"Feb. 22, 2011 -- The FDA has issued a safety announcement notifying health care professionals that it has updated the pregnancy section of drug labels for the entire class of antipsychotic medications.
Antipsychotic drugs are used to "...
Fanapt Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Fanapt (iloperidone) is used to treat schizophrenia. It is an antipsychotic medication. Common side effects include drowsiness, dizziness, dry mouth, tiredness, stuffy nose, and weight gain.
The recommended starting dose of Fanapt is 1 mg twice daily. The target dose range is 6-12 mg twice daily. Fanapt may interact with other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety), arsenic trioxide, droperidol, antibiotics, antidepressants, anti-malaria medications, heart rhythm medicines, medicine to prevent or treat nausea and vomiting, other medicines to treat psychiatric disorders, migraine headache medicines, or narcotics. Tell your doctor all medications you use. During pregnancy, Fanapt should be used only when prescribed. Do not stop taking this medication unless directed by your doctor. Babies born to mothers who have used this drug during the last 3 months of pregnancy may infrequently develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice symptoms in your newborn during their first month, tell the doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Our Fanapt (iloperidone) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Fanapt in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop taking this medication and call your doctor at once if you have a serious side effect such as:
- headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;
- very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
- twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
- high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss);
- thoughts about suicide or hurting yourself;
- fever, chills, body aches, flu symptoms, sores in your mouth and throat;
- seizure (convulsions);
- urinating less than usual or not at all;
- trouble swallowing; or
- penis erection that is painful or lasts 4 hours or longer.
Less serious side effects may include:
- dizziness, drowsiness, tired feeling;
- dry mouth, stuffy nose;
- breast swelling or discharge;
- weight gain; or
- changes in menstrual periods.
Read the entire detailed patient monograph for Fanapt (Iloperidone Tablets) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Fanapt Overview - Patient Information: Side Effects
Drowsiness, dizziness, dry mouth, tiredness, stuffy nose, and weight gain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
This medication may cause a serious drop in blood pressure, especially when starting or increasing the dose. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these rare but serious side effects occur: drooling/trouble swallowing, signs of infection (such as persistent cough, fever), shaking (tremor), muscle spasms.
Infrequently, this medication may cause face/muscle twitching and uncontrollable movements (tardive dyskinesia). In some cases, this condition may be permanent. Tell your doctor immediately if you develop any uncontrollable movements such as lip smacking, mouth puckering, tongue thrusting, chewing, or unusual arm/leg movements.
This drug may rarely make your blood sugar level rise, which can cause or worsen diabetes. Weight gain from this drug may increase the risk of this side effect. Tell your doctor immediately if you develop symptoms of high blood sugar such as increased thirst and urination. If you already have diabetes, be sure to check your blood sugar level regularly.
In rare cases, iloperidone may increase your level of a certain substance made by the body (prolactin). For females, this increase in prolactin may result in unwanted breast milk, missed/stopped periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor immediately.
Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and seek immediate medical attention, or permanent problems could occur.
Seek immediate medical attention if any of these rare but very serious side effects occur: fainting, slow heartbeat, seizures, severe dizziness, chest pain.
This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, muscle stiffness/pain/tenderness/weakness, severe tiredness, severe confusion, sweating, fast/irregular heartbeat, dark urine, change in the amount of urine.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Fanapt (Iloperidone Tablets)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Fanapt FDA Prescribing Information: Side Effects
Clinical Studies Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trial of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The information below is derived from a clinical trial database for FANAPT consisting of 2070 patients exposed to FANAPT at doses of 10 mg/day or greater, for the treatment of schizophrenia. Of these, 806 received FANAPT for at least 6 months, with 463 exposed to FANAPT for at least 12 months. All of these patients who received FANAPT were participating in multiple-dose clinical trials. The conditions and duration of treatment with FANAPT varied greatly and included (in overlapping categories), open-label and double-blind phases of studies, inpatients and outpatients, fixed-dose and flexible-dose studies, and short-term and longer-term exposure.
Adverse reactions during exposure were obtained by general inquiry and recorded by clinical investigators using their own terminology. Consequently, to provide a meaningful estimate of the proportion of individuals experiencing adverse reactions, reactions were grouped in standardized categories using MedDRA terminology.
The stated frequencies of adverse reactions represent the proportions of individuals who experienced a treatment-emergent adverse reaction of the type listed. A reaction was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.
The information presented in these sections was derived from pooled data from -4 placebo-controlled, 4-or 6-week, fixed-or flexible-dose studies in patients who received FANAPT at daily doses within a range of 10 to 24 mg (n=874).
Adverse Reactions Occurring at an Incidence of 2% or More among FANAPT-Treated Patients and More Frequent than Placebo
Table 7 enumerates the pooled incidences of treatment-emergent adverse reactions that were spontaneously reported in four placebo-controlled, 4-or 6-week, fixed-or flexible-dose studies, listing those reactions that occurred in 2% or more of patients treated with FANAPT in any of the dose groups, and for which the incidence in FANAPT-treated patients in any dose group was greater than the incidence in patients treated with placebo.
