DIRA 1.0: Atlas of Drug-induced Rhabdomyolysis

AMPHETAMINE

DIR Classification Postmarketing Surveillance Drug Property Information Reference

DIR Classification

Classification:Moderate-DIR concern

Severity Score:2

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

ADVERSE REACTIONS
Adverse Reactions from Clinical Trials and Spontaneous Postmarketing Reports of Other Amphetamine Products
The following adverse reactions are from clinical trials and spontaneous postmarketing reports of other amphetamine products in pediatric patients and adults with ADHD. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.
Cardiovascular: Palpitations, sudden death, myocardial infarction. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.
Central Nervous System: Restlessness, irritability, euphoria, dyskinesia, dysphoria, depression, tremor, aggression, anger, logorrhea, and paresthesia (including formication).
Eye Disorders: Vision blurred, mydriasis.
Gastrointestinal: Unpleasant taste, constipation, other gastrointestinal disturbances.
Allergic: Urticaria, rash, hypersensitivity reactions including angioedema and anaphylaxis. Serious skin rashes, including Stevens-Johnson Syndrome and toxic epidermal necrolysis have been reported.
Endocrine: Impotence, change in libido, frequent or prolonged erections.
Skin: Alopecia.
Musculoskeletal, Connective Tissue, and Bone Disorders: rhabdomyolysis.
Psychiatric Disorders: dermatillomania, bruxism.
Vascular Disorders: Raynaud's phenomenon.
OVERDOSAGE
Consult with a Certified Poison Control Center (1-800-222-1222) for up-to-date guidance and advice for treatment of overdosage. Individual patient response to amphetamines varies widely. Toxic symptoms may occur idiosyncratically at low doses.
Manifestations of amphetamine overdose include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states, hyperpyrexia and rhabdomyolysis. Fatigue and depression usually follow the central nervous system stimulation. Other reactions include arrhythmias, hypertension or hypotension, circulatory collapse, nausea, vomiting, diarrhea, and abdominal cramps. Fatal poisoning is usually preceded by convulsions and coma.

Postmarketing Surveillance

Contingency Table:

Current Drug

Other Drugs

Rhabdomyolysis

42907

Other ADRs

368

14116911

Odds Ratio = 4.471

Drug Property Information

ATC Code(s):

N06BA01 - amphetamine

N06BA - Centrally acting sympathomimetics
N06B - "PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS"
N06 - PSYCHOANALEPTICS
N - NERVOUS SYSTEM

Active Ingredient:amphetamine

Active Ingredient UNII:CK833KGX7E

Drugbank ID:DB00182

PubChem Compound:3007

CAS Number:300-62-9

Dosage Form(s):tablet, orally disintegrating

Route(s) Of Administrator:oral

Daily Dose:

15.0 mg/day N06BA01

Chemical Structure:

SMILE Code:
CC(CC1=CC=CC=C1)N

Reference

COHORT STUDY:

N/A

OTHER REFERENCE(S):

1: Rhabdomyolysis as the first manifestation of human immunodeficiency virus infection.

[Bhargava Rhea,Abohashem Aly Abdelrahman Abdallah,Mertz Jim I,Mustafa Reem]
CEN Case Rep.2016 May;5(1):48-50. doi: 10.1007/s13730-015-0189-7. Epub 2015 Aug 12. PMID: 28509166

2: Spontaneous pneumomediastinum: A rare complication of methamphetamine use.

[Albanese Jessica,Gross Cole,Azab Mohamed,Mahalean Sinziana,Makar Ranjit]
Respir Med Case Rep.2017 Mar 10;21:25-26. doi: 10.1016/j.rmcr.2017.03.007. eCollection 2017. PMID: 28348951

3: Rare case of severe serotonin syndrome leading to bilateral compartment syndrome.

[Clarissa Samara Verena,Warner Judith]
BMJ Case Rep.2017 Mar 3;2017. pii: bcr2016218842. doi: 10.1136/bcr-2016-218842. PMID: 28258180

4: Neurologic Complications of Psychomotor Stimulant Abuse.

