TYLENOL 8HR

Generic: ACETAMINOPHEN

Manufacturer: Kenvue Brands Llc

Nonsteroidal Anti-inflammatory Drug [EPC]Corticosteroid [EPC]Benzodiazepine [EPC]Proton Pump Inhibitor [EPC]Vitamin C [EPC]
241,606
Total Reports
148,181
Serious Reports
46,985
Death Reports
30
Reported Reactions
Death Report Ratio: High (19.45%)

Patient Demographics

Male
79,493
Female
132,064

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for TYLENOL 8HR.

# Reaction Reports % of Total
1 OFF LABEL USE 21,783
6.0%
2 FATIGUE 20,067
5.6%
3 DRUG INEFFECTIVE 17,985
5.0%
4 PAIN 17,837
4.9%
5 NAUSEA 17,243
4.8%
6 HEADACHE 16,374
4.5%
7 TOXICITY TO VARIOUS AGENTS 14,619
4.0%
8 DYSPNOEA 14,226
3.9%
9 ARTHRALGIA 14,154
3.9%
10 PYREXIA 13,973
3.9%
11 VOMITING 13,661
3.8%
12 DIARRHOEA 13,128
3.6%
13 RASH 12,217
3.4%
14 INFUSION RELATED REACTION 10,770
3.0%
15 PNEUMONIA 10,731
3.0%
16 MALAISE 10,017
2.8%
17 CONDITION AGGRAVATED 9,544
2.6%
18 DIZZINESS 9,451
2.6%
19 ASTHENIA 9,409
2.6%
20 PRURITUS 9,337
2.6%
21 DEATH 8,990
2.5%
22 NASOPHARYNGITIS 8,978
2.5%
23 JOINT SWELLING 8,798
2.4%
24 RHEUMATOID ARTHRITIS 8,719
2.4%
25 WEIGHT INCREASED 8,477
2.3%
26 SINUSITIS 8,301
2.3%
27 FALL 8,237
2.3%
28 HYPERTENSION 8,223
2.3%
29 HYPERSENSITIVITY 8,068
2.2%
30 COMPLETED SUICIDE 7,993
2.2%

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. Always consult your doctor or pharmacist before making medication decisions.