Fioricet (Butalbital / Acetaminophen / Caffeine)

Overview

Fioricet is a prescription combination medication containing butalbital, acetaminophen (paracetamol), and caffeine. It is used for the relief of certain tension-type headaches.

Butalbital is a barbiturate that produces a sedative effect, acetaminophen provides pain relief, and caffeine can enhance the pain-relieving effects of acetaminophen.

Because butalbital can cause sedation, dependence, and misuse, Fioricet should be used only under the supervision of a qualified healthcare professional.

Uses

Fioricet may be prescribed for the relief of certain tension-type headaches when a healthcare professional determines that this combination is appropriate.

It is not generally intended to be used as a routine treatment for every type of headache.

Dosage and Administration

Take Fioricet exactly as prescribed.

The commonly marketed Fioricet tablet contains:

• Butalbital 50 mg
• Acetaminophen 300 mg
• Caffeine 40 mg

Formulations can vary, so always verify the ingredients and strength on the specific product label.

Do not take more than prescribed or use it more frequently in an attempt to obtain faster pain relief.

Because the medication contains acetaminophen, account for acetaminophen from all other medicines you take.

Common Side Effects

Possible side effects include:

• Drowsiness
• Dizziness
• Lightheadedness
• Nausea
• Vomiting
• Stomach discomfort
• Headache
• Nervousness or restlessness
• Difficulty sleeping

Butalbital can impair alertness and coordination. Avoid driving or operating machinery if you feel drowsy or impaired.

Serious Side Effects

Seek urgent medical attention for:

• Severe drowsiness or inability to wake
• Slow or difficult breathing
• Loss of consciousness
• Severe confusion
• Fainting
• Serious allergic reaction
• Seizures
• Symptoms of significant liver injury

Signs of possible liver injury can include severe nausea, persistent vomiting, unusual tiredness, abdominal pain, dark urine, or yellowing of the skin or eyes.

Acetaminophen Safety

Fioricet contains acetaminophen, so taking additional acetaminophen-containing medicines can unintentionally result in excessive total exposure.

Excessive acetaminophen can cause serious and potentially fatal liver damage.

Check the ingredients of other pain relievers, cold medicines, and fever medicines before taking them with Fioricet. Avoid excessive alcohol consumption because it can increase the risk of liver injury and other adverse effects.

Warnings and Precautions

Butalbital can cause misuse, abuse, physical dependence, and addiction.

Frequent use of Fioricet for headaches may also contribute to medication-overuse headaches, in which headaches become more frequent or persistent.

Tell your healthcare professional if you have liver disease, a history of substance-use disorder, breathing problems, or other significant medical conditions.

Drug Interactions

Tell your healthcare professional about all prescription medicines, over-the-counter medicines, supplements, and recreational substances you use.

Important interactions may include:

• Alcohol
• Opioid pain medicines
• Benzodiazepines
• Sleeping medicines
• Other sedatives
• Other acetaminophen-containing medicines
• Other medications that depress the central nervous system

Combining multiple sedating substances can increase the risk of excessive sedation and respiratory depression.

Pregnancy and Breastfeeding

Tell your healthcare professional if you are pregnant, planning to become pregnant, or breastfeeding.

The individual ingredients can affect pregnancy and breastfeeding differently, so a healthcare professional should determine whether Fioricet is appropriate.

Dependence and Withdrawal

Repeated use of butalbital can lead to physical dependence.

Stopping regular use suddenly may cause withdrawal symptoms, particularly after prolonged or frequent use. These can include anxiety, restlessness, tremors, nausea, insomnia, and, in severe cases, seizures.

Do not abruptly discontinue regular use without discussing it with a healthcare professional.

Overdose

An overdose can cause severe drowsiness, confusion, impaired coordination, loss of consciousness, respiratory depression, coma, or death.

Because Fioricet contains acetaminophen, overdose can also cause severe liver injury, which may initially have few symptoms.

If an overdose is suspected, seek emergency medical assistance or contact your local poison-control service immediately.

Storage and Disposal

Store Fioricet securely and out of reach of children and anyone for whom it was not prescribed.

Never share prescription headache medication. Dispose of unused medication according to local pharmacy or healthcare-authority recommendations.

Important Safety Information

Fioricet should be used only as prescribed. Do not combine it with alcohol, opioids, benzodiazepines, or other sedating medicines unless specifically directed by a healthcare professional.

Avoid taking additional acetaminophen-containing products without medical guidance.

If headaches become more frequent while using Fioricet, contact your healthcare professional because frequent use can contribute to medication-overuse headaches.

This information is for educational purposes only and does not replace the official prescribing information or advice from a qualified healthcare professional.