Fanapt Warnings and Precautions

Some Fanapt Warnings and Precautions

Some warnings and precautions to be aware of with this product include:
  • The U.S. Food and Drug Administration (FDA) has issued a special warning (a "black box warning") about the use of atypical antipsychotic medications (including Fanapt) in elderly people with dementia (such as Alzheimer's disease). Elderly people with dementia who are treated with atypical antipsychotics are more likely to die (of various causes) than those who were not treated with those medications.

Studies also suggest that such medications may increase the risk of strokes or transient ischemic attacks (TIAs) in elderly people with dementia. Fanapt is not approved to treat dementia in the elderly, and caution should be used before using Fanapt in elderly people with dementia.

  • Fanapt can cause a change in the heart rhythm known as QT prolongation. QT prolongation can lead to life-threatening arrhythmias, including torsade de pointes. Fanapt should not be combined with other medications that can prolong the QT interval (see Fanapt Drug Interactions). Additionally, be aware that you may be at a higher risk for this problem if you have:


    • An electrolyte imbalance, such as low potassium or magnesium levels
    • An arrhythmia
    • Severe heart failure
    • Had a recent heart attack
    • Long QT syndrome
    • A slow heart rate.


  • Fanapt can cause a life-threatening condition called neuroleptic malignant syndrome (NMS). Some symptoms of NMS include:


    • A high fever
    • Stiff muscles
    • Confusion
    • Irregular pulse or blood pressure
    • A fast heart rate (tachycardia)
    • Sweating
    • Irregular heart rhythms (arrhythmias). 
Tell your healthcare provider right away if think you might have NMS.
  • Fanapt can cause tardive dyskinesia, which is a condition involving unusual and uncontrollable body or face movements. The condition can become permanent (even if Fanapt is stopped). The best way to prevent it from becoming permanent is to tell your healthcare provider right away if you notice any abnormal movements (including abnormal movements of the tongue) while taking Fanapt.
  • Fanapt can cause an increase in blood sugar levels and can increase the risk of developing diabetes. Tell your healthcare provider if you develop signs of diabetes while taking Fanapt. Possible signs of diabetes can include increased thirst, increased urination, or increased hunger.

If you have diabetes, your blood sugar levels should be monitored carefully and regularly during treatment with Fanapt to make sure your diabetes is not becoming more severe (see Fanapt and Diabetes).

  • Fanapt can increase the level of the hormone prolactin. Tell your healthcare provider if you have signs of high prolactin levels, such as breast enlargement, breast pain, or breast discharge.
  • Antipsychotic medications (including Fanapt) can sometimes cause low white blood cells, a problem that can lead to dangerous infections or other serious problems.
  • Fanapt can cause a drop in blood pressure when going from a sitting or lying position to standing (known medically as orthostatic hypotension). This can cause a person to have lightheadedness or dizziness, or to faint. Tell your healthcare provider if you have any of these symptoms when standing. Orthostatic hypotension can be especially dangerous in people with heart disease or congestive heart failure (CHF).
  • Like all antipsychotic medications, Fanapt should be used cautiously in people with epilepsy or a history of seizures (or with other medical conditions, such as Alzheimer's disease, which may increase the risk of seizures).
  • People who take Fanapt may be more likely to develop heat stroke. Be careful to stay hydrated and avoid overheating.
  • Fanapt can cause difficultly swallowing, which can lead to inhalation of food (which can cause pneumonia). Tell your healthcare provider if you notice any problems with swallowing.
  • Seek immediate medical attention if you have a painful penile erection that does not go away (this is known medically as priapism). Delaying treatment for this problem can lead to permanent damage (which can cause impotence).
  • Make sure to see how Fanapt affects you before driving or operating heavy machinery, as the medication may cause drowsiness or other problems.
  • Fanapt is considered a pregnancy Category C medication. This means that it may not be safe to take during pregnancy. Make sure to talk with your healthcare provider about the risks and benefits of using Fanapt during pregnancy (see Fanapt and Pregnancy).
  • It is not known if Fanapt passes through breast milk. Therefore, if you are breastfeeding or plan to start breastfeeding, make sure to talk with your healthcare provider about using Fanapt (see Fanapt and Breastfeeding for more information).
  • Generally, alcohol should be avoided while taking Fanapt.
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