"Feb. 23, 2012 -- The FDA has warned that treatment with antipsychotic drugs increases the risk of death among elderly patients with dementia, and now a new study confirms that some drugs are riskier than others.
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Haldol Consumer (continued)
Tell your doctor promptly if any of these side effects occur: muscle spasm/stiffness, shaking (tremor), restlessness, mask-like facial expression, drooling. Your doctor may prescribe another medication for you to take with haloperidol to decrease these side effects.
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.
In rare cases, haloperidol may increase your level of a certain chemical made by the body (prolactin). For females, this increase in prolactin may result in unwanted breast milk, missed/stopped periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor immediately.
For males, in the unlikely event you have a painful or prolonged erection (lasting more than 4 hours), stop using this drug and seek immediate medical attention, or permanent problems may occur.
This medication may rarely cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor immediately if you develop any facial/muscle twitching such as tongue thrusting, chewing movements, puffing or puckering of your mouth, or uncontrollable shaking.
This medication may rarely cause a serious condition called neuroleptic malignant syndrome (NMS). Seek immediate medical attention if you develop any of the following symptoms: fever, muscle stiffness, severe confusion, increased sweating, fast/irregular heartbeat.
Tell your doctor immediately if any of these rare but very serious side effects occur: dark urine, persistent nausea/vomiting, stomach/abdominal pain, yellowing of eyes/skin, seizures, signs of infection (such as fever, persistent sore throat).
Seek immediate medical attention if any of these rare but very serious side effects occur: slow/fast/irregular heartbeat, severe dizziness, chest pain, fainting.
A very severe allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction 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 Haldol (haloperidol injection) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking haloperidol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain severe nervous system problem (severe CNS depression), Parkinson's disease.
This medication should not be given to a patient who is unconscious.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: bipolar disorder, difficulty urinating (e.g., due to prostate problems), glaucoma, heart problems (e.g., angina), overactive thyroid (hyperthyroidism), seizures, low white blood cell count.
Haloperidol may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using haloperidol, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).
Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using haloperidol safely.
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
Before having surgery, be sure to tell your doctor or dentist that you are taking haloperidol.
This medication can reduce sweating, making you more likely to get heatstroke. Avoid hard work and exercise in hot weather.
Caution is advised when using this drug in elderly people because they may be more sensitive to the effects of the drug, especially drowsiness, difficulty urinating, and the effects on the heart.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Do not stop taking this medication unless directed by your doctor. Babies born to mothers who have used this drug during the last 3 months of pregnancy may infrequently develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn anytime during their first month, tell the doctor right away.
This drug passes into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.
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