TYLENOL EXTRA STRENGTH

Generic: ACETAMINOPHEN

Manufacturer: Kenvue Brands Llc

Nonsteroidal Anti-inflammatory Drug [EPC]Expectorant [EPC]Corticosteroid [EPC]Benzodiazepine [EPC]Proton Pump Inhibitor [EPC]
399,311
Total Reports
210,285
Serious Reports
57,894
Death Reports
30
Reported Reactions
Death Report Ratio: High (14.50%)

Patient Demographics

Male
123,469
Female
227,676

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for TYLENOL EXTRA STRENGTH.

# Reaction Reports % of Total
1 FATIGUE 33,741
6.2%
2 DRUG INEFFECTIVE 32,810
6.0%
3 OFF LABEL USE 31,797
5.8%
4 NAUSEA 28,832
5.3%
5 HEADACHE 27,753
5.1%
6 PAIN 27,680
5.1%
7 DIARRHOEA 22,979
4.2%
8 DYSPNOEA 22,223
4.1%
9 ARTHRALGIA 21,769
4.0%
10 VOMITING 20,013
3.7%
11 PYREXIA 19,087
3.5%
12 RASH 17,180
3.1%
13 DIZZINESS 16,327
3.0%
14 ASTHENIA 15,510
2.8%
15 PNEUMONIA 15,459
2.8%
16 TOXICITY TO VARIOUS AGENTS 15,182
2.8%
17 MALAISE 15,111
2.8%
18 DEATH 14,554
2.7%
19 PRURITUS 13,866
2.5%
20 FALL 13,529
2.5%
21 INFUSION RELATED REACTION 13,221
2.4%
22 PAIN IN EXTREMITY 12,826
2.3%
23 CONDITION AGGRAVATED 12,730
2.3%
24 COUGH 12,658
2.3%
25 NASOPHARYNGITIS 12,291
2.2%
26 WEIGHT DECREASED 12,060
2.2%
27 WEIGHT INCREASED 11,505
2.1%
28 HYPERTENSION 11,399
2.1%
29 BACK PAIN 11,260
2.1%
30 JOINT SWELLING 11,208
2.1%

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.