Hemangeol

Last updated on RxList: 7/1/2021
Hemangeol Side Effects Center

What Is Hemangeol?

Hemangeol (propranolol hydrochloride) Oral Solution is a beta-blocker used to treat proliferating infantile hemangioma requiring systemic therapy.

What Are Side Effects of Hemangeol?

Common side effects of Hemangeol include:

Dosage for Hemangeol

The recommended starting dose of Hemangeol is 0.15 mL/kg (0.6 mg/kg) twice daily, taken at least 9 hours apart. After 1 week, increase the daily dose to 0.3 mL/kg (1.1 mg/kg) twice daily. After 2 weeks of treatment, increase the dose to 0.4 mL/kg (1.7 mg/kg) twice daily and maintain this for 6 months. Readjust the dose periodically as the child's weight increases.

What Drugs, Substances, or Supplements Interact with Hemangeol?

Hemangeol may interact with phenytoin, phenobarbital, rifampin, and corticosteroids.

Hemangeol During Pregnancy and Breastfeeding

Consider both the infant's medications and those of a nursing mother. Tell your doctor all medications and supplements you and your child use. Hemangeol is not intended to be prescribed to pregnant or breastfeeding women.

Additional Information

Our Hemangeol (propranolol hydrochloride) Oral Solution 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.

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Hemangeol Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • slow or uneven heartbeats;
  • a light-headed feeling, like you might pass out;
  • wheezing or trouble breathing;
  • shortness of breath (even with mild exertion), swelling, rapid weight gain;
  • sudden weakness, vision problems, or loss of coordination (especially in a child with hemangioma that affects the face or head);
  • cold feeling in your hands and feet;
  • depression, confusion, hallucinations;
  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • low blood sugar--headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery;
  • low blood sugar in a baby--pale skin, blue or purple skin, sweating, fussiness, crying, not wanting to eat, feeling cold, drowsiness, weak or shallow breathing (breathing may stop for short periods), seizure (convulsions), or loss of consciousness; or
  • severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • nausea, vomiting, diarrhea, constipation, stomach cramps;
  • decreased sex drive, impotence, or difficulty having an orgasm;
  • sleep problems (insomnia); or
  • tired feeling.

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 Hemangeol (Propranolol Hydrochloride Oral Solution)

SLIDESHOW

Digestive Disorders: Common Misconceptions See Slideshow
Hemangeol Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

  • Hypoglycemia and related events, like hypoglycemic seizure [see WARNINGS AND PRECAUTIONS].
  • Bronchospasm [see WARNINGS AND PRECAUTIONS].

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug may not reflect the rates observed in clinical practice.

Clinical Trials Experience With HEMANGEOL In Infants With Proliferating Infantile Hemangioma

In clinical trials for proliferating infantile hemangioma, the most frequently reported adverse reactions (>10%) in infants treated with HEMANGEOL were sleep disorders, aggravated respiratory tract infections such as bronchitis and bronchiolitis associated with cough and fever, diarrhea, and vomiting. Adverse reactions led to treatment discontinuation in fewer than 2% of treated patients.

Overall, 479 patients in the pooled safety population were exposed to study drug in the clinical study program (456 in placebo-controlled trials). A total of 424 patients were treated with HEMANGEOL at doses 1.2 mg/kg/day or 3.4 mg/kg/day for 3 or 6 months. Of these, 63% of patients were aged 91-150 days and 37% were aged 35-90 days at randomization.

The following table lists according to the dosage the most common adverse reactions (treatment-emergent adverse events with an incidence at least 3% greater on one of the two doses than on placebo).

Table 2. Treatment-emergent adverse events occurring at least 3% more often on HEMANGEOL than on placebo

ReactionPlacebo
N=236
HEMANGEOL
1.2 mg/kg/day
N=200
HEMANGEOL
3.4 mg/kg/day
N=224
Sleep disorder5.9%17.5%16.1%
Bronchitis4.78.013.4
Peripheral coldness0.48.06.7
Agitation2.18.54.5
Diarrhea1.34.56.3
Somnolence0.45.00.9
Nightmare1.72.06.3
Irritability1.35.51.3
Decreased appetite0.42.53.6
Abdominal pain0.43.50.4

The following adverse events have been observed during clinical studies, with an incidence of less than 1%:

Cardiac disorders: Second degree atrioventricular heart block, in a patient with underlying conduction disorder, required definitive treatment discontinuation [see WARNINGS AND PRECAUTIONS].

Skin and subcutaneous tissue disorders: Urticaria, alopecia

Investigations: Decreased blood glucose, decreased heart rate

Compassionate Use Program

More than 600 infants received HEMANGEOL in a compassionate use program (CUP). Mean age at treatment initiation was 3.6 months. Mean dose of HEMANGEOL was 2.2 mg/kg/day and mean treatment duration was 7.1 months.

The adverse reactions reported in the CUP were similar to the ADRs observed during clinical trials but some were more severe.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of propranolol. 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.

These adverse reactions are as follows:

Blood and lymphatic system disorders: Agranulocytosis

Psychiatric disorders: Hallucination

Skin and subcutaneous tissues disorders: Purpura

Read the entire FDA prescribing information for Hemangeol (Propranolol Hydrochloride Oral Solution)

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

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