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Clozapine

CLOZAPINE is used to treat schizophrenia. This medicine is only used when others have not worked. It has a risk of serious side effects and is only available through a monitoring and dispensing system that includes special doctors, pharmacists, and laboratories. For the first few months of treatment, you will be required to have routine blood testing before your prescription can be refilled. Compare atypical antipsychotics.
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Fazaclo Side Effects

What should I watch for?

Visit your doctor or health care professional for regular checks on your progress. It may be several weeks before you see the full effects of this medicine. Contact your doctor or health care professional if your symptoms get worse or if you have new symptoms.

All patients receiving clozapine must be enrolled in a program called the Clozapine REMS Program. Your doctor is responsible for making sure you are enrolled in this program. You must have a weekly blood test when you first begin this medicine. If your blood counts stay in the right range, your doctor will reduce the frequency of the testing. Be sure to report any side effects from using clozapine to your healthcare provider. For more information, visit the Clozapine REMS Program website at www.clozapinerems.com and read the material in the information guide called "What You Need to Know about Clozapine and Neutropenia: A Guide for Patients and Caregivers".

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this drug affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol can make you more drowsy and dizzy. Avoid alcoholic drinks.

Do not treat yourself for colds, fever, diarrhea or allergies. Ask your doctor or health care professional for advice, some nonprescription medicines may increase possible side effects.

If you notice an increased hunger or thirst, different from your normal hunger or thirst, or if you find that you have to urinate more frequently, you should contact your health care provider as soon as possible. You may need to have your blood sugar monitored. This medicine may cause changes in your blood sugar levels. You should monitor you blood sugar frequently if you have diabetes.

If you smoke, tell your doctor if you notice this medicine is not working well for you. Talk to your doctor if you are a smoker or if you decide to stop smoking.

If you are going to have surgery tell your doctor or health care professional that you are taking this medicine.

This medicine can reduce the response of your body to heat or cold. Dress warm in cold weather and stay hydrated in hot weather. If possible, avoid extreme temperatures like saunas, hot tubs, very hot or cold showers, or activities that can cause dehydration such as vigorous exercise.

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Common and Rare Side Effects

Along with its needed effects, a medicine 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:

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 the arms or legs

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 or skin rash

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

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 side effects 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

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 ache or pain

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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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