Who the
ABILIFY MYCITE® System is for

Learn which of your patients may be appropriate for the system.
Female patient, Image
Not a real patient.

Video: Carlos’s Story—Finding the Right Support

Learn more about Carlos, a real patient living with major depressive disorder (MDD) who uses the ABILIFY MYCITE System.

The right patient

Consider patients who are1-3:

Adult patients within the indicated population for ABILIFY MYCITE® (aripiprazole tablets with sensor)

Patients who have goals and want to move forward or are going through a transitional time in their lives, like changing care settings, or starting something new, like a job or a relationship

Proactive patients who want to be more organized and involved in their treatment

Patients who are smartphone users,
feel comfortable using mental health apps, and have access to a reliable internet connection

Consider the ABILIFY MYCITE System for your patients who could benefit from you having more quantitative data and qualitative information when managing their condition.

The ABILIFY MYCITE System is appropriate for adult patients within the indicated population for ABILIFY MYCITE. Please see INDICATIONS and IMPORTANT SAFETY INFORMATION, including BOXED WARNING, here.

When to use the ABILIFY MYCITE System

There may be times in your patient's life when an option like the ABILIFY MYCITE System can be an important part of managing their condition.

The ABILIFY MYCITE System may be particularly useful for managing patients who are1,4:

Diagnosis with clock, Icon
Recently diagnosed
Hospital patient chart, Icon
Recently discharged from the hospital
House, Icon
Changing their living situation
Alarm clock, Icon
Lacking a daily routine
Arrow pointing up, Icon
Experiencing an increase in symptoms and/or side effects after being previously stable

Talk to an Otsuka representative to get your patient started on the ABILIFY MYCITE System.

Get in touch
Not a real patient.

Potential patients for the ABILIFY MYCITE System

Examples of adult patients who may be appropriate for the system

  • Bipolar I disorder
  • Major depressive disorder
  • Schizophrenia
Potential male patient Michael

Bipolar I disorder (BP-I)

Michael, 39

Not a real patient.

  • Diagnosed at 25 years old after his first manic episode5
  • Has had several manic episodes since his diagnosis5
  • Hospitalized once in the past 2 years5
  • Has tried various medications of adequate dose and duration
  • Currently taking oral aripiprazole as monotherapy
  • Vague with his prescriber about whether he’s taking his medication regularly

Michael lives with his wife and children and is the sole provider for his family. Recently, he has increased energy, is struggling at work, and his wife is concerned that he is not sleeping well. Michael is experiencing instability on his treatment, and it is unclear to his prescriber if that's because he's not taking his medication regularly or if he's not responding to treatment.

Illustrative data. Not from a real patient.
Potential female patient Annie

Major Depressive Disorder (MDD)

Annie, 28

Not a real patient.

  • Diagnosed 4 years ago
  • Currently taking oral aripiprazole as adjunctive therapy to her antidepressant
  • Acknowledges she sometimes forgets to take her medication

Annie lives with her partner and toddler and works remotely. She is controlled on her treatment, but lately she's been experiencing fatigue, mood fluctuations, and loss of interest in her hobbies.6 Her psychologist, with whom she meets weekly, wants her to try a mood-tracking app. That way, Annie can review what factors are likely contributing to her symptoms and learn and utilize coping activities.

Illustrative data. Not from a real patient.
Potential male patient Vincent


Vincent, 31

Not a real patient.

  • Diagnosed at 25 years old7
    • Presented with symptoms including auditory hallucinations and disorganized thoughts7
  • Hospitalized once in the past year
  • Currently taking oral aripiprazole7
  • Averse to using a long-acting injectable (LAI)

Vincent lives at home with his parents and works part-time at a grocery store. When he’s not working, he enjoys playing video games. He wants to move in with his friends, but his parents are apprehensive. They currently supervise his treatment and worry that he may not take his medication regularly if he lives on his own.

Illustrative data. Not from a real patient.

The impact of the ABILIFY MYCITE System on treatment adherence has not been demonstrated. Some factors, such as connectivity, transmitter malfunction, or device availability, may impact the consistency and reliability of data detection, collection and transmission. Only functions related to tracking drug ingestion have been evaluated or approved by FDA.

