Over-the-counter medication · Nonsteroidal Anti-Inflammatory Drug (NSAID)
naproxen
Also sold as Aleve, Naprosyn. Naproxen is used to relieve pain and inflammation.
Data updated 2026-05-15
- 75,912
- FDA reportsOften reported
- 23
- InteractionsSeveral interactions
- 4
- Recall records
What the data shows
naproxen (Aleve) is an over-the-counter Nonsteroidal Anti-Inflammatory Drug (NSAID), more reported than most tracked drugs (75,912 FDA reports), with 23 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
naproxen (Aleve) is an over-the-counter Nonsteroidal Anti-Inflammatory Drug (NSAID). Naproxen is used to relieve pain and inflammation.
Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). It helps reduce pain, swelling, and stiffness.
Verify with FDA → · CMS NADAC pricing →
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.
The sections below are summarized in plain English from naproxen's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
This is a plain-language summary of naproxen's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
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.
This is a plain-language summary of naproxen's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
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.
This is a plain-language summary of naproxen's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store naproxen at room temperature, away from moisture and heat.
Side Effects (from patient reports)
Based on 75,912 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for naproxen, by number of reports
- Pain
Pain
8,756 reports
- Tiredness
Tiredness
7,338 reports
- Joint pain
Joint pain
7,244 reports
- Feeling sick to your stomach
Feeling sick to your stomach
7,063 reports
- Headache
Headache
5,717 reports
- Diarrhea
Diarrhea
5,351 reports
- Throwing up
Throwing up
4,747 reports
- Feeling dizzy
Feeling dizzy
4,710 reports
- Skin rash
Skin rash
4,612 reports
- Difficulty breathing
Difficulty breathing
4,584 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for naproxen each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where naproxen sits
naproxen has more FDA adverse-event reports than 81% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is naproxen; the line is the median (50th percentile).
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
Reports Mentioning Death
7,527
9.9% of reports — not proof of cause
Hospitalization Reports
25,220
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 2 | PAIN | 8,756 |
| 3 | FATIGUE | 7,339 |
| 4 | ARTHRALGIA | 7,243 |
| 5 | NAUSEA | 7,062 |
| 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 |
| 16 | RHEUMATOID ARTHRITIS | 4,309 |
| 17 | CONDITION AGGRAVATED | 3,652 |
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.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
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
Chemical contamination; presence of lead and lithium above specification
Acella Pharmaceuticals, LLC
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
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 75,912 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 4 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.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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