Sold as Aspi-Cor, Bayer Aspirin, Bufferin, Durlaza, Ecotrin and 4 more.
Class: Platelet aggregation inhibitors excl. heparin; Salicylic acid and derivatives.
First FDA approval 06/25/1965: 61 years on the US market.
This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
B
Score breakdown (85/100)
Safety ×35%
B
Evidence ×25%
B
Regulatory ×15%
A
Money & lawsuits ×15%
A
Options ×10%
C
Safety: 79
FDA issued 2 Drug Safety Communication(s) naming this drug since 2010, most recently 2016 (-16)
Death share in reports is near or below the FAERS average (1.0x)
Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)
Evidence: 85
2377 randomized trials and 737 systematic reviews/meta-analyses indexed in PubMed
12 independent Cochrane review(s) exist
Only 31% of completed registered trials posted results (-15)
Regulatory history: 97
Recalls since 2016: 0 Class I, 1 Class II, 0 Class III (-3)
Money & lawsuits: 100
Pharma paid doctors $0 tied to this drug last year: negligible
Not named in any pending federal MDL
Options: 70
No generic version approved: brand-only pricing (-30)
Warnings the FDA chose to announce publicly after approval, as opposed to quiet label edits. Class-wide items name the drug's class, not this drug specifically.
What the FDA label says
Approved uses
Uses Temporary relief of minor aches and pains due to: a cold headache backache muscular aches toothache minor pains from arthritis
Contraindications
None listed.
Warnings and precautions
Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Aspirin may cause severe allergic reactions which may include: ■ hives ■ facial swelling ■ shock ■ asthma (wheezing) Stomach bleeding warning: This product contains an NSAID , which may cause severe stomach bleeding. The chance is higher if you: ■ are age 60 or older ■ have had stomach ulcers or bleeding problems ■ take a blood thinning (anticoagulant) or steroid drug ■ take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuproben, naproxen, or others) ■ have 3 or more alcoholic drinks every day while using this product ■ take more or for a longer time than directed Do not use ■ if you have ever had an allergic reaction to any other pain reliever/fever reducer Ask a doctor before use if ■ you have asthma ■ stomach bleeding warning applies to you ■ you have a history of stomach problems, such as heartburn ■ you have...
Adverse reactions (label)
Not available.
Source: FDA SPL label for Rapidol Aspirin (Pharmadel LLC), effective 20260706.
Full label on DailyMed.
Side-effect reports sent to the FDA
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
547,048reports that mention this drug
545,046of those blame this drug, not another one the person was taking
74%of reports describe a serious outcome, such as a hospital stay (average for all drugs: 57%)
9.3%of reports include a death, from any cause (average for all drugs: 9.1%)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
Recalls and regulatory record
1recall actions on file
4 / 0brand / generic applications
1label changes since 2021
NoREMS program
Date
Class
Firm
Reason
01/2022
Class II
CARDINAL HEALTHCARE
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
Money and lawsuits
In 2024, drug companies reported $0 in payments to US physicians and hospitals tied to this drug across 0 transactions.
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
Who takes it and what it costs
Not in the Medicare Part D spending file (typically hospital-administered or very new drugs).
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.
Questions to ask your prescriber
In 2016 the FDA issued a safety communication about this drug (FDA warns about serious bleeding risk with over-the-counter antacid products containing aspirin). Does that risk apply to me?
The most-reported problems in FDA's adverse event data are fatigue, diarrhoea, dyspnoea, nausea. How would we recognize and handle those?
Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?
Why this one over abciximab, aloxiprin, benorilate? What would make you pick one of those instead?
There is no generic. Is there an older generic in the same class that works as well for my situation?
What result are we expecting, by when, and what is the plan if it does not happen?
If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)