FACT: FACT:

Children’s Advil® has an excellent safety profile when used as directed1‑4

Children’s Advil Children’s Advil

Large-scale clinical studies and meta-analyses of smaller studies demonstrate that pediatric ibuprofen (the medicine in Children’s Advil) has an excellent safety profile when used as directed1-4

Children's Advil Suspension

A recent meta-analysis of 24 randomized clinical trials in pediatric subjects concluded that ibuprofen has an excellent tolerability and safety profile including gastrointestinal symptoms, asthma, and renal adverse events.2 

In a large, randomized, double-blind trial, it was shown that in short-term use of ibuprofen in children, there was a very low risk of hospitalization for renal failure, gastrointestinal bleeding, or anaphylaxis (N=84,192).

The follow-up period of an actual-use trial that included nearly 25,000 pediatric patients (approximately 13,800 of whom received ibuprofen) showed that less than 1% of pediatric patients treated with Children’s Advil experienced any of the most frequently reported adverse events, which are listed in the table below.

This trial was a national, multicenter, observational study conducted in a naturalistic outpatient pediatric setting to evaluate the experience of Children’s Advil in children with fever and pain

 

MOST COMMONLY REPORTED ADVERSE EVENTS IN PEDIATRIC PATIENTS TAKING IBUPROFEN

Adverse Event

% of Patients

Children’s Advil®

Nausea/Vomiting

<1%

Restlessness/Nervousness

<1%

Rash

<1%

Abdominal Pain

<1%

Somnolence

<1%

Diarrhea

<1%

Flatulence

<1%

Dizziness

<1%

Insomnia

<1%

Furthermore, Children’s Advil has a wide margin of safety and a low potential for toxicity from overdose as demonstrated in several studies.6,7

Infants’ Advil®—gentle infants’ fever relief

Infants Advil Concentrated Drops

Infants’ Advil delivers unsurpassed fever relief that baby can stomach.8,9† 

  • Nothing works faster8*
  • Nothing keeps fever down longer8†
  • Gentle on baby’s stomach9

Recommend Infants’ Advil first-line starting at 6 months and 12 pounds for fever relief that’s safe and effective when used as directed.

Children’s Advil® is indicated for children aged 2-11 years and Infants’ Advil is indicated for infants 12 pounds to 23 pounds and 6 months through 23 months of age. Please refer to Children’s Advil and Infants’ Advil Drug Facts for full product information by clicking here.