Digital medicine pioneers
Looking for more help with choosing the right patient?

See how the Digital Medicine Pioneers, real healthcare providers who use the ABILIFY MYCITE System, identify appropriate patients
for treatment. 

Watch now
The Digital Medicine Pioneers are paid consultants of Otsuka America Pharmaceutical, Inc.
Female Digital Medicine Pioneer
Female Digital Medicine Pioneer
Hatch A, Docherty JP, Carpenter D, Ross R, Weiden PJ. Expert consensus survey on medication adherence in psychiatric patients and use of a digital medicine system. J Clin Psychiatry. 2017;78(7):e803-e812. doi:10.4088/JCP.16m11252
Otsuka and Proteus® announce the first U.S. FDA approval of a digital medicine system: ABILIFY MYCITE® (aripiprazole tablets with sensor). News release. Otsuka America Pharmaceutical, Inc. November 14, 2017. Accessed November 30, 2022. https://www.otsuka-us.com/discover/articles-1075
Sawesi S, Rashrash M, Phalakornkule K, Carpenter JS, Jones JF. The impact of information technology on patient engagement and health behavior change: a systematic review of the literature. JMIR Med Inform. 2016;4(1):e1. doi:10.2196/medinform.4514
Rossom RC, Shortreed S, Coleman KJ, et al. Antidepressant adherence across diverse populations and healthcare settings. Depress Anxiety. 2016;33(8):765‑774. doi:10.1002/da.22532
Bipolar disorder. National Institute of Mental Health. Updated January 2020. Accessed November 30, 2022. https://www.nimh.nih.gov/health/topics/schizophrenia/index.shtml
Depression. National Institute of Mental Health. Updated February 2018. Accessed November 30, 2022. https://www.nimh.nih.gov/health/topics/depression/index.shtml
Schizophrenia. National Institute of Mental Health. Updated April 2022. Accessed November 30, 2022. https://www.nimh.nih.gov/health/topics/schizophrenia/index.shtml






Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death (1.6 to 1.7 times) compared to placebo-treated patients. ABILIFY MYCITE is not approved for the treatment of patients with dementia-related psychosis.


Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults. Those on antidepressant therapy should be monitored closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber. The safety and effectiveness of ABILIFY MYCITE have not been established in pediatric patients.

Contraindication: Known hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis.

Cerebrovascular Adverse Events, Including Stroke, in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, have been reported in clinical trials of elderly patients with dementia-related psychosis treated with aripiprazole.

Neuroleptic Malignant Syndrome (NMS): NMS is a potentially fatal symptom complex reported in association with administration of antipsychotic drugs, including ABILIFY MYCITE. Clinical signs of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability. Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. Manage NMS with immediate discontinuation of ABILIFY MYCITE, intensive symptomatic treatment, and monitoring.

Tardive Dyskinesia (TD): Risk of TD, and the potential to become irreversible, are believed to increase with duration of treatment and in total cumulative dose of antipsychotic drugs. TD can develop after a relatively brief treatment period, even at low doses, or after discontinuation. If antipsychotic treatment is withdrawn, TD may remit, partially or completely. Prescribing should be consistent with the need to minimize TD.

Metabolic Changes: Atypical antipsychotic drugs have caused metabolic changes including:

  • Hyperglycemia/Diabetes Mellitus: Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma, or death, has been reported in patients treated with atypical antipsychotics including aripiprazole. Patients with diabetes mellitus should be regularly monitored for worsening of glucose control; those with risk factors for diabetes (e.g., obesity, family history of diabetes), should undergo baseline and periodic fasting blood glucose testing. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug.
  • Dyslipidemia: Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics.
  • Weight Gain: Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended.

Pathological Gambling and Other Compulsive Behaviors: Intense urges, particularly for gambling, and the inability to control these urges have been reported while taking aripiprazole. Other compulsive urges have been reported less frequently. Prescribers should ask patients or their caregivers about the development of new or intense compulsive urges. Consider dose reduction or stopping ABILIFY MYCITE if such urges develop.

Orthostatic Hypotension: ABILIFY MYCITE may cause orthostatic hypotension and should be used with caution in patients with known cardiovascular disease, cerebrovascular disease, or conditions which would predispose them to hypotension.

