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 Most common adverse reactions are a cluster of symptoms called "cinchonism", which occurs to some degree in almost all patients taking quinine: headache, vasodilation and sweating, nausea, tinnitus, hearing impairment, vertigo or dizziness, blurred vision, disturbance in color perception, vomiting, diarrhea, abdominal pain, deafness, blindness, and disturbances in cardiac rhythm or conduction ( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc.
at 1-800-399-2561 or www.lupinpharmaceuticals.com.
or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Overall Quinine can adversely affect almost every body system.
The most common adverse events associated with quinine use are a cluster of symptoms called "cinchonism", which occurs to some degree in almost all patients taking quinine.
Symptoms of mild cinchonism include headache, vasodilation and sweating, nausea, tinnitus, hearing impairment, vertigo or dizziness, blurred vision, and disturbance in color perception.
More severe symptoms of cinchonism are vomiting, diarrhea, abdominal pain, deafness, blindness, and disturbances in cardiac rhythm or conduction.
Most symptoms of cinchonism are reversible and resolve with discontinuation of quinine.
The following ADVERSE REACTIONS have been reported with quinine sulfate.
5 WARNINGS AND PRECAUTIONS Not indicated for the prevention or treatment of nocturnal leg cramps.
Risk of serious and life-threatening adverse reactions ( 1 , 5.1 ).
Thrombocytopenia, including ITP and HUS/TTP, has been reported.
Discontinue drug ( 5.2 ).
QT prolongation and ventricular arrhythmias.
Like all medications, Quinine Sulfate 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: