The generic names of Fioricet are acetaminophen, caffeine and butalbital. This medicine contains a mixture of butalbital, caffeine and acetaminophen. Acetaminophen is best for giving a relief from pain and also reduces fever. Butalbital falls under the group of drugs known as barbiturates. This helps in relaxing the contractions of muscles caused due to the tension headache. The other ingredient, Caffeine is regarded as a stimulant for the central nervous system. It helps in relaxing the contraction of muscles in the blood vessels for improving the flow of blood.
How Fioricet works
- Fioricet is a combination pain-reliever (analgesic) containing acetaminophen, butalbital, and caffeine.
- Experts aren’t sure exactly how acetaminophen works, but suspect it blocks a specific type of cyclo-oxygenase (COX) enzyme, located mainly in the brain.
- Butalbital belongs to the class of medicines called barbiturates. When used for pain due to tension headaches experts believe it works by relaxing muscle contractions and causing sedation via an enhancement of the inhibitory effects of GABA (a neurotransmitter that regulates communication between brain cells).
- Caffeine is thought to enhance the pain-relieving effects of acetaminophen by up to 40%. In addition, it has vasoconstrictive properties, narrowing blood vessels in the brain thereby decreasing blood flow and oxygen tension (before a headache or a migraine, blood vessels tend to enlarge). This also helps to relieve pain.
- Fioricet belongs to the class of medicines known as barbiturates because it contains butalbital. It may also be called a combination analgesic.
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-salicylate analgesic andantipyretic. 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 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 may also be used for purposes not listed in this medication guide.
Important information about Fioricet
Do not use Fioricet if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.
Tell your doctor if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. Do not take more Fioricet than is recommended. An overdose of acetaminophen can damage your liver or cause death. 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.
Avoid drinking alcohol. It may increase your risk of liver damage while taking Fioricet due to the acetaminophen component.
Tips of Taking Fioricet
- Do not overuse Fioricet because you may become addicted to it and have difficulty stopping it.
- Over-use of Fioricet can also result in a medication-overuse headache (also known as a rebound headache) which occurs when analgesics are taken too frequently to relieve a headache.
- Never share your Fioricet with anybody else.
- May be administered without regards to food; although food may decrease any reported stomach upset.
- If you have been taking Fioricet regularly, or if you think you have become addicted to it, talk to your doctor about slowly withdrawing it, as sudden withdrawal may precipitate a withdrawal syndrome (symptoms include anxiety, dizziness, hallucinations, muscle twitching, nausea, seizures, sleeplessness, or tremor).
- Fioricet can cause sedation and affect your ability to drive or operate machinery.
- Do not drink more than two alcoholic drinks a day if you are a man or one alcoholic drink per day if you are women and taking Fioricet.
- Talk to your doctor if you have any side effects of concern. Seek urgent medical advice if you develop an allergic-type reaction (difficulty breathing or swallowing, rash, or facial swelling) soon after taking Fioricet.
- Not recommended for women who are pregnant or breastfeeding.
- Fioricet contains acetaminophen which may be “hidden” in other cough/cold medicines. The total dose of acetaminophen from any source should not exceed 4000mg per day (24 hours).
- Talk to your doctor or pharmacist before taking any other medications or natural products with Fioricet as it can interact with a large number of drugs.
Before taking Fioricet
Do not use Fioricet if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Tell your doctor if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. You should not take Fioricet if you are allergic to acetaminophen, butalbital, or caffeine, or if you have porphyria.
To make sure you can safely take Fioricet, tell your doctor if you have any of these other conditions:
- kidney disease,
- liver disease; or
- a history of mental illness or suicidal thoughts.
Butalbital may be habit forming and should be used only by the person it was prescribed for. Never share Fioricet with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.
FDA pregnancy category C. It is not known whether Fioricet will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Acetaminophen, butalbital, and caffeine can pass into breast milk and may harm a nursing baby. Do not use Fioricet without telling your doctor if you are breast-feeding a baby.
Fioriccet DOSAGE AND ADMINISTRATION
One or 2 tablets every 4 hours as needed. Total daily dosage should not exceed 6 tablets. Extended and repeated use of this product is not recommended because of the potential for physical dependence.
