Hydrocortisone Aguettant

Application withdrawnHuman

Details

EMA number	EMEA/H/C005201
ATC code	-
Authorisation	-
Revision	-

EMA page

Therapeutic indication

Not specified

MeSH: Bronchopulmonary Dysplasia

Active substances

hydrocortisone

Marketing Authorisation Holder

Laboratoire Aguettant

MAH

🇺🇸 Also approved in the US (FDA)

HYDROCORTISONE AND ACETIC ACID — TARO, approved 2005-04-28 (ANDA088759).

Most reported adverse events (US / FAERS)

140,606 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.

off label use

14,662

drug ineffective

13,695

fatigue

12,277

pain

10,664

🇺🇸 Also approved in the US (FDA)

HYDROCORTISONE AND ACETIC ACID — TARO, approved 2005-04-28 (ANDA088759).

Most reported adverse events (US / FAERS)

140,606 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.

off label use

14,662

drug ineffective

13,695

fatigue

12,277

pain

10,664

arthralgia

9,508

nausea

9,426

diarrhoea

8,878

rash

8,774

condition aggravated

8,724

headache

8,519

dyspnoea

8,255

pyrexia

7,336

vomiting

6,949

malaise

6,481

pruritus

6,458