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Ingredient in Tylenol possibly associated with child hyperactivity disorders

| Aug 19, 2016 | Defective Drugs

A study recently published by JAMA Pediatrics has provided evidence that acetaminophen, the active ingredient in Tylenol and other over the counter medications, could cause a pregnant mother’s offspring to have a hyperactivity disorder.

Details of the Study

The study titled “Association of Acetaminophen Use During Pregnancy With Behavioral Problems in Childhood” was written by Evie Stergiakouli, PhD.

The study collected data from the Avon Longitudinal Study of Parents and Children using a subject pool of 7,796 mothers who had been expected to deliver between 1991 and 1992. Of the total mothers observed in the study, 53 percent (4,415 patients) used acetaminophen at 18 weeks of pregnancy, and 42% (3,381 patients) used acetaminophen at 32 weeks of pregnancy. The test used to determine a child’s hyperactive disorder was the Strengths and Difficulties Questionnaire (SDQ), which recorded five domains of personality disorder symptoms that are:

  • Emotional Symptoms
  • Conduct Problems
  • Hyperactivity Symptoms
  • Peer Relationship Problems
  • Prosocial Behavior

The mothers of each child completed each SDQ on behalf of their children. The study adjusted for compounded factors like socioeconomic, genetic, consumption of other adverse substances (smoking, drinking, etc.) of the mother, maternal age at birth, and pregnancy body mass index (BMI) factors. The study used a 95 percent confidence interval and recorded postnatal and prenatal exposures.

Study Results

The study found that a total of five percent of children had behavioral problems as determined by the SDQ test. Mothers who used acetaminophen at 18 weeks of pregnancy had an offspring conduct problem risk ratio of 1.20 (meaning that their offspring was 1.20 times more likely to have conduct problems). Mothers who used acetaminophen at 18 weeks also had an offspring hyperactivity symptom risk ratio of 1.23. Mothers who used acetaminophen at 32 weeks of pregnancy had an offspring conduct problem risk ratio of 1.42 and a hyperactivity symptom risk ratio of 1.31.

The data presented by the study shows that the risk of a mother’s child having conduct and hyperactivity problems because of acetaminophen was only slightly more likely than a mother who did not use acetaminophen. Furthermore, this likelihood is in spite of the total five percent of children who showed signs of a behavioral disorder.


Acetaminophen is a common ingredient in many over the counter cold, flu, pain, and allergy drugs and has been considered to be safe for women to use in small doses when they are pregnant. Tylenol is particularly useful for women who are pregnant, as they are more susceptible to headaches and back pain but are very limited to medications that won’t affect their offspring. However, the data that was collected in this study, though the results are miniscule, should be taken note of for a possible factor in fetal development.

There may be other factors unaccounted for in the study that would affect the accuracy of the results. These variables could include the unrecorded dosage that each mother took of acetaminophen. Another variable that may have not been properly controlled is that behavioral problems were determined by mothers filling out a SDQ, instead of an evaluation by a psychiatric professional.

When it comes to behavioral disorders, there isn’t one underlying cause that has been discovered. Dr. Hal C. Lawrence, CEO of the American College of Obstetricians and Gynecologists states “Behavioral disorders are multifactorial and very difficult to associate with a singular cause. The brain does not stop developing until at least 15 months of age, which leaves room for children to be exposed to a number of factors that could potentially lead to behavioral issues,” according to CNN.

According to the US Food and Drug Administration (FDA) reports that 65-70 percent of US women use acetaminophen when they are pregnant. Many physicians, including Evie Stergiakouli (author of the study), agree that the benefits of reducing a pregnant woman’s fever and stress by using acetaminophen outweighs the risks of potential behavioral issues. If a mother is experiencing mild pain, but is concerned about the effects of acetaminophen on her offspring, she should consider using non-medication forms of pain relief such as a warm bath or a massage. The use of medications that would not normally affect the mother have been proven to have adverse affects on a pregnant mother’s child. To be certain of what would be safe to use when pregnant, mothers should consult their physician or pediatrician for guidance.