Hemangeol

Q: What are the side effects of Hemangeol?

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 (5.1) ]. Bronchospasm [see Warnings and Precautions (5.3) ]. The most common adverse reactions to HEMANGEOL (occurring ≥ 10% of patients) were sleep disorders, aggravated respiratory tract infections,… See the full label for the complete list.

Propranolol Hydrochloride · Solution · Oral

Prescription (Rx) beta-Adrenergic Blocker

Uses

1 INDICATIONS AND USAGE HEMANGEOL oral solution contains the beta-adrenergic blocker propranolol hydrochloride and is indicated for the treatment of proliferating infantile hemangioma requiring systemic therapy. HEMANGEOL oral solution is a beta-adrenergic blocker indicated for the treatment of proliferating infantile hemangioma requiring systemic therapy. ( 1 )

Dosage and administration

Initiate treatment at ages 5 weeks to 5 months. The recommended starting dose of HEMANGEOL is 0.15 mL/kg (0.6 mg/kg) (see Table 1) 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. To reduce the risk of hypoglycemia, administer HEMANGEOL orally during or right after a feeding. Skip the dose if the child is not eating or is vomiting [see Warnings and Precautions (5.1) ] . Monitor heart rate and blood pressure for 2 hours after HEMANGEOL initiation or dose increases [see Warnings and Precautions (5.2) ]. If hemangiomas recur, treatment may be re-initiated [see Clinical Studies (14) ] . HEMANGEOL is supplied with an oral dosing syringe for administration. Administration directly into the child’s mouth is recommended. Nevertheless, if necessary, the product may be diluted in a small quantity of milk or fruit juice, given in a baby’s bottle. Table 1. Dose Titration According to Weight Week 1 Week 2 Week 3 (maintenance) Weight (kg) Volume administered Volume administered Volume administered twice a day twice a day twice a day 2 to <2.5 0.3 mL 0.6 mL 0.8 mL 2.5 to <3 0.4 mL 0.8 mL 1 mL 3 to <3.5 0.5 mL 0.9 mL 1.2 mL 3.5 to <4 0.5 mL 1.1 mL 1.4 mL 4 to <4.5 0.6 mL 1.2 mL 1.6 mL 4.5 to <5 0.7 mL 1.4 mL 1.8 mL 5 to <5.5 0.8 mL 1.5 mL 2 mL 5.5 to <6 0.8 mL 1.7 mL 2.2 mL 6 to <6.5 0.9 mL 1.8 mL 2.4 mL 6.5 to <7 1 mL 2 mL 2.6 mL 7 to <7.5 1.1 mL 2.1 mL 2.8 mL 7.5 to <8 1.1 mL 2.3 mL 3 mL 8 to <8.5 1.2 mL 2.4 mL 3.2 mL 8.5 to <9 1.3 mL 2.6 mL 3.4 mL 9 to <9.5 1.4 mL 2.7 mL 3.6 mL 9.5 to <10 1.4 mL 2.9 mL 3.8 mL 10 to <10.5 1.5 mL 3 mL 4 mL 10.5 to <11 1.6 mL 3.2 mL 4.2 mL 11 to <11.5 1.7 mL 3.3 mL 4.4 mL 11.5 to <12 1.7 mL 3.5 mL 4.6 mL 12 to <12.5 1.8 mL 3.6 mL 4.8 mL Initiate treatment at ages 5 weeks to 5 months. ( 2 ) Starting dose is 0.15 mL/kg (0.6 mg/kg) twice daily. After 1 week, increase dose to 0.3 mL/kg (1.1 mg/kg) twice daily. After 2 weeks, increase to a maintenance dose of 0.4 mL/kg (1.7 mg/kg) twice daily. ( 2 ) Administer doses at least 9 hours apart during or after feeding. ( 2 ) Readjust dose for changes in the child’s weight. ( 2 ) Monitor heart rate and blood pressure for 2 hours after the first dose or increasing dose. ( 2 )

Dosage forms and strengths

Oral solution: 4.28 mg/mL propranolol hydrochloride. Alcohol-, paraben- and sugar-free. Oral solution: 4.28 mg/mL propranolol hydrochloride ( 3 )

Contraindications

4 CONTRAINDICATIONS HEMANGEOL is contraindicated in the following conditions: Premature infants with corrected age < 5 weeks Infants weighing less than 2 kg Known hypersensitivity to propranolol or any of the excipients [see Description (11) ] Asthma or history of bronchospasm Heart rate <80 beats per minute, greater than first degree heart block, or decompensated heart failure Blood pressure <50/30 mmHg Pheochromocytoma Premature infants with corrected age <5 weeks ( 4 ) Infants weighing less than 2 kg ( 4 ) Known hypersensitivity to propranolol or excipients ( 4 ) Asthma or history of bronchospasm ( 4 , 5.3 , 6 , 10 , 17 ) Bradycardia (<80 beats per minute), greater than first degree heart block, decompensated heart failure ( 4 , 5.2 , 5.4 , 10 , 17 ) Blood pressure <50/30 mmHg ( 4 , 5.2 , 10 , 17 ) Pheochromocytoma ( 4 )

