sebetralstat

INN (International Nonproprietary Name)

🇺🇸 Also approved in the US (FDA)

EKTERLY — KALVISTA, approved 2025-07-03 (NDA219301).

Most reported adverse events (US / FAERS)

184 reports across the top reactions. These are spontaneously reported events from the FDA Adverse Event Reporting System — they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.

hereditary angioedema

61

drug ineffective

25

headache

14

product dose omission issue

12

Medicines containing this active substance

1 medicines

Ekterly

Authorised

🇺🇸 Also approved in the US (FDA)

EKTERLY — KALVISTA, approved 2025-07-03 (NDA219301).

Most reported adverse events (US / FAERS)

184 reports across the top reactions. These are spontaneously reported events from the FDA Adverse Event Reporting System — they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.

hereditary angioedema

61

drug ineffective

25

headache

14

product dose omission issue

12

weight increased

10

stress

8

insurance issue

7

off label use

7

dizziness

6

hypersensitivity

6

incorrect dose administered

6

nausea

6

weight decreased

6

incorrect dosage administered

5

product use issue

5