Over-the-counter medication · Nonsteroidal Anti-Inflammatory Drug (NSAID)
ibuprofen
Also sold as Advil, Motrin. Ibuprofen can help with minor aches and pains.
Data updated 2026-05-15
- 262,453
- FDA reportsHeavily reported
- 9
- InteractionsFew interactions
- 11
- Recall records
What the data shows
ibuprofen (Advil) is an over-the-counter Nonsteroidal Anti-Inflammatory Drug (NSAID), in the top 5% of tracked drugs by FAERS report volume (262,453 FDA reports), with 9 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.
ibuprofen (Advil) is an over-the-counter Nonsteroidal Anti-Inflammatory Drug (NSAID). Ibuprofen can help with minor aches and pains.
Ibuprofen is a drug that can reduce pain and fever. It belongs to a class of drugs called NSAIDs.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$0.02/unit
Generic Available
Yes (70 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Ibuprofen can help with minor aches and pains.
Common side effects
Nausea, Headache, Diarrhea
Key warnings
NSAIDs like ibuprofen may increase the risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal.
The sections below are summarized in plain English from ibuprofen's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Ibuprofen works by reducing hormones that cause pain and swelling in the body. It blocks the production of prostaglandins. Prostaglandins contribute to inflammation and pain signals.
How to Take It
Adults and children 12 years and over can take 1 tablet every 4 to 6 hours as needed. If one tablet doesn't help, you can take 2 tablets. Do not take more than 6 tablets in 24 hours unless your doctor tells you to. Children under 12 years should ask a doctor.
This is a plain-language summary of ibuprofen's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Ask a doctor before using if you are pregnant or breastfeeding. NSAIDs like ibuprofen may cause harm to the fetus.
This is a plain-language summary of ibuprofen's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
Take the missed dose as soon as you remember. Do not take more than directed in a 24-hour period.
This is a plain-language summary of ibuprofen's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store between 68°-77°F (20°-25°C) and avoid high heat above 104°F (40°C).
Side Effects (from patient reports)
Based on 262,453 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for ibuprofen, by number of reports
- Pain
Pain
18,851 reports
- Tiredness
Tiredness
17,869 reports
- Feeling sick to your stomach
Feeling sick to your stomach
17,349 reports
- Headache
Headache
15,814 reports
- Joint pain
Joint pain
12,952 reports
- Difficulty breathing
Difficulty breathing
12,535 reports
- Throwing up
Throwing up
12,452 reports
- Diarrhea
Diarrhea
12,139 reports
- Feeling lightheaded
Feeling lightheaded
10,736 reports
- Skin rash
Skin rash
10,700 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 ibuprofen 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 ibuprofen sits
ibuprofen has more FDA adverse-event reports than 97% 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 ibuprofen; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 262,453 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 1998–2025.
Total Reports
262,453
Reports Mentioning Death
17,491
6.7% of reports — not proof of cause
Hospitalization Reports
81,556
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 2 | PAIN | 18,855 |
| 3 | FATIGUE | 17,866 |
| 4 | NAUSEA | 17,352 |
| 5 | HEADACHE | 15,815 |
| 6 | ARTHRALGIA | 12,950 |
| 7 | DYSPNOEA | 12,537 |
| 8 | VOMITING | 12,452 |
| 9 | DIARRHOEA | 12,138 |
| 10 | DIZZINESS | 10,737 |
| 11 | RASH | 10,700 |
| 13 | PYREXIA | 9,458 |
| 14 | PRURITUS | 9,418 |
| 15 | DRUG HYPERSENSITIVITY | 8,278 |
| 16 | ANXIETY | 7,917 |
| 17 | ASTHENIA | 7,877 |
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
NSAIDs like ibuprofen may increase the risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. NSAIDs also increase the risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal.
Known Drug Interactions
7.2 Platelet Inhibitors Drugs such as NSAIDS (including salicylic acid, ibuprofen, indomethacin, and celecoxib), dextran, phenylbutazone, thienopyridines, dipyridamole, hydroxychloroquine, glycoprotein IIb/IIIa antagonists (including abciximab, eptifibatide, and tirofiban), and others that interfere with platelet-aggregation reactions (the main hemostatic defense of heparinized patients) may induce bleeding and should be used with caution in patients receiving heparin sodium.
Mechanism: Heparin thins the blood, and ibuprofen stops blood cells called platelets from sticking together. Using them together significantly increases your risk of dangerous bleeding.
What to do: Use this combination with extreme caution. Watch for signs of unusual bruising or bleeding and tell your doctor immediately if they occur.
