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Clozaril

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Clozaril

Clozaril Side Effects Center

Medical Editor: Melissa Conrad Stöppler, MD

Clozaril (clozapine) is an antipsychotic medication that is used to treat severe schizophrenia symptoms in people who have not responded to other medications. Clozapine is also used to help reduce the risk of suicidal behavior in people with schizophrenia or similar disorders. Side effects can include constipation, drooling, sleep disorders, increased sweating, or weight gain. Other side effects can occur. Clozaril is taken orally in tablet form, and an orally-disintegrating tablet that can be taken without water is available.

While you are taking clozapine, your blood may need to be tested every week for the first 6 months of treatment. It has been associated with agranulocytosis in some patients, a potentially fatal decrease in a certain type of white blood cells. Clozaril is not expected to be harmful to an unborn baby. Do not use clozapine without telling your doctor if you are pregnant or plan to become pregnant during treatment. Clozapine can pass into breast milk and may harm a nursing baby.

Our Clozaril 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.

Clozaril in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with clozapine. Call your doctor right away if you have signs of infection such as:

  • fever, chills, body aches, flu symptoms;
  • mouth and throat ulcers;
  • cough, sore throat;
  • rapid heart rate; or
  • rapid and shallow breathing.

Stop using clozapine and call your doctor at once if you have any of these serious side effects:

  • headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;
  • seizure (black-out or convulsions);
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
  • unusual tiredness, trouble breathing;
  • feeling short of breath (even at night or with mild exertion), swelling in your hands or feet;
  • feeling like you might pass out;
  • slow heart rate, weak pulse, slow breathing (breathing may stop);
  • high blood sugar (increased thirst, extreme hunger, fruity breath odor, increased urination, drowsiness);
  • very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors;
  • twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs; or
  • nausea, vomiting, loss of appetite, and jaundice (yellowing of your skin or eyes).

Less serious side effects may include:

  • constipation;
  • dry mouth, blurred vision;
  • drooling, especially at night;
  • increased sweating;
  • drowsiness, dizziness, spinning sensation; or
  • sleep problems.

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 Clozaril (Clozapine) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Clozaril Overview - Patient Information: Side Effects

SIDE EFFECTS: Drooling, drowsiness, dizziness, headache, shaking (tremor), vision problems (e.g., blurred vision), weight gain, and constipation may occur. Many of these effects (especially drowsiness) lessen as your body gets used to the medication. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.

To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative (e.g., stimulant-type with stool softener).

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.

This medication may infrequently make your blood sugar level rise, which can cause or worsen diabetes. Rarely, very serious conditions such as diabetic coma may occur. 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 sugars regularly. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

This drug may also cause significant weight gain and a rise in your cholesterol (or triglyceride) levels. These effects, along with diabetes, may increase your risk for developing heart disease. Discuss the risks and benefits of treatment with your doctor.

Tell your doctor immediately if any of these unlikely but serious side effects occur: facial/muscle twitching, signs of infection (e.g., severe tiredness, fever, persistent sore throat), seizures, uncontrollable movements.

Seek immediate medical attention if any of these rare but very serious side effects occur: severe dizziness, fainting, mental/mood changes, difficulty breathing with exercise, swollen legs/feet, sudden weakness, pain/redness/swelling of the arms/legs, chest pain, persistent nausea/vomiting, stomach/abdominal pain, yellowing of eyes/skin.

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 unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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 Clozaril (Clozapine)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Clozaril FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are discussed in more detail in other sections of the labeling:

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 clinical practice.

The most commonly reported adverse reactions ( ≥ 5%) across CLOZARIL clinical trials were: CNS reactions, including sedation, dizziness/vertigo, headache, and tremor; cardiovascular reactions, including tachycardia, hypotension, and syncope; autonomic nervous system reactions, including hypersalivation, sweating, dry mouth, and visual disturbances; gastrointestinal reactions, including constipation and nausea; and fever. Table 8 summarizes the most commonly reported adverse reactions ( ≥ 5%) in CLOZARIL-treated patients (compared to chlorpromazine-treated patients) in the pivotal, 6-week, controlled trial in treatment-resistant schizophrenia.

Table 8: Common Adverse Reactions ( ≥ 5%) in the 6-Week, Randomized, Chlorpromazine-controlled Trial in Treatment-Resistant Schizophrenia

Adverse Reaction CLOZARIL
(N = 126)
(%)
Chlorpromazine
(N = 142)
(%)
Sedation 21 13
Tachycardia 17 11
Constipation 16 12
Dizziness 14 16
Hypotension 13 38
Fever (hyperthermia) 13 4
Hypersalivation 13 1
Hypertension 12 5
Headache 10 10
Nausea/vomiting 10 12
Dry mouth 5 20

Table 9 summarizes the adverse reactions reported in CLOZARIL-treated patients at a frequency of 2% or greater across all CLOZARIL studies (excluding the 2-year InterSePT™ Study). These rates are not adjusted for duration of exposure.

