Pregnancy

Tylenol In Pregnancy: Is It Safe Or Not?

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tylenol pregnancy

 

Is Tylenol Safe To Take During Pregnancy?

The evidence that suggests risks to Tylenol focuses largely on more extensive exposure — say, taking it for more than 28 days during pregnancy,” Emily Oster explained. (1)*

There is no credible evidence, even correlational, to suggest that taking it occasionally for a fever or headache would be an issue.” (1)

In short, Tylenol (acetaminophen) can be safe to take for pregnancy. It might even be more dangerous to abstain from treating fever and pain for fear that medication can harm your baby. (1)(2)

*Emily Oster is a ​​Brown University economics professor, health economics researcher, New York Times best-selling author (for books such as “Expecting Better”), and CEO of Parent Data. 

So, why is Tylenol controversial, and why are many pregnant ladies worried about taking it? Are the other OTC (over-the-counter) pain relief medications safer?

What are the risks of your baby developing autism and other neurobehavioral problems with Tylenol use? Which Tylenol product can you use, and how much of this OTC medication is okay to take during pregnancy? Can you take it anytime? 

Is it better to stay unmedicated to ensure your baby is safe from possible Tylenol risks? What do the experts say?

As parents ourselves, we understand how you feel about a drug that many people are calling unsafe. So, we researched all the angles to help you make a more informed choice for your safety and peace of mind.

We’ve also checked the possible safety issues of other OTC pain relief meds and what you can do if you accidentally took them while you’re pregnant.

Continue reading to learn more.

 

What’s The Difference Between Acetaminophen & Paracetamol?

None. Acetaminophen and paracetamol are the different generic names for a chemical substance formally called para-acetylaminophenol. In the US, these names are also used synonymously with Tylenol.

 

Research Controversy 

What The Study Found

A 2018 American Journal of Epidemiology meta-analysis of cohort studies (a study that monitors test subjects over a period of time, usually in years) and clinical trials showed that acetaminophen use during pregnancy can increase the risks of the following: (2)

  • ASD (autism spectrum disorder) by 20%
  • ADHD (attention-deficit/hyperactivity disorder) by 30%

 

Not surprisingly, this caused panic and concern among pregnant moms and women trying to conceive. 

Anticipating this, the researchers added the following statement in their study: (2)

Considering the significant limitations inherent in the available research, we believe care should be taken to avoid overstating the significance of the results of our analysis, because this could promote unnecessary anxiety among pregnant women.

They also explained that they didn’t couldn’t establish a direct link between acetaminophen use and neurodevelopmental disorders. However, they also called for a “careful inspection” of patient leaflets and health policies at the time because of the widespread, usually unsupervised use of OTC medication. (2)

Yet experts also questioned the study, pointing out certain limitations that might have affected the outcome and conclusions. (3)

Let’s discuss them below.

 

Study Limitations & Concerns

Limited Scope: Reasons For Acetaminophen Use Were Not Checked

The 2018 study focused on Tylenol use and its effects on the pregnant subjects’ children. However, the underlying reason for their medication use wasn’t considered. (2)

Let’s remember that those who take Tylenol do it to treat a headache, fever, or some other body pain – and these are common signs and symptoms of an infection or underlying medical condition. (2)(3)

So, the underlying condition or infection may have caused these developmental or neurological problems, not the use of acetaminophen.

The duration of the test subjects’ acetaminophen use ranged from four to 28+ days. Experts are also concerned that the prolonged drug exposure meant the underlying condition was more difficult to treat, and could be the true risk factor. (2)(3)

The authors also clarified that they were unable to check whether the study subjects used acetaminophen by itself or in combination with another form of medication. (2)

 

Direct Links For Neurobehavioral Disorders Aren’t Confirmed

Let’s also understand that the study was conducted as a review of other studies or trials involving pregnant women and acetaminophen. However, none of these studies ever confirmed a direct link between acetaminophen use and neurological disorders. (2)(3)

 

Recent Research Challenges The Old Study Results

The stats from the 2018 study might have been high at 20% for ASD and 30% for ADHD. Yet these have since been challenged by a 2024 JAMA Network (Journal of the American Medical Association) study using sibling control analysis. (3)(4)

The recently published study collected data from siblings, with one exposed to acetaminophen versus one without. The siblings were born from the same mother to keep this aspect consistent and constant. (3)(4)

Oster explains that by keeping the mom as a constant, the study was able to adjust for all of her characteristics, including ones that can’t be measured in research. That means the study can show that the results aren’t just a correlation between random test subjects. (3)

This 2024 study checked data from all the test subjects using “naive analysis” (the siblings aren’t compared with each other, but their data are analyzed with all the others). Like the previous study, the researchers also found a “modest increase” in neurobehavioral risks for the children exposed to the drug. (3)(4)