[Sanchez-Ramos Juan]
Int Rev Neurobiol.2015;120:131-60. doi: 10.1016/bs.irn.2015.02.003. Epub 2015 Mar 4. PMID: 26070756

5: Deaths from exposure to paramethoxymethamphetamine in Alberta and British Columbia, Canada: a case series.

[Nicol Jennifer J E,Yarema Mark C,Jones Graham R,Martz Walter,Purssell Roy A,MacDonald Judy C,Wishart Ian,Durigon Monica,Tzemis Despina,Buxton Jane A]
CMAJ Open.2015 Jan 13;3(1):E83-90. doi: 10.9778/cmajo.20140070. eCollection 2015 Jan-Mar. PMID: 25844375

6: Acute methoxetamine and amphetamine poisoning with fatal outcome: a case report.

[Wiergowski Marek,Anand Jacek Sein,Krzyżanowski Maciej,Jankowski Zbigniew]
Int J Occup Med Environ Health.2014 Aug;27(4):683-90. doi: 10.2478/s13382-014-0290-8. Epub 2014 Jul 24. PMID: 25060403

7: Altered mental status and end organ damage associated with the use of gacyclidine: a case series.

[Chenoweth J A,Gerona R R,Ford J B,Sutter M E,Rose J S,Albertson T E,Clarke S O,Owen K P]
J Med Toxicol.2015 Mar;11(1):115-20. doi: 10.1007/s13181-014-0415-2. PMID: 25048606

8: Rapidly reversible multiorgan failure after ingestion of "Molly" (pure 3,4-methylenedioxymethamphetamine): a case report.

[Vakde Trupti,Diaz Manuel,Uday Kalpana,Duncalf Richard]
J Med Case Rep.2014 Jun 18;8:204. doi: 10.1186/1752-1947-8-204. PMID: 24942782

9: Extreme Procalcitonin Elevation without Proven Bacterial Infection Related to Amphetamine Abuse.

[Lovas András,Agoston Zsuzsanna,Késmárky Klára,Hankovszky Péter,Molnár Zsolt]
Case Rep Crit Care.2014;2014:179313. doi: 10.1155/2014/179313. Epub 2014 Mar 11. PMID: 24826347

10: Sympathomimetic syndrome, choreoathetosis, and acute kidney injury following "bath salts" injection.

[Sutamtewagul Grerk,Sood Vineeta,Nugent Kenneth]
Clin Nephrol.2014 Jan;81(1):63-6. PMID: 24356039

11: Hypothesizing that designer drugs containing cathinones ("bath salts") have profound neuro-inflammatory effects and dangerous neurotoxic response following human consumption.

[Blum Kenneth,Foster Olive M,Wang Kevin K W,Febo Marcelo,Borsten Joan,Giordano John,Hauser Mary,Gold Mark S]
Med Hypotheses.2013 Sep;81(3):450-5. doi: 10.1016/j.mehy.2013.06.007. Epub 2013 Jul 8. PMID: 23845561

12: The agony with ecstasy: lessons from a recent rave.

[Hoo Guy W Soo]
J Intensive Care Med.2013 Jul-Aug;28(4):259-61. doi: 10.1177/0885066612457331. Epub 2012 Aug 21. PMID: 22914795

13: [Dialysis for severe rhabdomyolysis 7 days after multiple trauma].

[Malin A,Freyhoff J,Nobis W,Bone H G]
Anaesthesist.2012 Mar;61(3):224-6, 228. doi: 10.1007/s00101-012-1987-3. Epub 2012 Mar 21. PMID: 22430552

14: Toxicity of amphetamines: an update.

[Carvalho Márcia,Carmo Helena,Costa Vera Marisa,Capela João Paulo,Pontes Helena,Remião Fernando,Carvalho Félix,Bastos Maria de Lourdes]
Arch Toxicol.2012 Aug;86(8):1167-231. doi: 10.1007/s00204-012-0815-5. Epub 2012 Mar 6. PMID: 22392347

15: Methamphetamine-induced rhabdomyolysis.

