Fioricet capsules contain 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.
Extended and repeated use of Fioricet is not recommended because of the potential for physical dependence.
- 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.
Here are some practical, patient-friendly tips for safely taking Butalbital–Acetaminophen–Caffeine (Fioricet and similar brands):
How to Take It
- Follow your doctor’s instructions exactly.
- Usual dose: 1–2 tablets every 4–6 hours as needed.
- Do not exceed 6 tablets in 24 hours.
- Take with food or milk if it upsets your stomach.
- Hydrate well — caffeine can dehydrate you, and hydration helps with headaches.
⚠️ Safety Precautions
- Avoid alcohol completely.
- Alcohol + acetaminophen → liver damage risk.
- Alcohol + butalbital → severe sedation and breathing problems.
- Do not mix with other sedatives (opioids, sleep aids, benzodiazepines) unless approved by your doctor.
- Limit other acetaminophen sources.
- Check cold/flu or pain meds → many contain APAP.
- Stay under 4,000 mg acetaminophen/day (some doctors recommend ≤3,000 mg to be safe).
- Limit caffeine intake.
- Each tablet already has caffeine. Too much from coffee, tea, or energy drinks can cause jitteriness, insomnia, or palpitations.
- Do not drive or operate machinery until you know how it affects you (butalbital can cause drowsiness and slowed reflexes).
📅 Usage Tips
- Use only when needed. Not for daily use.
- Avoid overuse → taking it more than 2–3 days per week can lead to rebound headaches.
- Track your headache days and pill use — helps your doctor adjust treatment and prevent dependency.
👩⚕️ Special Populations
- Pregnant or breastfeeding women: Avoid unless specifically approved.
- Liver disease / heavy alcohol users: Increased risk of liver damage.
- Asthma, COPD, sleep apnea patients: Higher risk of breathing problems from butalbital.
🆘 When to Seek Help Immediately
- Signs of allergic reaction: rash, swelling, breathing trouble.
- Yellowing of skin/eyes, dark urine (possible liver damage).
- Severe drowsiness, confusion, slowed breathing (possible overdose).
- Headaches becoming more frequent or severe despite use (possible rebound headache).
📌 Quick Checklist for Safe Use
- Don’t exceed 6 tablets/day
- Don’t take more than 2–3 days/week
- No alcohol or other sedatives
- Count total daily acetaminophen (≤4,000 mg)
- Track your headache and pill use
- Call doctor if headaches worsen or become frequent
What side effects may I notice from receiving Butalbital APAP Caffeine?
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Redness, blistering, peeling, or loosening of the skin, including inside the mouth
Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):
- Dizziness
- Drowsiness
- Nausea
- Stomach pain
- Vomiting
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.