Hemangiol

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Hemangiol

Property Description
Active ingredient Propranolol hydrochloride
Form Oral solution
Pharmacological class Non-selective beta-blocker
Common use Systemic treatment of infantile hemangioma
Origin Prescription-only medication

Hemangiol is a prescription oral solution containing the active ingredient propranolol hydrochloride. It is a drug specifically formulated for the systemic treatment of proliferating infantile hemangioma (IH).

This medication is categorized as a non-selective beta-blocker, a class of medicine traditionally used for cardiovascular issues. Its specific formulation is intended for use in infants aged 5 weeks to 5 months at the start of treatment, a critical period for IH growth, and is supplied as an oral solution (3.75 mg/mL) for accurate, weight-based dosing.

The use of propranolol in IH is clinically recognized for its ability to halt the rapid growth phase of the vascular tumor and promote its involution. The mechanism involves constricting blood vessels and triggering cell death within the tumor mass. This treatment is generally reserved for hemangiomas that are life-threatening, function-impairing, or ulcerated, or those that have a high risk of permanent scarring or disfigurement.

Administration of Hemangiol requires strict supervision by a physician experienced in the diagnosis and treatment of infantile hemangioma.

What side effects are possible with Hemangiol?

Possible Side Effects and Safety Information

Adverse Reactions

The most common adverse reactions (10% incidence in clinical trials) observed with Hemangiol include sleep disorders (such as insomnia and poor quality sleep), aggravated respiratory tract infections (e.g., bronchitis, bronchiolitis), diarrhea, and vomiting.

Less common but serious adverse reactions are related to the pharmacological class of the drug, propranolol. These include:

  • Hypoglycemia (low blood sugar): This is a key concern, as the medication can mask the typical warning signs of low blood sugar, such as a fast heart rate. The risk increases if the child is not feeding regularly, is vomiting, or during periods of fasting.
  • Cardiovascular Effects: Bradycardia (slow heart rate) and hypotension (low blood pressure) may occur or worsen.
  • Respiratory Issues: Bronchospasm (wheezing or breathing problems).
  • Increased Risk of Stroke: In infants with PHACE syndrome and severe cerebrovascular anomalies, the medication may increase the risk of stroke by potentially lowering blood pressure and altering blood flow.

Contraindications and Safety Restrictions

Hemangiol is contraindicated in several specific situations:

  • Age and Weight: Premature infants with a corrected age of less than 5 weeks or infants weighing less than 2 kg.
  • Pre-existing Conditions: Asthma or a history of bronchospasm, certain cardiac conduction defects (e.g., greater than first-degree heart block, severe bradycardia), decompensated heart failure, or low blood pressure below specific thresholds.

Monitoring of the infant's heart rate and blood pressure is required for at least two hours following the start of treatment or any increase in the dose. The dose should be withheld if the child is not eating or is vomiting to reduce the risk of hypoglycemia. Treatment must be initiated and managed by healthcare professionals experienced in the diagnosis and management of infantile hemangioma in a controlled clinical environment.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory documents define the overdose profile for Hemangiol by focusing on severe, potentially life-threatening physiological effects, which require immediate medical intervention.

Documented Overdose Presentations

Classification Official Regulatory Statement
Documented Manifestations: Symptoms of overexposure include severe bradycardia (slow heart rate) and hypotension (low blood pressure), along with signs of hypoglycemia such as sweating, pallor, and an irregular or fast heartbeat [Source 1.6, 1.4].
Serious Outcomes: Overexposure may lead to severe consequences, including bronchospasm, seizures, coma (decreased level of consciousness), greater than first-degree heart block, and cardiac arrest [Source 1.5, 1.2, 3.7].
Population-Specific Risk: Infants and children are at a heightened risk for severe hypoglycemia, especially during periods of poor feeding, vomiting, or fasting, which is a documented cause of seizures and coma [Source 1.6, 1.3].

