Methylphenidate
Information last updated: November 2021
The baseline risk of major birth defects in Canada is 3-5%. This means that 3-5 out of 100 babies born in the general population in Canada will be born with a major birth defect. There are also baseline risks for miscarriages (15-25 out of 100 pregnancies), prematurity and other outcomes. The information provided will summarize if taking this drug is likely to change these risks.
Summary: Approximately 4000 pregnancies with exposure to methylphenidate in the first trimester of pregnancy were included in published studies. Based on this, it is not expected that taking methylphenidate in pregnancy will increase the risk of babies being born with major birth defects beyond the baseline risk. There have been some reports of higher rates of adverse pregnancy outcomes when pregnancies exposed to methylphenidate or ADHD stimulant medications, were compared to unexposed pregnancies. However, these were not found consistently and if there are increases in the risks, they are anticipated to be small. To see more details please click on the tabs below. Any decisions concerning methylphenidate treatment during pregnancy should be discussed with a healthcare provider, weighing the benefits of treatment against any possible risks.
Please consult with your health care provider if you are considering stopping or making any changes to your regular medications.
This information about methylphenidate is of a general nature and about medical use and does not replace the medical care and advice of your healthcare provider. For questions on dose, timing, side effects, interactions, etc. please consult your healthcare provider. Additionally, please read the patient insert provided with your medication. If you are using methylphenidate or other drugs or medications for non-medical reasons or beyond what was recommended by a healthcare provider, please see Harm Reduction section. In case of emergency, please go to the emergency room or call 911.
Although participants in the studies referenced below may have used methylphenidate in various combinations, the studies usually do not provide detailed information on drug combinations. This makes it challenging to comment on the safety of using this medication in combination with others during pregnancy or lactation.
Methylphenidate is a central nervous system (brain and spinal cord) stimulant.
It is prescribed to people with ADHD to increase concentration and performance. It is prescribed to people with narcolepsy to help them stay awake and alert longer.
If the product you are using contains other active ingredients, please check our Exposures A to Z for available information on the ingredient(s).
For more information on treating mental health conditions while pregnant or while providing your breastmilk to an infant, please see Mental Health in Pregnancy and Lactation.
Pronunciation
Please check back. We are in the process of reviewing if there is available information on the pre-pregnancy effects of methylphenidate.
Approximately 4000 pregnancies with exposure to methylphenidate in the first trimester of pregnancy were included in published studies. Based on this, it is not expected that taking methylphenidate in pregnancy will increase the risk of babies being born with major birth defects beyond the baseline risk. A large study observed a small increase in the risk of heart defects. Heart defects occur in 10/1,000 (or 1/100) infants. If the suggested association exists, the chance of heart defects occurring in pregnancies exposed to methylphenidate would be 13/1,000 (an additional 3 cases per thousand births). More information is needed before a conclusion can be made on the risk of heart defects with methylphenidate exposure.
Some studies have found higher rates of miscarriages in pregnancies exposed to ADHD medications (most were exposed to methylphenidate). Some of these studies reported similar rates of miscarriages in people who had ADHD and did not take medication in pregnancy. This suggests that the increase in the rates may be related to ADHD or other factors common in people with ADHD, and not the medication. It is important to know that the increased rates reported in pregnancies exposed to ADHD medications (9.7- 14.1%) are not higher than the baseline rates of miscarriages seen in the general population in Canada (15-25%).
Most studies have not found a higher risk of prematurity (delivery before 37 weeks of pregnancy) when methylphenidate was used early in pregnancy or stimulant ADHD medications were used in pregnancy. However, one study reported an increase in the risk of prematurity in pregnancies when stimulant ADHD medications were continued beyond 20 weeks (no information specific to methylphenidate was provided). Continuing treatment beyond 20 weeks may reflect more severe ADHD that is not controlled without medications. This suggests that the reported increased risk may be related to the severity of ADHD and not the medication. More information is needed before a conclusion can be made on the risk of prematurity with methylphenidate use in pregnancy.
The limited available information does not show higher rates of babies being born small for gestational age (birthweight that is lower than expected at the time of delivery) or of loss of a baby before, during or within days of delivery, when methylphenidate or other ADHD medications were used during pregnancy. However, more data is needed to confirm that there is no increased risk of these outcomes.
No increased risk of placenta abruption (when the placenta separates from the wall of the womb before birth) was found when methylphenidate was used during pregnancy. The same study did report an increased risk of preeclampsia (pregnancy related high blood pressure condition). However, if there is an actual increase in risk, it is anticipated to be small (1 to 2 additional cases per hundred births). More information is needed before conclusions can be made on these risks.
