Does BOSENTAN Cause Hypoacusis? 106 Reports in FDA Database

Q: Does BOSENTAN cause Hypoacusis?

106 reports of Hypoacusis have been filed with the FDA for BOSENTAN, representing 0.5% of all BOSENTAN adverse event reports.

Q: How dangerous is Hypoacusis from BOSENTAN?

Of 106 reports, 8 (7.5%) resulted in death and 32 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 106 reports of Hypoacusis have been filed in association with BOSENTAN (Tracleer). This represents 0.5% of all adverse event reports for BOSENTAN.

106

Reports of Hypoacusis with BOSENTAN

0.5%

of all BOSENTAN reports

Deaths

Hospitalizations

How Dangerous Is Hypoacusis From BOSENTAN?

Of the 106 reports, 8 (7.5%) resulted in death, 32 (30.2%) required hospitalization, and 1 (0.9%) were considered life-threatening.

Is Hypoacusis Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for BOSENTAN. However, 106 reports have been filed with the FAERS database.

What Other Side Effects Does BOSENTAN Cause?

Dyspnoea (2,492) Death (2,388) Pneumonia (1,064) Fatigue (1,025) Headache (962) Hospitalisation (915) Malaise (894) Diarrhoea (840) Product dose omission issue (798) Pulmonary arterial hypertension (778)

What Other Drugs Cause Hypoacusis?

SACUBITRIL\VALSARTAN (2,345) TOFACITINIB (1,535) INSULIN GLARGINE (1,406) APIXABAN (1,249) PREGABALIN (1,152) ETANERCEPT (1,109) INSULIN LISPRO (1,100) ADALIMUMAB (948) LENALIDOMIDE (938) PALBOCICLIB (890)

Which BOSENTAN Alternatives Have Lower Hypoacusis Risk?

BOSENTAN vs BOSENTAN\BOSENTAN BOSENTAN vs BOSUTINIB BOSENTAN vs BOTOX BOSENTAN vs BOTOX COSMETIC BOSENTAN vs BOTULINUM TOXIN NOS

BOSENTAN Full Profile All Hypoacusis Reports All Drugs Causing Hypoacusis BOSENTAN Demographics