatory Drug (NSAID)
Other drugs grouped near naproxen — same-class peers and common alternatives.
abatacept
Orencia
Orencia is a medicine that helps to reduce inflammation.
Compare with naproxen →
acetaminophen
Tylenol
Acetaminophen (Tylenol) is a medicine that can relieve pain and reduce fever.
Compare with naproxen →
acetaminophen/hydrocodone
Vicodin, Norco
This medicine contains acetaminophen and hydrocodone.
Compare with naproxen →
acetaminophen/oxycodone
Percocet
Percocet is a strong pain medicine.
Compare with naproxen →
adalimumab
Humira
Idacio is a medicine that blocks a protein called TNF.
Compare with naproxen →
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Pain Relievers Compared
NSAIDs vs acetaminophen — which OTC pain reliever to use
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
Related Health & Safety Data
🩺 Find a Doctor
Search prescribers for Nonsteroidal Anti-Inflammatory Drug (NSAID)
🏨 Hospital Quality
CMS hospital ratings, safety scores & patient outcomes
💊 Supplement Data
NIH DSLD — check supplement ingredients & label claims
🍽️ Food Safety Alerts
FDA recalls, inspections & outbreak investigations
⚠️ Product Recalls
FDA, CPSC & NHTSA recall search
💉 Procedure Costs
Medicare procedure pricing for 9,297 procedures
What the FDA Data Shows for naproxen
The FDA label for naproxen (sold under brand names such as Aleve, Naprosyn) classifies it as an over-the-counter product in the Nonsteroidal Anti-Inflammatory Drug (NSAID) class. Naproxen is used to relieve pain and inflammation. Official labeling lists 21 commonly reported side effects, including Heartburn, Abdominal pain, Nausea.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 66,724 voluntary reports. The database also lists 23 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $0.25.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 3 recall records on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: January 29, 2026
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages