NeoProfen Side Effects Center

Last updated on RxList: 5/9/2022
NeoProfen Side Effects Center

What Is NeoProfen?

NeoProfen (ibuprofen lysine) Injection is a nonsteroidal anti-inflammatory drug (NSAID) used to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support, etc.) is ineffective.

What Are Side Effects of NeoProfen?

Common side effects of NeoProfen include:

Dosage for NeoProfen

A course of therapy of NeoProfen is three doses administered intravenously. An initial dose of 10 mg per kilogram is followed by two doses of 5 mg per kilogram each, after 24 and 48 hours. All doses should be based on birth weight.

What Drugs, Substances, or Supplements Interact with NeoProfen?

NeoProfen may interact with other drugs. Tell your doctor all medications and supplements your child uses.

NeoProfen During Pregnancy and Breastfeeding

NeoProfen is usually used in infants and is unlikely to be used in pregnant or breastfeeding women; consult your doctor if you have questions.

Additional Information

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Our NeoProfen (ibuprofen lysine) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

About how much does an adult human brain weigh? See Answer
NeoProfen Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.

Tell your medical caregivers right away if you have:

  • changes in your vision;
  • swelling, rapid weight gain, feeling short of breath;
  • severe headache, pounding in your neck or ears;
  • little or no urination;
  • high blood potassium--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement;
  • liver problems--loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes);
  • low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or
  • signs of stomach bleeding--stomach pain, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

If your baby has been treated with Neoprofen, tell the doctor at once if the baby has:

  • signs of infection such as fever, chills, fussiness;
  • unusual bleeding; or
  • bruising, swelling, warmth, redness, or irritation around the IV needle.

Common side effects may include:

  • nausea, vomiting, gas;
  • headache; or
  • dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for NeoProfen (Ibuprofen Lysine Injection)

SLIDESHOW

Digestive Disorders: Common Misconceptions See Slideshow
NeoProfen Professional Information

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 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
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, necrotizing enterocolitis, and pulmonary hypertension. 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.

DRUG INTERACTIONS

Diuretics

Ibuprofen may reduce the effect of diuretics; diuretics can increase the risk of nephrotoxicity of NSAIDs in dehydrated patients. Monitor renal function in patients receiving concomitant diuretics.

Amikacin

Ibuprofen may decrease the clearance of amikacin.

Read the entire FDA prescribing information for NeoProfen (Ibuprofen Lysine Injection)

© NeoProfen Patient Information is supplied by Cerner Multum, Inc. and NeoProfen Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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