Olanzapine

Olanzapine Side Effects

In Summary

Commonly reported side effects of olanzapine include: asthenia, dizziness, drowsiness, extrapyramidal reaction, hyperkinetic muscle activity, akinesia, cogwheel rigidity, drug-induced parkinson's disease, dyspepsia, mask-like face, and xerostomia. Other side effects include: abnormal gait, back pain, constipation, fever, orthostatic hypotension, weight gain, myoclonus, and personality disorder. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to olanzapine: oral tablet, oral tablet disintegrating

Other dosage forms:

• intramuscular powder for solution, intramuscular powder for suspension extended release

Along with its needed effects, olanzapine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking olanzapine:

More common

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• blurred vision
• change in vision
• change in walking and balance
• clumsiness or unsteadiness
• difficulty with speaking
• difficulty with swallowing
• drooling
• impaired vision
• inability to sit still
• loss of balance control
• mask-like face
• muscle trembling, jerking, or stiffness
• need to keep moving
• rapid weight gain
• restlessness
• shuffling walk
• slowed movements
• slurred speech
• stiffness of the arms and legs
• tic-like (jerky) movements of the head, face, mouth, and neck
• tingling of the hands or feet
• trembling or shaking of the fingers, hands, feet, legs, or arms
• twisting movements of the body
• uncontrolled movements, especially of the face, neck, and back
• unusual weight gain or loss

Less common

• Bladder pain
• bloody or cloudy urine
• bruising
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain
• difficult or labored breathing
• difficult, burning, or painful urination
• dizziness
• excessive muscle tone
• frequent urge to urinate
• headache
• inability to move the eyes
• increased blinking or spasms of the eyelid
• itching of the vagina or genital area
• lack of coordination
• large, flat, blue, or purplish patches in the skin
• loss of bladder control
• loss of memory
• lower back or side pain
• muscle tension or tightness
• nervousness
• pain during sexual intercourse
• pounding in the ears
• problems with memory
• rhythmic movement of the muscles
• slow, fast, pounding, or irregular heartbeat or pulse
• speaking is less clear than usual
• sticking out the tongue
• thick, white vaginal discharge with no odor or with a mild odor
• tightness in the chest
• twitching
• uncontrolled twisting movements of the neck, trunk, arms, or legs
• unusual or incomplete body or facial movements
• weakness of the arms and legs

Some side effects of olanzapine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Acid or sour stomach
• back pain
• belching
• change in personality
• difficulty having a bowel movement (stool)
• discouragement
• feeling sad or empty
• fever
• heartburn
• increased appetite
• increased cough
• indigestion
• lack of appetite
• lack or loss of strength
• loss of interest or pleasure
• runny nose
• sneezing
• stomach discomfort, upset, or pain
• stuffy nose
• thirst
• trouble sleeping
• trouble with concentrating
• watering of the mouth

Less common

• Blemishes on the skin
• body aches or pain
• chills
• cold sweats
• congestion
• cough
• dry skin
• dryness or soreness of the throat
• false or unusual sense of well-being
• heavy menstrual bleeding (periods)
• hoarseness
• joint pain
• lack of feeling or emotion
• leg cramps
• pain in the arms or legs
• pimples
• sweating
• tender, swollen glands in the neck
• uncaring feelings
• voice change
• vomiting

For Healthcare Professionals

Applies to olanzapine: intramuscular powder for injection, intramuscular powder for injection extended release, oral tablet, oral tablet disintegrating

Nervous system

Post-Injection delirium/sedation syndrome, a collection of signs and symptoms consistent with olanzapine overdose has been reported following injections of the extended-release IM suspension. Events occurred in less than 0.1% of injections and in approximately 2% of patients receiving injections for up to 46 months. Onset of events ranged from soon after injection to greater than 3 hours later. The majority of patients were hospitalized and some required supportive care, including intubation. Two deaths have been reported occurring 3 to 4 days after receiving the appropriate dose of the extended-release IM suspension. In these patients, very high olanzapine blood levels were reported after death. A study undertaken to determine the cause of the elevated drug levels in these 2 deaths provides inconclusive results. As reported in a 3-23-2015 drug safety communication issued by the US Food and Drug Administration, a study in animals found much of the drug level increases could have occurred after death, but the possibility that the deaths were caused by a rapid, but delayed entry of the drug in to the bloodstream could not be ruled out.

