Fioricet is a tablet which contains three active ingredients, including 325 mg acetaminophen, 50 mg butalbital, and 40 mg caffeine. The drug was approved by the Food and Drug Administration in 1984.
But the FDA in 2011 advised drug manufacturers to limit acetaminophen to not more than 325 mg to prevent consumers from developing severe liver damage that was associated with too much acetaminophen.
Acetaminophen acts as a pain reliever and helps in reducing the patient’s fever. Butalbital, on the other hand, relaxes muscle contractions that develop in a tension headache. Similar to butalbital, caffeine, a widely used psychoactive drug, also helps patients to relax muscle contractions and improve blood flow.
The patients who used Fioricet reported varying effects. Some patients reportedly find it effective in managing migraine. A 50-year-old patient said she didn’t find any side effects whenever she used the drug at the onset of her migraine. She said the medicine works after about 20 minutes of taking Fioricet.
However, a 34-year-old patient found it “considerably effective” and noted some moderate side effects after taking the drug.
Butalbital, acetaminophen, caffeine, and codeine combination is used to relieve symptoms of tension (or muscle contraction) headaches. Extended and repeated use of this product is not recommended.
Butalbital belongs to the group of medicines called barbiturates. They act in the central nervous system (CNS) to produce their effects.
Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including serious liver damage. Although rare, use of acetaminophen has been reported to lead to liver transplantation and death, usually at high doses and when multiple acetaminophen-containing products have been used.
Caffeine is a CNS stimulant that is used with pain relievers to increase their effect. It has also been used for migraine headaches. Codeine belongs to the group of medicine called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.
When butalbital or codeine is used for a long time or in large doses, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics or barbiturates are used for this purpose. Physical dependence may lead to withdrawal side effects when you suddenly stop taking the medicine. In patients who get headaches, the first symptom of withdrawal may be new (rebound) headaches.
This medicine is available only under a restricted distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.
The patient took one to two tablets of Fioricet every four hours for the six months. She said each time she takes more than one pill since she finds the first dose ineffective in improving migraine, she will feel very dizzy and will be incapacitated until the effect has worn off. Some patients also reported having the feeling of agitation, insomnia, withdrawal syndrome and hallucination after taking Fioricet.
You should not use Fioricet if you have porphyria, or if you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications.
Do not use Fioricet if you have taken a MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.
Do not take more Fioricet than is recommended. An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).
In rare cases, acetaminophen may cause a severe skin reaction. Stop taking Fioricet and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.
Before taking this medicine
Do not use Fioricet 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 Fioricet if you are allergic to acetaminophen, butalbital, or caffeine, if you have porphyria, or if you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications.
To make sure Fioricet 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.
This medicine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.