Medical Editor: John P. Cunha, DO, FACOEP
What Is Perseris?
What Are Side Effects of Perseris?
Common side effects of Perseris include:
- weight gain,
- musculoskeletal pain,
- abdominal discomfort,
- dry mouth,
- increased appetite,
- back pain,
- pain in extremities,
- anxiety, and
- extrapyramidal symptoms
Dosage for Perseris
The initial dose of Perseris is 90 mg or 120 mg.
What Drugs, Substances, or Supplements Interact with Perseris?
Perseris may interact with paroxetine, fluoxetine, quinidine, rifampin, carbamazepine, phenytoin, phenobarbital, alcohol, other antipsychotics, blood pressure medications, and dopamine agonists. Tell your doctor all medications and supplements you use.
Perseris During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Perseris. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including Perseris, during pregnancy. Perseris may cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. Perseris passes into breast milk and may cause adverse effects in nursing infants. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop taking this Perseris.
Our Perseris (risperidone) for Extended-Release Injectable Suspension, for Subcutaneous Use 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.
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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
- breast swelling or tenderness (in men or women), nipple discharge, impotence, lack of interest in sex, missed menstrual periods;
- severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
- high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;
- low blood cell counts--fever, mouth sores, skin sores, sore throat, cough, easy bruising, unusual bleeding, trouble breathing, feeling light-headed; or
- penis erection that is painful or lasts 4 hours or longer.
Serious side effects may be more likely in older adults.
Common side effects may include:
- dizziness, drowsiness, tired feeling;
- tremors, twitching or uncontrollable muscle movements;
- depressed mood, agitation, anxiety, restless feeling;
- muscle or joint pain;
- dry mouth, upset stomach, constipation;
- weight gain; or
- pain in your arms or legs.
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.
Read the entire detailed patient monograph for Perseris (Risperidone)
The following are discussed in more detail in previous sections of the labeling:
- Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see BOX WARNING and WARNINGS AND PRECAUTIONS]
- Cerebrovascular Adverse Events, Including Stroke, in Elderly Patients with Dementia-Related Psychosis [see WARNINGS AND PRECAUTIONS]
- Neuroleptic Malignant Syndrome (NMS) [see WARNINGS AND PRECAUTIONS]
- Tardive Dyskinesia [see WARNINGS AND PRECAUTIONS]
- Metabolic Changes [see WARNINGS AND PRECAUTIONS]
- Hyperprolactinemia [see WARNINGS AND PRECAUTIONS]
- Orthostatic Hypotension [see WARNINGS AND PRECAUTIONS]
- Falls [see WARNINGS AND PRECAUTIONS]
- Leukopenia, Neutropenia and Agranulocytosis [see WARNINGS AND PRECAUTIONS]
- Potential for Cognitive and Motor Impairment [see WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
- Dysphagia [see WARNINGS AND PRECAUTIONS]
- Priapism [see WARNINGS AND PRECAUTIONS]
- Body Temperature Regulation [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of PERSERIS was evaluated in a total of 814 adult subjects with schizophrenia who received at least 1 dose of PERSERIS during the clinical development program. A total of 322 subjects were exposed to PERSERIS for at least 6 months, of which 234 subjects were exposed to PERSERIS for at least 12 months; 281 and 176 of these, respectively, received the 120 mg dose.
Adverse drug reactions in adult subjects with schizophrenia (≥ 5% in any PERSERIS-treated group and greater than placebo) during the 8-week double-blind, placebo-controlled study) were weight increased, constipation, sedation/somnolence, pain in extremity, back pain, akathisia, anxiety, and musculoskeletal pain. In addition, the frequency of reported injection site reactions was similar across treatment groups with both PERSERIS and placebo; the most common (≥ 5%) of which were injection site pain, and erythema. The systemic safety profile for PERSERIS, was consistent with the known safety profile of oral risperidone.