Akathisia most commonly occurred with oral doses of 15 mg/day; akathisia events included akathisia and hyperkinesia.

Dyskinetic events included buccoglossal syndrome, choreoathetosis, dyskinesia, and tardive dyskinesia.

Dystonic events included dystonia, generalized spasm, neck rigidity, oculogyric crisis, opisthotonos, and torticollis.

Parkinsonism/parkinsonism events most commonly occurred with oral doses of 15 mg/day and included akinesia, cogwheel rigidity, extrapyramidal syndrome, hypertonia, hypokinesia, masked facies, and tremor.

Sedation most commonly occurred in adolescent patients given oral doses at least 2.5 mg/day over 3 weeks; sedation included hypersomnia, lethargy, sedation, and somnolence.

Somnolence and tremor most commonly occurred with oral doses given with lithium or valproate.

Oral formulations:

Very common (10% or more): Somnolence (up to 52%), sedation (up to 48%), akathisia/akathisia events (up to 27%), tremor (up to 23%), parkinsonism/parkinsonism events (up to 20%), dizziness (up to 18%), headache (up to 17%), any extrapyramidal event (up to 10%)

Common (1% to 10%): Abnormal gait, amnesia, articulation impairment, dyskinesia/dyskinetic events, dystonia/dystonic events, hypertonia, incoordination, mild/transient anticholinergic effects, paresthesia, speech disorder

Uncommon (0.1% to 1%): Ataxia, cerebrovascular accident, dysarthria, restless legs syndrome, seizures, stupor, tardive dyskinesia

Rare (0.01% to 0.1%): Coma, hangover effect, neuroleptic malignant syndrome

Frequency not reported: Akinesia, choreoathetosis, cogwheel rigidity, dyskinesia, dystonia, extrapyramidal disorder, generalized spasm, hypersomnia, hypokinesia, masked facies, movement disorder, myoclonus, opisthotonos, tardive dyskinesia, twitching

Postmarketing reports: Diabetic coma

Immediate-release IM injection:

Very common (10% or more): Sedation (up to 44.1%)

Common (1% to 10%): Abnormal gait, akathisia/akathisia events, any extrapyramidal events, dizziness, parkinsonism/parkinsonism events, somnolence, speech disorder, tremor

Uncommon (0.1% to 1%): Amnesia, restless legs syndrome, syncope

Frequency not reported: Akinesia, choreoathetosis, cogwheel rigidity, dyskinesia, dyskinetic events, dystonia, dystonic events, extrapyramidal disorder, generalized spasm, hyperkinesia, hypersomnia, hypertonia, hypokinesia, masked facies, movement disorder, myoclonus, opisthotonos, twitching

Postmarketing reports: Diabetic coma, neuroleptic malignant syndrome, seizures

Extended-release IM injection:

Very common (10% or more): Headache/tension headache (up to 18%), sedation/somnolence (up to 13%)

Common (1% to 10%): Akathisia, dizziness, dysarthria, dyskinesia, hypersomnia, mild/transient anticholinergic effects, parkinsonism, tremor

Uncommon (0.1% to 1%): Amnesia, dystonia, seizures, restless legs syndrome, tardive dyskinesia

Rare (0.01% to 0.1%): Neuroleptic malignant syndrome

Frequency not reported: Abnormal gait, ataxia, cerebrovascular adverse reactions, coma, convulsions, dystonia, extrapyramidal symptoms, speech disorder, tardive extrapyramidal syndromes

Postmarketing reports: Diabetic coma

Cardiovascular

Oral formulations:

Common (1% to 10%): Chest pain, edema, hypertension, peripheral edema, postural/orthostatic hypotension, tachycardia

Uncommon (0.1% to 1%): Bradycardia, deep vein thrombosis, QT prolongation, vasodilation

Rare (0.01% to 0.1%): Ventricular tachycardia/fibrillation

Postmarketing reports: Cardiac arrest, torsade de pointes, venous thromboembolic events, venous thromboembolism, ventricular arrhythmia

Immediate-release IM injection:

Common (1% to 10%): Bradycardia, hypotension, peripheral edema, postural/orthostatic hypotension, tachycardia

Uncommon (0.1% to 1%): Photosensitivity reaction

Postmarketing reports: Deep vein thrombosis, cardiac arrest, QT prolongation, torsade de pointes, venous thromboembolic events, venous thromboembolism, ventricular arrhythmia

