Fioricet with Codeine
FDA: 2 More NECC Drugs Contaminated »
"Nov. 1, 2012 -- Two more drugs made by the New England Compounding Center (NECC) are crawling with various kinds of bacteria, FDA tests reveal.
The NECC is the Massachusetts compounding pharmacy whose drugs are the likely source of th"...
Fioricet with Codeine
Fioricet® with Codeine
(butalbital, acetaminophen, caffeine, and codeine phosphate) Capsules
Hepatotoxicity
Fioricet with Codeine contains butalbital, acetaminophen, caffeine, and codeine phosphate. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day and often involve more than one acetaminophen containing product.
DRUG DESCRIPTION
Fioricet with Codeine (Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate) is supplied in capsule form for oral administration.
Each capsule contains the following active ingredients:
butalbital, USP........................50 mg
acetaminophen, USP............325 mg
caffeine, USP..........................40 mg
codeine phosphate, USP.........30 mg
Butalbital (5-allyl-5-isobutylbarbituric acid) is a short- to intermediate-acting barbiturate. It has the following structural formula:
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C11H16N2O3 molecular weight 224.26
Acetaminophen (4'-hydroxyacetanilide) is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:
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C8H9NO2 molecular weight 151.16
Caffeine (1,3,7-trimethylxanthine) is a central nervous system stimulant. It has the following structural formula:
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C8H10N4O2 molecular weight 194.19
Codeine phosphate (7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate) is a narcotic analgesic and antitussive. It has the following structural formula:
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C18H24NO7P anhydrous molecular weight 397.37
Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, pregelatinized starch. Gelatin capsules contain black iron oxide, D&C Red No. 33, FD&C Blue No. 1, gelatin, red iron oxide, and titanium dioxide. The capsules are printed with edible inks containing D&C Red No. 7 Calcium Lake, FD&C Blue No. 1 Aluminum Lake, and titanium dioxide.
What are the possible side effects of acetaminophen, butalbital, caffeine, and codeine (Fioricet with Codeine, Phrenilin with Caffeine and Codeine)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using this medication and call your doctor at once if you have a serious side effect such as:
- shallow breathing, slow heart rate;
- fast or pounding heart rate, feeling short of breath;
- confusion, unusual thoughts or behavior, feeling light-headed, fainting;
- muscle twitching;
- easy bruising...
Read All Potential Side Effects and See Pictures of Fioricet with Codeine »
What are the precautions when taking butalbital, acetaminophen, caffeine and codeine phosphate capsule (Fioricet with Codeine)?
See also Warning section.
Before taking this medication, tell your doctor or pharmacist if you are allergic to acetaminophen, caffeine, codeine, or butalbital; or to other barbiturates (e.g., phenobarbital), xanthine derivatives (e.g., theophylline) or narcotic pain medications (e.g., morphine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe breathing problems (e.g., respiratory depression, hypercarbia, bronchopneumonia), infectious diarrhea, a certain enzyme disorder (porphyria),...
Last reviewed on RxList: 8/8/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Fioricet with Codeine Information
Fioricet with Codeine - User Reviews
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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