INFANTS IBUPROFEN

N/A

Manufactured by Aurohealth LLC

101 FDA adverse event reports analyzed

Last updated: 2026-04-14

About INFANTS IBUPROFEN

INFANTS IBUPROFEN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Aurohealth LLC. The most commonly reported adverse reactions for INFANTS IBUPROFEN include DIARRHOEA, VOMITING, RECALLED PRODUCT ADMINISTERED, DRUG INEFFECTIVE, ABDOMINAL DISCOMFORT. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for INFANTS IBUPROFEN.

Top Adverse Reactions

DIARRHOEA8 reports
VOMITING7 reports
RECALLED PRODUCT ADMINISTERED6 reports
DRUG INEFFECTIVE5 reports
ABDOMINAL DISCOMFORT3 reports
COUGH3 reports
CHOKING2 reports
CONDITION AGGRAVATED2 reports
IRRITABILITY2 reports
NASAL CONGESTION2 reports
NAUSEA2 reports
PRODUCT QUALITY ISSUE2 reports
PYREXIA2 reports
RECALLED PRODUCT2 reports
SEIZURE2 reports
SOMNOLENCE2 reports
VOMITING PROJECTILE2 reports
ABNORMAL BEHAVIOUR1 reports
ACCIDENTAL EXPOSURE TO PRODUCT BY CHILD1 reports
ACCIDENTAL OVERDOSE1 reports
ADVERSE EVENT1 reports
CANDIDA INFECTION1 reports
CELLULITIS1 reports
CONSTIPATION1 reports
DEATH1 reports
DECREASED APPETITE1 reports
DEHYDRATION1 reports
DIALYSIS1 reports
DRUG EFFECT PROLONGED1 reports
DYSGEUSIA1 reports
DYSPEPSIA1 reports
EAR INFECTION1 reports
ENCEPHALITIS1 reports
FAILURE OF CHILD RESISTANT MECHANISM FOR PHARMACEUTICAL PRODUCT1 reports
FALL1 reports
FATIGUE1 reports
FLATULENCE1 reports
GASTROINTESTINAL DISORDER1 reports
HAEMATOCHEZIA1 reports
HAEMOGLOBIN DECREASED1 reports
HAEMORRHAGIC ANAEMIA1 reports
HOSPITALISATION1 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION1 reports
INFANTILE VOMITING1 reports
INTENTIONAL SELF INJURY1 reports
LETHARGY1 reports
LOWER LIMB FRACTURE1 reports
ORAL DISCOMFORT1 reports
PRODUCT COMPLAINT1 reports
PRODUCT DOSE OMISSION ISSUE1 reports
PRODUCT TASTE ABNORMAL1 reports
PRODUCTIVE COUGH1 reports
PULMONARY OEDEMA1 reports
RASH1 reports
RENAL INJURY1 reports
RETCHING1 reports
SCREAMING1 reports
SMALL INTESTINAL ULCER HAEMORRHAGE1 reports
SOMNAMBULISM1 reports
STREPTOCOCCAL SEPSIS1 reports
THROAT IRRITATION1 reports
TUBULOINTERSTITIAL NEPHRITIS1 reports
VIRAL INFECTION1 reports
WEIGHT INCREASED1 reports

Report Outcomes

Out of 39 classified reports for INFANTS IBUPROFEN:

Serious 53.8%Non-Serious 46.2%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male24 (64.9%)
Female13 (35.1%)

Reports by Age

Age 23 reports
Age 63 reports
Age 73 reports
Age 12 reports
Age 82 reports
Age 102 reports
Age 91 reports
Age 111 reports
Age 121 reports
Age 131 reports
Age 141 reports
Age 161 reports
Age 181 reports
Age 211 reports
Age 301 reports
Age 631 reports
Age 641 reports
Age 3831 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with INFANTS IBUPROFEN?

This profile reflects 101 FDA FAERS reports that mention INFANTS IBUPROFEN. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for INFANTS IBUPROFEN?

Frequently reported terms in FAERS include DIARRHOEA, VOMITING, RECALLED PRODUCT ADMINISTERED, DRUG INEFFECTIVE, ABDOMINAL DISCOMFORT, COUGH. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures INFANTS IBUPROFEN?

Labeling and FAERS entries often list Aurohealth LLC in connection with INFANTS IBUPROFEN. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.