[Eilert Randy J,Kliewer Maurice L]
Int Anesthesiol Clin.2011 Spring;49(2):52-6. doi: 10.1097/AIA.0b013e3181ffc0e5. PMID: 21441799

16: Rhabdomyolysis accompanied by spontaneous spinal subdural and subarachnoid hematoma related to amphetamine abuse.

[Liu Chun-Lin,Cheng Cheng-Hsin,Cho Der-Yang]
Spine (Phila Pa 1976).2010 Jan 15;35(2):E71-3. doi: 10.1097/BRS.0b013e3181b9d577. PMID: 20081506

17: A fatal case of myocardial damage due to misuse of the "designer drug" MDMA.

[Sano Rie,Hasuike Toshikazu,Nakano Minoru,Kominato Yoshihiko,Itoh Hideaki]
Leg Med (Tokyo).2009 Nov;11(6):294-7. doi: 10.1016/j.legalmed.2009.09.003. Epub 2009 Oct 13. PMID: 19828353

18: Rhabdomyolysis associated with the nutritional supplement Hydroxycut.

[Dehoney Sarah,Wellein Marlea]
Am J Health Syst Pharm.2009 Jan 15;66(2):142-8. doi: 10.2146/ajhp070640. PMID: 19139478

19: Methamphetamine abuse.

[Winslow Bradford T,Voorhees Kenton I,Pehl Katherine A]
Am Fam Physician.2007 Oct 15;76(8):1169-74. PMID: 17990840

20: Rhabdomyolysis of the masseter muscle: case report.

[Shah H V,Irvine G H,Bradley M]
Br J Oral Maxillofac Surg.2008 Mar;46(2):138-40. Epub 2007 Jan 8. PMID: 17212974

21: Poisoning or primary nervous system disease?--difficulties of the differential diagnosis exemplified by four different clinical cases.

[Magdalan Jan,Antończyk Andrzej,Kochman Krystyna,Porebska Barbara]
Przegl Lek.2005;62(6):486-8. PMID: 16225102

22: [Rhabdomyolysis, disseminated intravascular coagulation and acute renal failure after severe narcotics intoxication (MDMA, THC, amphetamine)].

[Kunsdorf-Wnuk Anna,Musioł Ewa,Karpel Ewa,Arct-Danielak Danuta]
Pol Merkur Lekarski.2005 Apr;18(106):436-9. PMID: 16161930

23: Amphetamine toxicity.

[White Suzanne R]
Semin Respir Crit Care Med.2002 Feb;23(1):27-36. PMID: 16088595

24: Serotonin syndrome and the anaesthetist.

[Jones D,Story D A]
Anaesth Intensive Care.2005 Apr;33(2):181-7. PMID: 15960399

25: Toward directed therapy for amphetamine-mediated hyperthermia: is carvedilol worth raving about?

[Jackson William L]
Crit Care Med.2005 Jun;33(6):1443-5. PMID: 15942381

26: Measurement of 3,4-MDMA and related amines in diagnostic and forensic laboratories.

[Skrinska Victor A,Gock Susan B]
Clin Lab Sci.2005 Spring;18(2):119-23. PMID: 15916245

27: Ecstasy substance abuse.

[Nowicke Carole E]
Crit Care Nurse.2004 Apr;24(2):16. PMID: 15098306

28: Paramethoxyamphetamine (PMA) poisoning; a 'party drug' with lethal effects.

[Refstad S]
Acta Anaesthesiol Scand.2003 Nov;47(10):1298-9. PMID: 14616331

29: Immunohistochemical study of myoglobin and oxidative injury-related markers in the kidney of methamphetamine abusers.

