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Methadone (Methadone) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Methadone and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (35)
Death (21)
Life Threatening Events (2)
Disability (1)

Reports by Reaction Type

Respiratory Arrest (10)Cardiac Arrest (10)Drug Abuse (7)Completed Suicide (6)Death (4)Drug Ineffective (3)Toxicity To Various Agents (3)Pyrexia (2)Cholecystitis (2)Escherichia Sepsis (2)Epilepsy (2)Therapeutic Response Unexpected (1)

Below are a few examples of reports where side effects / adverse reactions may be related to Methadone. For a complete list or a specific selection of reports, please use the links above.

Possible Methadone side effects in 32 year old female

Reported by a health professional (non-physician/pharmacist) from Taiwan, Province of China on 2012-07-26

Patient: 32 year old female

Reactions: Breech Presentation

Drug(s) suspected as cause:
Heroin

Methadone
    Administration route: Oral
    Indication: Drug Withdrawal Maintenance Therapy



Possible Methadone side effects in female

Reported by a physician from United States on 2012-07-26

Patient: female, weighing 61.7 kg (135.8 pounds)

Reactions: Drug Ineffective, Drug Abuse

Drug(s) suspected as cause:
Heroin
    Dosage: unknown
    Indication: Drug Abuse

Opana ER
    Administration route: Oral
    Indication: Pain
    Start date: 2012-04-27
    End date: 2012-05-09

Methadone
    Dosage: unknown
    Indication: Drug Abuse

Other drugs received by patient: Adderall XR 10; Miralax; Valium; Adderall 5; Oxycodone HCL; Loestrin 1.5 / 30; Oxycodone HCL; Bupropion HCL; Bupropion HCL; Opana; Phenytoin



Possible Methadone side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-25

Patient: female

Reactions: Localised Infection, Drug Ineffective, Pain, Oedema Peripheral, Paraesthesia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Methadone
    Dosage: 10 mg, unk
    Indication: Pain

Methadone
    Dosage: 10 mg, 2x/day

Neurontin
    Dosage: 1000 mg, 3x/day
    Administration route: Oral
    Indication: Neuropathy Peripheral
    Start date: 2010-01-01
    End date: 2012-07-13

Other drugs received by patient: Lantus; Humalog



Possible Methadone side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-25

Patient: female

Reactions: Drug Screen Positive, Drug Screen, Emotional Disorder

Drug(s) suspected as cause:
Vistaril
    Dosage: 50 mg, unk

Methadone
    Dosage: 60 mg, unk



Possible Methadone side effects in female

Reported by a physician from United States on 2012-07-25

Patient: female, weighing 70.3 kg (154.7 pounds)

Reactions: Fibromyalgia, Drug Ineffective, Blood Cholesterol Increased, Memory Impairment, Depression

Drug(s) suspected as cause:
Effexor XR
    Dosage: 150 mg, 1x/day
    End date: 2011-01-01

Lyrica
    Dosage: 100 mg, 1x/day
    Indication: Fibromyalgia

Methadone
    Dosage: 5 mg, 4x/day
    Indication: Pain
    Start date: 2008-01-01

Effexor XR
    Dosage: 37.5 mg, 1x/day
    Indication: Pain
    Start date: 1998-01-01

Effexor XR
    Dosage: 75 mg, 1x/day
    Indication: Depression

Venlafaxine
    Dosage: 150 mg, daily
    Indication: Depression
    Start date: 2011-01-01

Other drugs received by patient: Protonix; Desyrel; Effexor; Creon; Zovirax; Combivent; Centrum; Proventil Gentlehaler; Voltaren; Micro-K; Effexor; Valium; Creon; Colace; Cozaar; Dolophine Hydrochloride; Robaxin; Robaxin; Flector; Zofran; Premarin; Zovirax; Dolophine Hydrochloride



Possible Methadone side effects in 45 year old male

Reported by a physician from United States on 2012-07-03

Patient: 45 year old male, weighing 83.9 kg (184.6 pounds)

Reactions: Victim of Homicide, GUN Shot Wound, Substance Abuse

Adverse event resulted in: death

Drug(s) suspected as cause:
Cocaine

Methadone

Morphine Sulfate



Possible Methadone side effects in 69 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-28

Patient: 69 year old female

Reactions: Accident, Toxicity To Various Agents

Adverse event resulted in: death

Drug(s) suspected as cause:
Oxycodone Hydrochloride
    Dosage: unk

Keppra
    Dosage: unk

Methadone
    Dosage: unk



Possible Methadone side effects in 48 year old female

Reported by a physician from United States on 2012-05-29

Patient: 48 year old female

Reactions: Completed Suicide

Adverse event resulted in: death

Drug(s) suspected as cause:
Methadone
    Dosage: unk
    Administration route: Oral
    Start date: 2008-01-01

Venlafaxine HCL
    Dosage: unk
    Administration route: Oral
    Start date: 2008-01-01

Oxycodone HCL
    Dosage: unk
    Start date: 2008-01-01

Lithium
    Dosage: unk
    Administration route: Oral
    Start date: 2008-01-01

Propoxyphene Hydrochloride
    Dosage: unk
    Administration route: Oral
    Start date: 2008-01-01

