Haloperidol Safety Questions, Haloperidol Answers
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Haloperidol Safety Reports
Total Haloperidol reports: 122.Haloperidol FDA safety alerts: 2007 .
Reported deaths: 28 Reported hospitalizations: 48.
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Reported Haloperidol Side Effects: neuroleptic malignant syndrome, extrapyramidal disorder, dystonia, agitation, intentional overdose, inappropriate antidiuretic hormone secretion, completed suicide, heart rate increased, cardio-respiratory arrest, death, akathisia.
Haloperidol Usage.
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Haloperidol Side Effects Report #5181782-0Pharmacist from FRANCE reported HALOPERIDOL problem on Dec 12, 2006. Female patient, 75 years of age, weighting 105.8 lb, was diagnosed with psychotic disorder and was treated with HALOPERIDOL. After drug was administered, patient experienced the following problems/side effects: weight decreased. HALOPERIDOL dosage: unknown. Patient recovered.
Haloperidol Side Effects Report #5190089-7
HALOPERIDOL problem was reported by a Physician from UNITED STATES on Dec 14, 2006. Female patient, 28 years of age, was diagnosed with schizoaffective disorder and was treated with HALOPERIDOL. After drug was administered, patient experienced the following problems/side effects: pericardial effusion, pericarditis. HALOPERIDOL dosage: unknown. During the same period patient was treated with ZYPREXA, COGENTIN, DEPAKOTE ER, LEVAQUIN, ALBUTEROL, NEXIUM. Patient was hospitalized. Patient recovered.
Haloperidol Side Effects Report #5380851-X
Physician from FRANCE reported HALOPERIDOL problem on June 07, 2007. Male patient, 53 years of age, was diagnosed with bipolar i disorder and was treated with HALOPERIDOL. After drug was administered, patient experienced the following problems/side effects: pulmonary embolism. HALOPERIDOL dosage: unknown. During the same period patient was treated with NOCTAMIDE, TEGRETOL. Patient was hospitalized. Patient recovered.
Haloperidol Side Effects Report #5385117-X
HALOPERIDOL problem was reported by a Pharmacist from UNITED STATES on July 06, 2007. Female patient, 82 years of age, was diagnosed with agitation and was treated with HALOPERIDOL. After drug was administered, patient experienced the following problems/side effects: convulsion, dystonia. HALOPERIDOL dosage: 2 MG ONCE IV. During the same period patient was treated with PLAVIX, LEVOTHYROXINE, CALCIUM, NEURONTIN, CELEXA, ASPIRIN, VYTORIN, BUPROPION. Patient recovered.
Haloperidol Side Effects Report #5385287-3
Pharmacist from UNITED STATES reported HALOPERIDOL problem on July 09, 2007. Male patient was diagnosed with bipolar disorder and was treated with HALOPERIDOL. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, dysarthria, neuroleptic malignant syndrome. HALOPERIDOL dosage: 5-10MG Q 6 HOURS PRN IV. During the same period patient was treated with LITHIUM CARBONATE. Patient recovered.
Haloperidol Side Effects Report #5387612-6
HALOPERIDOL problem was reported by a Pharmacist from UNITED STATES on July 11, 2007. Female patient, weighting 115.0 lb, was diagnosed with psychotic disorder and was treated with HALOPERIDOL. After drug was administered, patient experienced the following problems/side effects: neuroleptic malignant syndrome. HALOPERIDOL dosage: 5MG 2 DOSES INJ. Patient was hospitalized. Patient recovered.
Haloperidol Side Effects Report #5389953-5
Pharmacist from UNITED STATES reported HALOPERIDOL problem on July 16, 2007. Male patient, 50 years of age, was diagnosed with schizophrenia, disorganised type and was treated with HALOPERIDOL. After drug was administered, patient experienced the following problems/side effects: malaise. HALOPERIDOL dosage: 120 MG Q 4 WEEKS IM. Patient died on 07/02/2007.
Haloperidol Side Effects Report #5391057-2
HALOPERIDOL problem was reported by a Pharmacist from UNITED STATES on July 13, 2007. Male patient, 50 years of age, was diagnosed with schizophrenia and was treated with HALOPERIDOL. HALOPERIDOL dosage: 1200MG/IV (TOTAL FOR BOTH LOTS). During the same period patient was treated with HALOPERIDOL DECANOATE. Patient died on 07/02/2007.
Haloperidol Side Effects Report #5398957-8
Pharmacist from UNITED STATES reported HALOPERIDOL problem on July 24, 2007. Female patient, 39 years of age, was diagnosed with bipolar disorder and was treated with HALOPERIDOL. After drug was administered, patient experienced the following problems/side effects: extrapyramidal disorder. HALOPERIDOL dosage: 5 MG Q4PRN IM. During the same period patient was treated with TRAZODONE, TEGRETOL. Patient was hospitalized. Patient recovered.
Haloperidol Side Effects Report #5400205-7
HALOPERIDOL problem was reported by a Pharmacist from UNITED STATES on July 27, 2007. Male patient, 31 years of age, was treated with HALOPERIDOL. After drug was administered, patient experienced the following problems/side effects: dystonia. HALOPERIDOL dosage: 2MG PRN PO. Patient recovered.
Haloperidol Side Effects Report #5414940-8
Physician from JAPAN reported HALOPERIDOL problem on Aug 06, 2007. Male patient, 59 years of age, was treated with HALOPERIDOL. After drug was administered, patient experienced the following problems/side effects: blood creatine phosphokinase increased. HALOPERIDOL dosage: unknown. Patient was hospitalized. Patient recovered.
Haloperidol Side Effects Report #5421098-8
HALOPERIDOL problem was reported by a Health Professional from UNITED STATES on Aug 14, 2007. Male patient, weighting 116.0 lb, was diagnosed with schizophrenia, antiviral prophylaxis, hiv infection and was treated with HALOPERIDOL. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased. HALOPERIDOL dosage: unknown. During the same period patient was treated with HALDOL, TRUVADA, NORVIR, REYATAZ, COGENTIN. Patient recovered.
Haloperidol Side Effects Report #5428900-4
Physician from FRANCE reported HALOPERIDOL problem on Aug 22, 2007. Female patient, 42 years of age, was diagnosed with schizophrenia and was treated with HALOPERIDOL. After drug was administered, patient experienced the following problems/side effects: trismus. HALOPERIDOL dosage: unknown. Patient recovered.
Haloperidol Side Effects Report #5429616-0
HALOPERIDOL problem was reported by a Physician from CROATIA (local name: Hrvatska) on Aug 16, 2007. Male patient, 44 years of age, was diagnosed with psychotic disorder, anxiety, depression, hallucination, insomnia, schizophrenia and was treated with HALOPERIDOL. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, hyperglycaemia, inappropriate antidiuretic hormone secretion, pancreatitis haemorrhagic. HALOPERIDOL dosage: 12 MG, DAILY, ORAL. During the same period patient was treated with DIAZEPAM, ALPRAZOLAM, PAROXETINE HYDROCHLORIDE, FLUPHENAZINE DECANOATE. Patient died.
Haloperidol Side Effects Report #5445924-1
Health Professional from ITALY reported HALOPERIDOL problem on Aug 23, 2007. Female patient, 85 years of age, was diagnosed with psychomotor hyperactivity, diabetic neuropathy, abdominal pain upper and was treated with HALOPERIDOL. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, psychomotor hyperactivity, pulmonary congestion, renal failure acute, respiratory failure, rhabdomyolysis, somnolence. HALOPERIDOL dosage: 10 MG. During the same period patient was treated with GABAPENTIN, LANSOPRAZOLE, INSULIN LISPRO, RAMIPRIL, ASPIRIN, DILTIAZEM. Patient recovered.
Haloperidol Side Effects Report #5455417-3
HALOPERIDOL problem was reported by a Pharmacist from UNITED STATES on Sept 13, 2007. Female patient, weighting 150.3 lb, was treated with HALOPERIDOL. After drug was administered, patient experienced the following problems/side effects: tachypnoea, wheezing. HALOPERIDOL dosage: unknown. Patient recovered.
Haloperidol Side Effects Report #5466725-4
Pharmacist from UNITED STATES reported HALOPERIDOL problem on Sept 24, 2007. Female patient, 24 years of age, weighting 125.0 lb, was diagnosed with mania, paranoia and was treated with HALOPERIDOL. After drug was administered, patient experienced the following problems/side effects: cogwheel rigidity, extrapyramidal disorder, eye rolling. HALOPERIDOL dosage: 7.5 MG PO. Patient recovered.
Haloperidol Side Effects Report #5466731-X
HALOPERIDOL problem was reported by a Pharmacist from UNITED STATES on Sept 24, 2007. Female patient, 25 years of age, weighting 137.0 lb, was treated with HALOPERIDOL. After drug was administered, patient experienced the following problems/side effects: mental status changes, muscle rigidity, nuchal rigidity, oculogyric crisis, restlessness. HALOPERIDOL dosage: 5MG PRN PO 2 DOSES. Patient recovered.
Haloperidol Side Effects Report #5466821-1
Pharmacist from UNITED STATES reported HALOPERIDOL problem on Sept 24, 2007. Male patient, 24 years of age, weighting 166.0 lb, was treated with HALOPERIDOL. After drug was administered, patient experienced the following problems/side effects: blepharospasm, musculoskeletal stiffness, parkinsonism, vision blurred. HALOPERIDOL dosage: 5 MG PO. Patient recovered.
Haloperidol Side Effects Report #5468010-3
HALOPERIDOL problem was reported by a Pharmacist from UNITED STATES on Sept 25, 2007. Male patient, weighting 200.0 lb, was diagnosed with schizophrenia, depression and was treated with HALOPERIDOL. After drug was administered, patient experienced the following problems/side effects: akathisia, dystonia, extrapyramidal disorder, facial palsy, mental disorder, musculoskeletal stiffness, speech disorder, tongue disorder. HALOPERIDOL dosage: 5MG BID PO. During the same period patient was treated with PAROXETINE. Patient recovered.
Haloperidol Side Effects Report #5470279-6
Physician from UNITED STATES reported HALOPERIDOL problem on Sept 11, 2007. Male patient, 26 years of age, was diagnosed with bipolar disorder and was treated with HALOPERIDOL. After drug was administered, patient experienced the following problems/side effects: dysarthria, dystonia, headache, joint dislocation, mastication disorder, weight decreased. HALOPERIDOL dosage: unknown. Patient recovered.
Haloperidol Side Effects Report #5472101-0
HALOPERIDOL problem was reported by a Physician from UNITED STATES on Sept 11, 2007. Male patient, 26 years of age, was diagnosed with bipolar disorder and was treated with HALOPERIDOL. After drug was administered, patient experienced the following problems/side effects: bipolar disorder, dystonia, headache, joint dislocation, weight decreased. HALOPERIDOL dosage: unknown. During the same period patient was treated with QUETIAPINE FUMARATE, MOOD STABILIZER. 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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