Drug Safety Information for FIORICET W/ CODEINE (Acetaminophen; butalbital; caffeine; codeine phosphate)

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

Adverse Drug Reactions for FIORICET W/ CODEINE* (Acetaminophen; butalbital; caffeine; codeine phosphate)

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 FIORICET W/ CODEINE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug ineffective14
2Nausea*13
3Fatigue12
4Headache*12
5Migraine10
6Fall9
7Dyspnoea8
8Insomnia7
9Vomiting7
10Back pain7
11Product quality issue7
12Abdominal pain upper7
13Pain7
14Feeling abnormal7
15Malaise6
16Pain in extremity6
17Depression6
18Arthralgia6
19Dizziness*5
20Muscle spasms5

* This side effect also appears in "Top 10 Side Effects of FIORICET W/ CODEINE " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking FIORICET W/ CODEINE
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Migraine*95
2Headache*62
3Product used for unknown indication53
4Pain52
5Aneurysm6
6Head injury4
7Respiratory disorder3
8Analgesic therapy3
9Osteoarthritis1
10Tension headache1

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


Types of Adverse Events for FIORICET W/ CODEINE

Total Reports Filed with FDA: 726


Number of FDA Adverse Event Reports by Patient Age for FIORICET W/ CODEINE

Total Reports Filed with FDA: 726*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Acetaminophen; butalbital; caffeine; codeine phosphate (Fioricet w/ codeine)

Charts are based on 726 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 FIORICET W/ CODEINE 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.