[Ishigami Akiko,Tokunaga Itsuo,Gotohda Takako,Kubo Shin-ichi]
Leg Med (Tokyo).2003 Mar;5(1):42-8. PMID: 12935649

30: Importance of early identification of methylenedioxymethamphetamine ('ecstasy') ingestion in victims of motor vehicle accidents.

[Weinbroum Avi A]
Eur J Emerg Med.2003 Mar;10(1):19-22. PMID: 12637856

31: Drug-induced hyperthermia and rhabdomyolysis during the perioperative period: report of three patients.

[Vorrakitpokatorn Puthipanee,Limsakul Aticha]
J Med Assoc Thai.2002 Sep;85 Suppl 3:S884-92. PMID: 12452225

32: [Variability of the clinical expression of Ecstasy-induced hepatotoxicity].

[Núñez O,Bañares R,Barrio J,Menchén L,Diego A de,Salinero E,Clemente G]
Gastroenterol Hepatol.2002 Oct;25(8):497-500. PMID: 12361531

33: Acute liver failure following intravenous methamphetamine.

[Kamijo Yoshito,Soma Kazui,Nishida Manami,Namera Akira,Ohwada Takashi]
Vet Hum Toxicol.2002 Aug;44(4):216-7. PMID: 12136967

34: Pneumomediastinum following Ecstasy (methylenedioxymetamphetamine, MDMA) ingestion in two people at the same 'rave'.

[Rejali Darius,Glen Paul,Odom Nicholas]
J Laryngol Otol.2002 Jan;116(1):75-6. PMID: 11860664

35: A comprehensive review of MDMA and GHB: two common club drugs.

[Teter C J,Guthrie S K]
Pharmacotherapy.2001 Dec;21(12):1486-513. PMID: 11765302

36: The pharmacology and toxicology of "ecstasy" (MDMA) and related drugs.

[Kalant H]
CMAJ.2001 Oct 2;165(7):917-28. PMID: 11599334

37: [Myopathies in drug addicts].

[Ueyama H,Kumamoto T]
Ryoikibetsu Shokogun Shirizu.2001;(36):267-70. PMID: 11596387

38: Rhabdomyolysis and drugs of abuse.

[Richards J R]
J Emerg Med.2000 Jul;19(1):51-6. PMID: 10863119

39: [Amphetamine, ecstasy and cocaine. Clinical aspects of acute poisoning].

[Hedetoft C,Christensen H R]
Ugeskr Laeger.1999 Dec 13;161(50):6907-11. PMID: 10643376

40: Methamphetamine abuse and rhabdomyolysis in the ED: a 5-year study.

[Richards J R,Johnson E B,Stark R W,Derlet R W]
Am J Emerg Med.1999 Nov;17(7):681-5. PMID: 10597089

41: [Ecstasy--cool dope with long-lasting effects?].

[Liberg J P,Hovda K E,Nordby G,Jacobsen D]
Tidsskr Nor Laegeforen.1998 Nov 20;118(28):4384-7. PMID: 9889612

42: [Amphetamine poisoning].

[Robertsen A,Kowalczyk M,Gabrielsen A M,Jacobsen D]
Tidsskr Nor Laegeforen.1998 Nov 20;118(28):4340-3. PMID: 9889603

43: Survival after massive ecstasy overdose.

[Ramcharan S,Meenhorst P L,Otten J M,Koks C H,de Boer D,Maes R A,Beijnen J H]
J Toxicol Clin Toxicol.1998;36(7):727-31. PMID: 9865243

44: Clinical manifestations and prognostic features of acute methamphetamine intoxication.

[Lan K C,Lin Y F,Yu F C,Lin C S,Chu P]
J Formos Med Assoc.1998 Aug;97(8):528-33. PMID: 9747062

45: [Ecstasy].

[Trkulja V,Lacković Z]
Lijec Vjesn.1997 May-Jun;119(5-6):158-66. PMID: 9379824

46: 'Raver's' haematuria.

[Sultana S R,Byrne D J]
J R Coll Surg Edinb.1996 Dec;41(6):419-20. PMID: 8997037

47: [Epileptic insults, cerebral infarct and rhabdomyolysis as complication of amphetamine use].