However, when using sibling control, the 2024 research showed that acetaminophen use during pregnancy doesn’t increase a baby’s risks for ADHD, autism, or intellectual disability. (3)(4)

 

Studies Used Moms’ Self-Reporting & Impressions To Collect Data

According to the researchers, data on acetaminophen use was collected from the test subjects using the following methods: (2)

  • Prospective interviews
  • Telephone interviews
  • Prenatal and postnatal questionnaires
  • Self-report of medication and dose (5 months of gestation)
  • Questionnaires (18 and 32 weeks of gestation)
  • Interview (soon after birth)

 

Sometimes, patient recall might be unreliable compared to clinical testing. After all, as tired and busy moms, it can be easy to forget the frequency and duration of Tylenol use.

 

Increased Risks Leaned Towards Older Moms

The 2018 study also found that increased maternal age might also increase the risks for babies’ neurological disorders. (2)

This is backed up by other studies that showed a higher risk for autism in babies whose moms were older than 35 years old (considered a geriatric pregnancy). Older maternal age is also associated with higher risks of other medical conditions, including genetic disorders. (4)(5)

So, the higher autism risks in the study may have been due to the mother’s more advanced years and not directly from Tylenol use. 

 

Actual Risks For Dangerous Effects Might Be Low

The results of the 2024 study mentioned above (the one that used sibling analysis) showed that the risks for the dangerous effects of Tylenol use might be low. (3)(4)

 

Other Researchers Release Consensus Statement To Warn About Acetaminophen Use

A group of Nature Reviews Endocrinology researchers (Ann Z. Bauer et al.) published a Consensus Statement calling for precautionary action against acetaminophen. (6)

They cited studies that show evidence of the drug’s possible risks for altered fetal development when used during pregnancy, leading to: (6)

  • Neurodevelopmental disorders (e.g., ASD and ADHD)
  • Reproductive and urogenital disorders

 

They acknowledged that acetaminophen is an important medication for treating severe pain and high fever, and other options are limited. However, they also have the following guidelines: (6)

  • Don’t take acetaminophen, unless it’s medically indicated
  • Consult with your healthcare provider if you’re unsure about taking acetaminophen
  • As much as possible, only take the lowest effective dose for the shortest time

 

Did The Study’s Results & Consensus Statement Change The Existing Acetaminophen Recommendations?

No. The ACOG (American College of Obstetricians and Gynecologists) didn’t change their recommendations based on the allegations that acetaminophen can be harmful to the unborn baby when used during pregnancy. (7)

Instead, they released a statement that continues to back the medication as “one of the only safe pain relievers” for use by pregnant people. (7)

The association of OB-GYNs explained that there isn’t a need to worry. It slammed the Consensus Statement and past studies for not showing clear evidence between these alleged fetal development problems and prenatal acetaminophen use. (7)

The ACOG also explained that the guidelines released by the researchers aren’t new. These have been used by doctors in the obstetrics and gynecology department when prescribing acetaminophen. (7)

 

Other Possible Risks Of Tylenol Use During Pregnancy

Acetaminophen Is An Endocrine Disruptor

A 2021 Toxicological Sciences study explained that this drug has endocrine-disrupting properties that can alter hormones critical for your baby’s normal fetal development. (8)

 

Does Tylenol Directly Affect The Baby In Your Womb?

The placenta is your unborn baby’s source of nourishment and protection. It can stop harmful chemicals and toxins from reaching your little one in utero (in the womb). (9)

However, the 2021 study showed that acetaminophen exposure can have direct effects on your baby. (8)

At high concentrations, the drug can have the following effects: (8)

  • Reduce the protein and gene expression of the enzyme CYP19A1 aromatase (essential in estrogen production) 
  • Reduce the gene expression of the enzyme HSD3B1 (1 3β-hydroxysteroid dehydrogenase; essential in progesterone production)
  • Increase the expression of HSD17B1 (17β-hydroxysteroid dehydrogenase; important in the production of sex steroids such as estradiol and testosterone)

 

The combination of all these effects can lead to significant decrease in estradiol production, which is These effects can lead to a significant decrease in estradiol production, which depends on the acetaminophen dose (i.e., the higher its dose, the greater the decrease). Estradiol is essential in your baby’s brain and reproductive organ development. (8)

However, it’s important to note that the study found these effects from exposure to high drug concentrations. (8)

 

Prenatal Acetaminophen Exposure Linked To Possible Language Delays

A 2023 Pediatric Research study showed that a higher prenatal acetaminophen intake, especially during the second or third trimester, can increase the risk for language delays. The problems in language development include: (10)

  • Fewer vocabularies 
  • Shorter utterance length – measured as the M3L score (mean length of the three longest utterances)
  • Lower SLAS (Speech and Language Assessment Scale) score, particularly with boys exposed to acetaminophen during the third trimester

 

This recently published research had similar results to a 2018 European Psychiatry study that also found links between prenatal acetaminophen exposure and language delays. (11) 

Aside from maternal reporting of acetaminophen usage, the cohort study also measured urinary concentration. Their babies underwent language assessment at 30 months. (11)

Language delay was also more prevalent among boys than girls in this older study: (11)

  • Boys (12.6%)
  • Girls (4.1%)

 

Also, exposure to higher acetaminophen concentrations showed higher risks of language delays. (11)

 

Considerations When Sick: Take Medications (Like Tylenol) Or Not?