Extended-release IM injection:

Common (1% to 10%): Bradycardia with/without hypotension/syncope, edema, electrocardiogram QT-corrected interval prolonged, hypertension, hypotension, orthostatic hypotension, peripheral edema, tachycardia

Uncommon (0.1% to 1%): Deep vein thrombosis, thromboembolism

Rare (0.01% to 0.1%): Ventricular tachycardia/fibrillation

Postmarketing reports: Cardiac arrest, deep vein thrombosis, torsades de pointes, venous thromboembolic events/venous thromboembolism

Collective data gathered from 17 placebo-controlled clinical studies (n=5106) involving the use of atypical antipsychotic agents, including olanzapine, for the treatment of behavioral disorders in the elderly patient with dementia showed a risk of death 1.6 to 1.7 times greater in the drug treated patient than in the placebo treated patient. The average length of duration for the trials was 10 weeks with the cause of death in the majority of cases, though not all, reported as either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Olanzapine is not approved by the FDA for use in the treatment of behavioral disorders in elderly patients with dementia.

Metabolic

Oral formulations:

Very common (10% or more): Weight gain/increased weight greater than/equal to 7% of baseline body weight (up to 89.4%), fasting borderline to high triglycerides (up to 59.5%), fasting borderline to high total cholesterol (up to 38.9%), increased appetite (up to 29%), fasting normal to high triglycerides (up to 26.9%), fasting borderline to high glucose (up to 14.3%) thirst (up to 10%)

Common (1% to 10%): Fasting normal to high glucose, fasting normal to high total cholesterol, high uric acid, hyperglycemia, increased alkaline phosphatase, increased triglyceride levels, weight gain greater than/equal to 15% of baseline body weight

Uncommon (0.1% to 1%): Development/exacerbation of diabetes with/without ketoacidosis or coma (sometimes fatal)

Postmarketing reports: Diabetic ketoacidosis, hypertriglyceridemia, random cholesterol levels of 240 mg/dL or higher, random triglyceride levels of 1000 mg/dL or higher

Immediate-release IM injection:

Very common (10% or more): Weight gain/increased weight greater than/equal to 7% of baseline body weight (up to 89.4%), fasting borderline to high triglycerides/hypertriglyceridemia (up to 70.7%), fasting borderline to high total cholesterol/hypercholesterolemia (up to 55.2%), fasting borderline to high glucose/hyperglycemia (up to 26%)

Common (1% to 10%): Increased appetite, weight gain greater than/equal to 15% of baseline body weight

Postmarketing reports: Diabetic ketoacidosis, pre-existing diabetes exacerbation, random cholesterol levels of 240 mg/dL or higher, random triglyceride levels of 1000 mg/dL or higher

Extended-release IM injection:

Very common (10% or more): Weight gain/increased weight greater than/equal to 7% of baseline body weight (up to 64.4%)

Common (1% to 10%): Fasting borderline to high cholesterol/glucose/triglycerides, fasting normal to high cholesterol/triglycerides/glucose, high uric acid, increased alkaline phosphatase, increased appetite, weight gain greater than/equal to 15% of baseline body weight

Uncommon (0.1% to 1%): Development/exacerbation of diabetes with/without ketoacidosis or coma (sometimes fatal)

Frequency not reported: Changes in cholesterol/LDL/triglycerides/sodium

Postmarketing reports: Diabetic ketoacidosis, hyperglycemia, random cholesterol levels of 6.21 mmol/L or higher, random triglyceride levels of 11.29 mmol/L or higher

Olanzapine appears to have a greater association than some other atypical antipsychotics for increasing glucose levels. Mean increases of up to 15 mg/dL have been reported. The differences in mean changes in serum glucose were higher in patients with evidence of glucose dysregulation at baseline. In an analysis of patients who completed 9 to 12 months of therapy, the rate on increase in mean blood glucose slowed after approximately 6 months.

Clinically significant alterations in lipids have been observed including serum triglyceride elevations greater than 500 mg/dL. In long-term studies of at least 48-weeks in adults, increased from baseline in mean fasting cholesterol, LDL, triglycerides were 5.6 mg/dL, 2.5 mg/dL, and 18.7 mg/dL, respectively. Mean increases in fasting lipid values (total cholesterol, LDL and triglycerides) were greater in patients without evidence of lipid dysregulation at baseline.

