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Fioricet

Fioricet Pregnancy and Breastfeeding Warnings

Fioricet is a combination medication that is used to treat complex tension headaches when other medications have not been effective.

Fioricet is a combination medication used to treat migraines or severe headaches. Learn the uses, effects and how to use Fioricet safely.

What is Fioricet?

Fioricet is the brand name multi-ingredient medication that’s used to treat some types of headaches. It’s also available in generic form.
Fioricet contains:

  • butalbital 50mg
  • acetaminophen 300mg
  • caffeine 40mg

It’s FDA-approved to treat symptoms of a common type of headache known as tension headache but is also prescribed off-label for migraine.

Butalbital APAP Caffeine is used to treat tension headaches. Acetaminophen helps to decrease the pain from the headache. Caffeine helps increase the effects of acetaminophen. Butalbital is a sedative that helps to decrease anxiety and cause sleepiness and relaxation.

Butalbital APAP Caffeine has following side effects: Bloated or “gassy” feeling, dizziness or lightheadedness (mild), drowsiness (mild), nausea, vomiting, or stomach pain (occurring without other symptoms of overdose), Bleeding or crusting sores on lips, chest pain, fever with or without chills, hive-like swellings (large) on eyelids, face, lips, and/or tongue, muscle cramps or pain

Butalbital APAP Caffeine can not be taken for a long time, your body may get used to it so that larger amounts are needed to produce the same effects. This is called tolerance to the medicine. Also, butalbital may become habit-forming (causing mental or physical dependence) when it is used for a long time or in large doses. Physical dependence may lead to withdrawal side effects when you stop taking the medicine. In patients who get headaches, the first symptom of withdrawal may be new (rebound) headaches.

Gabapentin Neurontin is a good medicine for Migraine Prevention.

Acetaminophen / butalbital / caffeine Pregnancy Warnings

Use is not recommended unless clearly needed

US FDA pregnancy category: C

Comment: Monitor for barbiturate withdrawal in neonates

Animal reproduction studies have not been conducted on this combination product.   Epidemiologic data for acetaminophen, including a population based case-control study from the National Birth Defects Prevention Study (n= 11,610) and data from 26,424 live singleton births have shown no increased risk of major birth defects in children with first trimester prenatal exposure.

In 2015, the US Food and Drug Administration released results of their evaluation on published research studies looking at mothers who took acetaminophen (either over the counter or as a prescription product) at any time during their pregnancy and the risk of attention deficit hyperactivity (ADHD) in their babies.

They found all studies reviewed had potential limitations in their designs that prevented drawing reliable conclusions. Barbiturates have been reported to readily cross the placental barrier. A 2-day old infant whose mother had taken a butalbital-containing product during the last two months of pregnancy experienced withdrawal seizures; butalbital was found in the infant’s serum. There are no controlled data in human pregnancy.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Acetaminophen / butalbital / caffeine Breastfeeding Warnings

Acetaminophen, butalbital, and caffeine are excreted into human milk in small concentrations. The significance of the effects on nursing infants has not been reported, but due to the potential for serious adverse reactions in nursing infants, other agents may be preferred.

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes (acetaminophen); Yes (barbiturates); Yes (caffeine)