We understand you’re worried about taking Tylenol because of the possible effects. Staying untreated for fever and pain might also have harmful effects on you and your baby. (2)

If left untreated, fever can lead to the following: (12)

  • Birth defects
  • Miscarriage
  • Preterm birth
  • Stillbirth
  • Chorioamnionitis (an infection that moves from the urinary tract to the amniotic cavity)
  • Sepsis (the body’s extreme, life-threatening response to an infection)
  • Organ damage

 

Avoiding Tylenol with fever and body pains can do more harm than good.

 

How Much Tylenol Is Okay During Pregnancy?

Depending on your needs, your OB-GYN may prescribe 325 to 650 mg of Tylenol every 4 to 6 hours. (13)

However, you mustn’t exceed 3,000 mg per day. (13)

 

Types Of Tylenol & Safe Use During Pregnancy

Is It Alright To Take Tylenol PM While Pregnant?

Yes. The ACOG hasn’t specified the type of acetaminophen drug you can or can’t use during pregnancy. It’s best to follow your doctor’s recommendations. (7)(13)

 

Is It Alright To Take Tylenol Extra Strength While Pregnant?

Yes. However, it’s best to consult your OB-GYN before taking Tylenol type, even if it’s an over-the-counter medication (OTC). (7)

 

When Can A Pregnant Woman Take Tylenol?

If used correctly and under your doctor’s supervision, Tylenol can be safe anytime during pregnancy. (7)

The ACOG explained that none of the studies showed clear evidence that this drug could have negative effects on your baby during any trimester. (7)

 

Can You Take Tylenol During The First Trimester?

Yes. Based on the ACOG recommendations, you can use this drug anytime during pregnancy, including the first trimester. (7)

 

When Should You Stop Taking Tylenol When Pregnant?

Every situation is different. Follow your doctor’s recommendations and only stop taking Tylenol when you no longer need it (i.e., your fever and body pains are gone).

 

What OTC Pain Relief Can You Take When You’re Pregnant?

Tylenol or other acetaminophen drugs are generally safe for use during pregnancy. (7)

However, not all analgesics (painkillers) are safe. (see below)

 

Are NSAIDs Safe For Pregnant Women?

The FDA (US Food and Drug Administration) cautions against NSAIDs or non-steroidal anti-inflammatory drugs during pregnancy, especially at 20+ weeks.  (14)

NSAIDs include: (14)

  • Aspirin (e.g., Zorprin and Asatab)
  • Ibuprofen (e.g., Advil and Motrin)
  • Naproxen (e.g., Aleve)
  • Diclofenac (e.g., Cataflam and Zorvolex)
  • Celecoxib (e.g., Celebrex and Elyxyb)

 

Prenatal exposure to NSAIDs, especially in the third trimester, can lead to increased risks of heart issues and kidney problems in your unborn baby. It can also cause reduced or low amniotic fluid levels. (14)

The amniotic fluid helps your baby’s lung development by pushing the air sacs in their lungs to open. 

When your amniotic fluid is low, their air sacs might remain unopened. It might also affect the production of their lung tissues. Without adequate lung tissue, your newborn baby can experience breathing problems. (15)

(source: hsc.unm.edu) (11)

 

Is Advil Safe For Pregnancy?

No. Advil is an ibuprofen drug. It isn’t recommended for pregnant women because it can harm your baby’s kidneys and affect their circulation. The risks also increase when you’re 20+ weeks pregnant. (16)

Ibuprofen is not usually recommended in pregnancy, especially if you’re more than 20 weeks pregnant unless a doctor prescribes it. This is because ibuprofen can affect your baby’s circulation and kidneys.

 

Are Opioid Painkillers Safe For Use During Pregnancy?

Opioid painkillers such as Fentanil are prescribed to treat severe pain. However, they aren’t safe for use during pregnancy. (17)

Also, they have the same class as the illicit drug Heroin. They can be addictive and are commonly abused, especially in the US. (17)

The problematic use of opioids (called opioid use disorder) during pregnancy can cause serious risks to moms and babies, including: (17)

  • Preterm birth
  • Stillbirth
  • NAS (neonatal abstinence syndrome) – withdrawal symptoms experienced by newborns who were exposed to drugs while in the womb
  • Maternal mortality

 

Reducing Your Risks & Staying Safe During Pregnancy

Consult Your Doctor Before Taking Any Medication

While the ACOG backs the safety of acetaminophen, it’s best to check with your doctor before taking any medication.

