Haldol Side Effects
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Haldol Safety Reports submitted to FDA
Total Haldol reports: 204.Haldol FDA safety alerts: 2007 .
Reported deaths: 17 Reported hospitalizations: 96.
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Reported Haldol Side Effects: suicide attempt, somnolence, tremor neonatal, agitation, extrapyramidal disorder, accidental exposure, weight increased, intentional overdose, dyspnoea, hypertonia, neuroleptic malignant syndrome.
Haldol Usage.
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Haldol Side Effects Report #5467865-6Consumer or non-health professional from GERMANY reported HALDOL problem on Sept 17, 2007. Male patient, 24 years of age, was diagnosed with schizophrenia and was treated with HALDOL. After drug was administered, patient experienced the following problems/side effects: aggression, anxiety, disturbance in attention, facial spasm, gastric disorder, hypoaesthesia oral, paraesthesia, rash, sensory disturbance. HALDOL dosage: unknown. During the same period patient was treated with NEUROCIL. Patient recovered.
Haldol Side Effects Report #5468121-2
HALDOL problem was reported by a Physician from BRAZIL on Sept 17, 2007. Female patient, child 7 years of age, weighting 44.09 lb, was diagnosed with accidental exposure and was treated with HALDOL. After drug was administered, patient experienced the following problems/side effects: accidental exposure, dystonia, mutism, staring, tachycardia, tremor. HALDOL dosage: unknown. During the same period patient was treated with LITHIUM CARBONATE. Patient recovered.
Haldol Side Effects Report #5469199-2
Consumer or non-health professional from BRAZIL reported HALDOL problem on Sept 17, 2007. Female patient, 26 years of age, was treated with HALDOL. After drug was administered, patient experienced the following problems/side effects: incorrect dose administered. HALDOL dosage: unknown. During the same period patient was treated with BIPERIDEN HYDROCHLORIDE, LORAZEPAM. Patient recovered.
Haldol Side Effects Report #5471096-3
HALDOL problem was reported by a Physician from BRAZIL on Sept 19, 2007. Female patient, 29 years of age, weighting 132.3 lb, was treated with HALDOL. After drug was administered, patient experienced the following problems/side effects: agitation, suicide attempt. HALDOL dosage: unknown. During the same period patient was treated with CARBAMAZEPINE. Patient was hospitalized. Patient recovered.
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Drug Information: Haloperidol Oral
URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a682180.html
(ha loe per' i dole)IMPORTANT WARNING:
| [Posted 09/17/2007] Johnson and Johnson and FDA informed healthcare professionals that the WARNINGS section of the prescribing information for haloperidol has been revised to include a new Cardiovascular subsection regarding cases of sudden death, QT prolongation and Torsades de Pointes(TdP) in patients treated with haloperidol, especially when given intravenously, or at doses higher than recommended. Although injectable haloperidol is only approved by the FDA for intramuscular injection, there is considerable evidence that the intravenous administration of haloperidol is a relatively common off-label clinical practice.There are at least 28 case reports of QT prolongation and TdP, some with fatal outcome in the context of off-label intravenous haloperidol. Healthcare professionals should consider this new risk information when making individual treatment decisions for their patients. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Haloperidol and http://www.fda.gov/cder/drug/InfoSheets/HCP/haloperidol.htm. |
Why is this medication prescribed?
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Haloperidol is used to treat psychotic disorders and symptoms such as hallucinations, delusions, and hostility and to control muscular tics of the face, neck, hands, and shoulders. It is also used to treat severe behavioral problems in children and in hyperactive children (short-term use).
This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
How should this medicine be used?
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Haloperidol comes as a tablet and liquid concentrate to take by mouth. It usually is taken two or three times a day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take haloperidol exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
The liquid concentrate must be diluted before use. It comes with a specially marked dropper for measuring the dose. Ask your pharmacist to show you how to use the dropper if you have difficulty. To dilute the liquid concentrate, add it to at least 2 ounces of milk, water, orange juice, or grapefruit juice just before you take it. If any beverage gets on the dropper, rinse the dropper with tap water before replacing it in the bottle. Do not allow the liquid concentrate to touch your skin or clothing; it can irritate your skin. If you spill the liquid concentrate on your skin, wash it off immediately with soap and water.
Continue to take haloperidol even if you feel well. Do not stop taking haloperidol without talking to your doctor, especially if you have taken large doses for a long time. Your doctor probably will decrease your dose gradually. This drug must be taken regularly for a few weeks before its full effect is felt.
Other uses for this medicine
Haloperidol is also used to prevent and control nausea and vomiting. Talk to your doctor about the possible risks of using this drug for your condition.
What special precautions should I follow?
Before taking haloperidol,
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
- tell your doctor and pharmacist if you are allergic to haloperidol, aspirin, tartrazine (a yellow dye in some processed foods and drugs), or any other drugs.
- tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially antacids (Amphogel, Maalox), antihistamines, appetite reducers (amphetamines), benztropine (Cogentin), bromocriptine (Parlodel), carbamazepine (Tegretol), dicyclomine (Bentyl), fluoxetine (Prozac), guanethidine (Ismelin), lithium, meperidine (Demerol), methyldopa (Aldomet), phenytoin (Dilantin), propranolol (Inderal), sedatives, trihexyphenidyl (Artane), valproic acid (Depakane), medication for colds or depression, and vitamins.
- tell your doctor if you have or have ever had depression; seizures; shock therapy; allergies; asthma; emphysema; chronic bronchitis; problems with your urinary system or prostate; glaucoma; history of alcohol abuse; thyroid problems; bad reaction to insulin; angina; irregular heartbeat; problems with your blood pressure; blood disorders; or blood vessel, heart, kidney, liver, or lung disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking haloperidol, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking haloperidol.
- you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you.
- remember that alcohol can add to the drowsiness caused by this drug.
- plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Haloperidol may make your skin sensitive to sunlight.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it and take any remaining doses for that day at evenly spaced intervals. However, if you remember a missed dose when it is almost time for your next scheduled dose, skip the missed dose. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Side effects from haloperidol are common. Your urine may turn pink or reddish-brown; this effect is not harmful. Tell your doctor if any of these symptoms are severe or do not go away:
- drowsiness
- dry mouth
- constipation
- restlessness
- headache
- weight gain
If you experience any of the following symptoms, call your doctor immediately:
- tremor
- restlessness or pacing
- fine worm-like tongue movements
- unusual face, mouth, or jaw movements
- shuffling walk
- slow, jerky movements
- seizures or convulsions
- fast, irregular, or pounding heartbeat
- difficulty urinating or loss of bladder control
- confusion
- eye pain or discoloration
- difficulty breathing or fast breathing
- fever
- skin rash
- severe muscle stiffness
- unusual tiredness or weakness
- unusual bleeding or bruising
- yellowing of the skin or eyes
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].
What storage conditions are needed for this medicine?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Protect the liquid from light. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
What other information should I know?
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to haloperidol.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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