Drug Safety Information for EXCEDRIN (MIGRAINE) (Acetaminophen; aspirin; caffeine)

Safety-related Labeling Changes for EXCEDRIN (MIGRAINE) (ACETAMINOPHEN; ASPIRIN; CAFFEINE) Over-the-counter Drug: FDA Link

Adverse Drug Reactions for EXCEDRIN (MIGRAINE)* (Acetaminophen; aspirin; caffeine)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with EXCEDRIN (MIGRAINE)
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug ineffective719
2Nausea*336
3Headache*299
4Dizziness*226
5Pain201
6Vomiting191
7Abdominal pain upper*189
8Dyspnoea149
9Overdose148
10Insomnia*142
11Drug dependence138
12Underdose138
13Off label use129
14Feeling abnormal124
15Migraine123
16Medication error121
17Diarrhoea*119
18Fatigue105
19Malaise105
20Chest pain103

* This side effect also appears in "Top 10 Side Effects of EXCEDRIN (MIGRAINE) " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking EXCEDRIN (MIGRAINE)
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Headache*3164
2Migraine*2516
3Pain498
4Product used for unknown indication423
5Arthritis203
6Back pain146
7Sinus headache*124
8Arthralgia89
9Toothache*78
10Tension headache*70

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for EXCEDRIN (MIGRAINE)

Total Reports Filed with FDA: 14985


Number of FDA Adverse Event Reports by Patient Age for EXCEDRIN (MIGRAINE)

Total Reports Filed with FDA: 14985*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Acetaminophen; aspirin; caffeine (Excedrin (migraine), Arthriten, Headache formula, Medique pain off, Pain reliever plus, Headache relief, Bioelectro day, Conrx pain reliever, Pain aid esf, Vanquish, Extra pain relief, Pain stoppers extra, Sohmed pain reliever, Uricalm, Backaid, Migraine formula, Migraine relief)

Charts are based on 14985 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and EXCEDRIN (MIGRAINE) Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.