Recommended Topic Related To:

NeoProfen

"The U.S. Food and Drug Administration today approved the MemoryShape Breast Implant to increase breast size (augmentation) for use in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age. The MemoryShape B"...

NeoProfen

SIDE EFFECTS

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
NeoProfen Placebo
Sepsis 43 37
Anemia 32 25
Total Bleeding** 32 29
  Intraventricular Hemorrhage, Grades ½ 15 13
  Intraventricular Hemorrhage, Grades 3/4 15 10
  Other Bleeding 6 13
Intraventricular Hemorrhage, All Grades 29 24
Apnea 28 26
Gastrointestinal Disorders non-Necrotizing Enterocolitis 22 18
Total Renal Events** 21 15
  Renal Failure 1 3
  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
Respiratory Infection 19 13
Skin Lesion/Irritation 16 6
Hypoglycemia 12 6
Hypocalcemia 12 9
Respiratory Failure 10 4
Urinary Tract Infection 9 4
Adrenal Insufficiency 7 1
Hypernatremia 7 4
Edema 4 0
Atelectasis 4 1
* 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.

Renal Function

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.

Post-marketing Experience

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

DRUG INTERACTIONS

Drug interactions of NeoProfen in neonates have not been assessed.

Read the NeoProfen Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 12/12/2013
This monograph has been modified to include the generic and brand name in many instances.

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.

advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations