Drugs with the Most Serious Adverse Event Reports

These drugs have the most reports classified as "serious" by the FDA, which includes hospitalization, disability, life-threatening events, and death. Serious report counts reflect both the severity profile and the size of the patient population taking each drug.

# Drug Name ↕ Generic Name ↕ Serious Reports ↕ Total Reports ↕ Deaths ↕
1 DUPIXENT DUPILUMAB 344,853 411,692 1,769
2 PAIN RELIEF ACETAMINOPHEN 217,329 448,952 62,730
3 TYLENOL EXTRA STRENGTH ACETAMINOPHEN 210,285 399,311 57,894
4 TYLENOL REGULAR STRENGTH ACETAMINOPHEN 204,564 383,023 57,180
5 PREDNISONE TABLETS, USP, 10 MG PREDNISONE 203,210 482,841 50,086
6 PREDNISONE TABLETS, USP, 20 MG PREDNISONE 203,210 482,841 50,086
7 PREDNISONE TABLETS, USP, 5 MG PREDNISONE 203,210 482,841 50,086
8 PREDNISONE PREDNISONE 203,208 482,828 50,086
9 PREDNISONE DELAYED RELEASE PREDNISONE 203,208 482,828 50,086
10 GOODNOW PAIN RELIEF ACETAMINOPHEN 200,098 406,155 58,126
11 HUMIRA ADALIMUMAB 196,301 695,826 28,959
12 MEDLINE ACETAMINOPHEN 170,125 298,818 52,727
13 RAPIDOL ACETAMINOPHEN 170,021 291,586 52,969
14 ECOTRIN ASPIRIN 169,560 499,686 45,970
15 BAYER LOW DOSE ASPIRIN 169,077 497,097 46,064
16 ASPIRIN 325 ASPIRIN 168,629 499,522 45,850
17 ASPIRIN 81 ASPIRIN 168,629 499,522 45,850
18 LOW DOSE ASPIRIN ASPIRIN 168,311 493,984 45,324
19 LOW DOSE ASPIRIN ENTERIC SAFETY COATED ASPIRIN 168,311 493,984 45,324
20 ASPIRIN REGULAR STRENGTH ASPIRIN 168,161 492,987 45,346
21 ASPIRIN 81MG ASPIRIN 168,160 492,982 45,345
22 ASPIRIN 81MG ADULT LOW DOSE ASPIRIN 168,160 492,982 45,345
23 ASPIRIN ENTERIC COATED ASPIRIN 168,133 493,090 45,358
24 ASPIRIN CHEWABLE ASPIRIN 81 MG 168,129 492,997 45,353
25 ASPIRIN LOW DOSE ASPIRIN 168,126 493,474 45,354
26 ASPIRIN ASPIRIN 168,125 492,967 45,350
27 ASPIRIN 325 MG ASPIRIN 168,125 492,967 45,350
28 ASPIRIN 81 MG ASPIRIN 168,125 492,967 45,350
29 ASPIRIN 81 MG LOW DOSE ASPIRIN 168,125 492,967 45,350
30 ASPIRINA CAPLETS ASPIRIN 168,114 493,016 45,348
31 BAYER GENUINE ASPIRIN ASPIRIN 168,105 493,125 45,339
32 ENTERIC ASPIRIN ASPIRIN 168,076 492,536 45,296
33 ENTERIC COATED ASPIRIN ASPIRIN 168,067 492,506 45,295
34 ENTERIC COATED ASPIRIN REGULAR STRENGTH ASPIRIN 168,067 492,506 45,295
35 CHILDRENS ASPIRIN ASPIRIN 168,065 492,454 45,288
36 BAYER ASPIRIN 168,059 492,478 45,281
37 ADULT LOW DOSE ASPIRIN ASPIRIN 168,050 492,352 45,284
38 GOOD SENSE ASPIRIN ASPIRIN 168,050 492,334 45,279
39 TRI-BUFFERED ASPIRIN ASPIRIN 168,050 492,311 45,277
40 COATED ASPIRIN ASPIRIN 168,049 492,400 45,279
41 CHEWABLE ASPIRIN ASPIRIN 168,048 492,332 45,279
42 CHEWABLE ASPIRIN LOW DOSE ASPIRIN 168,048 492,332 45,279
43 ASPIRIN LOW STRENGTH ASPIRIN 168,048 492,309 45,282
44 BUFFERED ASPIRIN ASPIRIN 168,047 492,356 45,276
45 CAREALL ASPIRIN ASPIRIN 168,047 492,309 45,276
46 ASPIRIN REGIMEN ASPIRIN 168,047 492,308 45,277
47 ASPIRIN PAIN RELIVER ASPIRIN 168,046 492,303 45,276
48 ST. JOSEPH LOW DOSE ASPIRIN ASPIRIN 168,045 492,307 45,277
49 LOW DOSE ASPIRIN 81MG ASPIRIN 168,045 492,305 45,276
50 EQUATE ASPIRIN CHEWABLE ASPIRIN 168,044 492,343 45,277

Key Takeaways

  • Serious reports include hospitalizations, life-threatening events, disabilities, and deaths.
  • Drugs treating serious conditions (cancer, autoimmune diseases) naturally accumulate more serious reports.
  • The ratio of serious to total reports varies significantly by drug class and patient population.

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.