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Clozapine Side Effects

Not all side effects for clozapine may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to clozapine: oral suspension, oral tablet, oral tablet disintegrating

In addition to its needed effects, some unwanted effects may be caused by clozapine. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking clozapine:

More common
  • Blurred vision
  • confusion
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fainting
  • fast, pounding, or irregular heartbeat or pulse
  • fever
  • shakiness in the legs, arms, hands, or feet
  • sleepiness or unusual drowsiness
  • sweating
  • trembling or shaking of the hands or feet
  • unusual tiredness or weakness
Less common
  • Anxiety
  • black, tarry stools
  • chest pain
  • chills
  • convulsions
  • cough or hoarseness
  • decrease in the frequency of urination
  • decrease in urine volume
  • difficult or labored breathing
  • difficulty in passing urine (dribbling)
  • discouragement
  • dry mouth
  • feeling sad or empty
  • fever with or without chills
  • frequent strong or increased urge to urinate
  • general feeling of tiredness or weakness
  • headache
  • hyperventilation
  • irritability
  • lack of appetite
  • loss of bladder control
  • loss of interest or pleasure
  • lower back or side pain
  • muscle spasm or jerking of all extremities
  • painful or difficult urination
  • pounding in the ears
  • restlessness or need to keep moving
  • severe or continuing headache
  • shakiness and unsteady walk
  • slurred speech
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • sudden jerky movements of the body
  • sudden loss of consciousness
  • swollen glands
  • throat discomfort
  • tightness in the chest
  • trouble concentrating
  • trouble sleeping
  • unsteadiness, trembling, or other problems with muscle control or coordination
Rare
  • Absence of or decrease in movement
  • change in appetite
  • dark urine
  • decreased sexual ability
  • difficult or fast breathing or sudden shortness of breath
  • increased sweating
  • increased thirst
  • increased urination
  • lip smacking or puckering
  • muscle stiffness (severe)
  • nausea
  • puffing of the cheeks
  • rapid or worm-like movements of the tongue
  • swelling or pain in the leg
  • uncontrolled chewing movements
  • uncontrolled movements of the arms and legs
  • unusual bleeding or bruising
  • unusually pale skin
  • vomiting
  • weakness
  • yellow eyes or skin
Incidence not known
  • Abdominal or stomach pain
  • bloating
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • clay-colored stools
  • confusion as to time, place, or person
  • constipation
  • diarrhea
  • epileptic seizure that will not stop
  • feeling that others are watching you or controlling your behavior
  • feeling that others can hear your thoughts
  • feeling, seeing, or hearing things that are not there
  • holding false beliefs that cannot be changed by fact
  • inability to move the eyes
  • increased blinking or spasms of the eyelid
  • indigestion
  • itching
  • joint pain
  • light-colored stools
  • muscle twitching
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • rhythmic movement of the muscles
  • severe mood or mental changes
  • skin rash
  • sticking out of the tongue
  • swelling around the eyes
  • swelling of the body or feet and ankles
  • trouble with speaking
  • unpleasant breath odor
  • unusual behavior
  • unusual excitement, nervousness, or restlessness
  • unusual facial expressions
  • unusual weight gain
  • upper right abdominal or stomach pain
  • vomiting of blood

Some of the side effects that can occur with clozapine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Acid or sour stomach
  • belching
  • feeling of constant movement of self or surroundings
  • heartburn
  • relaxed and calm sensation of spinning
  • sleepiness
Less common
  • Blurred or loss of vision
  • change or problem with discharge of semen
  • disturbed color perception
  • double vision
  • halos around lights
  • inability to sit still
  • increase in body movements
  • muscle pain or ache
  • muscle weakness
  • night blindness
  • nightmares
  • overbright appearance of lights
  • pain in the back, neck, or legs
  • pain in the chest below the breastbone
  • severe muscle stiffness
  • sore tongue
  • stuffy nose
  • tunnel vision
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
Incidence not known
  • Blistering, peeling, or loosening of the skin
  • hives
  • increased sensitivity of the skin to sunlight
  • painful or prolonged erection of the penis
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • reddening of the skin, especially around the ears
  • severe stomach pain
  • severe sunburn
  • sores, welting, or blisters
  • swelling of the eyes, face, or inside of the nose
  • swelling of the salivary glands

