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Neoprofen (Ibuprofen Lysine) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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 1
% Incidence
Adverse Event NeoProfen Placebo
Sepsis 43 37
Anemia 32 25
Total Bleeding 2       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

1 Within 30 days of therapy, with an event rate greater on NeoProfen than on placebo, and greater than 2 events on NeoProfen.
2 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.



REPORTS OF SUSPECTED NEOPROFEN SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Neoprofen. The information is not vetted and should not be considered as verified clinical evidence.

Possible Neoprofen side effects / adverse reactions in 26 year old female

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-03-02

Patient: 26 year old female

Reactions: Hepatitis C, Drug Interaction, Toxicity TO Various Agents

Adverse event resulted in: death

Suspect drug(s):
Nordiazepam (Nordazepam)
    Indication: Product Used FOR Unknown Indication

Desoxyn
    Indication: Product Used FOR Unknown Indication

Amphetamine Sulfate
    Indication: Product Used FOR Unknown Indication

Neoprofen
    Indication: Product Used FOR Unknown Indication

Diazepam
    Indication: Product Used FOR Unknown Indication

Methylenedioxymethamphetamine (Methylebedioxymethamphetamine)
    Indication: Product Used FOR Unknown Indication

Fluvoxamine Maleate
    Indication: Product Used FOR Unknown Indication

Olanzapine
    Indication: Product Used FOR Unknown Indication



See index of all Neoprofen side effect reports >>

Drug label data at the top of this Page last updated: 2013-12-17

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