Safety Information

As you and your doctor decide on your best treatment, your doctor will consider factors including symptoms you're experiencing, current medical conditions, medications you're already taking, and any potential side effects that a new medication might cause.

Side effects vary from person to person and are not always the same for everyone.

People taking Fanapt might experience one or more of the following most common side effects:

Safety Dissination
Please see additional Important Safety Information below.
  • Most people taking Fanapt did not have significant weight gain in clinical studies. Across all studies, overall weight gain averaged 5 lb. In clinical studies lasting 4–6 weeks, the proportion of patients who gained weight equal to 7% or more of body weight was reported in 12% of patients receiving a 10–16 mg/day dose, 18% of patients receiving a 20–24 mg/day dose, versus 4% of patients receiving a placebo.
  • People on Fanapt reported occurrence of EPS (extrapyramidal symptoms, i.e., uncontrollable facial or body twitching) and akathisia (extreme restlessness) at similar rates as those on a placebo.
  • Tell your doctor if you have diabetes or risk factors for diabetes (for example, obesity, family history of diabetes), or if you have unexpected increases in thirst, urination, or hunger. If so, your blood sugar should be monitored. Increases in blood sugar levels (hyperglycemia), which in some cases can be serious and associated with coma or death, have been reported in patients taking Fanapt and medicines like it.
  • Abnormal or uncontrollable movements of the face, tongue, or other parts of the body may be signs of a serious condition called tardive dyskinesia (TD), which could become permanent. The chance of this condition going away decreases depending on how long and how much medication has been taken. Tell your doctor if you have body movements you can't control.

If you experience any side effects that concern you, talk to your doctor right away.

Fanapt Important Safety Information Click here Patient Assistance Now

FANAPT® is a registered trademark of Vanda Pharmaceuticals Inc. and is used by Novartis Pharmaceuticals Corporation under license.

FANAPT® is licensed by Novartis Pharmaceuticals Corporation from Titan Pharmaceuticals, Inc.