Emergency Regulatory Mandates

Classification Official Regulatory Statement
Action Required: Seek emergency medical attention immediately, call a Poison Control Center, or go to the nearest hospital emergency room if an overdose is suspected [Source 1.4, 1.6].
Supportive Measures: Management is based on symptomatic and supportive treatment and requires continuous monitoring of vital signs and Electrocardiogram (ECG), along with frequent blood glucose checks [Source 1.1, 1.2, 3.7].

The official documentation explicitly mandates that the medicine be discontinued upon the onset of severe or symptomatic bradycardia, hypotension, or hypoglycemia. This regulatory structure emphasizes that the presence of these severe clinical signs is a direct trigger for seeking urgent, specialized hospital care.

Therapeutic Uses of Hemangiol

What Hemangiol Treats: Main Uses and Benefits

Hemangiol is commonly used to help manage complicated proliferating infantile hemangiomas (IH) where symptoms create noticeable physiological strain or interfere with functional stability. This management approach is considered relevant for conditions presenting with acute or disruptive symptom patterns, including those where symptoms may interfere with daily functioning, create noticeable physiological strain, or pose a high risk of permanent scarring.

The medication is applied during the active proliferative phase of the lesion to assist with stabilizing the tumor and may help support the lesion's involution (shrinking). This action helps ease the overall symptom load related to the vascular mass and supports movement toward resolution. For complications like ulcerated hemangiomas—open, painful sores where short-term symptomatic assistance is needed—the solution is considered relevant for managing the resulting discomfort and assists with maintaining functional stability.

Quick Fact: Relief for Functional Strain

The treatment is applied in clinical settings that involve acute or unstable symptom patterns, particularly to ease pressure on critical structures like the airway and visual axis, assisting with maintaining functional stability.

Regulatory References

  1. European Medicines Agency (EMA) overview

Eligibility and Restrictions for Use

Official Eligibility Rules for Hemangiol

The eligibility for Hemangiol is narrowly defined, primarily restricted by age, weight, and pre-existing medical conditions, as specified in regulatory documents (FDA, EMA).


Age-Related Eligibility

The medicine is approved for use in infants who are between 5 weeks and 5 months of age at the start of treatment. Treatment initiation is not recommended for infants older than 5 months. Safety and effectiveness have not been established in children older than 1 year.


Contraindicated Populations

Use is prohibited (contraindicated) in infants with:

  • A corrected age of less than 5 weeks or a weight of less than 2 kg (or 2.5 kg, depending on the region).
  • Asthma or history of bronchospasm.
  • Specific cardiac issues, including severe bradycardia (slow heart rate), greater than first-degree heart block, hypotension (low blood pressure), or decompensated heart failure.
  • Hypersensitivity to propranolol or any components of the oral solution.

Condition-Specific Restrictions

Administration is not recommended in infants with hepatic (liver) impairment or renal (kidney) impairment due to the absence of specific data. Infants with PHACE syndrome must undergo thorough screening prior to use, and the dose must be withheld if the infant is not eating or is vomiting due to the risk of hypoglycemia.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The active substance in Hemangiol (propranolol) may interact with other medicinal products. These interactions are primarily based on effects on the heart's rhythm and conduction, or the potential for metabolic effects such as blood glucose regulation.

Key interactions that require caution or are not recommended include:


Pharmacodynamic Interactions

Interacting Product Category Specific Medicines Interaction Context
Bradycardia-inducing Calcium-Channel Blockers Diltiazem, Verapamil Concomitant use is not recommended due to an increased risk of severe bradycardia, sino-atrial or atrio-ventricular conduction disorders, and potential heart failure. Close clinical and ECG monitoring is required if this combination is unavoidable.
Oral Corticosteroids (Various) May increase the risk of hypoglycemia in the patient due to the potential loss of the counter-regulatory cortisol response when combined with propranolol.
Breastfeeding Restriction (Various) Hemangiol is contraindicated in breastfed infants if the mother is being treated with any medicine that is contraindicated for use with propranolol.

