INFANTS TYLENOL

Generic: ACETAMINOPHEN

Manufacturer: Kenvue Brands Llc

Nonsteroidal Anti-inflammatory Drug [EPC]Corticosteroid [EPC]Benzodiazepine [EPC]Proton Pump Inhibitor [EPC]Vitamin C [EPC]
240,160
Total Reports
147,183
Serious Reports
46,907
Death Reports
30
Reported Reactions
Death Report Ratio: High (19.53%)

Patient Demographics

Male
79,264
Female
131,100

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for INFANTS TYLENOL.

# Reaction Reports % of Total
1 OFF LABEL USE 21,730
6.0%
2 FATIGUE 19,929
5.5%
3 DRUG INEFFECTIVE 17,816
5.0%
4 PAIN 17,732
4.9%
5 NAUSEA 17,124
4.8%
6 HEADACHE 16,278
4.5%
7 TOXICITY TO VARIOUS AGENTS 14,611
4.1%
8 DYSPNOEA 14,180
3.9%
9 ARTHRALGIA 14,075
3.9%
10 PYREXIA 13,962
3.9%
11 VOMITING 13,659
3.8%
12 DIARRHOEA 13,046
3.6%
13 RASH 12,173
3.4%
14 INFUSION RELATED REACTION 10,763
3.0%
15 PNEUMONIA 10,707
3.0%
16 MALAISE 9,985
2.8%
17 CONDITION AGGRAVATED 9,504
2.6%
18 DIZZINESS 9,377
2.6%
19 ASTHENIA 9,361
2.6%
20 PRURITUS 9,279
2.6%
21 NASOPHARYNGITIS 8,950
2.5%
22 DEATH 8,935
2.5%
23 JOINT SWELLING 8,783
2.4%
24 RHEUMATOID ARTHRITIS 8,704
2.4%
25 WEIGHT INCREASED 8,448
2.3%
26 SINUSITIS 8,283
2.3%
27 HYPERTENSION 8,204
2.3%
28 FALL 8,189
2.3%
29 HYPERSENSITIVITY 8,056
2.2%
30 COMPLETED SUICIDE 7,992
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.