Drugs with the Most FDA Adverse Event Reports

These drugs have the most adverse event reports submitted to the FDA's FAERS database. Higher report counts typically reflect wider usage, not necessarily greater risk. A drug used by millions will naturally generate more reports than a niche medication.

# Drug Name ↕ Generic Name ↕ Total Reports ↕ Serious ↕ Deaths ↕
1 HUMIRA ADALIMUMAB 695,826 196,301 28,959
2 ENBREL ETANERCEPT 591,577 67,663 16,506
3 ECOTRIN ASPIRIN 499,686 169,560 45,970
4 ASPIRIN 325 ASPIRIN 499,522 168,629 45,850
5 ASPIRIN 81 ASPIRIN 499,522 168,629 45,850
6 BAYER LOW DOSE ASPIRIN 497,097 169,077 46,064
7 LOW DOSE ASPIRIN ASPIRIN 493,984 168,311 45,324
8 LOW DOSE ASPIRIN ENTERIC SAFETY COATED ASPIRIN 493,984 168,311 45,324
9 ASPIRIN LOW DOSE ASPIRIN 493,474 168,126 45,354
10 BAYER GENUINE ASPIRIN ASPIRIN 493,125 168,105 45,339
11 ASPIRIN ENTERIC COATED ASPIRIN 493,090 168,133 45,358
12 ASPIRINA CAPLETS ASPIRIN 493,016 168,114 45,348
13 ASPIRIN CHEWABLE ASPIRIN 81 MG 492,997 168,129 45,353
14 ASPIRIN REGULAR STRENGTH ASPIRIN 492,987 168,161 45,346
15 ASPIRIN 81MG ASPIRIN 492,982 168,160 45,345
16 ASPIRIN 81MG ADULT LOW DOSE ASPIRIN 492,982 168,160 45,345
17 ASPIRIN ASPIRIN 492,967 168,125 45,350
18 ASPIRIN 325 MG ASPIRIN 492,967 168,125 45,350
19 ASPIRIN 81 MG ASPIRIN 492,967 168,125 45,350
20 ASPIRIN 81 MG LOW DOSE ASPIRIN 492,967 168,125 45,350
21 ENTERIC ASPIRIN ASPIRIN 492,536 168,076 45,296
22 ENTERIC COATED ASPIRIN ASPIRIN 492,506 168,067 45,295
23 ENTERIC COATED ASPIRIN REGULAR STRENGTH ASPIRIN 492,506 168,067 45,295
24 BAYER ASPIRIN 492,478 168,059 45,281
25 CHILDRENS ASPIRIN ASPIRIN 492,454 168,065 45,288
26 COATED ASPIRIN ASPIRIN 492,400 168,049 45,279
27 BUFFERED ASPIRIN ASPIRIN 492,356 168,047 45,276
28 ADULT LOW DOSE ASPIRIN ASPIRIN 492,352 168,050 45,284
29 EQUATE ASPIRIN CHEWABLE ASPIRIN 492,343 168,044 45,277
30 EQUATE ASPIRIN ASPIRIN 492,342 168,044 45,277
31 GOOD SENSE ASPIRIN ASPIRIN 492,334 168,050 45,279
32 CHEWABLE ASPIRIN ASPIRIN 492,332 168,048 45,279
33 CHEWABLE ASPIRIN LOW DOSE ASPIRIN 492,332 168,048 45,279
34 BAYER ASPIRIN REGIMEN CHEWABLE LOW DOSE ASPIRIN ORANGE ASPIRIN 492,325 168,043 45,276
35 BAYER ASPIRIN REGIMEN ENTERIC COATED ASPIRIN 492,318 168,042 45,276
36 ASPIRIN 325 MG EC ASPIRIN 492,312 168,044 45,278
37 TRI-BUFFERED ASPIRIN ASPIRIN 492,311 168,050 45,277
38 ASPIRIN LOW STRENGTH ASPIRIN 492,309 168,048 45,282
39 CAREALL ASPIRIN ASPIRIN 492,309 168,047 45,276
40 ASPIRIN REGIMEN ASPIRIN 492,308 168,047 45,277
41 ECOTRIN REGULAR STRENGTH ASPIRIN 492,307 168,043 45,277
42 ST. JOSEPH LOW DOSE ASPIRIN ASPIRIN 492,307 168,045 45,277
43 LOW DOSE ASPIRIN 81MG ASPIRIN 492,305 168,045 45,276
44 ASPIRIN DELAYED RELEASE ASPIRIN 492,304 168,043 45,277
45 ASPIRIN 81MG ENTERIC COATED LOW STRENGTH ASPIRIN REGIMEN ASPIRIN 492,303 168,043 45,277
46 ASPIRIN PAIN RELIVER ASPIRIN 492,303 168,046 45,276
47 REGULAR STRENGTH ASPIRIN ASPIRIN 492,303 168,043 45,276
48 ASPIRIN 81MG ENTERIC COATED ASPIRIN 492,302 168,042 45,276
49 ASPIRIN 81MG ENTERIC COATED DELAYED RELEASE ASPIRIN 492,302 168,042 45,276
50 EXTRA STRENGTH ASPIRIN ASPIRIN 492,302 168,042 45,276

Key Takeaways

  • Report volume correlates strongly with prescription volume and patient population size.
  • Biologic drugs like HUMIRA and ENBREL appear prominently due to mandatory post-market reporting requirements.
  • A high report count alone does not indicate a drug is unsafe. Context around usage and patient population is essential.

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. These rankings reflect reporting volume, not drug safety. Always consult your doctor or pharmacist before making medication decisions.