Fioricet contains a combination of acetaminophen, butalbital, and caffeine. Acetaminophen is a pain reliever and fever reducer.
Butalbital is in a group of drugs called barbiturates. It relaxes muscle contractions involved in a tension headache.
Caffeine is a central nervous system stimulant. It relaxes muscle contractions in blood vessels to improve blood flow.
Fioricet is used to treat tension headaches that are caused by muscle contractions.
Fioricet® (Butalbital, Acetaminophen, and Caffeine Tablets USP) is supplied in tablet form for oral administration.
Each tablet contains the following active ingredients:
butalbital USP . . . . . . . . . . . .50 mg
acetaminophen USP . . . . . . 325 mg
caffeine USP . . . . . . . . . . . . .40 mg
Inactive Ingredients: crospovidone, FD&C Blue #1, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid.
Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate. It has the following structural formula:
 |
C11H16N2O3 Mol. wt. 224.26
Acetaminophen (4´-hydroxyacetanilide), is a non-opiate, non-salicylateanalgesic and antipyretic. It has the following structural formula:
 |
C8H9NO2 Mol. wt. 151.17
Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant. It has the following structural formula:
 |
C8H10N4O2 Mol. wt. 194.19
Fioricet can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.
Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.
While you are taking Fioricet, avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor’s advice.
Fioricet (butalbital, acetaminophen and caffeine) ® (Butalbital,Acetaminophen, and Caffeine Tablets USP) is indicated for the relief of the symptom complex of tension (or muscle contraction) headache.
Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.
Why is Fioricet used to treat migraine?
Fioricet is an older medication that used to frequently be prescribed to treat migraine symptoms. However, there is not enough evidence that shows it’s effective for migraine attacks, especially when compared to safer products.
Although Fioricet has been used for many years for migraine, it’s not approved for this use, and there are greater risks than benefits with this medication.
Fioricet may be an option if other migraine treatment options have not worked. Your doctor will just want to monitor you closely to avoid side effects.
It’s prescribed to help relieve immediate headache symptoms, but not to prevent migraine attacks.
How does Fioricet work?
The acetaminophen in Fioricet is a pain reliever, the caffeine works as a stimulant to increase the acetaminophen’s effectiveness, and the butalbital is a sedative that decreases anxiety while causing relaxation and sleepiness. These actions are believed to ease migraine symptoms, but there is limited evidence that barbituates ease migraine symptoms.
What are the possible side effects of Fioricet?
The most common side effects from Fioricet include:
- Drowsiness
- Upset stomach
- Vomiting
- Stomach pain
- Depression
- Lightheadedness
- Confusion
The following side effects could be signs of allergy or more serious complications and should be reported to health provider immediately:
- Skin rash
- Itching
- Difficulty breathing
This is not an exhaustive list of all potential side effects of Fioricet. For more information, consult your doctor or healthcare provider. Patients should talk to their doctor about what to expect with treatment with Fioricet. If you notice any new or worsening side effects, contact your doctor or healthcare provider immediately.
Things to note about Fioricet
Fioricet can be habit-forming, so you should use extreme caution if you decide to take it. Additionally, some people who take barbituates or opioids for extended periods can experience rebound headaches, which can increase in severity. These are also known as MOH, or medication overuse headaches.1
Barbituates can cause drowsiness, and their effect can be increased by alcohol use. It is important not to drive or use heavy machinery until you know how this drug affects you.2
Before taking Fioricet, tell your doctor if you:
- Are allergic to any ingredients in the medication
- Are taking blood thinners, antidepressants, antihistamines, or other sedatives like sleeping pills or tranquilizers.
- Are taking pain medications. Many over-the-counter pain relievers contain acetaminophen, and too much of this drug can be harmful.
- Have ever had liver disease, porphyria, or depression
- Are pregnant, plan to become pregnant, or are breastfeeding2
You should begin no medication or supplement without first checking with your health care provider and should let them know of any other prescriptions, OTCs, and herbals you are taking to ensure there are no interactions.
What is the most important information I should know about Fioricet (Acetaminophen, Butalbital, And Caffeine)?
Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.
You should not use acetaminophen, butalbital, and caffeine if you are allergic to it, if you have porphyria, or if you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications.
To make sure acetaminophen, butalbital, and caffeine is safe for you, tell your doctor if you have:
- liver disease, cirrhosis, a history of alcoholism or drug addiction, or if you drink more than 3 alcoholic beverages per day;
- kidney disease;
- asthma, sleep apnea, or other breathing disorder;
- stomach ulcer or bleeding;
- a history of skin rash caused by any medication;
- a history of mental illness or suicidal thoughts; or
- if you use medicine to prevent blood clots.
It is not known whether this medicine will harm an unborn baby. If you use butalbital while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.
This medicine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
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