This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
Listed on the WHO Model List of Essential Medicines: a global expert panel judged it among the medicines a health system should always have, on evidence of value, not marketing.
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 )
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 )
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 fo...
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 ...
Source: FDA SPL label for HEMANGEOL (Pierre Fabre Pharmaceuticals, Inc.), effective 20260625. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 5,820 | 5,690 | 4,837 | 5,489 | 5,846 | 6,688 | 5,903 | 3,234 |
3,767 reports blaming this drug for every million Medicare prescriptions filled, which is 1.4× the typical drug on this site. (15,687 reports in 2024–2026, against 4,164,278 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 01/2022 | Class II | CARDINAL HEALTHCARE | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. |
| 08/2014 | Class II | Fresenius Kabi USA, LLC | CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical deficiencies which caused a recall of the API lot used to manufacture Propanolo HCl Injection. |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $53,230 in payments to US physicians and hospitals tied to this drug across 159 transactions (Hemangeol $53,230).
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Propranolol HCl | 3,038,695 | $17 |
| Propranolol HCl ER | 1,123,421 | $43 |
| Inderal La | 1,324 | $5,459 |
| Innopran XL | 584 | $4,659 |
| Inderal XL | 254 | $4,252 |
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.