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.
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
18,855 reports
- Fatigue
Fatigue
17,866 reports
- Nausea
Nausea
17,352 reports
- Headache
Headache
15,815 reports
- Arthralgia
Arthralgia
12,950 reports
- Dyspnoea
Dyspnoea
12,537 reports
- Vomiting
Vomiting
12,452 reports
- Diarrhoea
Diarrhoea
12,138 reports
- Dizziness
Dizziness
10,737 reports
- Rash
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) 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.
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.
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.
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.
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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
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?
What pregnancy or breastfeeding source fields are listed for ibuprofen?
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
Orencia
Orencia is a medicine that helps to reduce inflammation.
Compare with ibuprofen →
acetaminophen
Tylenol
Acetaminophen (Tylenol) is a medicine that can relieve pain and reduce fever.
Compare with ibuprofen →
acetaminophen/hydrocodone
Vicodin, Norco
This medicine contains acetaminophen and hydrocodone.
Compare with ibuprofen →
acetaminophen/oxycodone
Percocet
Percocet is a strong pain medicine.
Compare with ibuprofen →
adalimumab
Humira
Idacio is a medicine that blocks a protein called TNF.
Compare with ibuprofen →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for ibuprofen: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 262,453.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 6.66%.
- cefixime Δ 0.01 pts · 2,824 reports · Third-Generation Cephalosporin 6.66%death share
- ketoconazole Δ 0.02 pts · 16,231 reports · Azole Antifungal 6.65%death share
- polyethylene glycol 3350 Δ 0.02 pts · 91,655 reports · Osmotic Laxative 6.65%death share
- dronedarone Δ 0.02 pts · 9,899 reports · Class III Antiarrhythmic 6.65%death share
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
FDA bioequivalence and label-record context for narrow therapeutic index medicines
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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: April 1, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
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 from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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