For Healthcare Professionals

Applies to clozapine: oral suspension, oral tablet, oral tablet disintegrating

Hematologic

Hematologic side effects have included agranulocytosis, leukopenia, neutropenia, and eosinophilia. Anemia and leukocytosis have been reported in less than 1% of patients. Elevated hemoglobin/hematocrit, increased erythrocyte sedimentation rate (ESR), thrombocytosis, and thrombocytopenia have also been reported; however, causality has not been established. Lymphopenia has also been reported.

During premarketing testing, the cumulative incidence of agranulocytosis at one year was approximately 1.3%. A later study has suggested that the cumulative incidence at one year is 0.8%. The incidence of agranulocytosis increases with age and may be higher in women.

The mechanism of clozapine-induced agranulocytosis is not completely understood.

Some investigators have suggested that the presence of HLA-B38 may predispose certain patients to the development of agranulocytosis during clozapine therapy. An increased incidence of clozapine-induced agranulocytosis has been reported in patients of Ashkenazi Jewish ancestry, a population in which HLA-B38 is prevalent.

Another study has suggested that one of the principal metabolites of clozapine, N-desmethylclozapine, is particularly toxic to the bone marrow.

Individuals with a fall in total WBC count to below 2000/mm3 or ANC below 1000/mm3 may not be rechallenged. However, individuals with an initial episode of moderate leukopenia (WBC of at least 2000/mm3 and less than 3000/mm3) have up to a 12 fold increased risk of having a subsequent episode of agranulocytosis upon rechallenge compared to the full cohort of patients treated with clozapine. To reduce the chances of rechallenge occurring in this patient population a report should be filed with the Clozapine National Registry (CNR), phone 1-800-448-5938), a single, national, confidential data base.

Because of the potential of agranulocytosis, clozapine is only available in the United States through distribution systems which ensure that a patient's WBC count and ANC are checked per a predetermined schedule.

Some investigators have suggested that filgrastim, a granulocyte colony stimulating factor, may be useful in the management of clozapine-induced agranulocytosis.

The incidence of agranulocytosis is reported to rise steeply during the first 2 months of therapy, peak at approximately the third month of therapy, and then decrease to approximately 3 per 1000 person-years at 6 months of therapy. After 6 months of therapy the incidence decreases further; however, it never reaches zero.

A 45 year old African American woman with diagnosis of schizophrenia and mild mental retardation developed agranulocytosis after 6 years of continuous clozapine therapy at a dose of 500 mg per day. At the time of this incident, concomitant therapy for the preceding 4 years consisted of olanzapine, benazepril, and haloperidol decanoate injection. Clozapine was discontinued and the WBC count returned to normal limits two days later. The remaining pharmacological therapy remained constant. Clozapine therapy, without granulocyte colony-stimulating factor, was reinitiated two and a half months later under strict monitoring parameters. The dose was gradually titrated over a 5 month period to 800 mg per day. At the time of report, the patient had received clozapine for 3 years following reinitiation without an abnormal blood event.

Several cases of chronic leukocytosis associated with clozapine use have been reported and all appear to be benign. To date, all reported cases of chronic or persistent leukocytosis have occurred in males. In one case series, chronic leukocytosis was tracked for a period of 2 to 5 years in seven patients receiving clozapine (mean dose 457 mg/day; range 50 to 600 mg daily). Leukocytosis resolved in 2 patients when clozapine was discontinued and returned in 1 when the drug was restarted.