[Roebroek R M,Korten J J]
Ned Tijdschr Geneeskd.1996 Jul 20;140(29):1519. PMID: 8765941

48: [Epileptic insults, cerebral infarct and rhabdomyolysis as as complications of amphetamine use].

[Hofland E,Fauser C G]
Ned Tijdschr Geneeskd.1996 Mar 23;140(12):681. PMID: 8668245

49: Drugs of abuse and renal disease.

[Bakir A A,Dunea G]
Curr Opin Nephrol Hypertens.1996 Mar;5(2):122-6. PMID: 8744532

50: [Epileptic insults, cerebral infarction and rhabdomyolysis as complications of amphetamine use].

[Roebroek R M,Korten J J]
Ned Tijdschr Geneeskd.1996 Jan 27;140(4):205-7. PMID: 8618644

51: [Abuse of Ecstasy (3,4-methylenedioxymethamphetamine). Pharmacological, neuropsychiatric and behavioral aspects].

[Nielsen J C,Nicholson K,Pitzner-Jørgensen B L,Undén M]
Ugeskr Laeger.1995 Feb 6;157(6):724-7. PMID: 7701630

52: Hyperthermia in psychostimulant overdose.

[Callaway C W,Clark R F]
Ann Emerg Med.1994 Jul;24(1):68-76. PMID: 8010552

53: Exertional heat stroke induced by amphetamine analogues. Does dantrolene have a place?

[Watson J D,Ferguson C,Hinds C J,Skinner R,Coakley J H]
Anaesthesia.1993 Dec;48(12):1057-60. PMID: 7904429

54: 'Ecstasy' ingestion: a case report of severe complications.

[Barrett P J,Taylor G T]
J R Soc Med.1993 Apr;86(4):233-4. PMID: 8099372

55: An overdose of ecstasy. A role for dantrolene.

[Singarajah C,Lavies N G]
Anaesthesia.1992 Aug;47(8):686-7. PMID: 1355634

56: Tc-99m PYP imaging in amphetamine intoxication associated with nontraumatic rhabdomyolysis.

[Kao C H,Liao S Q,Wang S J,Yeh S H]
Clin Nucl Med.1992 Feb;17(2):101-2. PMID: 1532931

57: [A case of amphetamine poisoning manifesting rhabdomyolysis and reversible cardiomyopathy].

[Yamazaki F,Hamashige N,Hamamatsu A,Tamura A,Kusunome O,Matsubayashi K,Doi Y,Ozawa T]
Nihon Naika Gakkai Zasshi.1990 Jan 10;79(1):100-1. PMID: 2324592

58: Pathogenesis and treatment of neuroleptic malignant syndrome.

[Ebadi M,Pfeiffer R F,Murrin L C]
Gen Pharmacol.1990;21(4):367-86. PMID: 1974219

59: Amphetamine-induced myoglobinuric acute renal failure.

[Terada Y,Shinohara S,Matui N,Ida T]
Jpn J Med.1988 Aug;27(3):305-8. PMID: 3057269

60: Pemoline-induced choreoathetosis and rhabdomyolysis.

[Briscoe J G,Curry S C,Gerkin R D,Ruiz R R]
Med Toxicol Adverse Drug Exp.1988 Jan-Dec;3(1):72-6. PMID: 3367787

61: Amphetamine-induced acute renal failure.

[Foley R J,Kapatkin K,Verani R,Weinman E J]
South Med J.1984 Feb;77(2):258-60. PMID: 6701599

62: Amphetamine-associated myoglobinuric renal failure.

[Scandling J,Spital A]
South Med J.1982 Feb;75(2):237-40. PMID: 7058372

63: Rhabdomyolysis and shock after intravenous amphetamine administration.

[Kendrick W C,Hull A R,Knochel J P]
Ann Intern Med.1977 Apr;86(4):381-7. PMID: 848798

Search for drugs: