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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.

Butalbital, acetaminophen and caffeine are supplied in capsule form for oral administration.

Each capsule contains:

Butalbital ……………….. 50 mg

Warning: May be habit-forming.

Acetaminophen ………. 325 mg

Caffeine …………………. 40 mg

In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose with capsule shell composed of gelatin (silicon dioxide and sodium lauryl sulfate added as manufacturing aides to the gelatin) and titanium dioxide. Impriting ink composed of n-butyl alcohol, pharmaceutical glaze modified in SD-45, propylene glycol, SDA-3A alcohol, titanium dioxide, D&C Yellow No. 10 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake.

Fioricet is used to treat tension headaches that are caused by muscle contractions.Acetaminophen/butalbital is indicated for the treatment of tension headaches. It is also commonly prescribed for migraines, although it is not approved by the FDA for this. The usual adult dose is one to two tablets every four hours as needed, not to exceed six tablets in a twenty-four-hour period

The combination was approved for medical use in the United States in 1984. It is available as a generic medication. In the United States the wholesale cost is about 1.20 USD per dose as of 2019. In 2016 it was the 202nd most prescribed medication in the United States with more than 2 million prescriptions. In the United States it is a schedule III controlled substance in some states but not federally. It is banned in a number of European countries.

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.

It is not known whether Fioricet 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.

WARNINGS

Butalbital is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.

Hepatotoxicity

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. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products.

The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.

Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well.

Serious Skin Reactions

Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Hypersensitivity/anaphylaxis

There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue Esgic® Capsules immediately and seek medical care if they experience these symptoms. Do not prescribe Esgic® Capsules for patients with acetaminophen allergy.

How should I take Fioricet?

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Take Fioricet exactly as prescribed. Follow all directions on your prescription label. Do not take more of this medication than recommended. An overdose can damage your liver or cause death. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Butalbital may be habit-forming. 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. Selling or giving away Fioricet is against the law.

Take Fioricet with food or milk if it upsets your stomach.

Store Fioricet at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Butalbital is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Fioricet side effects

Get emergency medical help if you have signs of an allergic reaction to Fioricet: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

Stop using this medicine and call your doctor at once if you have:

  • confusion, seizure (convulsions);
  • shortness of breath;
  • a light-headed feeling, like you might pass out; or
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
  • drowsiness, dizziness;
  • feeling anxious or restless;
  • drunk feeling; or
  • sleep problems (insomnia).

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.

Fioricet Mechanism of action

Fioricet Mechanism of action
Fioricet Mechanism of action

Butalbital exerts a generalized depressant effect on the central nervous system and, in very high doses, has peripheral effects. Acetaminophen has analgesic and antipyretic effects mediated by a metabolite that acts at cannabinoid receptors. Caffeine is thought to produce constriction of cerebral blood vessels and serves to counteract the sedative effect of butalbital.

Butalbital has a half-life of about 35 hours. Acetaminophen has a half-life of about 1.25 to 3 hours, but may be increased by liver damage and after an overdose. Caffeine has a half-life of about 2.5 to 4.5 hours.

What should I avoid while taking Fioricet?

This medication 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 this medication, avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor’s advice.

Does Fioricet Work for Migraine Headaches?

Fioricet has been around forever and is used by many for the treatment of chronic migraine or tension headaches. It is a mixture of a barbiturate, Tylenol (acetaminophen) and caffeine.

Now, many formularies are no longer covering Fioricet capsules. For those of you who have relied on it for years, this (understandably) may make you nervous.

Well, it turns out it doesn’t really work that well—and there are much better options out there.

  • Fioricet and Fioricet with Codeine are not as effective for acute migraine as newer medications. There isn’t any evidence that shows that barbiturate-containing meds (the butalbital in Fioricet) help for migraine treatment. In fact, the use of Fioricet with Codeine often results in chronic migraine and a “medication overuse headache.”
  • NSAIDS. Start with these instead. There is good evidence that nonsteroidal anti-inflammatory drugs—ibuprofen, naproxen, and others—work well for the treatment of acute migraine.
  • Triptans. Imitrex (sumatriptan), Maxalt (rizatriptan), Relpax(eletriptan), and Frova (frovatriptan) are examples. Used alone or in combination with an NSAID, triptans work well for moderate to severe headaches that aren’t relieved by NSAIDs alone. Wondering which to choose? They generally work the same but you may notice fewer side effects with one over the other. Cost can also be an issue so you’ll want to pick a triptan that is covered by your insurance plan. It’s also a good idea to check GoodRx to see if the cash or discount price beats your co-pay.
  • Adding a nausea medication. For folks with moderate to severe migraine accompanied by nausea or vomiting, adding Reglan(metoclopramide) , Zofran (ondansetron) or Compazine(prochlorperazine) also helps.

 

Tension Headaches –

The most common type of headache disorder, a tension headache occurs when neck and scalp muscles become tense, or contract, meaning they squeeze down. This causes pain, often described as a rubber-band-around-the-head feeling or a pressure sensation, on both sides of the head.

Tension headaches can be triggered by a number of factors including stress, hunger, lack of sleep, anxiety, and temperature changes. They may occur at any age but are most common in adults and older teens. Some people are more prone or vulnerable to developing tension headaches than others, although the reason behind this is not very clear.

The good news is that most tension headaches are mild in pain and can be easily alleviated with rest, fluids, removal of the trigger, and/or an over-the-counter medication like Motrin (ibuprofen) or Tylenol (acetaminophen). Behavioral therapies too can be effective like physical therapy or cognitive-behavioral therapy.

Butalbital

When recurring tension headaches do not respond to other treatments, your doctor may prescribe Fiorinal or Fioricet. Codeine may also be added to this combination of medicine. While this medication is very effective in the short-term, there are some things to watch out for.
Butalbital is a barbiturate, which means that it helps to slow down the central nervous system and relax the muscle tension believed to be associated with tension headaches.
Before taking medication containing butalbital, tell your doctor if you:
  • are allergic to any ingredients in the medication, such as acetaminophen or aspirin.
  • are currently taking blood thinners, antidepressants, antihistamines, or other sedatives such as sleeping pills or tranquilizers
  • have or previously had liver disease, porphyria, or depression
  • are pregnant, plan to become pregnant, or are currently breastfeeding

Fioricet Withdrawal

When taking butalbital, you may experience withdrawal symptoms 8 to 36 hours after the last dose. Withdrawal symptoms may include anxiety, muscle twitching, tremor, weakness, dizziness, nausea and vomiting, insomnia, weight loss, and even seizures when the medication is discontinued.

Due to the risk of seizures with a withdrawal from butalbital, medical treatment in a monitored setting under the care of a physician is indicated.

Fioricet Tolerance and Addiction

Tolerance and addiction may also occur with butalbital. Tolerance means that a person needs more of the medication to achieve headache relief. Addiction to butalbital is characterized by persistent behaviors, like compulsions, to take a butalbital-containing medication.

These behaviors impair their life in some way, negatively impacting relationships and/or everyday functioning.

Acetaminophen Overdose

Do not take Fioricet along with other medications that contain acetaminophen as it can be toxic to the liver.