Is It Safe to Take Fioricet While Pregnant?

If you’re pregnant, it may be difficult to keep track of the different drugs you should avoid. Trying to understand the complexities of these substances and what they can do to your body or unborn child can induce stress.Luckily, the Food and Drug Administration made this process easier by categorizing drugs based on their risk to pregnancies. These categories are labeled A, B, C, D, and X. Category A includes drugs that are safe to take during pregnancy, while Category X contains substances that should never be taken while pregnant.

  • Category A
    • Research indicates that these drugs show no evidence of risk to the fetus throughout a pregnancy. Many multivitamins taken during pregnancy fit into this category.
  • Category B
    • If a clinical need must be met, substances in this category are considered safe to take during pregnancy. These drugs include acetaminophen, found in Tylenol, and amoxicillin.
  • Category C
    • These substances can be risky to take during pregnancy. If these drugs are given to pregnant women, the potential benefits should outweigh the potential risks. Category C drugs include aspirin, saccharine and gentamicin.
  • Category D
    • Studies show that these substances could harm the fetus. Despite these health risks, some pregnant women still take these drugs, which include tetracyclines and ACE inhibitors, for the potential benefits.
  • Category X
    • Because these drugs demonstrate clear risks to the fetus, they are contraindicated in women who are or could become pregnant. Category X substances include Lipitor and oral contraceptives.

Fioricet 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.