Acetaminophen, Aspirin, / Caffeine

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

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]
20,831
Total Reports
6,259
Serious Reports
303
Death Reports
30
Reported Reactions
Death Report Ratio: Moderate (1.45%)

Patient Demographics

Male
3,043
Female
11,024

Reported Adverse Reactions (30)

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

# Reaction Reports % of Total
1 DRUG INEFFECTIVE 4,004
15.9%
2 PRODUCT USE IN UNAPPROVED INDICATION 3,839
15.2%
3 DRUG EFFECTIVE FOR UNAPPROVED INDICATION 3,311
13.1%
4 HEADACHE 1,325
5.3%
5 NAUSEA 1,196
4.7%
6 FATIGUE 744
3.0%
7 DIZZINESS 678
2.7%
8 MIGRAINE 648
2.6%
9 PAIN 648
2.6%
10 VOMITING 582
2.3%
11 ABDOMINAL PAIN UPPER 559
2.2%
12 INCORRECT DOSE ADMINISTERED 522
2.1%
13 INSOMNIA 518
2.1%
14 OFF LABEL USE 504
2.0%
15 DIARRHOEA 494
2.0%
16 FEELING ABNORMAL 454
1.8%
17 MALAISE 452
1.8%
18 ABDOMINAL DISCOMFORT 451
1.8%
19 DYSPNOEA 449
1.8%
20 OVERDOSE 449
1.8%
21 THERAPEUTIC RESPONSE UNEXPECTED 447
1.8%
22 ANXIETY 404
1.6%
23 DRUG DEPENDENCE 340
1.3%
24 PRODUCT QUALITY ISSUE 340
1.3%
25 FALL 328
1.3%
26 ARTHRALGIA 318
1.3%
27 PRODUCT USE ISSUE 312
1.2%
28 DRUG INEFFECTIVE FOR UNAPPROVED INDICATION 299
1.2%
29 ASTHENIA 289
1.1%
30 PAIN IN EXTREMITY 283
1.1%

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.