In 13 placebo-controlled monotherapy trials, olanzapine-treated patients gained an average of 2.6 kg compared to an average 0.3 kg weight loss in placebo patients; 22.5% gained at least 7% of their baseline weight, 4.2% at least 15% of their baseline (compared to 3% and 0.3% in placebo). Clinically significant weight gain was observed across all baseline BMIs. With longer term exposure (at least 24 weeks), weight gain of 7%, 15%, or 25% or more were reported in 89.4%, 55.3%, and 29.1%, respectively. Weight gain and increased appetite were reported in 40.6%, 7.1%, and 2.5% of adolescents receiving this drug in short term treatment (approximately 22 days), respectively.

Gastrointestinal

Oral formulations:

Very common (10% or more): Dry mouth (up to 32%), constipation (up to 11%), dyspepsia (up to 11%)

Common (1% to 10%): Abdominal pain, diarrhea, dyspepsia, increased salivation, nausea, vomiting

Uncommon (0.1% to 1%): Abdominal distention, tongue edema

Rare (0.01% to 0.1%): Ileus, intestinal obstruction, pancreatitis

Frequency not reported: Buccoglossal syndrome, lower/upper abdominal pain

Immediate-release IM injection:

Common (1% to 10%): Constipation, dry mouth

Uncommon (0.1% to 1%): Abdominal distention, nausea

Frequency not reported: Buccoglossal syndrome

Postmarketing reports: Pancreatitis, vomiting

Extended-release IM injection:

Common (1% to 10%): Abdominal pain/upper abdominal pain, constipation, diarrhea, dry mouth, flatulence, nausea, toothache, tooth infection/abscess, vomiting

Uncommon (0.1% to 1%): Abdominal distention

Rare (0.01% to 0.1%): Pancreatitis

Abdominal pain included abdominal pain, lower abdominal pain, and upper abdominal pain.

Nausea and dry mouth have been reported to be dose related. Dry mouth was more commonly reported when given orally with lithium or valproate.

Hepatic

Oral formulations:

Very common (10% or more): AST elevated (up to 27.6%), decreased total bilirubin (up to 22.1%), ALT 3-times upper limit of normal (3 x ULN) (up to 12.1%)

Common (1% to 10%): Asymptomatic liver enzyme elevations (ALT, AST), high gamma glutamyltransferase (GGT)

Uncommon (0.1% to 1%): Bilirubinemia/increased total bilirubin

Rare (0.01% to 0.1%): Fatty liver deposit

Frequency not reported: Hepatitis, hepatocellular/cholestatic hepatitis, mixed liver injury

Postmarketing reports: Jaundice

Immediate-release IM injection:

Very common (10% or more): AST elevated (up to 27.6%), decreased total bilirubin (up to 22.1%), ALT 3 x ULN (up to 12.1%)

Postmarketing reports: Cholestatic/mixed liver injury, jaundice, total bilirubin increased

Extended-release IM injection:

Common (1% to 10%): ALT 3 x ULN, High GGT levels, asymptomatic liver enzyme elevations (ALT, AST), increased hepatic enzymes (AST, ALT, GGT), low total bilirubin

Uncommon (0.1% to 1%): ALT elevation greater than 200 international units/L, increased total bilirubin

Rare (0.01% to 0.1%): Hepatocellular/cholestatic hepatitis, mixed liver injury

Frequency not reported: Changes in direct bilirubin/GGT

Postmarketing reports: Jaundice

Transient, asymptomatic elevations of hepatic transaminases were commonly seen, especially early in treatment.

Respiratory

Oral formulations:

Common (1% to 10%): Dyspnea, increased cough, nasopharyngitis, pharyngitis, respiratory tract infection, rhinitis, sinusitis

Uncommon (0.1% to 1%): Epistaxis, pulmonary embolism

Rare (0.01% to 0.1%): Lung edema

Frequency not reported: Lower respiratory tract infection, pneumonia, upper respiratory tract infection, viral respiratory tract infection, viral upper respiratory tract infection

Immediate-release IM injection:

Common (1% to 10%): Pneumonia

Uncommon (0.1% to 1%): Epistaxis

Postmarketing reports: Pulmonary embolism

Extended-release IM injection:

Common (1% to 10%): Cough, nasal/sinus congestion, nasopharyngitis, pharyngolaryngeal pain, sneezing, upper respiratory tract infection

