Possible Side Effects

In short‑term (6 weeks) and long‑term (6 months) clinical trials:

• Most people who took CAPLYTA did not gain weight

  At 6 months, the average weight change for people on CAPLYTA was -0.02 lbs.

  CAPLYTA may cause weight gain. You and your healthcare provider should monitor your weight.

• Most people did not have a change in their blood sugar or cholesterol

  CAPLYTA may cause serious side effects, including problems with your metabolism such as increased fat levels (cholesterol and triglycerides) in your blood. Your healthcare provider should check the fat levels in your blood before you start, or soon after you start CAPLYTA, and then periodically during treatment with CAPLYTA.

• Most people who took CAPLYTA did not experience movement disorders

  Movement disorders, including inner feelings of restlessness or the need to move around (akathisia) were not common when taking CAPLYTA.

  CAPLYTA may cause serious side effects, including uncontrolled body movements (tardive dyskinesia, TD) in your face, tongue, or other body parts. TD may not go away, even if you stop taking CAPLYTA. It may also occur after you stop taking CAPLYTA.

The most common side effects experienced by people with bipolar depression taking CAPLYTA were sleepiness, dizziness, nausea, and dry mouth.