Acetaminophen, Aspirin (Nsaid) / Caffeine

Common brands: Excedrin Migraine, Excedrin Rapid Relief, Excedrin Tension Headache, Excedrin Extra Strength Headache, Excedrin Extra Strength Geltabs

Top reporter: Haleon Us Holdings Llc

Central Nervous System Stimulant [EPC]Methylxanthine [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]Platelet Aggregation Inhibitor [EPC]Provitamin D2 Compound [EPC]
16,792
Total Reports
3,613
Serious Reports
220
Death Reports
30
Reported Reactions
Death Report Ratio: Moderate (1.31%)

Patient Demographics

Male
2,534
Female
9,473

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Acetaminophen, Aspirin (Nsaid) / Caffeine.

# Reaction Reports % of Total
1 DRUG INEFFECTIVE 3,792
19.7%
2 PRODUCT USE IN UNAPPROVED INDICATION 2,042
10.6%
3 DRUG EFFECTIVE FOR UNAPPROVED INDICATION 1,569
8.1%
4 HEADACHE 1,126
5.8%
5 NAUSEA 1,034
5.4%
6 FATIGUE 622
3.2%
7 DIZZINESS 594
3.1%
8 MIGRAINE 591
3.1%
9 PAIN 533
2.8%
10 VOMITING 520
2.7%
11 ABDOMINAL PAIN UPPER 498
2.6%
12 INSOMNIA 439
2.3%
13 OVERDOSE 413
2.1%
14 INCORRECT DOSE ADMINISTERED 406
2.1%
15 DIARRHOEA 404
2.1%
16 MALAISE 386
2.0%
17 FEELING ABNORMAL 383
2.0%
18 OFF LABEL USE 371
1.9%
19 ABDOMINAL DISCOMFORT 369
1.9%
20 ANXIETY 356
1.8%
21 DYSPNOEA 356
1.8%
22 THERAPEUTIC RESPONSE UNEXPECTED 333
1.7%
23 PRODUCT QUALITY ISSUE 315
1.6%
24 DRUG DEPENDENCE 297
1.5%
25 PRODUCT USE ISSUE 272
1.4%
26 FALL 260
1.3%
27 ARTHRALGIA 259
1.3%
28 DRUG INEFFECTIVE FOR UNAPPROVED INDICATION 255
1.3%
29 WRONG TECHNIQUE IN PRODUCT USAGE PROCESS 254
1.3%
30 ASTHENIA 247
1.3%

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.