Drug Safety Information for ESGIC-PLUS (Acetaminophen; butalbital; caffeine)

Safety-related Labeling Changes for FIORICET W/ CODEINE (ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE) Rx Drug: FDA Link

Adverse Drug Reactions for ESGIC-PLUS* (Acetaminophen; butalbital; 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 ESGIC-PLUS
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Headache*465
2Nausea*392
3Pain390
4Drug ineffective324
5Fatigue277
6Dizziness*245
7Migraine242
8Vomiting219
9Depression218
10Death213
11Dyspnoea208
12Diarrhoea205
13Anxiety204
14Back pain168
15Asthenia165
16Insomnia*162
17Arthralgia157
18Chest pain157
19Abdominal pain153
20Pain in extremity147

* This side effect also appears in "Top 10 Side Effects of ESGIC-PLUS " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking ESGIC-PLUS
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Migraine*3415
2Headache*2512
3Product used for unknown indication1589
4Pain724
5Tension headache*227
6Neck pain141
7Cluster headache94
8Multiple sclerosis82
9Therapeutic skin care topical79
10Foetal exposure during pregnancy56

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


Types of Adverse Events for ESGIC-PLUS

Total Reports Filed with FDA: 24138


Number of FDA Adverse Event Reports by Patient Age for ESGIC-PLUS

Total Reports Filed with FDA: 24138*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Acetaminophen; butalbital; caffeine (Anoquan, Margesic, Femcet, Medigesic plus, Alagesic, Orbivan, Zebutal, Triad, Dolgic plus, Capacet, Esgic, Fioricet, Esgic-plus)

Charts are based on 24138 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 ESGIC-PLUS Reviews and Review Summary .

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.

Visit   DrugInformer.com more on ESGIC-PLUS's side effects.