Acetaminophen and Ibuprofen Equally Safe for Babies, Ibuprofen Lowers Fever Faster

By Linda Carroll

November 02, 2020

(Reuters Health) - While acetaminophen and ibuprofen are equally safe for children under age 2, ibuprofen may bring down fevers more quickly in the first four hours of use, a new study suggests.

In a meta-analysis of data from 19 studies with more than 200,000 patients from seven countries and a variety of healthcare settings, researchers also found that compared with acetaminophen, ibuprofen resulted in reduced temperatures and less pain at 24 hours, according to the results published in JAMA Network Open.

"Both medications are safe," said study coauthor Dr. Stuart Dalziel, a professor of pediatrics and emergency medicine at The University of Auckland, Cure Kids Chair of Child Health Research, and director of emergency medicine research at Starship Children's Hospital.

"We found evidence that ibuprofen is better than acetaminophen with respect to temperature control within four hours of the first dose," Dr. Dalziel said in an email. "Unfortunately, none of the studies reported pain or discomfort at this time point. Yet, for children who are febrile it is the discomfort associated with that fever that international bodies like the WHO say we should use ibuprofen and acetaminophen for."

"This is a major gap in our current evidence for these two medications, and is somewhat surprising when you consider that ibuprofen and acetaminophen are the most commonly prescribed over the counter medications in childhood," Dr. Dalziel said. "However, we did find that ibuprofen was better with respect to pain control between four and 24 hours of use. Given this limited evidence I would be happy using ibuprofen first in my own infant."

In the past there have been questions about the safety of ibuprofen when it comes to possible renal and gastrointestinal side effects, Dr. Dalziel said. "We did not find statistical evidence of an excess of serious renal or gastrointestinal side effects in over 42,000 children contributing safety data," he said. "Both medications are safe when given at the prescribed dose and adverse events from either medication were extremely uncommon."

To take a closer look at possible differences between the two medications with respect to safety and efficacy, Dr. Dalziel and his colleagues scoured the medical literature for published studies from any healthcare setting or country that compared short-term use of acetaminophen with ibuprofen for fever or pain in children younger than 2 years.

After scrutinizing 3,933 potential studies, the researchers winnowed their list down to 19, which included a total of 241,138 participants. Overall, 11 studies (12 publications) reported data from randomized controlled trials involving 28,450 participants. Four of those studies reported pain outcomes, and nine (10 publications) reported safety outcomes. Eight studies reported data from nonrandomized studies involving 212,688 participants, with two reporting fever outcomes, zero reporting pain outcomes, and eight reporting safety outcomes.

The studies included in the analysis were conducted in France, Iran, Israel, the Netherlands, Turkey, the United Kingdom, and the United States. They took place in various clinical settings, including pediatric and mixed emergency departments, pediatric wards, hospital-based clinics, and community clinics.

Although these two medications have been around for a long time, there have been questions about how they compared head to head, said Dr. C. Anthoney Lim, an associate professor of emergency medicine and pediatrics at the Icahn School of Medicine at Mount Sinai and director of pediatric emergency medicine for the Mount Sinai Health System and the medical director of the pediatric emergency department and Pediatric Short Stay Unit at Mount Sinai Beth Israel.

While pediatricians may have had hunches that one medication might be superior to another, there's no substitute for rigorous science, Dr. Lim said. "This systematic review is supportive of some of the beliefs pediatricians have had," he said. "For those who are pro Tylenol, it's reassuring that its safety profile is equivalent to that of ibuprofen. And for those who like ibuprofen, it seems to work better in this acute four hour period at reducing fever and in a 24 hour period at reducing pain and fever."

SOURCE: JAMA Network Open, October 30, 2020.