Nervous system

Nervous system side effects have included drowsiness/sedation (39%), dizziness/vertigo (19%), headache (7%), tremor (6%), syncope (6%), disturbed sleep/nightmares (4%), restlessness (4%), hypokinesia/akinesia (4%), agitation (4%), seizures (3%), rigidity (3%), akathisia (3%), confusion (3%), fatigue (2%), insomnia (2%), hyperkinesia (1%), weakness (1%), lethargy (1%), ataxia (1%), slurred speech (1%), depression (1%), epileptiform movements/myoclonic jerks (1%), and anxiety (1%). Loss of speech, amentia, tics, poor coordination, involuntary movement, stuttering, dysarthria, amnesia/memory loss, histrionic movements, changes in libido, shakiness, Parkinsonism, and irritability have been reported in less than 1% of patients. Delirium, EEG abnormalities, myoclonus, overdose, paresthesia, mild cataplexy, and status epilepticus have also been reported; however, causality has not been established. Dyskinesia, coma, dystonia, and neuroleptic malignant syndrome have been reported rarely. One case of clozapine-induced restless legs syndrome (RLS) has been reported. Symptoms (e.g., unpleasant sensation in calves, burning sensation over feet) of RLS developed on the third day of treatment, recurred on rechallenge, and completely resolved following discontinuation. At least one case of reversible Pisa syndrome has also been reported. In addition, clozapine-induced oculogyric crises have also been reported. Postmarketing clinical experience has included obsessive compulsive symptoms.

Symptoms of dystonia 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. While 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 is observed in males and younger age groups. Clozapine, an atypical antipsychotic, is associated with a low incidence of dystonia.

Clozapine may lower the seizure threshold in a dose-dependent fashion.

Rapid dose increase or preexisting epilepsy may increase the incidence of seizures.

Reports of sedation and/or drowsiness appear to decrease with dose reduction or length of clozapine therapy.

Fever, altered consciousness, autonomic dysfunction and muscle rigidity are the hallmarks of the neuroleptic malignant syndrome. The neuroleptic malignant syndrome is associated with a case fatality rate of about 20%. Immediate discontinuation of neuroleptic therapy, consideration of dantrolene therapy, as well as intensive monitoring and supportive care are indicated.

Although considered rare, there have been at least 21 cases of clozapine associated neuroleptic malignant syndrome (NMS) reported. The mean age of patients who developed NMS has been 40 years, the mean dose of clozapine has been 318 mg daily and the mean number of days to onset of NMS has been 218 days. In approximately half the cases, NMS occurred during a dose increase while the remainder of patients were on stable doses.

In one case report involving a 16 year old patient, NMS characterized by fever, autonomic changes, muscle rigidity, and elevated creatine kinase developed at a low dose (12.5 mg) within 8 hours of initiation of treatment.

There are reports of possible clozapine associated atypical neuroleptic malignant syndrome characterized by fever, diaphoresis, no muscle rigidity, and mild or no elevation of creatine kinase level.

Gastrointestinal

Gastrointestinal side effects have included hypersalivation (31% to 80%), salivation (31%), constipation (14%), dry mouth (6%), nausea (5%), abdominal discomfort/heartburn (4%), vomiting (3%), and diarrhea (2%). Abdominal distention, gastroenteritis, rectal bleeding, nervous stomach, abnormal stools, hematemesis, gastric ulcer, bitter taste, eructation, polydipsia, and dry throat have been reported in less than 1% of patients. Acute pancreatitis, dysphagia, fecal impaction, intestinal obstruction, paralytic ileus, and swelling of salivary gland have also been reported; however, causality has not been established. There have been a number of case reports in the literature citing clozapine as a potential cause of colitis. Clozapine has also been associated with rare cases of esophageal dysfunction resulting in dysphagia.

Specific subtypes of colitis associated with clozapine have included eosinophilic, neutropenic, pseudomembranous, necrotizing, and microscopic colitis.

Elderly patients may be more susceptible to the anticholinergic effects of clozapine, such as constipation.

