Does ALTEPLASE Cause Dysphonia? 12 Reports in FDA Database

Q: Does ALTEPLASE cause Dysphonia?

12 reports of Dysphonia have been filed with the FDA for ALTEPLASE, representing 0.1% of all ALTEPLASE adverse event reports.

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According to the FDA Adverse Event Reporting System (FAERS), 12 reports of Dysphonia have been filed in association with ALTEPLASE (Activase). This represents 0.1% of all adverse event reports for ALTEPLASE.

Reports of Dysphonia with ALTEPLASE

0.1%

of all ALTEPLASE reports

Deaths

Hospitalizations

How Dangerous Is Dysphonia From ALTEPLASE?

Of the 12 reports, 1 (8.3%) required hospitalization, and 4 (33.3%) were considered life-threatening.

Is Dysphonia Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for ALTEPLASE. However, 12 reports have been filed with the FAERS database.

What Other Side Effects Does ALTEPLASE Cause?

No adverse event (2,456) Off label use (1,752) Gingival bleeding (1,018) Cerebral haemorrhage (819) Death (818) Haemorrhage intracranial (615) Angioedema (603) Haemorrhage (536) Drug ineffective (524) Haemorrhagic transformation stroke (496)

What Other Drugs Cause Dysphonia?

FLUTICASONE\SALMETEROL (1,729) CABOZANTINIB S-MALATE (1,229) ADALIMUMAB (1,216) BUDESONIDE\FORMOTEROL (1,204) FLUTICASONE FUROATE\VILANTEROL TRIFENATATE (1,143) ALBUTEROL (1,114) LENVATINIB (1,021) FLUTICASONE FUROATE\UMECLIDINIUM\VILANTEROL TRIFENATATE (943) LENALIDOMIDE (931) AMIKACIN (914)

Which ALTEPLASE Alternatives Have Lower Dysphonia Risk?

ALTEPLASE vs ALTERNARIA ALTERNATA ALTEPLASE vs ALTHIAZIDE ALTEPLASE vs ALTHIAZIDE\SPIRONOLACTONE ALTEPLASE vs ALUMINUM ALTEPLASE vs ALUMINUM HYDROXIDE

ALTEPLASE Full Profile All Dysphonia Reports All Drugs Causing Dysphonia ALTEPLASE Demographics