Over-the-counter medication · Antiplatelet / NSAID
aspirin
Also sold as Bayer, Ecotrin. Aspirin is used to temporarily relieve minor aches and pains.
Data updated 2026-05-15
- 518,554
- FDA reportsHeavily reported
- 47
- InteractionsMany interactions
- 2
- Recall records
What the data shows
aspirin (Bayer) is an over-the-counter Antiplatelet / NSAID, one of the most-reported medications in the FDA FAERS database (518,554 FDA reports), with 47 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.
aspirin (Bayer) is an over-the-counter Antiplatelet / NSAID. Aspirin is used to temporarily relieve minor aches and pains.
Aspirin is a common medicine used to relieve minor pain. It can also be prescribed by your doctor for other uses.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$0.02/unit
Generic Available
Yes (4 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Aspirin is used to temporarily relieve minor aches and pains.
Common side effects
Upset stomach, Heartburn
Key warnings
No specific warnings noted. Always follow your prescriber's instructions.
The sections below are summarized in plain English from aspirin's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Aspirin belongs to a class of drugs called NSAIDs and antiplatelets. It works by reducing substances in the body that cause pain and inflammation. It also helps to prevent blood clots.
How to Take It
Take each dose with a full glass of water. Adults and children 12 years and over can take 4 to 8 tablets every 4 hours. Do not take more than 48 tablets in 24 hours unless your doctor tells you to. Children under 12 years old should ask a doctor.
This is a plain-language summary of aspirin's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Ask your doctor for advice if you are pregnant or breastfeeding.
This is a plain-language summary of aspirin'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 double your dose to catch up.
This is a plain-language summary of aspirin's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store between 59-86ºF (15-30ºC).
Side Effects (from patient reports)
Based on 518,554 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for aspirin, by number of reports
- Tiredness
Tiredness
31,969 reports
- Shortness of breath
Shortness of breath
27,184 reports
- Feeling sick to your stomach
Feeling sick to your stomach
26,582 reports
- Loose stools
Loose stools
26,451 reports
- Feeling lightheaded
Feeling lightheaded
22,392 reports
- Head pain
Head pain
19,480 reports
- Weakness
Weakness
18,896 reports
- Accidental fall
Accidental fall
18,611 reports
- General pain
General pain
18,013 reports
- Lung infection
Lung infection
15,906 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 aspirin 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 aspirin sits
aspirin has more FDA adverse-event reports than 99% 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 aspirin; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 518,554 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2001–2025.
Total Reports
518,554
Reports Mentioning Death
47,820
9.2% of reports — not proof of cause
Hospitalization Reports
203,341
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | FATIGUE | 31,963 |
| 2 | DYSPNOEA | 27,179 |
| 3 | NAUSEA | 26,579 |
| 4 | DIARRHOEA | 26,452 |
| 5 | DIZZINESS | 22,390 |
| 7 | HEADACHE | 19,476 |
| 8 | ASTHENIA | 18,889 |
| 10 | FALL | 18,601 |
| 11 | PAIN | 18,007 |
| 12 | PNEUMONIA | 15,900 |
| 13 | VOMITING | 15,779 |
| 14 | MYOCARDIAL INFARCTION | 15,009 |
| 15 | DEATH | 14,883 |
| 16 | ARTHRALGIA | 14,086 |
| 17 | PRURITUS | 13,452 |
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
Known Drug Interactions
Information on concurrent usage of atenolol and aspirin is limited. Data from several studies, i.e., TIMI-II, ISIS-2, currently do not suggest any clinical interaction between aspirin and beta-blockers in the acute myocardial infarction setting.
Mechanism: Current medical studies do not show a clear way these two drugs interfere with each other when used for heart attacks.
What to do: These drugs can generally be used together, but you should still follow your doctor's specific instructions.
NSAIDs, Aspirin, Warfarin): May potentiate the risk of bleeding ( 7.4 ) Drugs Tightly Bound to Plasma Proteins: May cause a shift in plasma concentrations ( 7.6 , 7.7 ) Olanzapine: When used in combination with fluoxetine, also refer to the Drug Interactions section of the package insert for Symbyax ( 7.7 ) Drugs that Prolong the QT Interval: Do not use fluoxetine with thioridazine or pimozide. 7.4 Drugs that Interfere with Hemostasis (e.g., NSAIDs, Aspirin, Warfarin) Serotonin release by platelets plays an important role in hemostasis. Epidemiological studies of the case-control and...