Warnings and precautions

Hypoglycemia: Administer during or after feeding. Do not use in patients who are not able to feed or are vomiting ( 4 , 5.1 , 6 , 10, 17 )
• Bradycardia and hypotension ( 4 , 5.2 , 17 )
• Bronchospasm: Avoid use in patients with asthma or lower respiratory infection ( 4 , 5.3 , 6 , 10 , 17 )
• Increased risk of stroke in PHACE syndrome ( 5.5 ) 5.1 Hypoglycemia HEMANGEOL prevents the response of endogenous catecholamines to correct hypoglycemia and masks the adrenergic warning signs of hypoglycemia, particularly tachycardia, palpitations and sweating. HEMANGEOL can cause hypoglycemia at any time during treatment. Risk is increased during a fasting period (e.g., poor oral food intake, infection, vomiting) or when glucose demands are increased (e.g., cold, stress, infections). Withhold the dose under these conditions. Hypoglycemia may present in the form of seizures, lethargy, or coma. Discontinue HEMANGEOL if hypoglycemia develops and treat appropriately Concomitant treatment with corticosteroids may increase the risk of hypoglycemia [ see Drug Interactions (7) ] . 5.2 Bradycardia and Hypotension HEMANGEOL may cause or worsen bradycardia or hypotension. In the studies of HEMANGEOL for infantile hemangioma the mean decrease in heart rate was about 7 bpm with little effect on blood pressure. Monitor heart rate and blood pressure after treatment initiation or increase in dose. Discontinue treatment if severe (<80 beats per minute) or symptomatic bradycardia or hypotension (systolic blood pressure <50 mmHg) occurs. 5.3 Bronchospasm HEMANGEOL can cause bronchospasm; do not use in patients with asthma or a history of bronchospasm. Interrupt treatment in the event of a lower respiratory tract infection associated with dyspnea and wheezing. 5.4 Cardiac Failure Sympathetic stimulation supports circulatory function in patients with congestive heart failure, beta blockade may precipitate more severe failure. 5.5 Increased Risk of Stroke in PHACE Syndrome By dropping blood pressure, HEMANGEOL may increase the risk of stroke in PHACE syndrome patients with severe cerebrovascular anomalies. Investigate infants with large facial infantile hemangioma for potential arteriopathy associated with PHACE syndrome prior to HEMANGEOL therapy. 5.6 Hypersensitivity Beta-blockers will interfere with epinephrine used to treat serious anaphylaxis.

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 (5.1) ]. Bronchospasm [see Warnings and Precautions (5.3) ]. The most common adverse reactions to HEMANGEOL (occurring ≥ 10% of patients) were sleep disorders, aggravated respiratory tract infections, diarrhea, and vomiting. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pierre Fabre Pharmaceuticals, Inc. at 1-855-PFPHARM (737-4276) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . See 17 for PATIENT COUNSELING INFORMATION and Medication Guide 6.1 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 Reaction Placebo N=236 HEMANGEOL 1.2 mg/kg/day N=200 HEMANGEOL 3.4 mg/kg/day N=224 Sleep disorder 5.9% 17.5% 16.1% Bronchitis 4.7 8.0 13.4 Peripheral coldness 0.4 8.0 6.7 Agitation 2.1 8.5 4.5 Diarrhea 1.3 4.5 6.3 Somnolence 0.4 5.0 0.9 Nightmare 1.7 2.0 6.3 Irritability 1.3 5.5 1.3 Decreased appetite 0.4 2.5 3.6 Abdominal pain 0.4 3.5 0.4 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 ( 5.4 ) ] . 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. 6.2 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, dermatitis psoriasform

Drug interactions

In the absence of specific studies in children, the drug interactions with propranolol are those known in adults. Consider both the infant’s medications and those of a nursing mother. Pharmacokinetic drug interactions Impact of co-administered drugs on propranolol: CYP2D6, CYP1A2 or CYP2C19 inhibitors increase propranolol plasma concentration. CYP1A2 inducers (phenytoin, phenobarbital) or CYP2C19 inducers (rifampin) decrease propranolol plasma concentration when co-administered. Pharmacodynamic drug interactions Corticosteroids: Patients on corticosteroids may be at increased risk of hypoglycemia because of loss of the counter-regulatory cortisol response; monitor patients for signs of hypoglycemia.

Use in specific populations

8.4 Pediatric Use Of 460 infants with proliferating infantile hemangioma requiring systemic therapy who were treated with HEMANGEOL starting at 5 weeks to 5 months of age, 60% had complete or nearly complete resolution of their hemangioma at Week 24 [see Clinical Studies (14) ]. Safety and effectiveness for infantile hemangioma have not been established in pediatric patients greater than 1 year of age. 8.6 Hepatic Impairment There is no experience in infants with hepatic impairment . 8.7 Renal Impairment There is no experience in infants with renal impairment .