Falls: Antipsychotics may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls causing fractures or other injuries. For patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating treatment and recurrently during therapy.

Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia, neutropenia and agranulocytosis have been reported with antipsychotics. Monitor complete blood count in patients with pre-existing low white blood cell count (WBC)/absolute neutrophil count or history of drug-induced leukopenia/neutropenia. Discontinue ABILIFY MYCITE at the first sign of a clinically significant decline in WBC and in severely neutropenic patients.

Seizures: ABILIFY MYCITE should be used with caution in patients with a history of seizures or with conditions that lower the seizure threshold.

Potential for Cognitive and Motor Impairment: ABILIFY MYCITE may impair judgment, thinking, or motor skills. Instruct patients to avoid operating hazardous machinery, including automobiles, until they are certain ABILIFY MYCITE does not affect them adversely.

Body Temperature Regulation: Use ABILIFY MYCITE with caution in patients who may experience conditions that increase body temperature (e.g., strenuous exercise, extreme heat, dehydration, or concomitant use with anticholinergics).

Dysphagia: Esophageal dysmotility and aspiration have been associated with ABILIFY MYCITE. Use caution in patients at risk for aspiration pneumonia.

Dosage Adjustments and Cytochrome P450 Considerations: For patients with schizophrenia and bipolar I disorder taking ABILIFY MYCITE who are:

  • Known CYP2D6 poor metabolizers, administer half the recommended dose

  • Known CYP2D6 poor metabolizers taking concomitant strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin), administer a quarter the recommended dose.

  • Taking strong CYP2D6 (e.g., quinidine, fluoxetine, paroxetine) or CYP3A4 inhibitors, administer half the recommended dose.

  • Taking strong CYP2D6 and CYP3A4 inhibitors, administer a quarter the recommended dose. When co‑administered drug is withdrawn, adjust ABILIFY MYCITE dosage to its original level.

  • Taking strong CYP3A4 inducers (e.g., carbamazepine, rifampin), double recommended dose over 1 to 2 weeks. When co‑administered drug is withdrawn, reduce ABILIFY MYCITE dosage to original level over 1 to 2 weeks.

Commonly Observed Adverse Reactions (incidence ≥5% and at least twice that for placebo) in adult patients:

  • Schizophrenia: akathisia

  • Bipolar mania (monotherapy): akathisia, sedation, restlessness, tremor, and extrapyramidal disorder

  • Bipolar mania (adjunctive therapy with lithium or valproate): akathisia, insomnia, and extrapyramidal disorder

  • Major depressive disorder (adjunctive treatment to antidepressant therapy): akathisia, restlessness, insomnia, constipation, fatigue, and blurred vision

Dystonia: Symptoms of dystonia may occur in susceptible individuals during the first days of treatment and at low doses.

Skin Irritation for MYCITE Patch: Symptoms of skin irritation localized at the site of the MYCITE Patch may occur. In clinical studies, 12.4% of patients (n=61) experienced skin rashes at the site of patch placement.

Pregnancy: Neonates exposed to antipsychotic drugs, including ABILIFY MYCITE, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms. Consider the benefits and risks of ABILIFY MYCITE and possible risks to the fetus when prescribing ABILIFY MYCITE to a pregnant woman. Advise pregnant women of potential fetal risk. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ABILIFY MYCITE during pregnancy. For more information contact the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.

Lactation: Aripiprazole is present in human breast milk; however, there are insufficient data to assess the amount in human milk, effects on the breastfed infant, or effects on milk production. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for ABILIFY MYCITE and any potential adverse effects on the infant or from the underlying maternal condition.

To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).





ABILIFY MYCITE, a drug-device combination product comprised of aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor intended to track drug ingestion, is indicated in adults for the:

  • Treatment of schizophrenia
  • Treatment of bipolar I disorder as monotherapy and as adjunct to lithium or valproate for:
    • Acute treatment of manic and mixed episodes
    • Maintenance treatment
  • Adjunctive treatment of major depressive disorder

Limitations of Use: ABILIFY MYCITE has not been shown to improve patient compliance or for use in modifying aripiprazole dosage. It should not be used in “real-time” or during an emergency, because detection may be delayed or not occur.