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The U.S. Food and Drug Administration has approved Fanapt
tablets (iloperidone) on May 6, 2009 to treat adults with
schizophrenia, a chronic, severe and disabling brain
Fanapt is included in the atypical antipsychotic class of drugs.
All atypical antipsychotics contain a boxed warning, the FDA's
strongest warning. The warning alerts prescribers to an
increased risk of death associated with off-label use of these
drugs to treat behavioral problems in older people with
dementia-related psychosis. Fanapt is not approved for
patients with dementia-related psychosis.
Fanapt demonstrated efficacy in two placebo-controlled
short-term clinical trials. In both, Fanapt was superior to
placebo (sugar pill) in reducing the symptoms of
What are the common side effects of Fanapt?
The most common side effects reported by patients using
Fanapt in clinical trials were dizziness, dry mouth, fatigue,
nasal congestion, sudden fall in blood pressure causing
light-headedness upon standing (orthostatic hypotension),
drowsiness, rapid heart rate (tachycardia) and weight
Fanapt is manufactured by Patheon Inc. of Mississauga,
Ontario, for Vanda Pharmaceuticals Inc., Rockville, Md.
SOURCE FDA Approves Fanapt to Treat Schizophrenia FDA
NEWS RELEASE May 6, 2009