Table 7: Percentage of Treatment-Emergent Adverse
Reactions in Short-Term, Fixed-or Flexible-Dose, Placebo-Controlled Trials in
|Body System or Organ Class Dictionary-derived Term||Placebo % (N=587)||FANAPT 10-16 mg/day % (N=483)||FANAPT 20-24 mg/day % (N=391)|
|Body as a Whole|
|Upper Respiratory Tract Infection||1||2||3|
|Nervous System Disorders|
|Ejaculation Failure||< 1||2||2|
|Hypotension||< 1||< 1||3|
|* Table includes adverse reactions that were reported in 2% or more of patients in any of the FANAPT dose groups and which occurred at greater incidence than in the placebo group. Figures rounded to the nearest integer.|
Dose-Related Adverse Reactions in Clinical Trials
Based on the pooled data from 4 placebo-controlled, 4-or 6-week, fixed-or flexible-dose studies, adverse reactions that occurred with a greater than 2% incidence in the patients treated with FANAPT, and for which the incidence in patients treated with FANAPT 20-24 mg/day were twice than the incidence in patients treated with FANAPT 10-16 mg/day were: abdominal discomfort, dizziness, hypotension, musculoskeletal stiffness, tachycardia, and weight increased.
Common and Drug-Related Adverse Reactions in Clinical Trials
Based on the pooled data from 4 placebo-controlled, 4-or 6-week, fixed-or flexible-dose studies, the following adverse reactions occurred in ≥ 5% incidence in the patients treated with FANAPT and at least twice the placebo rate for at least 1 dose: dizziness, dry mouth, fatigue, nasal congestion, somnolence, tachycardia, orthostatic hypotension, and weight increased. Dizziness, tachycardia, and weight increased were at least twice as common on 20-24 mg/day as on 10-16 mg/day.
Extrapyramidal Symptoms (EPS) in Clinical Trials
Pooled data from the 4 placebo-controlled, 4-or 6-week, fixed-or flexible-dose studies provided information regarding treatment-emergent EPS. Adverse event data collected from those trials showed the following rates of EPS-related adverse events as shown in Table 8.
Table 8: Percentage of EPS Compared to Placebo
|Adverse Event Term||Placebo (%)
|FANAPT 10-16 mg/day (%)
|FANAPT 20-24 mg/day (%)
|All EPS events||11.6||13.5||15.1|
Adverse Reactions Associated with Discontinuation of Treatment in Clinical Trials
Based on the pooled data from 4 placebo-controlled, 4-or 6-week, fixed-or flexible-dose studies, there was no difference in the incidence of discontinuation due to adverse events between FANAPT-treated (5%) and placebo-treated (5%) patients. The types of adverse events that led to discontinuation were similar for the FANAPT-and placebo-treated patients.
Demographic Differences in Adverse Reactions in Clinical Trials
An examination of population subgroups in the 4 placebo-controlled, 4-or 6-week, fixed-or flexible-dose studies did not reveal any evidence of differences in safety on the basis of age, gender or race [see WARNINGS AND PRECAUTIONS].
Laboratory Test Abnormalities in Clinical Trials
In short-term placebo-controlled trials (4-to 6-weeks), there were 1.0% (13/1342) iloperidone-treated patients with hematocrit at least one time below the extended normal range during post-randomization treatment, compared to 0.3% (2/585) on placebo. The extended normal range for lowered hematocrit was defined in each of these trials as the value 15% below the normal range for the centralized laboratory that was used in the trial.
Other Reactions During the Pre-marketing Evaluation of FANAPT
The following is a list of MedDRA terms that reflect treatment-emergent adverse reactions in patients treated with FANAPT at multiple doses ≥ 4 mg/day during any phase of a trial with the database of 3210 FANAPT-treated patients. All reported reactions are included except those already listed in Table 7, or other parts of the ADVERSE REACTIONS section, those considered in the WARNINGS AND PRECAUTIONS, those reaction terms which were so general as to be uninformative, reactions reported in fewer than 3 patients and which were neither serious nor life-threatening, reactions that are otherwise common as background reactions, and reactions considered unlikely to be drug related. It is important to emphasize that, although the reactions reported occurred during treatment with FANAPT, they were not necessarily caused by it.
Reactions are further categorized by MedDRA system organ class and listed in order of decreasing frequency according to the following definitions: Frequent adverse events are those occurring in at least 1/100 patients (only those not listed in Table 7 appear in this listing); InFrequent adverse reactions are those occurring in 1/100 to 1/1000 patients; rare events are those occurring in fewer than 1/1000 patients.
Endocrine Disorders: InFrequent - hypothyroidism
Gastrointestinal Disorders: InFrequent - gastritis, salivary hypersecretion, fecal incontinence, mouth ulceration; Rare aphthous stomatitis, duodenal ulcer, hiatus hernia, hyperchlorhydria, lip ulceration, reflux esophagitis, stomatitis
General Disorders and Administrative Site Conditions: InFrequent - edema (general, pitting, due to cardiac disease), difficulty in walking, thirst; Rare -hyperthermia
Hepatobiliary Disorders: InFrequent - cholelithiasis
Metabolism and Nutrition Disorders: InFrequent - increased appetite, dehydration, hypokalemia, fluid retention
Psychiatric Disorders: Frequent - restlessness, aggression, delusion; InFrequent - hostility, libido decreased, paranoia, anorgasmia, confusional state, mania, catatonia, mood swings, panic attack, obsessive-compulsive disorder, bulimia nervosa, delirium, polydipsia psychogenic, impulse-control disorder, major depression
Reproductive System and Breast Disorders: Frequent - erectile dysfunction; InFrequent - testicular pain, amenorrhea, breast pain; Rare - menstruation irregular, gynecomastia, menorrhagia, metrorrhagia, postmenopausal hemorrhage, prostatitis.
The following adverse reactions have been identified during postapproval use of FANAPT-: retrograde ejaculation. Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Read the entire FDA prescribing information for Fanapt (Iloperidone Tablets) »
Additional Fanapt Information
Fanapt - User Reviews
Fanapt User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get tips on therapy and treatment.