Hypersalivation may be dose-dependent.

One hypothesis is that hypersalivation may be due to the blockade of alpha-2 adrenoceptors.

Some case reports have suggested that clozapine may rarely cause pancreatitis.

There have been rare reports of severe diarrhea in association with lymphopenia and/or neutropenia.

Cardiovascular

Elderly patients, particularly those with preexisting cardiovascular dysfunction, may be more susceptible to cardiovascular side effects, especially orthostatic hypotension and tachycardia. In addition, an increased risk of mortality, possibly due to heart failure or sudden death, has been reported with the use of atypical antipsychotic agents in the treatment of behavioral disorders in the elderly patient with dementia.

Collective data gathered from 17 placebo-controlled clinical studies (n=5106) involving the use of atypical antipsychotic agents 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. Although clozapine was not included in these studies, the consistent findings across all three relevant chemical classes support the opinion that these findings are likely to be applicable to all atypical antipsychotic agents. Clozapine is not approved by the FDA for use in the treatment of behavioral disorders in elderly patients with dementia.

The results of a large retrospective cohort study appear to indicate that atypical antipsychotic agents (i.e., risperidone, olanzapine, clozapine, quetiapine) increase the risk of venous thromboembolism in elderly patients; however, these events seem to be rare.

Orthostatic hypotension (sometimes associated with syncope and rarely associated with cardiovascular collapse) has been reported particularly at initial titration in association with rapid dose escalation and has been reported with the first dose.

Case reports have suggested that clozapine may cause a paradoxical increase in blood pressure. A chart review (n=82) revealed the incidence of hypertension to be higher in first six months of clozapine therapy.

One recent study has suggested that mild tachycardia may occur in as many as 51% of treated patients and a case report has suggested that the tachycardia may be associated with PVCs.

There are reports of numerous cases of myocarditis (including eighteen deaths) and forty one cases of cardiomyopathy (including 10 deaths). Clozapine associated myocarditis has been reported to occur most often within one to two months of starting clozapine, but it may develop at any time while on clozapine and may even occur at very low doses. Fatal myocarditis is reportedly more likely to occur during (but not limited to) the first month of therapy.

One study (n=61) reported that although a substantial portion of patients treated with clozapine developed ECG abnormalities, most of the abnormalities were benign and did not hinder further treatment.

Cardiovascular side effects have included tachycardia (25%), hypotension (9%), hypertension (4%), chest pain/angina (1%), and ECG/cardiac abnormalities (1%). Edema, palpitations, phlebitis/thrombophlebitis, cyanosis, premature ventricular contraction, bradycardia, and nose bleed have been reported in less than 1% of patients. Atrial or ventricular fibrillation, periorbital edema, venous thromboembolism (i.e., deep vein thrombosis), hypercholesterolemia, and hypertriglyceridemia have also been reported. Polyserositis, pericarditis, pericardial tamponade, pericardial effusion, and potentially fatal myocarditis and cardiomyopathy have been reported rarely. Postmarketing clinical experience has included ventricular tachycardia, cardiac arrest, QT prolongation, and Torsades de Pointes.

Hepatic

Hepatic side effects have included transient moderate asymptomatic elevations in liver function tests in up to 50% of patients. Cholestasis, hepatitis, and jaundice have also been reported; however, causality has not been established. One case of reversible marked hepatotoxicity has been reported.

Postmarketing reports: Hepatotoxicity, hepatic steatosis, hepatic necrosis, hepatic fibrosis, hepatic cirrhosis, liver injury (hepatic, cholestatic, and mixed), and liver failure

Psychiatric

Psychiatric side effects have included delusions, hallucinations, and paranoia in less than 1% of patients. Obsessive-compulsive symptoms, worsening of bulimia nervosa, and exacerbation of psychosis have also been reported. Rebound psychosis (or supersensitivity psychosis) may occur after withdrawal of clozapine therapy.

