Butalbital Acetaminophen Caffeine Risks, Warnings, and Complications

EXTREME DROWSINESS AND DIFFICULTY CONCENTRATING: Taking butalbital, acetaminophen, caffeine can lead to extreme drowsiness and an impaired ability to focus, think, and react. The risk of this happening is higher if you are on high doses, 65 years of age or older, or taking other medications that also cause sleepiness or affect your thinking. Avoid drinking alcohol while on this medicine because alcohol can make these side effects worse. Do not drive or do anything that requires your full concentration until you know how this medication affects you. Tell your doctor if you have severe dizziness or drowsiness on this medicine.

RISK OF MISUSE, DEPENDENCE, AND WITHDRAWAL: Butalbital is habit-forming and has the potential for misuse and abuse. Taking this medicine at higher doses, taking it more frequently, or taking it for longer than prescribed increases the risk of dependence. Accidental overdose of butalbital, acetaminophen, caffeine can be possibly fatal. Lowering the dose or stopping the medicine suddenly can cause withdrawal symptoms such as trouble sleeping, restlessness, shakiness, and seizures. To reduce your risk of these adverse effects, take butalbital, acetaminophen, caffeine exactly as prescribed. Tell your doctor if you have a history of substance use disorder (drug abuse). If you want to stop taking this medicine, talk to your healthcare professional about how to do so safely. Seek emergency medical help if you take too much of the medicine and have trouble breathing, drowsiness, dizziness, confusion, or loss of consciousness. 

MEDICATION OVERUSE HEADACHE: People who take over-the-counter pain medications such as acetaminophen, butalbital-containing medications, or combination medications containing caffeine on more than 10-15 days per month can develop medication overuse headaches or rebound headaches. Do not take butalbital, acetaminophen, caffeine more frequently than prescribed without your doctor’s approval. Call your doctor for advice if your headaches are not well controlled on the prescribed dosage of this medication.

LIVER DAMAGE: Taking more than 3,000-4,000 mg of acetaminophen in a day can lead to severe liver injury which may be life-threatening, resulting in the need for a liver transplant or even death. The risk of liver damage is higher in people who drink alcohol. Acetaminophen is present in many over-the-counter pain relievers and fever reducers. Check all your prescription and non-prescription medications to make sure you do not exceed the maximum daily dose. Tell your healthcare provider if you have a history of liver disease. Call your doctor without delay if you develop tiredness, stomach pain, yellowing of the skin or eyes, or dark urine, as these can be signs of liver injury.

UNUSUAL OR ALLERGIC REACTION: Rarely, acetaminophen can cause life-threatening skin reactions and allergic reactions. If you are allergic to acetaminophen, you should not take Fioricet or the generic combination of butalbital, acetaminophen, caffeine. Stop taking the medicine and get emergency medical help if you develop a skin rash, itching, hives, skin peeling or blistering, difficulty breathing, or swelling of the face, mouth, lips, or throat.