NeoProfen
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NeoProfen
SIDE EFFECTS
Clinical Trials
The most frequently reported adverse events with NeoProfen (ibuprofen lysine injection) 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 1/2 | 15 | 13 |
| Intraventricular Hemorrhage, Grades 3/4 | 15 | 10 |
| Other Bleeding | 6 | 13 |
| Intraventricular Hemorrhage, All Grades | 29 | 24 |
| Apnea | 28 | 26 |
| Gastrointestinal Disorders | 22 | 18 |
| non-Necrotizing Enterocolitis | ||
| 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 (ibuprofen lysine injection) than on placebo, and greater than 2 events on
NeoProfen (ibuprofen lysine injection) . **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 (ibuprofen lysine injection) in neonates have not been assessed.
Last reviewed on RxList: 1/20/2010
This monograph has been modified to include the generic and brand name in many instances.
Additional NeoProfen Information
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.
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