Table 9: Adverse Reactions ( ≥ 2%) Reported in CLOZARIL-treated Patients (N=842) across all CLOZARIL Studies (excluding the 2-year InterSePT™ Study)

Body System Adverse Reaction* CLOZARIL
N = 842
Percentage of Patients
Central Nervous System
  Drowsiness/Sedation 39
  Dizziness/Vertigo 19
  Headache 7
  Tremor 6
  Syncope 6
  Disturbed Sleep/Nightmares 4
  Restlessness   4
  Hypokinesia/Akinesia 4
  Agitation 4
  Seizures (convulsions)   3†
  Rigidity 3
  Akathisia 3
  Confusion 3
  Fatigue 2
  Insomnia 2
Cardiovascular
  Tachycardia 25†
  Hypotension 9
  Hypertension 4
Gastrointestinal
  Constipation 14
  Nausea 5
  Abdominal Discomfort/Heartburn 4
  Nausea/Vomiting 3
  Vomiting 3
  Diarrhea 2
Urogenital
  Urinary Abnormalities 2
Autonomic Nervous System
  Salivation 31
  Sweating 6
  Dry Mouth 6
  Visual Disturbances 5
Skin
  Rash 2
Hemic/Lymphatic
  Leukopenia/Decreased WBC/Neutropenia 3
Miscellaneous
  Fever 5
  Weight Gain 4
†Rate based on population of approximately 1700 exposed during premarket clinical evaluation of CLOZARIL.

Table 10 summarizes the most commonly reported adverse reactions ( ≥ 10% of the CLOZARIL or olanzapine group) in the InterSePT™ Study. This was an adequate and well-controlled, two-year study evaluating the efficacy of CLOZARIL relative to olanzapine in reducing the risk of suicidal behavior in patients with schizophrenia or schizoaffective disorder. The rates are not adjusted for duration of exposure.

Table 10: Incidence of Adverse Reactions in Patients Treated with CLOZARIL or Olanzapine in the InterSePT™ Study ( ≥ 10% in the CLOZARIL or olanzapine group)

Adverse Reactions CLOZARIL
N = 479
% Reporting
Olanzapine
N = 477
% Reporting
Salivary hypersecretion 48% 6%
Somnolence 46% 25%
Weight increased 31% 56%
Dizziness (excluding vertigo) 27% 12%
Constipation 25% 10%
Insomnia 20% 33%
Nausea 17% 10%
Vomiting 17% 9%
Dyspepsia 14% 8%

Dystonia

Class effect: 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. 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.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of clozapine. 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.

Central Nervous System

Delirium, EEG abnormal, myoclonus, paresthesia, possible cataplexy, status epilepticus, obsessive compulsive symptoms, and post-discontinuation cholinergic rebound adverse reactions.

Cardiovascular System

Atrial or ventricular fibrillation, ventricular tachycardia, QT interval prolongation, Torsades de Pointes, myocardial infarction, cardiac arrest, and periorbital edema.

Gastrointestinal System

Acute pancreatitis, dysphagia, salivary gland swelling.

Hepatobiliary System

Cholestasis, hepatitis, jaundice, hepatotoxicity, hepatic steatosis, hepatic necrosis, hepatic fibrosis, hepatic cirrhosis, liver injury (hepatic, cholestatic, and mixed), and liver failure.

Urogenital System

Acute interstitial nephritis, nocturnal enuresis, priapism, and renal failure.

Skin

Hypersensitivity reactions: photosensitivity, vasculitis, erythema multiforme, and Stevens-Johnson Syndrome.

Musculoskeletal System

Myasthenic syndrome and rhabdomyolysis.

Respiratory System

Aspiration, pleural effusion, pneumonia, lower respiratory tract infection.

Hemic and Lymphatic System

Deep-vein thrombosis, elevated hemoglobin/hematocrit, erythrocyte sedimentation rate (ESR) increased, sepsis, thrombocytosis, and thrombocytopenia.

Vision Disorders

Narrow-angle glaucoma.

Miscellaneous

Creatine phosphokinase elevation, hyperuricemia, hyponatremia, and weight loss.

Read the entire FDA prescribing information for Clozaril (Clozapine) »

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Clozaril - User Reviews

Clozaril User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Clozaril sorted by most helpful. Patient Discussions FAQs

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.


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