Ibuprofen/Diphenhydramine Hydrochloride Wyeth

Application withdrawnHuman

Details

EMA number	EMEA/H/C/001108
ATC code	-
Authorisation	-
Revision	-

EMA page

Therapeutic indication

Not specified

MeSH: Pain

Active substances

Ibuprofen

Marketing Authorisation Holder

Wyeth Consumer Healthcare

MAH

🇺🇸 Also approved in the US (FDA)

IBUPROFEN — GRANULES, approved 2024-11-21 (ANDA091625).

Most reported adverse events (US / FAERS)

211,826 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.

drug ineffective

27,091

pain

19,275

fatigue

18,493

nausea

17,969

headache

🇺🇸 Also approved in the US (FDA)

IBUPROFEN — GRANULES, approved 2024-11-21 (ANDA091625).

Most reported adverse events (US / FAERS)

211,826 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.

drug ineffective

27,091

pain

19,275

fatigue

18,493

nausea

17,969

headache

16,345

arthralgia

13,265

dyspnoea

12,933

vomiting

12,851

diarrhoea

12,546

dizziness

11,269

rash

10,995

off label use

10,851

pruritus

9,753

pyrexia

9,681

product use in unapproved indication

8,509