Procedural Constraint

If the patient is scheduled for surgery requiring general anesthesia, consideration may be given to discontinuing Hemangiol at least 48 hours before the procedure, depending on the anesthetic agents used and the patient’s condition. This is to avoid potentially severe hemodynamic reactions, such as profound hypotension, related to the beta-blocking effects.

Mechanism of Action

The mechanism of action of propranolol hydrochloride is complex and involves three core biological activities that work simultaneously to suppress proliferation and induce involution of the lesion.

Modulation of Local Vascular Tone

This domain covers the immediate physiological response driven by antagonism of the beta2 adrenergic receptors on the blood vessels. This receptor blockade causes the localized microvasculature to narrow (vasoconstriction), which reduces blood volume and pressure within the lesion.


Suppression of Angiogenesis and Cell Proliferation

This mechanism targets the signals that drive growth by inhibiting the activation of key growth factor receptors, such as VEGFR-2, and reducing the expression of VEGF. By interfering with these pro-angiogenic signals, the drug modulates the proliferation and migration rates of the structural cells.


Induction of Programmed Cell Death (Apoptosis)

This long-term mechanism actively triggers the intrinsic apoptosis pathway within the rapidly dividing endothelial cells. This cellular process leads to the controlled elimination and structural breakdown of the cellular components, thereby contributing to the lesion's physiological involution over time.

Dosage and Administration Information

How to use Hemangiol (Propranolol Hydrochloride) Oral Solution

This medicine is an oral solution that must be administered strictly according to the official, weight-based dosing schedule and administration rules.

Administration and Dosing Protocol

Instruction Category Official Rule
Route of Administration Oral (by mouth).
Age for Initiation Infants aged 5 weeks to 5 months.
Frequency and Timing Twice daily (BID), with doses taken at least 9 hours apart.
Timing with Meals Administer during or immediately after a feeding to mitigate risks.
Dosing Adjustment The prescribed dose must be periodically readjusted by a physician as the child’s weight increases.

Preparation and Procedural Rules

  • Preparation Method: The solution should not be shaken before use. The dose must be measured using the specific oral dosing syringe provided with the product.
  • Optional Dilution: If necessary, the dose may be diluted in a small quantity of milk or fruit juice and given in a baby bottle, but the mixture must be used within 2 hours. Do not mix the medicine into a full bottle of liquid.
  • Missed or Vomited Dose: If the child is not eating (poor appetite) or vomits the dose, that dose must be skipped. Do not give a replacement dose or double dose before the next regularly scheduled time.
  • Clinical Monitoring: Heart rate and blood pressure monitoring for at least 2 hours is required following the first dose and after any subsequent dose increase.
  • Course Duration: Treatment is generally administered for a total period of six months.

Recent Clinical Evidence

Research evidence / Overview of studies for Hemangiol

Evidence for the Systemic Treatment of Proliferating Infantile Hemangioma

This section will outline the structure of the research, focusing on the controlled studies that evaluated the medicine's use in infants with complicated proliferating hemangioma. It will describe the types of outcomes researchers monitored, such as the achievement of complete or near-complete lesion resolution.

Research included one Randomized, Double-Blind, Placebo-Controlled Trial (RCT). This type of research was applied in studies examining infants whose hemangiomas were actively growing and required systemic treatment. These trials specifically compared the medication against an inactive substance (placebo). Researchers monitored how outcomes related to physical discomfort and lesion appearance were measured over a defined time interval.

Research Focused on Specific Patient Age Groups

The population studied was specific, consisting of infants who were between 5 weeks and 5 months of age when treatment was initiated. The evidence derived from these studies applies to the populations studied in this specific age window. Studies explored various hemangioma locations, including facial and non-facial lesions. Studies describe that the data collected were consistent across the populations studied, including different locations and age subgroups within the defined range.