Hypersensitivity

Hypersensitivity side effects have included photosensitivity, vasculitis, erythema multiforme, and Stevens-Johnson Syndrome. Bronchospasm, respiratory arrest, cardiovascular collapse, polyserosits, and hypersensitivity myocarditis have also been reported.

Genitourinary

Genitourinary side effects have included urinary abnormalities (2%), incontinence (1%), abnormal ejaculation (1%), urinary urgency/frequency (1%), and urinary retention (1%). Dysmenorrhea, impotence, breast pain/discomfort, vaginal itch/infection, hot flashes, and hyperuricemia have been reported in less than 1% of patients. Acute interstitial nephritis and priapism have also been reported; however, causality has not been established.

Postmarketing reports: Nocturnal enuresis

Elderly patients may be more susceptible to the anticholinergic effects of clozapine, such as urinary retention.

Endocrine

Numerous studies have demonstrated that clozapine treatment is associated with an increased risk for development or exacerbation of diabetes mellitus. Cases of transient hyperglycemia, diabetic ketoacidosis, new onset diabetes, and exacerbation of preexisting diabetes have been reported. In some studies, the prevalence of clozapine related diabetes has ranged from 4% to 36.6%. In one study, the prevalence of diabetes was considerably higher among patients taking clozapine compared with the general population (25.7% vs 7.9%, respectively). Attempts to associate the frequency of clozapine related diabetes with specific risk factors, other than those known for the general population (e.g., family history, obesity, age group), have been unsuccessful and in some cases resulted in conflicting data. Compared to conventional antipsychotics (i.e., haloperidol, chlorpromazine), the risk of diabetes is higher among patients receiving clozapine.

A study of U.S. military veterans with schizophrenia has reported that patients on clozapine had 1.48 times as many cases of diabetes when compared to patients taking decades old drugs for psychosis including haloperidol, thioridazine, and others.

A survey of FDA MedWatch reports of the development or exacerbation of diabetes, or hyperglycemia, in patients receiving clozapine therapy (n=384) concluded a possible causal relationship may exist. The results stated the onset of hyperglycemia may be rapid, within the first 3 months of clozapine therapy, and severe. There was no obvious association between dose and severity of hyperglycemia or time to onset of hyperglycemia in this patient population. In addition, the reports that were complete suggest the risk may not end with extended clozapine therapy, and, in some cases, clozapine-induced sedation may delay the diagnosis of hyperglycemia.

Additional studies have confirmed that patients receiving atypical antipsychotics (i.e., clozapine, risperidone, olanzapine, quetiapine, ziprasidone) are at an increased risk of developing hyperglycemia and/or diabetes mellitus.

Endocrine side effects have included hyperglycemia, hyponatremia, clozapine induced or exacerbated diabetes mellitus, and diabetic ketoacidosis.

Musculoskeletal

Musculoskeletal side effects have included muscle weakness, back, neck, and leg pain, muscle spasm, and muscle pain/ache in 1% of patients. Twitching and joint pain have been reported in less than 1% of patients. Myasthenic syndrome and rhabdomyolysis have been reported; however, causality has not been established. One case report has suggested that clozapine may induce dramatic elevations in creatine phosphokinase (CPK) levels (without other features of the neuroleptic malignant syndrome).

Immunologic

A 55 year old female with a history of paranoid hallucinatory schizophrenia developed systemic lupus erythematosus (SLE) following 15 years of continuous therapy with clozapine 200 mg per day. Clinical symptoms resolved and the elevated erythrocyte sedimentation rate (ESR) returned to normal within 2 weeks of discontinuation of clozapine. Subsequently, several pharmacological options were tried to treat the patient's schizophrenia; however, following a risk benefit analysis clozapine therapy was restarted. The clinical symptoms and lab findings indicating SLE returned within weeks of therapy reinitiation. The patient consented to continue on clozapine therapy with appropriate monitoring.

