Is Miralax Safe for Kids?

If your child has ever experienced constipation, you might have heard about the benefits of the laxative Miralax. Miralax is regularly prescribed to treat constipation in kids, so it may be surprising to learn that the common over-the-counter medication is not technically approved for use in kids under 17. It may be even more surprising that there have even been reported side effects in kids like behavioral issues, speech problems, anxiety, and depression.

So is Miralax actually safe for kids? The jury is still out among some doctors and researchers if Miralax is safe for kids, but many still prescribe it for pediatric patients with success. Here's what you should know about using Miralax for kids.

What Is Miralax?

Miralax is an over-the-counter (OTC) powdered laxative that is available in most pharmacies, drug stores, grocery stores, and big box stores. The product is commonly mixed with water before taking.

The active ingredient in the name brand Miralax and its generics is polyethylene glycol or PEG 3350, which was called a "game changer" by researchers looking to relieve constipation in pediatric patients. It works by pulling water into the colon, which helps bulk up and soften stool enough to help it pass.

Miralax was first released as a prescription-based laxative for adults in 1999, and then in 2006, Miralax became approved as an OTC product by the Food and Drug Administration (FDA) for use in people aged 17 and up.

How Much Miralax Should I Give My Child?

Although the labeling on the product states that Miralax is not for kids under 17, many doctors believe Miralax is safe for children as young as 6 months, so they prescribe it through a method called off-labeling. Off-labeling is a term used to describe situations when a doctor prescribes a drug that is not approved for the condition or patient being treated.

Currently, there are no OTC or prescription products that are FDA-approved to treat constipation in children. The label on Miralax states that it is intended for people 17 and up and that kids 16 and under should consult with a health care provider before using PEG 3350.

So, how much Miralax can a child take for constipation? That depends on who you ask. Since the product is not approved for kids under 17, the recommended dosage for children is at the discretion of the health care provider who prescribes it.

Miralax Side Effects in Kids

Miralax may be effective at relieving symptoms of constipation in kids, but it can also cause several unpleasant side effects, including:

• Bloating
• Gas
• Nausea
• Stomach cramping

Beyond the known side effects, many parents have also reported that PEG 3350 has caused other, more serious side effects in their kids, including anxiety, mood swings, behavior issues, and paranoia.

Media coverage of the controversy over Miralax began in February 2017 after 6 ABC Action News reported that Philadelphia mom Jeanie Ward gave her 3-and-a-half-year-old daughter Nicole the laxative on the advice of a doctor, and within 10 days, Nicole's personality changed drastically. "Near psychiatric events with paranoia, mood swings, aggression, rage," Ward explained. "It was horrifying to see my daughter change like that and to not completely go back to normal."

But doctors like Steve J. Hodges, M.D., associate professor of pediatric urology at Wake Forest University School of Medicine in Winston-Salem, North Carolina, have been prescribing Miralax to their adolescent patients for years. "More than 100 studies have found PEG 3350 is safe to use in children," says Dr. Hodges.

Is Miralax Safe for Kids?

In 2012, Jeanie Ward helped author and direct a petition to the FDA asking for a warning label and an investigation into Miralax. In 2014, an FDA-funded study by the Children's Hospital of Philadelphia (CHOP) began after the agency's own findings indicated "small amounts of ethylene glycol and diethylene glycol"—the same ingredients found in anti-freeze—in Miralax. The FDA also found 167 cases of adverse side effects in children who took the laxative, including 37 kids who displayed neurological or psychiatric symptoms.

In April 2018, the FDA said the labeling for PEG 3350 accurately conveyed its risks, and no additional warnings about neuropsychiatric issues in children were needed. "We look forward to [the] results of the CHOP study to further determine the benefits and risks associated with the use of these products in children," the agency said. The study's results will be disclosed to the FDA once they are released.

Experts like David Bunkin, M.D., assistant professor of pediatric gastroenterology and hepatology at Mount Sinai in New York City, remain hopeful that the CHOP study will eventually confirm the laxative's safety for kids. He tells Parents that while the FDA found trace amounts of those two potentially toxic chemicals in batches of Miralax tested years ago, ownership of the drug has since changed hands, and follow-up screenings have not revealed the chemicals.

"This medication has been used safely for a long time in children without any known side effects and is a medication we routinely use in our pediatric gastrointestinal specialty office," Dr. Bunkin explains. "We continue to prescribe it in cases where diet changes to help constipation are not effective or possible, and feel that it is likely safe to use in children."

The scrutiny of PEG 3350 and the supporting anecdotal evidence of behavioral and psychological effects on kids led researchers to conduct an animal study in 2021 to see if they could show a connection between PEG 3350 and neuropsychiatric symptoms, but none were found.

Instead, researchers found that PEG 3350 changed mice's stool consistency and microbiome but not behaviors. Researchers noted in the study that reported behavioral and psychological side effects in kids may be due to other causes related to constipation and not the use of PEG 3350.

As of 2023, the FDA has not updated its stance on using PEG 3350, which is still not FDA-approved for use in kids under 17.

Alternatives to Miralax for Kids

If you're feeling wary of giving even a small dose of Miralax to treat your child's constipation, you may want to consider some alternative treatments such as:

• Ensuring that your child stays hydrated, which can keep stool soft
• Offering high-fiber foods such as apples, carrots, lentils, oatmeal, and dried apricots to keep things moving
• Giving small amounts of prune puree or prune juice, which can soften stools
• Asking your health care provider for an enema or physical therapy

Do note: Once constipation becomes severe, fiber and dietary changes are usually too little, too late.

"Ultimately, it doesn't matter what method is used to empty a child's clogged rectum—as long as that method doesn't harm the child, of course," says Dr. Hodges. "What does matter is that the child's bowels empty completely on daily basis, so the kid doesn't show up at the ER with painful urinary tract infections or opt out of sleep-away camp because she wets the bed."