Long-Term Research and Follow-up Durations

The main evaluation of outcomes was structured over a short-term, 6-month (24-week) treatment period. Following this core trial, studies monitored patient responses and safety during an intermediate-term open-label follow-up phase that extended up to 72 weeks. This extended observation period contributes to the broader evidence landscape but does not provide extensive long-term data.

Known Gaps and Unanswered Research Questions

Evidence is limited in several key areas. The primary, high-level research excluded the most severe and complex hemangiomas, such as those that are acutely life-threatening or function-impairing. Data for certain groups remain insufficient. There is limited information for long-term outcomes, and few data are available describing starting treatment in infants older than 5 months of age. Study results reflect the specific conditions and populations under which they were conducted.

Frequently Asked Questions (FAQ)

Common questions about Hemangiol (FAQ)


Q: Does Hemangiol come in different flavors or concentrations?

A: The medicine is an oral solution supplied at a concentration of 3.75 mg/mL, which is the only concentration available for this specific product. According to the official patient material, the formulation contains both strawberry and vanilla flavorings.


Q: Are there long-term side effects noted in regulatory documents for Hemangiol use?

A: The primary safety data was collected during the six-month treatment period, with an intermediate follow-up phase lasting up to 72 weeks (about 1.5 years). Official information indicates that the amount of data available for outcomes extending far beyond this observation period is limited.


Q: What should a parent watch out for during the first few days of giving Hemangiol?

A: The regulatory documents highlight the importance of careful monitoring for serious reactions, which may include signs of low heart rate or blood pressure, such as fatigue, paleness, or bluish skin color. The risk of low blood sugar (hypoglycemia) is also a key safety concern outlined in the product information.


Q: How is the safety of Hemangiol monitored after it has been approved?

A: The safety of the drug continues to be monitored by regulatory authorities even after its approval. This process, called post-marketing surveillance, requires the manufacturer to collect and review ongoing safety data from the public to assess potential long-term risks or rare side effects.


Q: What are the signs that Hemangiol is working as expected?

A: Studies focused on the goal of achieving complete or near-complete resolution of the hemangioma lesion. Visible signs of improvement, such as changes in the lesion’s size or color, are expected as the treatment progresses. The prescribing physician assesses this progress regularly.


Q: How do doctors decide when to stop the Hemangiol treatment?

A: Official guidelines establish the standard treatment duration as generally six months. The doctor determines the final decision to stop based on this recommended period, alongside the child's age, weight, and whether the desired therapeutic response (resolution of the lesion) has been achieved.


Q: Why is the drug given twice a day?

A: The prescribed use involves administration twice daily, with at least nine hours between doses. This schedule is designed to maintain a consistent therapeutic level of the drug in the body, which is necessary for effective treatment of the hemangioma.


Q: Is there information on Hemangiol's use during pregnancy or breastfeeding, if relevant for the mother?

A: Propranolol, the active ingredient, is known to pass into breast milk. The official label notes a specific restriction: the drug is contraindicated for the infant if the mother is taking any medication that is also contraindicated with propranolol. Available information suggests that the amount of the drug the infant receives through breast milk is typically small.


Q: Are there any common foods or drinks that should be avoided while taking Hemangiol?

A: The regulatory product information indicates the drug is administered during or immediately after a feeding. The main concern is avoiding the risk of low blood sugar (hypoglycemia), which is heightened if the child is not eating regularly. The regulatory warning highlights the importance of consistent feeding at the time of administration to mitigate risks.


Q: Is there a generic version of Hemangiol available?

A: Currently, there is no generic equivalent of the specific Hemangiol oral solution formulation (3.75 mg/mL) that has been approved by the U.S. Food and Drug Administration (FDA).


Q: Is it okay to give other cough or cold medicines alongside Hemangiol?