Pediatric use

Overdosage

Few cases of propranolol overdose were reported. For a single intake, the maximum dose was 20 mg/kg. Symptomatic cases featured hypotension, hypoglycemic seizure, and restlessness/euphory/insomnia; for most cases, propranolol was maintained or reintroduced. The toxicity of beta-blockers is an extension of their therapeutic effects: - Cardiac symptoms of mild to moderate poisoning are decreased heart rate and hypotension. Atrioventricular blocks, intraventricular conduction delays, and congestive heart failure can occur with more severe poisoning. - Bronchospasm may develop particularly in patients with asthma. - Hypoglycemia may develop and manifestations of hypoglycemia (tremor, tachycardia) may be masked by other clinical effects of beta-blocker toxicity. Support and treatment: Place the patient on a cardiac monitor, and monitor vital signs, mental status and blood glucose. Give intravenous fluids for hypotension and atropine for bradycardia. Glucagon then catecholamines should be considered if the patient does not respond appropriately to IV fluid. Isoproterenol and aminophylline may be used for bronchospasm. Propranolol is not dialyzable.

Description

11 DESCRIPTION HEMANGEOL is an oral solution of propranolol that is alcohol free, paraben free and sugar free. Each mL of HEMANGEOL contains 4.28 mg of propranolol hydrochloride, USP equivalent to 3.75 mg of propranolol. Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as (2RS)1-[(1-methylethyl)amino]-3-(naphthalene-1-yloxy)-propan-2-ol hydrochloride. Its structural formula is shown in Figure 1: Figure 1. Propranolol HCl Structure Molecular formula: C 16 H 21 NO 2 -HCl Propranolol hydrochloride is a stable, white, crystalline solid with a molecular weight of 295.8. It is readily soluble in water and ethanol. HEMANGEOL contains the following inactive ingredients: strawberry/vanilla flavorings, hydroxyethylcellulose, saccharin sodium, citric acid monohydrate, and water. Figure 1. Propranolol HCl structure

Mechanism of action

12.1 Mechanism of Action The mechanism of HEMANGEOL’s effects on infantile hemangiomas is not well understood.

How supplied

16.1 How Supplied HEMANGEOL is supplied as an oral solution. Each 1 mL contains 4.28 mg propranolol. HEMANGEOL is supplied in a carton containing one 120 mL bottle with syringe adapter and one 5-mL oral dosing syringe. NDC 64370-375-01 Bottle 120 mL 16.2 Storage and Handling Store at 25 °C (77 °F); excursions permitted from 15° to 30 °C (59° to 86 °F). [See USP Controlled Room Temperature.] Do not freeze. Do not shake the bottle before use. Dispense in original container with enclosed oral dosing syringe. The product can be kept for 2 months after first opening. See instructions for using enclosed oral dosing syringe.

Patient information

See FDA-approved patient labeling (Medication Guide and Instructions for Use). Patient advice Advise parents or caregivers to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Instructions for using oral dosing syringe Instruct parents or caregivers on use of the oral dosing syringe. Risk of hypoglycemia Inform parents or caregivers that there is a risk of hypoglycemia while on HEMANGEOL. Hypoglycemia can occur at any time during treatment. Instruct caregivers to skip dosing in patients who are fasting (e.g., poor oral food intake, infection, vomiting), or when glucose demands are increased (e.g., cold, stress, infections). Instruct parents or caregivers how to recognize the signs of hypoglycemia. Tell them to discontinue HEMANGEOL if hypoglycemia develops and call their health care provider immediately or take the child to the emergency room. [see Warnings and Precautions 5.1] Cardiovascular risks Advise parents or caregivers that there is a potential risk for bradycardia, aggravation of pre-existing conduction disorders, and hypotension associated with the use of HEMANGEOL. Instruct them to contact their healthcare provider in case of fatigue, pallor, slow or uneven heart beats, peripheral coldness or fainting. Respiratory risks Inform parents or caregivers that HEMANGEOL carries risk of bronchospasm or exacerbation of lower respiratory tract infections. Instruct them to contact their healthcare provider or go to the nearest hospital emergency room if their child has breathing problems or wheezing during treatment with HEMANGEOL. Other risks Inform parents or caregivers that changes in sleep patterns may occur during HEMANGEOL therapy. Ask parents or caregivers to tell you all the medications they are administering to their child including prescription and over the counter medicines, vitamins, and herbal supplements. Ask breastfeeding mothers to tell you all the medications they are currently taking, as these may pass into the milk.

Label text from the FDA structured product label by Pierre Fabre Pharmaceuticals, Inc. (revised Jun 25, 2026). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Propranolol Hydrochloride in 2 products

Hemangeol NDC products (2)

NDC	Strength & form	Labeler	Type
71863-132	Propranolol Hydrochloride 4.28 mg/mL Solution	Eton Pharmaceuticals, Inc.	NDA
64370-375	Propranolol Hydrochloride 4.28 mg/mL Solution	Pierre Fabre Pharmaceuticals, Inc.	NDA

Frequently asked questions

What is Hemangeol used for?

What are the side effects of Hemangeol?

Who makes Hemangeol?

Hemangeol is listed by 2 labelers in the FDA NDC directory, including Eton Pharmaceuticals, Inc., Pierre Fabre Pharmaceuticals, Inc..