Table 3: Drugs that Can Increase the Risk of Bleeding Drug Class Specific Drugs Anticoagulants argatroban, dabigatran, bivalirudin, desirudin, heparin, lepirudin Antiplatelet Agents aspirin, cilostazol, clopidogrel, dipyridamole, prasugrel, ticlopidine Non-steroidal Anti-Inflammatory Agents celecoxib, diclofenac, diflunisal, fenoprofen, ibuprofen, indomethacin, ketoprofen, ketorolac, mefenamic acid, naproxen, oxaprozin, piroxicam, sulindac Serotonin Reuptake Inhibitors citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, fluvoxamine, milnacipran, paroxetine, sertraline,...
Mechanism: Ibuprofen is an anti-inflammatory drug that increases the risk of bleeding when taken with warfarin. Both medications interfere with the body's natural ability to form blood clots.
What to do: Your doctor should monitor you closely for signs of bleeding, such as unusual bruising. Report any dark or bloody stools to your healthcare provider immediately.
Concomitant use of carbamazepine with olanzapine, dantrolene, or ibuprofen may increase plasma carbamazepine levels.
Mechanism: Ibuprofen can cause carbamazepine to build up in your blood by slowing down how your body processes it.
What to do: Your doctor may need to monitor your blood levels or adjust your dose to avoid side effects.
Conivaptan 33% 43% Diltiazem 20% NA Indomethacin 40% NA Mirabegron 29% 27% Nefazodone 27% 15% Nifedipine 45% NA Propantheline 24% 24% Quinine NA 33% Rabeprazole 29% 19% Saquinavir 27% 49% Spironolactone 25% NA Telmisartan 20 to 49% NA Tricagrelor 31% 28% Tolvaptan 30% 20% Trimethoprim 22 to 28% NA Digoxin concentrations increased, but magnitude is unclear Alprazolam, azithromycin, cyclosporine, diclofenac, diphenoxylate, epoprostenol, esomeprazole, ibuprofen, ketoconazole, lansoprazole, metformin, omeprazole Measure serum digoxin concentrations before initiating concomitant drugs.
Mechanism: Ibuprofen can lead to higher levels of digoxin in your bloodstream. This could increase the risk of side effects from the digoxin.
What to do: Your doctor should check your digoxin levels before you begin taking ibuprofen and monitor you for side effects.
Similarly, the C max and AUC of the pharmacologically active isomer [S-(+)-ibuprofen] were increased by 15% and 82%, respectively, when fluconazole was coadministered with racemic ibuprofen (400 mg) compared to administration of racemic ibuprofen alone.
Mechanism: Fluconazole slows down how your body processes this pain reliever, which can lead to much higher levels of the drug in your system.
What to do: You should be monitored for side effects and your doctor may need to lower your ibuprofen dose.
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
What is the active ingredient?
How often can I take this?
Can children take this medication?
What should I do if I accidentally take too much?
Can I take this with other medications?
Does ibuprofen interact with alcohol?
How long does it take for ibuprofen to work?
Can I take ibuprofen on an empty stomach?
Is it safe to take ibuprofen every day?
What is the shelf life of ibuprofen?
What are the common side effects of ibuprofen?
Does ibuprofen interact with other medications?
What drug class is ibuprofen?
Is ibuprofen safe during pregnancy?
Has ibuprofen been recalled?
Active Recalls
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
STRIDES PHARMA INC
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC
CGMP Deviations
Glenmark Pharmaceuticals Inc., USA
Failed Tablet/Capsule Specifications
Dr. Reddy's Laboratories, Inc.
Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Direct Rx
Failed Impurities/Degradation Specifications - at 18-month Stability testing
Preferred Pharmaceuticals, Inc.
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Dr. Reddy's Laboratories, Inc.
Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
Ascend Laboratories, LLC
CGMP deviation: product outside labeled storage temperature requirements.
Family Dollar Stores, Llc.
CGMP deviation: product outside labeled storage temperature requirements.
Family Dollar Stores, Llc.
Related Medications in Nonsteroidal Anti-Inflammatory Drug (NSAID)
Other drugs grouped near ibuprofen - same-class peers and common alternatives.
abatacept
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
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FDA requirements, cost savings, and when the difference matters
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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 ibuprofen
The FDA label for ibuprofen (sold under brand names such as Advil, Motrin) classifies it as an over-the-counter product in the Nonsteroidal Anti-Inflammatory Drug (NSAID) class. Ibuprofen can help with minor aches and pains. Official labeling lists 6 commonly reported side effects, including Nausea, Headache, Diarrhea.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 262,453 voluntary reports. The database also lists 9 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 $0.02.
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 11 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: April 1, 2025
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