A: The product information indicates that specific drug interactions exist with certain categories of medicines, including NSAIDs and some antacids, which can be found in common over-the-counter cold treatments. Furthermore, the official label states that the use of Hemangiol is contraindicated if the child has a history of breathing problems, such as asthma or bronchospasm.


Q: Does taking Hemangiol cause changes to the skin?

A: Adverse effects reported for this class of medicine include the possibility of a skin rash. Additionally, due to how the drug works to narrow blood vessels, a child may experience peripheral coldness, appearing as cool or clammy skin.


Q: Is Hemangiol used in other countries under different names?

A: Hemangiol is the registered brand name for this specific propranolol oral solution in multiple international jurisdictions, including the US, the European Union, and Canada. While the active ingredient is propranolol, this specific formulation is known by the brand name Hemangiol in these regions.


Q: Are there any religious or dietary restrictions related to the ingredients in Hemangiol?

A: The official formulation is specifically free of alcohol, sugar, and parabens. This information is provided in the product labeling as part of the composition disclosure.


Q: Can Hemangiol interact with common vitamins or supplements?

A: Official warnings indicate that propranolol may interact with certain supplements, such as multivitamins containing minerals. Official information indicates that administration of the drug and the supplement may need to be separated by several hours to avoid reduced effectiveness. For safety, official documents recommend that healthcare providers be aware of all vitamins and supplements being used.


Q: Does Hemangiol contain alcohol or sugar?

A: No, the specific formulation of Hemangiol oral solution is officially designated as both alcohol-free and sugar-free.


Q: Is there any research on the effects of Hemangiol on growth or development?

A: Published medical literature has investigated the effect of propranolol on a child’s physical development, such as weight and height. These studies suggest that the medication does not significantly impact short-term growth.


Q: Do official documents mention any potential interactions with herbal remedies?

A: Regulatory documents advise informing healthcare professionals about all products being used, including herbal remedies, as a general safety measure to manage potential drug interactions.


Q: If a child has a fever, should they still take Hemangiol?

A: When a child is ill and is experiencing poor appetite or vomiting, regardless of the cause (such as a fever), the regulatory label indicates the dose should be withheld. This is a critical safety measure intended to reduce the risk of severe low blood sugar (hypoglycemia). The product information emphasizes the need for medical guidance if the child is unwell.


Q: What does 'systemic' mean in the context of how Hemangiol works?

A: The term 'systemic treatment' means that the medication is administered orally and works throughout the entire body after being absorbed into the bloodstream. This is in contrast to a topical medicine that would only work locally on the skin's surface.


Q: Does Hemangiol have any known drug interactions with antacids?

A: Official documents indicate that certain types of antacids, including those that contain aluminum or calcium carbonate, may interact with the active ingredient. This interaction could potentially reduce the effects of Hemangiol, and may require separating the administration times of the two medicines.


Q: What is the significance of the 'solution' form of Hemangiol?

A: The medication is supplied as an oral solution because this liquid form is specifically necessary to achieve accurate, weight-based dosing for infants. This formulation is critical for ensuring the proper dose is given as the child's weight changes.

How should Hemangiol be stored and disposed of?

Storage and Disposal Requirements

Hemangiol oral solution must be stored at Controlled Room Temperature (25 C or 77 F), with excursions permitted between 15 C and 30 C (59 F and 86 F). The medication must be kept in its original container, tightly closed, and protected from light, moisture, and excess heat. It is strictly required that the solution is not frozen and the bottle is not shaken before use.

Classification Official Regulatory Wording
Storage Condition Store at Controlled Room Temperature.
In-Use Stability Discard 60 days after first opening.
Handling Constraints Do not freeze. Do not shake.

For stability, any remaining solution must be discarded 2 months (60 days) after the bottle is first opened. To ensure safety, the product must be kept out of the sight and reach of children. Unused or expired Hemangiol must not be disposed of via wastewater or in household garbage; consult a pharmacist or follow specific governmental guidelines for proper disposal.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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