Drug Safety Information for ASPIRIN (Aspirin)

FDA Safety-related Labeling Changes for PERCODAN (ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE) Discontinued Drug: Safety Information Link

FDA Safety-related Labeling Changes for SYNALGOS-DC (ASPIRIN; CAFFEINE; DIHYDROCODEINE BITARTRATE) Discontinued Drug: Safety Information Link

FDA Safety-related Labeling Changes for EQUAGESIC (ASPIRIN; MEPROBAMATE) Discontinued Drug: Safety Information Link

FDA Safety-related Labeling Changes for NORGESIC (ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE) Rx Drug: Safety Information Link

FDA Safety-related Labeling Changes for NORGESIC FORTE (ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE) Rx Drug: Safety Information Link

FDA Safety-related Labeling Changes for FIORINAL (ASPIRIN; BUTALBITAL; CAFFEINE) Rx Drug: Safety Information Link

FDA Safety-related Labeling Changes for FIORINAL W/CODEINE (ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE) Rx Drug: Safety Information Link

FDA Safety-related Labeling Changes for AGGRENOX (ASPIRIN; DIPYRIDAMOLE) Rx Drug: Safety Information Link

FDA Safety-related Labeling Changes for VAZALORE (ASPIRIN) Over-the-counter Drug: Safety Information Link

Adverse Drug Reactions for ASPIRIN* (Aspirin)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with ASPIRIN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dyspnoea11039
2Nausea*10679
3Flushing10217
4Dizziness9626
5Fatigue8784
6Myocardial infarction7809
7Diarrhoea7790
8Asthenia7639
9Drug ineffective7244
10Headache*6957
11Vomiting*6628
12Chest pain6626
13Pain6564
14Fall6449
15Pruritus6424
16Anaemia5521
17Cerebrovascular accident5337
18Hypotension5229
19Pain in extremity5207
20Pneumonia5112

* This side effect also appears in "Top 10 Side Effects of ASPIRIN " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking ASPIRIN
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication116856
2Prophylaxis22078
3Cardiac disorder11720
4Anticoagulant therapy8996
5Coronary artery disease6808
6Thrombosis prophylaxis5693
7Cardiovascular event prophylaxis5656
8Myocardial infarction4169
9Atrial fibrillation3508
10Pain*3475

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for ASPIRIN

Total Reports Filed with FDA: 920376


Number of FDA Adverse Event Reports by Patient Age for ASPIRIN

Total Reports Filed with FDA: 920376*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Aspirin (Rhinocaps, Chewable aspirin, Magnecyl, Halfprin, 8-hour bayer, Childrens aspirin, Ascriptin, Alka-seltzer pm, St. joseph aspirin, Tri-buffered aspirin, Aspirin to go, Conney aspirin, Dg health aspirin, Formucare aspirin, Good sense aspirin, Health mart aspirin, Henry schein aspirin, Kroger value aspirin, Leader aspirin, Low dose miniprin, Medi-first aspirin, Medique aspirin, North aspirin, Rexall aspirin, Durlaza, Fasprin, Rx act aspirin, Smart health aspirin, Smart sense aspirin, Sunmark aspirin, Topcare aspirin, Micro-coated aspirin, Ec-81aspirin, Value pharma, Zee aspirin, Equate aspirin, Bayer, Buffered aspirin, Zorprin, Pain relief aspirin, Aspir low, Miniprin, Genacote, Up and up aspirin, Aspiring, Claradin, Aspergum, Equaline aspirin, Acylpyrin, Polopiryna, Cvs aspirin, Ecotrin, Low dose aspirin, Aspirin nsaid, Rugby aspirin, Solves - aspirin, Bufferin, Aspir-trin, Lortab asa, Enteric aspirin, Low dose asprin, Roxiprin, Nu-seals aspirin, Paynocil, Percodan-demi, Solprin, Asprin, Colfarit, Uncoated aspirin, Aspirin 81 mg, Genuine aspirin, Care one aspirin, Easprin, Low-dose aspirin, Aspirin low dose, Solupsan, Aspirin ec, Dispril, Caprin, Aspirin chewable, Aspirin, Measurin, Empirin)

Charts are based on 920376 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and ASPIRIN Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.