How to Report Infant Medication Side Effects from Breastfeeding

Breastfeeding
09/16/2025 12:24
Medwatch

Why Should I Report Side Effects? 

 

The FDA MedWatch program is the United States’ safety reporting system for medical products. If you are breastfeeding and notice unexpected side effects in yourself or your baby, reporting these events can help the FDA identify potential risks sooner. These reports may lead to updated product warnings, recalls, or further studies to protect other families (FDA, MedWatch Program). 

What Can Be Reported? 

 

While the InfantRisk Center is focused on medication side effects, medications and supplements are not the only types of events that you can report.

You can report any unexpected problem with an FDA-regulated product, including: 

  • Medications (prescription or over-the-counter)  
  • Dietary supplements or vitamins  
  • Medical devices (breast pumps, glucose monitors)  
  • Combination products (prefilled syringes, nasal sprays) 

 

Examples of reportable events: 

 

  • Allergic reactions or rashes  
  • Changes in milk supply or baby’s feeding patterns 
  • Severe complications (hospitalization)
  • Minor reactions in the baby (increased fussiness, diarrhea, sleep changes) 
  • Product defects (strange odor, incorrect labeling) 

You don’t need to be sure the medication caused the problem—just report what happened. The FDA will use this information to monitor for patterns. They use scoring systems to determine the likelihood an event was related to the unexpected problem, and use that likelihood when assessing potential flags.

 

Why This Matters for Breastfeeding Parents 

 

  • Most medications have limited research on safety data on use during lactation.  
  • Reports help identify rare or delayed side effects affecting breastfeeding families.  
  • FDA uses this data to improve product labeling and safety alerts.  
  • Your report can protect other parents and infants experiencing similar issuesmay help prevent future harm to other families.
  • Because most medications aren’t studied in lactating people, your experience matters. Every report builds a clearer picture of what’s safe—and what might not be—for breastfeeding families.

 

How to Report a Lactational Adverse Event Using MedWatch

 

Step 1. Access the Form

  • Go to the FDA MedWatch Reporting Page
  • Select Form 3500B (for consumers)
     

Step 2. Select “Product”

  • If reporting a medication or supplement taken by the mother, choose “Product” (not “Device”).
     

Step 3. Provide Product Details (Section C)

  • List the mother’s medication (name, strength, manufacturer, lot number if available).
  • Include dates of use and note any changes in the infant’s symptoms when the medication was started, stopped, or restarted.
     

Step 4. Describe the Side Effect (Section B)

  • Clearly describe the infant’s symptoms, timing, and severity.
  • Always specify: “Exposure occurred via breast milk.”
  • Specify the degree of exposure via milk (exclusive breastfeeding, breastfed 3 times per day for 15 minutes)
  • Include test results, clinical findings (symptoms), or the pediatrician's comments if available.
  • Example: “Infant developed diarrhea and increased fussiness after 1 month of maternal use of [drug]. Exposure occurred through exclusive breastfeeding. Infant symptoms resolved when formula was introduced.”
     

Step 5. Fill Out Patient and Reporter Sections

  • Patient Section (A): The patient is the infant. Enter age (in months), sex, and weight.
  • Reporter Section (E): The reporter is the mother or caregiver completing the form. Provide your contact details if you agree to follow-up (you may remain anonymous).
  • Keeping these separate ensures the FDA can analyze the infant’s event while tracking the caregiver as the reporter.
     

Step 6. Submit and Save Confirmation

  • Submit the form online.
  • Save the confirmation number for follow-up or additional reports.
     

What Happens After You Report? 

 

  • FDA reviews the report and may contact you for clarification.  
  • Reports go into the FAERS (FDA Adverse Event Reporting System) database to monitor safety patterns.  
  • Your personal details remain confidential. 
  • Over time, the FDA reviews reports for patterns and may flag topics for future research. Sometimes, data from the reports alone can trigger safety notices.
     

Reporting Medication Side Effects Outside the U.S. 

 

If you live outside the United States, medication side effect reporting is handled by your national regulatory agency rather than the FDA. Here’s where to report in some major regions: 

 

Canada

Europe (EU)

  • Report through your country’s national medicines agency (ANSM in France, BfArM in Germany). 
  • You can also use the European Medicines Agency (EMA) portal: https://www.adrreports.eu.
  • Most EU countries have patient-friendly online forms in local languages. 
     

United Kingdom 

  • Use the MHRA Yellow Card Scheme to report suspected side effects: https://yellowcard.mhra.gov.uk.
  • Reports can be made online or via the Yellow Card mobile app. 
     

 India 

  • Use the Pharmacovigilance Programme of India (PvPI) via the CDSCO website: https://www.ipc.gov.in.
  • Reports can be submitted online, by email, or through toll-free numbers provided by PvPI. 

 

Every Report Helps

 

If you’re not sure whether a side effect is worth reporting—go ahead and submit it. Even small changes in milk supply, baby behavior, or unusual symptoms could be part of a bigger safety story. Your report can make a real difference in how we understand medication use during breastfeeding. It helps build better guidance safer labels, and stronger protections for other families just like yours. Again, the regulatory agency will determine how likely the reported event was due to the exposure.

 

Reporting in Action--it works!

 

In 2023, HealthCanada announced results from a Safety Review completed on domperidone in lactating women, finding "Psychiatric withdrawal events including, but not limited to, depression, anxiety and insomnia following sudden discontinuation or tapering (dose reduction) of domperidone used to stimulate lactation (Health Canada Safety Review)." This review was the result of aligning reports from 9 cases in the Canada Vigilance Database and international reports along with published scientific literature. The efforts of nine parents and providers in completing their reports supported HealthCanada in updating domperidone labeling -- warning patients and their healthcare providers of this lactation-specific risk! 

 

Luke Lusby

Katie Boatler, RN, BSN

Kaytlin Krutsch, PhD, PharmD, MBA, BCPS

 

 

References

1. U.S. Food and Drug Administration. MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Available at: https://www.fda.gov/medwatch. Accessed July 2025.