Please check back. We are in the process of reviewing if there is available information on the effects of paternal exposure to methylphenidate.
One study found that neonates who were exposed to methylphendiate or other stimulant drugs during pregnancy had higher chances of being admitted to the Neonatal Intensive Care Unit (NICU). The findings in this study might be explained by other medications that were used during pregnancy, the severity of ADHD, as well as other maternal conditions that were more common in those who took stimulant drugs during pregnancy.
Information last updated November 2021
If you are taking medications and you notice any new health concerns or symptoms in your nursing infant, please contact their health care provider. In case of emergency, please go to the emergency room or call 911.
People who are taking a medication or substance while providing their breastmilk to an infant need to know how much of the medication or substance is passing into their milk. One of the commonly used measurements to estimate this is the Relative Infant Dose (RID). The RID is estimated by comparing the dose of drug taken in by the infant through breastmilk to the dose that the nursing parent takes. Most medications with an RID of less than 10% are usually compatible with nursing a healthy infant. The RID does not need to be calculated for each person because most of the time it is expected to be similar to what has been found in research studies. We will provide the RID in the information below, when available.
According to the available information, methylphenidate passes into breastmilk in small amounts and is not expected to affect the nursing infant. Based on breastmilk levels of 7 nursing women treated with 35-80mg of methylphenidate, the RID is estimated to be less than 1%. No adverse effects were reported in 5 infants who were exposed to methylphenidate through breastmilk.
We did not find information on whether taking methylphenidate while nursing can affect breastmilk supply.
We did not find published studies on the effects of methylphenidate use in pregnancy on the long-term child/adult health outcomes. We will update this section if studies become available.
Costs of some medications are covered for eligible people under provincial or national Indigenous drug benefit plans. Please visit the Ontario Drug Benefit (ODB) program Check medication coverage or the Non-Insured Health Benefits (NIHB) program Drug Benefit List to check if methylphenidate is covered for you.
Methylphenidate has potential for addiction and problematic (non-medical) use. If used in ways other than prescribed, over time, higher doses may be needed to get the same effects. It can also lead to dependency, causing cravings and withdrawal.
Using methylphenidate not as prescribed may result in harmful effects. Some of these effects such as high blood pressure, seizures, and fast or irregular heartbeat may lead to increased risks of unfavorable pregnancy outcomes.
Methylphenidate pills contain fillers. When the pill is crushed into a powder and snorted (inhaled) the fillers get into the lungs and can cause breathing and lung problems. When it is crushed and dissolved to be injected (with a needle), the fillers, which do not dissolve, can harm the veins and other organs. These practices are unsafe.
A study which included 38 pregnancies exposed to substance use of IV methylphenidate and pentazocine (opioid pain medication) found higher than expected rates of prematurity (delivery before 37 weeks of pregnancy), growth restriction (baby did not grow as expected while in the womb) and withdrawal symptoms (such as tremors, fussiness, difficultly sucking) in the newborns. Most of the pregnancies in the study were also exposed to alcohol and some to other substances.
Medications, if not taken as prescribed, if taken beyond the prescribed amount, or if taken in combination with certain other drugs, may cause harm to you and/or your pregnancy or your nursing child.
If you are using methylphenidate or other drugs or medications for non-medical reasons or beyond what was recommended by a healthcare practitioner and you are pregnant, providing your breastmilk to an infant, or parenting please click here Harm Reduction for additional information. In case of emergency, please go to the emergency room or call 911.
Using drugs beyond what your clinician prescribes during pregnancy or parenting in a way that harms you or your baby may result in a community member or care provider contacting child protective services.
Pregnancy:
Based on approximately 4000 pregnancies with exposure to methylphenidate in the first trimester, there does not appear to be an increased risk of major congenital malformations above the baseline risk. The information on risk for cardiac malformations is conflicting. A large study reported a small increased risk for cardiac malformations. The 1.3% absolute risk that was detected is above the baseline risk (1%) and would correspond to an additional 3 cases of babies born with cardiac malformations per thousand births. More studies are needed before a conclusion can be made on the risk of cardiac defects.
Some studies have found an increased risk of miscarriages in pregnancies exposed to ADHD medications (most were exposed to methylphenidate). A number of these studies reported similar risks in people diagnosed with ADHD who were not treated in pregnancy. This suggests the reported increased risk may be associated with factors common in people with ADHD and not the treatment. The miscarriage rates reported in exposed pregnancies in these studies were 9.7- 14.1%, which are similar to the baseline rates in the general population in Canada (15-25%).