Mechanism: Both drugs can interfere with how your blood cells clump together to stop bleeding, which increases your risk of bruising or bleeding.
What to do: Your doctor should monitor you closely for any signs of unusual bleeding or bruising while taking these together.
Do not take within 60 minutes of dosing ( 7.1 ) Use caution when co-prescribing aspirin/nonsteroidal anti-inflammatory drugs that may worsen gastrointestinal irritation. 7.2 Aspirin/Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Because aspirin, NSAIDs, and bisphosphonates are all associated with gastrointestinal irritation, caution should be exercised in the concomitant use of aspirin or NSAIDs with ibandronate sodium tablets.
Mechanism: Both of these medicines can irritate your stomach and throat, which increases the chance of developing sores or pain.
What to do: Be very careful when taking these together and wait at least 60 minutes after taking ibandronate before taking aspirin.
( 7.1 ) Use caution when co-prescribing aspirin/nonsteroidal anti- inflammatory drugs that may worsen gastrointestinal irritation. 7.2 Aspirin In clinical studies, the incidence of upper gastrointestinal adverse events was increased in patients receiving concomitant therapy with daily doses of alendronate sodium greater than 10 mg and aspirin-containing products.
Mechanism: Both of these medicines can be hard on your stomach and esophagus. Using them together increases the chance of developing irritation or ulcers in your digestive system.
What to do: Use caution when taking these drugs together. Tell your doctor if you have any stomach pain or heartburn.
7.3 Anticoagulants and Antiplatelet Agents Coadministration of antiplatelet agents, fibrinolytics, heparin, aspirin, and chronic NSAID use increases the risk of bleeding. APPRAISE-2, a placebo-controlled clinical trial of apixaban in high-risk, post-acute coronary syndrome patients treated with aspirin or the combination of aspirin and clopidogrel, was terminated early due to a higher rate of bleeding with apixaban compared to placebo. In ARISTOTLE, concomitant use of aspirin increased the bleeding risk on apixaban from 1.8% per year to 3.4% per year and concomitant use of aspirin and...
Mechanism: Aspirin and apixaban both thin the blood, and taking them together can nearly double your risk of having a bleeding event. This happens because both drugs make it harder for your blood to clot.
What to do: Your doctor should monitor you closely for bleeding while you are on both medications. Do not start or stop taking aspirin without first consulting your healthcare provider.
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 aspirin used for?
How often can I take aspirin?
How many aspirin tablets can I take at once?
Can children under 12 take aspirin?
Can aspirin provide fast relief for headaches?
Should I take aspirin with food?
What should I do if I miss a dose?
How should I store aspirin?
Can I take more than 48 tablets in 24 hours?
What should I do if I think I'm having a side effect?
What are the common side effects of aspirin?
Does aspirin interact with other medications?
What drug class is aspirin?
Is aspirin safe during pregnancy?
Has aspirin been recalled?
Active Recalls
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Safecor Health, LLC
Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
Aurobindo Pharma USA Inc
Related Medications in Antiplatelet / NSAID
Other drugs grouped near aspirin - same-class peers and common alternatives.
apixaban
Eliquis
Apixaban (Eliquis) is a medicine that helps prevent blood clots.
Compare with aspirin →
cilostazol
Pletal
Cilostazol is a medicine that helps improve walking distance in people with leg pain due to poor circulation.
Compare with aspirin →
clopidogrel
Plavix
Clopidogrel is a drug that helps to prevent blood clots.
Compare with aspirin →
dabigatran
Pradaxa
Dabigatran (Pradaxa) is a drug that helps to prevent blood clots from forming.
Compare with aspirin →
dalteparin
Fragmin
Dalteparin (Fragmin) is a type of blood thinner medicine.
Compare with aspirin →
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 aspirin
The FDA label for aspirin (sold under brand names such as Bayer, Ecotrin) classifies it as an over-the-counter product in the Antiplatelet / NSAID class. Aspirin is used to temporarily relieve minor aches and pains. Official labeling lists 2 commonly reported side effects, including Upset stomach, Heartburn.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 518,554 voluntary reports. The database also lists 47 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major 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 2 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 16, 2024
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