Commonly-Observed Adverse Drug Reactions In Double-Blind, Placebo-Controlled Clinical Studies – Schizophrenia
Adverse Reactions with an incidence of 2% or more and greater than placebo are shown in Table 4.
Table 4. Adverse Drug Reactions in 2% or More of PERSERIS-Treated Subjects (and Greater than
Placebo) in an 8-Week Double-Blind, Placebo-Controlled Study
|System Organ Class||PERSERIS
|Preferred Term||(n = 115)||(n = 117)||(n =118)|
|Percentage of Subjects Reporting ADR|
|Metabolism and nutrition disorders|
|Musculoskeletal and connective tissue disorders|
|Pain in extremity||0.9||7.7||5.1|
|Nervous system disorders|
|* Sedation includes sedation and somnolence|
Other Adverse Drug Reactions Observed During The Clinical Trial Evaluation Of PERSERIS
The following list does not include reactions: 1) already listed in previous tables or elsewhere in labeling, 2) which are part of the disease state, 3) for which a drug cause was remote, 4) which were so general as to be uninformative, or 5) which were not considered to have significant clinical implications.
Blood and Lymphatic System Disorders: neutropenia
Ear and Labyrinth Disorders: vertigo
Endocrine Disorders: hyperprolactinemia
Eye Disorders: blepharospasm
Gastrointestinal Disorders: nausea, dyspepsia, vomiting, diarrhea, abdominal pain upper, salivary hypersecretion, hypoesthesia oral, tongue movement disturbance
General Disorders and Administration Site Conditions: injection site reaction (including injection site pain, induration, pruritus, bruising, erythema, inflammation, swelling and irritation) fatigue, edema peripheral, asthenia, chest discomfort
Investigations: blood prolactin increased, blood glucose increased, glycosylated hemoglobin increased, electrocardiogram abnormal, electrocardiogram QT prolonged, blood creatine phosphokinase increased
Metabolism and Nutrition Disorders: diabetes mellitus, decreased appetite Musculoskeletal, Connective Tissue, and Bone Disorders: arthralgia, muscle twitching, joint stiffness, trismus
Nervous System Disorders: headache, dizziness, tremor, drooling, dyskinesia, lethargy, dystonia, hypoesthesia, oromandibular dystonia, tardive dyskinesia, cogwheel rigidity, dysarthria, balance disorder, parkinsonian rest tremor, parkinsonism, slow speech
Psychiatric Disorders: insomnia, libido decreased, bruxism, restlessness, anorgasmia, loss of libido Reproductive System and Breast Disorders: erectile dysfunction, galactorrhea, breast tenderness, breast pain, amenorrhea, breast engorgement, ejaculation delayed, ejaculation disorder, gynecomastia, hypomenorrhea, breast discharge, breast enlargement, ejaculation failure, menstruation delayed, menstruation irregular, polymenorrhea
Skin and Subcutaneous Tissue Disorders: night sweats
Vascular Disorders: hypertension, hypotension, orthostatic hypotension
Other Adverse Reactions Observed During the Clinical Trial Evaluations of Oral Risperidone
The following is a list of additional ADRs that have been reported during the clinical trial evaluation of oral risperidone, regardless of frequency of occurrence:
Blood and Lymphatic System Disorders: anemia, granulocytopenia
Cardiac Disorders: tachycardia, sinus bradycardia, sinus tachycardia, atrioventricular block first degree, bundle branch block left, bundle branch block right, atrioventricular block
Ear and Labyrinth Disorders: ear pain, tinnitus
Eye Disorders: vision blurred, oculogyration, ocular hyperemia, eye discharge, conjunctivitis, eye rolling, eyelid edema, eye swelling, eyelid margin crusting, dry eye, lacrimation increased, photophobia, glaucoma, visual acuity reduced
Gastrointestinal Disorders: dysphagia, fecaloma, fecal incontinence, gastritis, lip swelling, cheilitis, aptyalism
General Disorders: thirst, gait disturbance, chest pain, influenza-like illness, pitting edema, edema, chills, sluggishness, malaise, face edema, discomfort, generalized edema, drug withdrawal syndrome, peripheral coldness, feeling abnormal