Most studies have not found an increased risk of prematurity when methylphenidate was used early in pregnancy or ADHD stimulant medications were used any time in pregnancy. However, one study reported an increased risk of prematurity when ADHD stimulant medications were continued beyond 20 weeks of pregnancy compared to use up to 20 weeks. No sub-analysis was performed for methylphenidate. Continuing treatment beyond 20 weeks may also reflect more severe ADHD that is not controlled without medications. This reported increased risk may be confounded by the condition severity, for which no adjustments were made. More information is needed before a conclusion can be made on the risk of prematurity.
The limited available information did not report an increased risk of small for gestational age, stillbirth or neonatal death, when methylphenidate or other ADHD medications were used during pregnancy. However, more data is needed to confirm that there is no increased risk of these outcomes.
One study reported no increased risks of placenta abruption with the use of methylphenidate or other ADHD medications during pregnancy. This study also reported an increased risk of preeclampsia with exposure to methylphenidate during pregnancy. However, if there is an actual increase in risk, it is anticipated to be small (1 to 2 additional cases per hundred births). More studies are needed before conclusions can be made on these risks.
A study reported an increased risk of NICU admissions in babies exposed to methylphenidate or other stimulant drugs during pregnancy. The authors mention that concomitant medications used during pregnancy, the severity of ADHD as well as other maternal conditions that were more common in the exposed group, may have confounded the results.
Lactation:
One of the factors that helps to determine if a medication is compatible with nursing is the Relative Infant Dose (RID). The RID provides an estimate of infant’s exposure to a medication through breastmilk. It is the ratio between the infant’s and the nursing individual’s weight-adjusted doses. The infant weight adjusted dose is estimated based on the concentration of medication in breastmilk, and an assumption of infant daily milk consumption of 150 ml/kg/day. In general, for infants with normal growth and development, most medications with an RID of less than 10% are considered compatible with nursing. The RID does not account for infant’s drug metabolism, clearance, or infant blood levels. Although some variability may exist in the RID, in most cases the estimated RID is adequate for clinical purposes and does not need to be calculated for each individual. We will provide the RID in the information below, when available.
According to the available information, methylphenidate passes into breastmilk in small amounts and is not expected to affect the nursing infant. Based on breastmilk levels of 7 nursing women treated with 35-80mg of methylphenidate, the RID is estimated to be less than 1%. No adverse effects were reported in 5 infants who were exposed to methylphenidate through breastmilk.
We did not find information whether taking methylphenidate can affect milk supply while nursing.
Harm Reduction:
Methylphenidate has potential for addiction and problematic use. If used in ways other than prescribed, tolerance and dependance may occur. It may result in harmful effects such as hypertension, seizures, arrhythmia, which may be associated with increased risk for adverse pregnancy outcomes.
Methylphenidate pills contain fillers. When crushed and inhaled, the fillers can reach the lungs and cause breathing and lung problems. When crushed and dissolved for IV use the undissolved fillers can cause vascular complications and damage to other organs.
A study which included 38 pregnancies exposed to substance use of IV methylphenidate and pentazocine found higher than expected rates of prematurity, growth restriction and withdrawal (such as tremors, irritabily, hyperactivity, hypertonus, disorganized suck) in the newborns. Most of the pregnancies in the study were also exposed to alcohol and some to other substances.
If your patient may be using methylphenidate or other drugs or medications not as indicated during pregnancy, while providing breastmilk to an infant, or parenting please click here Harm Reduction for additional information. In case of emergency, please advise them to go to the emergency room or call 911.
For additional resources see Health Canada Drug and Natural Health Product Monographs, Making Sense of Risk and Statistics.
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Ekinci O, Gunes S, Ekinci N. Galactorrhea Probably Related with Switching from Osmotic-release Oral System Methylphenidate (MPH) to Modified-release MPH: An Adolescent Case. Clin Psychopharmacol Neurosci. 2017 Aug 31;15(3):282-284. [PMID: 28783939]. [PMC5565079].
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Disclaimer
First Exposure does not offer health care treatment. If you have an urgent question about your pregnancy or your baby’s health, you should contact your health care provider directly. If you don’t have a health care provider and you live in Ontario, you have a variety of health care options. In the case of an emergency, visit a hospital emergency room or call 911.