OTC medications are easy to acquire but as already mentioned above, some of them can be dangerous to you and your baby. 

 

Check The Label Before Taking Any Medication

Analgesics are common ingredients in cold and flu medications or other multi-symptom drugs. 

So, it’s ideal to check the label so that you won’t accidentally take something that contains NSAIDs or other analgesics that can potentially harm your baby.

 

Try To Avoid Acetaminophen & Other Drugs During Pregnancy

As much as possible when you’re pregnant, don’t take acetaminophen or any drug/medication unless your doctor allows it.

The Society For Maternal-Fetal Medicine explains that acetaminophen can easily cross the placenta. There have also been reports that it was detected in umbilical cord blood after it was given to the mom during labor. (18)

 

Minimize Use Of OTC & Herbal Medications

These medications can contain different types of analgesics, which can potentially harm your baby. Don’t use them unless you have your doctor’s prior approval.

 

Drug-Free Ways To Manage Pain During Pregnancy

  • Massage (be careful; only get a massage from a therapist with experience in helping pregnant women alleviate pain)
  • Essential oils (be careful about using EOs during pregnancy)
  • Warm bath
  • Apply a warm compress (but not on your abdomen)
  • Ice pack (on the affected area only; avoid your abdomen)
  • Relax
  • Get some sleep
  • Meditation and breathing exercises might also help
  • Exercise (e.g., prenatal yoga)

 

What To Do You Accidentally Took Tylenol Before Learning You’re Pregnant

Don’t worry too much about it. Remember that ACOG backs Tylenol’s safety even during pregnancy. It’s more important that your fever and pain symptoms are treated before they can also harm you and your little one.

For your peace of mind, you can also call your doctor.

 

Acetaminophen Lawsuit

At least 440 lawsuits have been filed against Kenvue, the manufacturer of Tylenol, over the alleged links to ADHD and autism. These lawsuits cited the studies and Consensus Statement we discussed above in their claims for compensation. (19)

Many of these lawsuits involved families with children who have these neurological problems. (19)

In December 2023, United States District Judge Denise Cote ruled that the evidence from the studies presented by the plaintiffs didn’t show sufficient cause-and-effect links between prenatal acetaminophen use and ADHD or autism. (19)(20)

Judge Cote wrote that one of the plaintiff’s experts, who testified to the supposed acetaminophen risks had “cherry-picked” and misrepresented the results of studies presented in court. Also, the expert refused to acknowledge that genetics might also play a role in ADHD and ASD. (19)

 

References

(1) https://parentdata.org/tylenol-pregnancy-and-that-new-lawsuit/

(2) https://academic.oup.com/aje/article/187/8/1817/4980325?login=false

(3) https://parentdata.org/can-take-tylenolwhile-pregnant/

(4) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7396152/

(5) https://my.clevelandclinic.org/health/diseases/22438-advanced-maternal-age

(6) https://www.researchgate.net/publication/354795187_Paracetamol_use_during_pregnancy_-_a_call_for_precautionary_action

(7) https://www.acog.org/news/news-articles/2021/09/response-to-consensus-statement-on-paracetamol-use-during-pregnancy

(8) https://pubmed.ncbi.nlm.nih.gov/33098425/

(9) https://my.clevelandclinic.org/health/body/22337-placenta

(10) https://pubmed.ncbi.nlm.nih.gov/38081897/

(11) https://pubmed.ncbi.nlm.nih.gov/29331486/

(12) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7444605/

(13) https://hsc.unm.edu/health/patient-care/womens-health/taking-medicine-while-pregnant_7-28-20_eng_2017-472.pdf

(14) https://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-recommends-avoiding-use-nsaids-pregnancy-20-weeks-or-later-because-they-can-result-low-amniotic

(15) https://www.marchofdimes.org/find-support/topics/planning-baby/oligohydramnios

(16) https://www.nhs.uk/medicines/ibuprofen-for-adults/pregnancy-breastfeeding-and-fertility-while-taking-ibuprofen/

(17) https://www.cdc.gov/reproductivehealth/maternalinfanthealth/substance-abuse/substance-abuse-during-pregnancy.htm

(18) https://www.smfm.org/publications/234-smfm-statement-prenatal-acetaminophen-and-outcomes-in-children

(19) https://www.wbay.com/2023/12/21/judge-rejects-research-linking-acetaminophen-autism-adhd/

(20) https://storage.courtlistener.com/recap/gov.uscourts.nysd.587481/gov.uscourts.nysd.587481.1381.0.pdf

 

 

 

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