HOW Fioricet SUPPLIED
Fioricet® (Butalbital, Acetaminophen, and Caffeine Tablets USP)
Containing 50 mg butalbital, 325 mg acetaminophen, and 40 mg caffeine. Available as light-blue, speckled, round uncoated tablets, engraved “FIORICET (butalbital, acetaminophen and caffeine) ” on one side, and a three-head profile on other side. Bottles of 100 (NDC 52544-957-01) and 500 (NDC 52544-957-05).
Store below 30°C (86°F); dispense in a tight container.
Fioricet side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Fioricet: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using Fioricet 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, chills, body aches, flu symptoms.
Less serious Fioricet side effects may include:
- dizziness, confusion or lightheadedness;
- dry mouth;
- nausea, vomiting, stomach pain, loss of appetite;
- feeling anxious or jittery;
- drunk feeling; or
Animal reproduction studies have not been conducted on this combination product. Epidemiologic data for acetaminophen, including a population based case-control study from the National Birth Defects Prevention Study (n= 11,610) and data from 26,424 live singleton births have shown no increased risk of major birth defects in children with first trimester prenatal exposure.
In 2015, the US Food and Drug Administration released results of their evaluation on published research studies looking at mothers who took acetaminophen (either over the counter or as a prescription product) at any time during their pregnancy and the risk of attention deficit hyperactivity (ADHD) in their babies. They found all studies reviewed had potential limitations in their designs that prevented drawing reliable conclusions.
Barbiturates have been reported to readily cross the placental barrier. A 2-day old infant whose mother had taken a butalbital-containing product during the last two months of pregnancy experienced withdrawal seizures; butalbital was found in the infant’s serum. There are no controlled data in human pregnancy. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Fioricet?
Tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by butalbital.
Tell your doctor about all other medicines you use, especially:
- an antibiotic;
- a blood thinner such as warfarin (Coumadin, Jantoven);
- isoniazid (for treating tuberculosis);
- zidovudine (Retrovir, AZT);
- seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton);
- gout medications such as probenecid (Benemid) or sulfinpyrazone;
- steroids such as prednisone, fluticasone (Advair), mometasone (Asmanex, Nasonex), dexamethasone (Decadron, Hexadrol) and others; or
- an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Janimine, Tofranil), and others.
This list is not complete and other drugs may interact with Fioricet. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
I have suffered from severe, debilitating cervigenic migraines every few days, each lasting from 3 to 10 days. Little to no sleep at night. Tried it all; Cervical blocks, occipital blocks, facet injections, tramadol, amitriptylene, protriptylene,soma, halcion, skelaxin, flexeril, codiene, vicodin, physical therapy, deep tissue massage, bio feedback, surgery, etc. This is the only med that touchs them. It must be taken at the first hint of a migraine. In 15+ years I have never had an adiction problem.
Since I have suffered migraines since the age of 6, I have been through a huge amount of treatments and medications to try to help with my migraines. After several stays overnight at the hospital hooked up to IV’s being given the strong medication DHE(if anyone has ever gone through taking this I am sure you understand the horricfic experience I had with it), a few years ago I finally came into contact with a doctor who had enough sense to prescribe Fioricet for me…and ever since then it has been the number one thing to relieve my pain. I understand that doctors have to take precautions when prescribing this drug, but when there are only so many days supply there, and I have to make it last a month or so it can become hard at times, especially when I have the really really bad attacks…making sure that I have enough to relieve the migraine, and enough just incase I have another attack before I am able to get a refill…so that can be extemely frustrating at times! But, overall this has been the best thing I have found, and the list of meds I have been through consists of 3 long pages. Only being 22yrs old it can be scary having to deal with these consistant headaches, but I feel that as long as I am cautious with my use of this medication and use it as I am supposed to I will make it through, and those of you who suffer from migraines and feel the same, I strongly reccomend giving Fioricet a try.
this medication has helped me with my migrains. it is a good drug but only if you really need because it is a strong medication. this drug works so good for me that their are several days that go by that i do not have to take it and i like that beacause i hate getting migrains.