Uncommon (0.1% to 1%): Epistaxis, pulmonary embolism

Rare (0.01% to 0.1%):

Frequency not reported: Pneumonia

Endocrine

Oral formulations:

Very common (10% or more): Prolactin level elevation (up to 47.4%)

Uncommon (0.1% to 1%): Gynecomastia/male breast enlargement

Immediate-release IM injection:

Very common (10% or more): Increased prolactin (up to 47.4%)

Uncommon (0.1% to 1%): Gynecomastia/male breast enlargement

Extended-release IM injection:

Very common (10% or more): Plasma prolactin level elevation (up to 30%)

Uncommon (0.1% to 1%): Gynecomastia/male breast enlargement

In clinical studies, changes in prolactin levels were found to be statistically significantly different based on dose, higher doses were associated with higher levels of prolactin. In a study of up to 12 weeks, plasma prolactin concentrations exceeded the upper limit of normal (ULN) in approximately 30% of patients who had normal baseline prolactin values. The majority of these elevations were mild, and remained below 2 x ULN.

Approximately 47% of treated adolescent patients had significantly higher prolactin levels compared to adults.

Hematologic

Oral formulations:

Common (1% to 10%): Eosinophilia, leukopenia, neutropenia

Uncommon (0.1% to 1%): Thrombocytopenia, thromboembolism

Immediate-release IM injection:

Common (1% to 10%): Eosinophilia, leukopenia, neutropenia

Postmarketing reports: Thrombocytopenia

Extended-release IM injection:

Common (1% to 10%): Eosinophilia, leukopenia, neutropenia

Rare (0.01% to 0.1%): Thrombocytopenia

Frequency not reported: Changes in monocytes/eosinophils, high leukocyte count, treatment-emergent low platelet count

Ocular

Oral formulations:

Common (1% to 10%): Amblyopia, abnormal vision

Uncommon (0.1% to 1%): Accommodation abnormality, dry eyes, oculogyration

Rare (0.01% to 0.1%): Mydriasis

Frequency not reported: Oculogyric crisis

Immediate-release IM injection:

Frequency not reported: Oculogyric crisis

Extended-release IM injection:

Uncommon (0.1% to 1%): Oculogyration

Other

Oral formulations:

Very common (10% or more): Asthenia (up to 20%), fatigue (up to 14%), accidental injury (up to 12%)

Common (1% to 10%): Fever/pyrexia, extremity pain (other than joint), lethargy, residual events, nonspecific events

Uncommon (0.1% to 1%): Chills

Rare (0.01% to 0.1%): Chills and fever, hypothermia, sudden death/sudden unexplained death

Frequency not reported: Falls, increased body temperature, neonatal drug withdrawal syndrome

Immediate-release IM injection:

Common (1% to 10%): Asthenia, fatigue, pyrexia, residual events

Frequency not reported: Falls, lethargy

Postmarketing reports: Sudden unexplained death

Extended-release IM injection:

Common (1% to 10%): Asthenia, ear pain, fatigue, fever/pyrexia, overdose, pain, procedural pain

Rare (0.01% to 0.1%): Hypothermia

Frequency not reported: Death, falls, increased body temperature, lethargy, neonatal drug withdrawal syndrome, sudden death/sudden unexplained death, weakness

Asthenia most frequently occurred in oral doses of 15 mg/day.

Residual events included movement disorder, myoclonus, and twitching.

Hypersensitivity

Oral formulations:

Uncommon (0.1% to 1%): Hypersensitivity

Postmarketing reports: Allergic reaction, anaphylactoid reaction, angioedema

Immediate-release IM injection:

Postmarketing reports: Allergic reaction, anaphylactoid reaction, angioedema

Extended-release IM injection:

Uncommon (0.1% to 1%): Hypersensitivity

Postmarketing reports: Allergic reaction, anaphylactoid reaction, angioedema

Genitourinary

Oral formulations:

Common (1% to 10%): Dysmenorrhea, erectile dysfunction, glucosuria, urinary incontinence, urinary tract infection, vaginitis

Uncommon (0.1% to 1%): Amenorrhea, breast enlargement/pain, decreased menstruation, galactorrhea, impaired urination, impotence, increased menstruation, menorrhagia, metrorrhagia, polyuria, urinary frequency, urinary hesitation, urinary retention, urinary urgency

