Tamiflu Safe For Children, Study Concludes

By Dennis Thompson HealthDay Reporter

Medically reviewed by Drugs.com

via HealthDay

THURSDAY, Aug. 7, 2025 — Researchers have debunked long-standing concerns that Tamiflu can cause neurological and psychiatric problems when given to influenza-stricken children.

For decades, doctors have debated whether the antiviral drug oseltamivir (Tamiflu) increases kids’ risk of seizures, mental problems and hallucinations.

But Tamiflu actually cuts by half a child’s risk of such problems, compared to leaving influenza untreated, researchers reported Aug. 4 in JAMA Neurology.

“Our findings demonstrated what many pediatricians have long suspected, that the flu, not the flu treatment, is associated with neuropsychiatric events,” said lead investigator Dr. James Antoon, an assistant professor of pediatrics at Vanderbilt University’s Monroe Carell Jr. Children’s Hospital in Nashville, Tenn.

“In fact, oseltamivir treatment seems to prevent neuropsychiatric events rather than cause them,” Antoon added in a news release.

Tamiflu is the most commonly prescribed antiviral drug for flu in both children and adults, researchers said in background notes. When used promptly, it can shorten a bout of the flu, ease symptoms and prevent further spread of the virus.

In 2006, the U.S. Food and Drug Administration (FDA) started receiving reports of self-injury and delirium among children who’d received Tamiflu, mostly from Japan. Based on these reports, the FDA added a warning to this effect to the drug’s label but confirmed Tamiflu’s overall safety among children.

Nevertheless, some remained concerned about the potential risk posed by Tamiflu, prompting the new study.

For the study, researchers analyzed data for more than 692,000 children ages 5 to 17 enrolled in Tennessee Medicaid between July 2016 and June 2020, including about 129,000 treated for influenza.

Two-thirds (67%) of children with the flu were treated with Tamiflu, researchers found. Nearly all (89%) received Tamiflu the day doctors diagnosed their flu.

Influenza itself was associated with an increased risk of problems like seizures, mood disorders, and suicidal or self-harm behaviors, results showed.

However, children treated with Tamiflu had about a 50% reduction in these problems, researchers found.

Further, healthy kids who received Tamiflu to protect them against flu developed neurological and psychiatric problems at the same rate as all other healthy kids, the study says.

“Taken together, these three findings do not support the theory that oseltamivir increases the risk of neuropsychiatric events,” Antoon said. “It’s the influenza.”

The research team hopes the findings will reassure parents and doctors about the safety of Tamiflu and its ability to help kids get through the flu.

“These flu treatments are safe and effective, especially when used early in the course of clinical disease,” senior researcher Dr. Carlos Grijalva, a professor of health policy and biomedical informatics at Vanderbilt University Medical Center, said in a news release.

Sources

  • Vanderbilt University Medical Center, news release, Aug. 4, 2025
  • JAMA Neurology, Aug. 4, 2025
  • Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

    Source: HealthDay

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