Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The most common adverse reactions occurring in 1% of patients with XTORO were ear pruritus and nausea.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fonseca Biosciences, LLC at 1-877-436-6732 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
A total of 618 patients were treated with XTORO in two Phase 3 clinical trials.
The most frequently reported adverse reactions of those exposed to XTORO occurring at an incidence of 1% included ear pruritus and nausea.
5 WARNINGS AND PRECAUTIONS Prolonged use of this product may lead to overgrowth of nonsusceptible organisms.
Discontinue use if this occurs.
( 5.1 ) Allergic reactions may occur in patients with a history of hypersensitivity to finafloxacin, to other quinolones, or to any of the components in this medication.
Discontinue use if this occurs.
( 5.2 ) 5.1 Growth of Resistant Organisms with Prolonged Use As with other antibacterial preparations, prolonged use of XTORO may lead to overgrowth of nonsusceptible organisms, including yeast and fungi.
Like all medications, Xtoro can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: