"Jan. 13, 2011 - The FDA is warning about the dangers of acetaminophen in popular prescription pain drugs, but did it go far enough?
Acetaminophen, the active ingredient in Tylenol, is found in a wide range of over-the-counter and prescr"...
(butalbital, acetaminophen, and caffeine) Capsules, USP
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.
Fioricet is supplied in hard-gelatin capsule form for oral administration.
Each capsule contains the following active ingredients:
Butalbital, USP 50 mg
Acetaminophen, USP 300 mg
Caffeine, USP 40 mg
Inactive Ingredients: sodium lauryl sulfate, talc, microcrystalline cellulose, stearic acid, FD&C red #40, titanium dioxide, FD&C blue #1, FD&C yellow #6, gelatin.
Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate of molecular weight 224.26. It has the following structural formula:
Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant of molecular weight 194.19. It has the following structural formula:
What are the possible side effects of acetaminophen, butalbital, and caffeine?
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 any of these serious side effects:
- fast, pounding, or uneven heartbeat;
- feeling light-headed or short of breath;
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
- easy bruising or bleeding, unusual weakness, fever,...
What are the precautions when taking butalbital, acetaminophen and caffeine (Fioricet)?
See also Warning section.
Before taking this medication, tell your doctor or pharmacist if you are allergic to acetaminophen, caffeine, or butalbital; or to other barbiturates (such as phenobarbital) or xanthine derivatives (such as theophylline); 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.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: severe breathing problems (such as bronchopneumonia), a certain enzyme disorder (porphyria), liver disease, kidney disease, personal or family history of regular use/abuse of drugs/alcohol, mental/mood disorders, abdominal/stomach problems (such as stomach...
Last reviewed on RxList: 4/4/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Fioricet Information
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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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