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Clinical Trials Experience
The most frequently reported adverse events with NeoProfen were as shown in Table 1.
Table 1: Adverse Events within 30 Days of Therapy in
the Multicenter Study*
|Adverse Event||% Incidence|
|Intraventricular Hemorrhage, Grades ½||15||13|
|Intraventricular Hemorrhage, Grades 3/4||15||10|
|Intraventricular Hemorrhage, All Grades||29||24|
|Gastrointestinal Disorders non-Necrotizing Enterocolitis||22||18|
|Total Renal Events**||21||15|
|Renal Insufficiency, Impairment||6||4|
|Urine Output Reduced||3||1|
|Blood Creatinine Increased||3||1|
|Blood Urea Increased with Hematuria||1||1|
|Blood Urea Increased||7||4|
|Urinary Tract Infection||9||4|
|* Within 30 days of therapy,
with an event rate greater on NeoProfen than on placebo, and greater than 2
events on NeoProfen.
** A given subject may have experienced more than one specific event within these adverse event categories. Only the most severe grade of IVH counted for a given subject.
Compared to placebo, there was a small decrease in urinary output in the ibuprofen group on days 2-6 of life, with a compensatory increase in urine output on day 9. In other studies, adverse events classified as renal insufficiency including oliguria, elevated BUN, elevated creatinine, or renal failure were reported in ibuprofen treated infants.
Additional Adverse Events
The adverse events reported in the multicenter study and of unknown association include tachycardia, cardiac failure, abdominal distension, gastroesophageal reflux, gastritis, ileus, inguinal hernia, injection site reactions, cholestasis, various infections, feeding problems, convulsions, jaundice, hypotension, and various laboratory abnormalities including neutropenia, thrombocytopenia, and hyperglycemia.
The following adverse reactions have been identified from spontaneous post-marketing reports or published literature: gastrointestinal perforation and necrotizing enterocolitis. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency, or establish a causal relationship to drug exposure.
Read the NeoProfen (ibuprofen lysine injection) Side Effects Center for a complete guide to possible side effects
Additional NeoProfen Information
- NeoProfen Drug Interactions Center: ibuprofen lysine (pf) iv
- NeoProfen Side Effects Center
- NeoProfen FDA Approved Prescribing Information including Dosage
Report Problems to the Food and Drug Administration
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