Immune System Disorders: drug hypersensitivity
Infections and Infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, urinary tract infection, pneumonia, influenza, ear infection, viral infection, pharyngitis, tonsillitis, bronchitis, eye infection, localized infection, cystitis, cellulitis, otitis media, onychomycosis, acarodermatitis, bronchopneumonia, respiratory tract infection, tracheobronchitis, otitis media chronic
Investigations: body temperature increased, alanine aminotransferase increased, heart rate increased, eosinophil count increased, white blood cell count decreased, hemoglobin decreased, blood creatine phosphokinase increased, hematocrit decreased, body temperature decreased, blood pressure decreased, transaminases increased
Metabolism and Nutrition Disorders: polydipsia, anorexia
Musculoskeletal, Connective Tissue, and Bone Disorders: joint swelling, musculoskeletal chest pain, posture abnormal, myalgia, neck pain, muscular weakness, muscle rigidity, muscle contracture, rhabdomyolysis
Nervous System Disorders: dizziness postural, disturbance in attention, unresponsive to stimuli, depressed level of consciousness, movement disorder, hypokinesia, bradykinesia, transient ischemic attack, coordination abnormal, cerebrovascular accident, masked facies, speech disorder, syncope, loss of consciousness, muscle contractions involuntary, Parkinson’s disease, tongue paralysis, akinesia, cerebral ischemia, cerebrovascular disorder, neuroleptic malignant syndrome, diabetic coma, head titubation
Psychiatric Disorders: agitation, blunted affect, confusional state, middle insomnia, nervousness, sleep disorder, listlessness
Renal and Urinary Disorders: enuresis, dysuria, pollakiuria, urinary incontinence
Reproductive System and Breast Disorders: vaginal discharge, menstrual disorder, retrograde ejaculation, sexual dysfunction
Respiratory, Thoracic, and Mediastinal Disorders: nasal congestion, dyspnea, epistaxis, wheezing, pneumonia aspiration, sinus congestion, dysphonia, productive cough, pulmonary congestion, respiratory tract congestion, rales, respiratory disorder, hyperventilation, nasal edema
Skin and Subcutaneous Tissue Disorders: rash, dry skin, erythema, skin discoloration, skin lesion, pruritus, skin disorder, rash erythematous, rash papular, acne, hyperkeratosis, seborrheic dermatitis, rash generalized, rash maculopapular
Vascular Disorders: flushing
Discontinuations Due To Adverse Drug Reactions (ADRs)
There was no single adverse reaction leading to discontinuation that occurred at a rate of ≥ 2% in PERSERIS-treated patients and greater than placebo.
Dose Dependency Of Adverse Drug Reactions In Clinical Trials
Changes in Body Weight
Data from the double-blind placebo-controlled study indicated there was a dose-dependent increase in mean changes in weight from baseline to postdose assessments in the PERSERIS 90 mg and 120 mg groups compared with the placebo group [see WARNINGS AND PRECAUTIONS, Clinical Trials Experience].
In the 8-week double-blind, placebo-controlled study, there was a typical increase in mean prolactin levels in fasting blood samples from baseline to the EOS assessments in both the PERSERIS 90 mg and 120 mg groups, while mean prolactin for the placebo group remained stable during the study. Changes in mean prolactin were dose-dependent and more pronounced in female subjects than male subjects.
Extrapyramidal Symptoms (EPS)
Several methods were used to measure EPS, including: (1) the Barnes Akathisia Rating Scale (BARS) global clinical rating score which evaluates akathisia, (2) the Abnormal Involuntary Movement Scale (AIMS) scores which evaluates dyskinesia, (3) the Simpson-Angus Scale (SAS) global score which broadly evaluates parkinsonism, and (4) the incidence of spontaneous reports of EPS-related adverse reactions.
