HEMANGEOL SIDE EFFECTS
- Generic Name: propranolol hydrochloride oral solution
- Brand Name: Hemangeol
- Drug Class: How Do Anti-anginal Agents Work?, Antidysrhythmics, II,
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
- Bronchospasm
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 1. 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.
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
SRC: NLM .