Hemangeol: adverse event reports filed with FDA

4,383

reports as suspect product

0% of all reports · about 363 a year

441

reports, 12 months to June 2026

1,551 in the 12 months before

5.4%

marked serious by the reporter

78.7% across the class

0.1%

record death among outcomes, as reported

6 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Hemangeol reports recording the termmedian drug in beta-adrenergic blocker

1. Off label useused for a purpose or in a way not on the label39%1,711
2. Inappropriate schedule of product administrationthe product was taken at the wrong times15.5%680
3. Product administered to patient of inappropriate age15%657
4. Sleep disordera sleep problem8.9%391
5. Illness8.3%363
6. Haemangioma7.2%315
7. Condition aggravatedthe condition being treated got worse7.1%312
8. Product use issuea problem in how the product was used6.9%303
9. Diarrhoealoose or frequent stools5.1%222
10. Infantile spitting up4.3%189
11. Peripheral coldness4.1%178
12. Vomitingbeing sick3.8%168
13. Decreased appetitereduced appetite3.4%149
14. Nasopharyngitisa cold3.4%148
15. Pyrexiafever3.2%140
16. Ear infectionan ear infection3.2%139
17. Insomniadifficulty sleeping3.2%139
18. Irritabilityirritability2.9%125
19. Product dose omission issuea dose was missed2.7%117
20. Coughcough2.6%113
21. Product use in unapproved indicationused for a purpose not on the label2.4%105
22. Drug ineffectivethe medicine did not work as expected2.3%102
23. Somnolencedrowsiness2.2%96
24. Respiratory syncytial virus infection1.9%84
25. Sleep terror1.9%82
26. Constipationconstipation1.8%78
27. Gastrooesophageal reflux diseaseacid reflux1.7%73
28. Drug administered to patient of inappropriate age1.5%66
29. Intentional product misusedeliberate use not as intended1.4%60
30. Disease recurrencethe disease came back1.3%57

Top 30 of 227 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 22 drugs in the beta-adrenergic blocker class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 148,208 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 99.5% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 4,383 reports.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the beta-adrenergic blocker class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Hemangeol as a suspect or interacting product; reports listing it only as a concomitant medication (6) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.