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.
ADVERSE REACTIONS In clinical trials, Neurolite has been administered to 1063 subjects (255 normals, 808 patients).
Of these, 566 (53%) were men and 494 (47%) were women.
The mean age was 58 years (range 17 to 92 years).
In the 808 patients, who had experienced neurologic events, there were 11 (1.4%) deaths, none of which were clearly attributed to Neurolite.
A total of 60 subjects experienced adverse reactions;
the adverse reaction rates were comparable in the <65 year, and the >65 year age groups.
The following adverse effects were observed in ≤ 1% of the subjects: headache, dizziness, seizure, agitation/anxiety, malaise/somnolence, parosmia, hallucinations, rash, nausea, syncope, cardiac failure, hypertension, angina, and apnea/cyanosis.
In clinical trials of 197 patients, there were inconsistent changes in the serum calcium and phosphate levels.
The cause of the changes has not been identified and their frequency and magnitude have not been clearly characterized.
None of the changes required medical intervention.
WARNINGS None known.
Like all medications, Neurolite 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: