DIRA 1.0: Atlas of Drug-induced Rhabdomyolysis

HALOPERIDOL

DIR Classification Postmarketing Surveillance Drug Property Information Reference

DIR Classification

Classification:Most-DIR concern

Severity Score:4

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

WARNINGS
Cardiovascular Effects
Cases of sudden death, QT-prolongation, and Torsades de Pointes have been reported in patients receiving haloperidol. Higher than recommended doses of any formulation of haloperidol appear to be associated with a higher risk of QT-prolongation and Torsades de Pointes. Although cases have been reported even in the absence of predisposing factors, particular caution is advised in treating patients with other QT-prolonging conditions (including electrolyte imbalance [particularly hypokalemia and hypomagnesemia], drugs known to prolong QT, underlying cardiac abnormalities, hypothyroidism, and familial long QT-syndrome).
ADVERSE REACTIONS
Cardiovascular Effects
Tachycardia, hypotension, and hypertension have been reported. QT prolongation and/or ventricular arrhythmias have also been reported, in addition to ECG pattern changes compatible with the polymorphous configuration of torsade de pointes, and may occur more frequently with high doses and in predisposed patients (see WARNINGS and PRECAUTIONS).
Cases of sudden and unexpected death have been reported in association with the administration of haloperidol. The nature of the evidence makes it impossible to determine definitively what role, if any, haloperidol played in the outcome of the reported cases. The possibility that haloperidol caused death cannot, of course, be excluded, but it is to be kept in mind that sudden and unexpected death may occur in psychotic patients when they go untreated or when they are treated with other antipsychotic drugs.

Postmarketing Surveillance

Contingency Table:

Current Drug

Other Drugs

Rhabdomyolysis

185

42727

Other ADRs

8959

14108320

Odds Ratio = 6.819

Drug Property Information

ATC Code(s):

N05AD01 - haloperidol

N05AD - Butyrophenone derivatives
N05A - ANTIPSYCHOTICS
N05 - PSYCHOLEPTICS
N - NERVOUS SYSTEM

Active Ingredient:haloperidol

Active Ingredient UNII:J6292F8L3D

Drugbank ID:DB00502

PubChem Compound:3559

CAS Number:52-86-8

Dosage Form(s):solution, concentrate

Route(s) Of Administrator:oral

Daily Dose:

8.0 mg/day N05AD01

Chemical Structure:

SMILE Code:
C1CN(CCC1(C2=CC=C(C=C2)Cl)O)CCCC(=O)C3=CC=C(C=C3)F

Reference

COHORT STUDY:

N/A

OTHER REFERENCE(S):

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[Hoshi S,Itoh A,Kato S,Suzuki K,Kawamura S,Orikasa S]
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22: Status dystonicus: the syndrome and its management.

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23: Rhabdomyolysis associated with haloperidol without evidence of NMS.

[Marinella M A]
Ann Pharmacother.1997 Jul-Aug;31(7-8):927-8. PMID: 9220062

24: Marked elevations of serum creatine kinase activity associated with antipsychotic drug treatment.

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Neuropsychopharmacology.1996 Oct;15(4):395-405. PMID: 8887994

25: [Rhabdomyolysis and acute renal failure caused by haloperidol-decanoate (neuroleptic malignant syndrome)].

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Recenti Prog Med.1996 Sep;87(9):422-4. PMID: 9053957

26: [Clinical investigation of 10 cases with acute renal failure induced by neuroleptics].

[Soejima A,Suzuki M,Ishizuka S,Miyake N,Karube M,Fukuoka K,Minoshima S,Tanaka U,Arimura Y,Nakabayasi K,Kitamoto K,Saitou M,Nagasawa T]
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27: Acute renal failure in the setting of the neuroleptic malignant syndrome.

[Korzets Z,Zelter E,Bernheim J]
Nephrol Dial Transplant.1996 May;11(5):885-6. PMID: 8671918

28: Rhabdomyolysis and hyperthermia after cocaine abuse: a variant of the neuroleptic malignant syndrome?

[Daras M,Kakkouras L,Tuchman A J,Koppel B S]
Acta Neurol Scand.1995 Aug;92(2):161-5. PMID: 7484066

29: Rhabdomyolysis and acute renal failure during high-dose haloperidol therapy.

[Marsh S J,Dolson G M]
Ren Fail.1995 Jul;17(4):475-8. PMID: 7569118

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Minerva Med.1995 Jul-Aug;86(7-8):327-30. PMID: 7478078

31: [Haloperidol, a new cause of rhabdomyolysis, in the absence of neuroleptic malignant syndrome].

[Girard T,Samet S,Bianchi-Fior P,Gasnault J,Brivet F]
Presse Med.1994 Oct 22;23(32):1493. PMID: 7824471

32: [A case of acute renal failure in neuroleptic malignant syndrome associated with rhabdomyolysis--possible contributing role of hyperreninemia].

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Nihon Jinzo Gakkai Shi.1994 Oct;36(10):1169-74. PMID: 7815749

33: A fulminant case of neuroleptic malignant syndrome.

[Teo S K,Lam K N,Chew W L]
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34: The neuroleptic malignant syndrome and acute renal failure.

[Becker B N,Ismail N]
J Am Soc Nephrol.1994 Jan;4(7):1406-12. PMID: 8161722

35: [Malignant neuroleptic syndrome: complete anticoagulant treatment or not?].

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Ned Tijdschr Geneeskd.1992 Sep 19;136(38):1870-2. PMID: 1407153

36: [Acute renal failure due to rhabdomyolysis--clinical investigation on our 6 cases].

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Nihon Jinzo Gakkai Shi.1992 Mar;34(3):317-24. PMID: 1630034

37: [Malignant neuroleptic syndrome associated with myocardial infarction, acute renal insufficiency and rhabdomyolysis].

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38: [Rhabdomyolysis].

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J Clin Psychiatry.1984 Aug;45(8):356-7. PMID: 6746581

40: Detection and management of the neuroleptic malignant syndrome.

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41: Neuroleptic malignant syndrome and dopaminergic blockade.

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42: Fatal complications of neuroleptic drugs. A clinico-pathological study of three cases.

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Acta Neurol Belg.1984 Mar-Apr;84(2):75-83. PMID: 6145281

43: [Neuroleptic malignant syndrome with myoglobinuria].

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44: Acute myoglobinuric renal failure. A consequence of the neuroleptic malignant syndrome.

[Eiser A R,Neff M S,Slifkin R F]
Arch Intern Med.1982 Mar;142(3):601-3. PMID: 6121542

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