Clozapine-induced systemic lupus erythematosus has been reported in a 32 year old patient with schizophrenia and confirmed upon rechallenge. Clinical symptoms and laboratory markers (i.e., antinuclear antibodies (ANA), erythrocyte sedimentation rate (ESR)) completely resolved following discontinuation of clozapine after both the first exposure and the rechallenge.

Immunologic side effects have included asymptomatic antiphospholipid antibodies (1 small study), acute reaction resembling systemic lupus erythematosus (1 case report), and systemic lupus erythematosus.

Ocular

Ocular side effects have included visual disturbances (5%). Mydriasis, eyelid disorder, bloodshot eyes, and nystagmus have been reported in less than 1% of patients. Narrow angle glaucoma has also been reported; however, causality has not been established. Oculogyric crisis has been reported rarely. Pigmentary changes affecting the cornea and retina have been reported.

Other

Other side effects have included anorexia (1%), sweating (6%), fever (5%), and tongue numb/sore (1%). Chills (with and without a fever), malaise, appetite increase, ear disorder, hypothermia, and numbness have been reported in less than 1% of patients. Sepsis has been reported; however, causality has not been established. Transient hyperthermia has been reported in as many as 50% of patients started on clozapine therapy.

Hyperthermia most commonly occurs between days 8 and 16 of treatment and may last several days.

Clozapine related fever is generally benign but difficult to assess and manage as it can be confused with much more serious conditions.

Dermatologic

Dermatologic side effects have included rash (2%). Pruritus, pallor, eczema, erythema, bruise, dermatitis, petechiae, and urticaria have been reported in less than 1% of patients. Photosensitivity, vasculitis, erythema multiforme and Stevens-Johnson Syndrome have been reported; however, causality has not been established.

Respiratory

An increased risk of mortality, possibly due to an infection, such as pneumonia, has been reported with the use of atypical antipsychotic agents in the treatment of behavioral disorders in the elderly patient with dementia.

Collective data gathered from 17 placebo-controlled clinical studies (n=5106) involving the use of atypical antipsychotic agents 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. Although clozapine was not included in these studies, the consistent findings across all three relevant chemical classes support the opinion that these findings are likely to be applicable to all atypical antipsychotic agents. Clozapine is not approved by the FDA for use in the treatment of behavioral disorders in elderly patients with dementia.

Respiratory side effects have included throat discomfort, dyspnea, and nasal congestion in 1% of patients. Coughing, pneumonia, pneumonia like symptoms, rhinorrhea, hyperventilation, wheezing, bronchitis, laryngitis, and sneezing have been reported in less than 1% of patients. Aspiration, pleural effusion, and pulmonary embolism have also been reported; however, causality has not been established. Pleural inflammation/effusions have been reported rarely. Postmarketing clinical experience has included pneumonia and lower respiratory tract infection some of which were fatal.

Metabolic

One study has reported an average weight gain of 8.9% of body weight during the first 16 weeks of clozapine therapy.

Metabolic side effects have included weight gain in up to 67% of patients. Binge eating and increases in food craving have been associated with clozapine. Weight loss has also been reported; however, causality has not been established. Hypercholesterolemia and hypertriglyceridemia have been reported very rarely. Studies have shown that patients receiving clozapine are at an increased risk of developing metabolic syndrome (a clustering of risk factors such as dyslipidemia, hypertension, hyperglycemia for cardiovascular disease). Postmarketing clinical experience has included new onset diabetes.

Renal

A 33 year old male titrated to clozapine 100 mg per day developed acute interstitial nephritis over seven to fourteen days following initiation of clozapine therapy. Concomitant medications included valproic acid, risperidone, and gabapentin. All medications, except valproic acid, were discontinued and the patient improved within one week.

A 49 year old male developed acute interstitial nephritis within 10 days following initiation of clozapine therapy. The patient recovered following discontinuation of clozapine.

Renal side effects have rarely included acute interstitial nephritis.

Postmarketing reports: Renal failure

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