Betamethasone dipropionate: adverse event reports filed with FDA

2,043

reports as suspect product

0% of all reports · about 91 a year

223

reports, 12 months to June 2026

181 in the 12 months before

77.7%

marked serious by the reporter

77.7% across the class

12.5%

record death among outcomes, as reported

256 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 Betamethasone dipropionate reports recording the termmedian drug in corticosteroid

1. Drug ineffectivethe medicine did not work as expected47.1%963
2. Macular degenerationa disease of the central retina25.3%516
3. Off label useused for a purpose or in a way not on the label15.6%318
4. Condition aggravatedthe condition being treated got worse12.6%258
5. Therapeutic product effect incomplete12.4%253
6. Pain in extremitypain in an arm or leg11.7%239
7. Painpain, site not specified9.8%201
8. Product use in unapproved indicationused for a purpose not on the label8.6%175
9. Nauseafeeling sick8.4%172
10. Dyspnoeashortness of breath7.9%162
11. Pyrexiafever7.6%156
12. Pneumonialung infection7.4%152
13. Lung disordera lung problem, type not specified7%144
14. Muscle spasmsmuscle cramps7%142
15. Abdominal painstomach or belly pain6.9%141
16. Asthmaasthma6.9%141
17. Hypersensitivityan allergic-type reaction6.9%140
18. Erythemaskin redness6.8%138
19. Constipationconstipation6.7%137
20. Anaemialow red blood cells6.5%133
21. Pulmonary embolisma blood clot in the lung6.5%133
22. Stomatitissore mouth6.5%133
23. Thrombosis6.5%133
24. Headachehead pain6.4%131
25. Urticariahives6.3%129
26. Wheezingwheezing6.3%128
27. Weight decreasedweight loss6.1%125
28. Infusion related reactiona reaction during or soon after an infusion6.1%124
29. Respiratory symptom5.7%117
30. Drug eruption5.7%116

Top 30 of 612 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 74 drugs in the corticosteroid 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 808,789 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. 24.6% 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 2,043 reports.

Drugs most often listed in the same reports

Other products listed in reports where Betamethasone dipropionate is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

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 corticosteroid 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 Betamethasone dipropionate as a suspect or interacting product; reports listing it only as a concomitant medication (3,674) 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.