Acetaminophen, Guaifenesin, / Phenylephrine Hydrochloride

Common brands: Tylenol Cold Plus Head Congestion Severe, Tylenol Extra Strength, Tylenol Regular Strength, Vitamin D, Pain Relief

Top reporter: Kenvue Brands Llc

Expectorant [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]Corticosteroid [EPC]Provitamin D2 Compound [EPC]Benzodiazepine [EPC]
156,099
Total Reports
67,050
Serious Reports
11,868
Death Reports
30
Reported Reactions
Death Report Ratio: High (7.60%)

Patient Demographics

Male
42,754
Female
93,542

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Acetaminophen, Guaifenesin, / Phenylephrine Hydrochloride.

# Reaction Reports % of Total
1 DRUG INEFFECTIVE 17,035
7.0%
2 FATIGUE 16,384
6.8%
3 HEADACHE 13,234
5.5%
4 PAIN 13,081
5.4%
5 NAUSEA 12,885
5.3%
6 OFF LABEL USE 12,162
5.0%
7 DIARRHOEA 11,025
4.5%
8 ARTHRALGIA 10,211
4.2%
9 DYSPNOEA 9,985
4.1%
10 VOMITING 7,514
3.1%
11 PYREXIA 7,480
3.1%
12 RASH 7,474
3.1%
13 DIZZINESS 7,331
3.0%
14 ASTHENIA 7,328
3.0%
15 PRURITUS 6,633
2.7%
16 PAIN IN EXTREMITY 6,293
2.6%
17 MALAISE 6,112
2.5%
18 BACK PAIN 6,066
2.5%
19 COUGH 5,756
2.4%
20 PNEUMONIA 5,738
2.4%
21 FALL 5,737
2.4%
22 NASOPHARYNGITIS 5,691
2.3%
23 DEATH 5,633
2.3%
24 PERIPHERAL SWELLING 5,519
2.3%
25 WEIGHT DECREASED 5,518
2.3%
26 WEIGHT INCREASED 5,252
2.2%
27 JOINT SWELLING 5,134
2.1%
28 INSOMNIA 4,863
2.0%
29 INFUSION RELATED REACTION 4,792
2.0%
30 ANXIETY 4,566
1.9%

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.