Rare (0.01% to 0.1%): Priapism

Immediate-release IM injection:

Common (1% to 10%): Erectile dysfunction, urinary incontinence

Uncommon (0.1% to 1%): Amenorrhea, breast enlargement, galactorrhea

Postmarketing reports: Priapism, urinary hesitation, urinary retention

Extended-release IM injection:

Common (1% to 10%): Erectile dysfunction, vaginal discharge

Uncommon (0.1% to 1%): Amenorrhea, breast enlargement, galactorrhea, urinary hesitation, urinary incontinence, urinary retention

Rare (0.01% to 0.1%): Priapism

Musculoskeletal

Oral formulations:

Common (1% to 10%): Arthralgia, back pain, high creatine/creatinine phosphokinase, joint pain, musculoskeletal stiffness

Rare (0.01% to 0.1%): Osteoporosis, rhabdomyolysis

Frequency not reported: Neck rigidity, torticollis

Immediate-release IM injection:

Common (1% to 10%): Arthralgia

Uncommon (0.1% to 1%): Increased creatinine phosphokinase

Rare (0.01% to 0.1%): Elevated creatine kinase levels

Frequency not reported: Neck rigidity, torticollis

Postmarketing reports: Rhabdomyolysis

Extended-release IM injection:

Common (1% to 10%): Arthralgia, back pain, high creatine phosphokinase, muscle spasms, musculoskeletal spasms

Rare (0.01% to 0.1%): Rhabdomyolysis

Dermatologic

Oral formulations:

Common (1% to 10%): Acne, dry skin, ecchymosis, rash, sweating/diaphoresis

Uncommon (0.1% to 1%): Alopecia, face edema, photosensitivity reaction

Frequency not reported: Drug reaction with eosinophilia and systemic symptoms (DRESS), erythema, pruritus, urticaria

Immediate-release IM injection:

Postmarketing reports: Alopecia, drug reaction with eosinophilia and systemic symptoms (DRESS), pruritus, rash, sweating/diaphoresis, urticaria

Extended-release IM injection:

Common (1% to 10%): Acne, rash

Uncommon (0.1% to 1%): Alopecia, photosensitivity reaction

Frequency not reported: Diaphoresis/sweating, erythema

Postmarketing reports: Drug reaction with eosinophilia and systemic symptoms (DRESS), pruritus, urticaria

Psychiatric

Oral formulations:

Very common (10% or more): Depression (up to 18%), insomnia (up to 12%)

Common (1% to 10%): Apathy, confusion, decreased libido, euphoria, personality disorder, restlessness

Uncommon (0.1% to 1%): Suicide attempt

Rare (0.01% to 0.1%): Discontinuation symptoms

Frequency not reported: Anxiety, visual hallucinations/hallucinations

Postmarketing reports: Discontinuation reaction

Immediate-release IM injection:

Common (1% to 10%): Decreased libido

Frequency not reported: Hallucinations

Postmarketing reports: Anxiety, discontinuation reaction, insomnia

Extended-release IM injection:

Common (1% to 10%): Abnormal dreams, abnormal thinking, auditory hallucinations, decreased libido, restlessness, sleep disorder

Rare (0.01% to 0.1%): Discontinuation reaction/symptoms

Frequency not reported: Aggression, agitation, anxiety, confusion, delirium, hallucinations, insomnia, other cognitive impairment, visual hallucinations

For the collection of adverse reactions, the term personality disorder was used to collect data on nonaggressive objectionable behavior.

Depression most commonly occurred with oral doses given with lithium or valproate.

Local

Immediate-release IM injection:

Common (1% to 10%): Injection site pain

Extended-release IM injection:

Common (1% to 10%): Anesthesia, bruising, buttock pain, hemorrhage, induration, injection site induration/mass/pain, irritation

Rare (0.01% to 0.1%): Injection site abscess requiring/not requiring surgical intervention

Frequency not reported: Edema-type reaction, erythema-type reaction, nodule-type reaction, non-specific injection-site reaction

Immunologic

Extended-release IM injection:

Common (1% to 10%): Viral infection

Renal

Oral formulations:

Common (1% to 10%): Glycosuria

Immediate-release IM injection:

Common (1% to 10%): Glycosuria

Extended-release IM injection:

Common (1% to 10%): Glycosuria