Does OMALIZUMAB Cause Ear disorder? 45 Reports in FDA Database

Q: Does OMALIZUMAB cause Ear disorder?

45 reports of Ear disorder have been filed with the FDA for OMALIZUMAB, representing 0.1% of all OMALIZUMAB adverse event reports.

Q: How dangerous is Ear disorder from OMALIZUMAB?

Of 45 reports, 1 (2.2%) resulted in death and 14 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 45 reports of Ear disorder have been filed in association with OMALIZUMAB (Omalizumab-igec). This represents 0.1% of all adverse event reports for OMALIZUMAB.

Reports of Ear disorder with OMALIZUMAB

0.1%

of all OMALIZUMAB reports

Deaths

Hospitalizations

How Dangerous Is Ear disorder From OMALIZUMAB?

Of the 45 reports, 1 (2.2%) resulted in death, 14 (31.1%) required hospitalization, and 7 (15.6%) were considered life-threatening.

Is Ear disorder Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for OMALIZUMAB. However, 45 reports have been filed with the FAERS database.

What Other Side Effects Does OMALIZUMAB Cause?

No adverse event (9,736) Asthma (9,354) Urticaria (9,231) Off label use (9,199) Dyspnoea (8,323) Drug ineffective (6,747) Cough (5,926) Pruritus (5,224)