In the 8-week double-blind, placebo-controlled study, the mean changes from baseline in BARS, AIMS, and SAS total scores were comparable between PERSERIS- and placebo-treated patients. At all postbaseline assessments, mean changes from baseline were between -0.1 and 0.2 (inclusive) for the BARS, between 0 and 0.2 (inclusive) for the AIMS and between -0.1 and 0.2 (inclusive) for the SAS.
The rates of ADRs associated with EPS were similar across treatment groups, including placebo. There was a higher incidence of akathisia in the PERSERIS 120 mg (6.8%) group compared with the PERSERIS 90 mg (2.6%) and placebo group (4.2%); reports of extrapyramidal disorders were higher in the PERSERIS 90 mg group (4.3%) compared with the PERSERIS 120 mg (1.7%) and placebo group (0.8%). In contrast, there was a higher incidence of dystonia in the placebo group (2.5%) compared with the PERSERIS groups (0 and 0.9%, respectively).
Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. Although these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia has been observed in males and younger age groups.
Changes In ECG
In the 8-week double-blind, placebo-controlled study, there were no clinically relevant differences in mean changes from baseline to EOS in ECG parameters, including QTcF (Fridericia’s corrected QT interval), QRS and PR intervals, and heart rate, in subjects in either PERSERIS treatment group (90 mg and 120 mg) compared with placebo. Similarly, in the 12-month, long-term safety study, there were no clinically relevant changes in mean ECG interval values from baseline to postdose assessments.
Pain Assessment And Local Injection Site Reactions
Local injection site pain was assessed using subject-reported VAS scales (0 = no pain to 100 = unbearably painful). In the 8-week, double-blind placebo-controlled study, the mean subject-reported injection site pain VAS scores were similar for all treatment groups following both injections. Pain scores decreased from a mean of 27 (VAS score) 1 minute after the first dose to a range of 3 to 7 (VAS score) 30 to 60 minutes postdose. In the 12-month, long-term safety study, the 1-minute postdose injection site pain VAS scores were highest on Day 1 (mean of 25) and decreased over time with subsequent injections (14 to 16 following last injection).
The local injection site was assessed by appropriately trained personnel. Throughout the clinical development program, the maximum reported intensity at any time point for each injection site assessment (pain, tenderness, inflammation/swelling and erythema) was none or mild for most subjects receiving PERSERIS.
Most subjects (≥ 79%) reported no tenderness and most who had tenderness reported mild severity. Less than 1% of subjects had moderate tenderness at any time point and 1 subject at Injections 1, 2, and 5 had severe tenderness. At each time point, most subjects (≥ 75%) reported no pain on injection. Of subjects who did have pain on injection, almost all of these were mild at each time point; only 1 or 2 subjects at Injections 1, 2, 7, and 12 had moderate pain on injection. At least 92% of subjects reported no erythema on each injection. All reports of erythema were of mild severity except for 2 cases of moderate erythema on Injection 1. Inflammation/swelling had a similar profile, with at least 88% of subjects reporting no inflammation/swelling and only mild symptoms except for 1 case of moderate severity on Injection 1.
The following adverse reactions have been identified during post approval use of oral risperidone. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These adverse reactions include: alopecia, anaphylactic reaction, angioedema, atrial fibrillation, cardiopulmonary arrest, diabetic ketoacidosis in patients with impaired glucose metabolism, dysgeusia, hypoglycemia, hypothermia, ileus, inappropriate antidiuretic hormone secretion, intestinal obstruction, jaundice, mania, pancreatitis, pituitary adenoma, precocious puberty, pulmonary embolism, QT prolongation, sleep apnea syndrome, sudden death, thrombocytopenia, thrombotic thrombocytopenic purpura, urinary retention, and water intoxication.
Read the entire FDA prescribing information for Perseris (Risperidone)
© Perseris Patient Information is supplied by Cerner Multum, Inc. and Perseris Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.