When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to haloperidol, or if you have Parkinson disease. This medicine should not be given to patients with severe brain disease.

How to Use This Medicine:
Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• You must be careful if you are also using other medicine that might cause similar side effects as haloperidol. This includes medicine that might cause low blood pressure, overheating, or liver problems. Make sure your doctor knows about all other medicines you are using.
• Tell you doctor if you are also using lithium, phenindione, medicine for seizures, or medicine to treat Parkinson's disease.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have liver disease, kidney disease, heart or blood vessel disease, blood pressure problems, overactive thyroid, or history of seizures or breast cancer.
• Tell your doctor about any other medicine you have used to treat a mental disorder, especially if the medicine caused problems.
• This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.
• You might get overheated more easily while using this medicine. Be aware of this if you are exercising or the weather is hot. Drinking water might help. If you get too hot and feel dizzy, weak, tired, confused, or sick to your stomach, you need to cool down.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate.
• Changes in vision.
• Fast or pounding heartbeat.
• Fever or chills.
• Jerky muscle movement you cannot control (often in your face, tongue, or jaw).
• Headache, confusion, lightheadedness, or fainting.
• Painful, prolonged erection of your penis.
• Problems with balance or walking.
• Seeing or hearing things which are not there.
• Seizures or tremors.
• Severe muscle stiffness.
• Troubled breathing.
• Unusual bleeding, bruising, or weakness.
• Yellowing of skin and eyes.

If you notice these less serious side effects, talk with your doctor:

• Breast pain or swelling.
• Change in menstrual periods.
• Decreased thirst or dry mouth.
• Loss of appetite.
• Nausea, vomiting, diarrhea, or constipation.
• Skin rash.
• Trouble sleeping, restlessness.

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088