Varenicline Tartrate
    Dosage: unk
    Administration route: Oral
    Start date: 2008-01-01

Quetiapine
    Dosage: unk
    Administration route: Oral
    Start date: 2008-01-01



Possible Methadone side effects in 43 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-05-22

Patient: 43 year old male, weighing 70.0 kg (154.0 pounds)

Reactions: Cholecystitis, Pyrexia, Escherichia Sepsis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Methadone
    Dosage: 60 mg, 1x/day
    Administration route: Oral
    Indication: Drug Dependence
    Start date: 2011-03-01

Vfend
    Dosage: 200 mg, 2x/day
    Administration route: Oral
    Indication: Meningitis Candida
    Start date: 2011-10-21

Acetaminophen and Tramadol HCL
    Dosage: 2 df, 3x/day
    Administration route: Oral
    Indication: Pain
    Start date: 2011-08-16

Other drugs received by patient: Trimeprazine Tartrate; Imovane; Cacit D3; Atarax; Prednisone TAB; Potassium Chloride



Possible Methadone side effects in 43 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-05-21

Patient: 43 year old male, weighing 70.0 kg (154.0 pounds)

Reactions: Pyrexia, Cholecystitis, Escherichia Sepsis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Acetaminophen and Tramadol HCL
    Dosage: 2 df, 3x/day
    Administration route: Oral
    Indication: Pain
    Start date: 2011-08-16

Vfend
    Dosage: 200 mg, 2x/day
    Administration route: Oral
    Indication: Meningitis Candida
    Start date: 2011-10-21

Methadone
    Dosage: 60 mg, 1x/day
    Administration route: Oral
    Indication: Drug Dependence
    Start date: 2011-03-01

Other drugs received by patient: Prednisone TAB; Trimeprazine Tartrate; Potassium Chloride; Cacit D3; Imovane; Atarax



Possible Methadone side effects in 26 year old male

Reported by a physician from Germany on 2012-05-17

Patient: 26 year old male, weighing 70.0 kg (154.0 pounds)

Reactions: Poor Quality Sleep, Nightmare, Mental Disorder, Abnormal Behaviour, Withdrawal Syndrome, Polysubstance Dependence, Drug Abuse

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Methadone
    Dosage: 12 ml, daily
    Indication: Substance Use

Nicotine
    Dosage: one package per day

Magnesiocard
    Dosage: unk

Lyrica
    Dosage: 75 mg, 4x/day

Lyrica
    Dosage: 300 mg, 4x/day

Dominal Forte
    Dosage: 40 mg, as needed

Lyrica
    Dosage: 600 mg, daily

Methadone
    Dosage: 5-10 ml/day

Lyrica
    Dosage: 300 mg, 3x/day

Lyrica
    Dosage: 75 mg, daily
    End date: 2011-07-05

Cocaine
    Dosage: 5 mg, 2-3x/ day

Heroin
    Dosage: unk



Possible Methadone side effects in female

Reported by a consumer/non-health professional from Australia on 2012-05-16

Patient: female

Reactions: Overdose, Drug Abuse

Adverse event resulted in: death

Drug(s) suspected as cause:
Methadone

Tolterodine Tartrate
    Dosage: unk
    Start date: 2008-11-10

Seroquel



Possible Methadone side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-23

Patient: male, weighing 107.0 kg (235.4 pounds)

Reactions: Malaise, Therapeutic Response Unexpected, Hyperhidrosis

Drug(s) suspected as cause:
Toviaz
    Dosage: 4 mg, daily
    Indication: Urinary Incontinence
    Start date: 2011-01-01
    End date: 2012-01-01

Methadone
    Dosage: 180 mg, daily
    Indication: Drug Dependence



Possible Methadone side effects in female

Reported by a consumer/non-health professional from United States on 2012-02-08

Patient: female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Methadone
    Dosage: unk

Iodine
    Dosage: unk

Penicillin G Potassium
    Dosage: unk

Gabapentin
    Dosage: unk



Possible Methadone side effects in 30 year old male

Reported by a consumer/non-health professional from United States on 2012-01-05

Patient: 30 year old male

Reactions: Toxicity To Various Agents

Adverse event resulted in: death

Drug(s) suspected as cause:
Methadone



Possible Methadone side effects in male

Reported by a consumer/non-health professional from United States on 2012-01-04

Patient: male, weighing 96.1 kg (211.5 pounds)

Reactions: Abdominal Pain, Lung Disorder, Cyst, Hernia, Headache, Back Disorder, Hepatic Steatosis

Drug(s) suspected as cause:
Zoloft
    Dosage: 100 mg, daily
    Indication: Apathy

Zoloft
    Dosage: 50 mg, daily
    Indication: Decreased Interest

Methadone
    Dosage: unk
    Indication: Pain Management

Dilaudid
    Dosage: unk
    Indication: Pain Management

Zoloft
    Dosage: unk

Codeine
    Dosage: unk
    Indication: Pain Management

Percocet
    Dosage: unk
    Administration route: Oral
    Indication: Pain Management

Other drugs received by patient: Tizanidine; Gabapentin; Clonazepam



Possible Methadone side effects in 49 year old male

Reported by a physician from United States on 2011-12-29

Patient: 49 year old male

Reactions: Death, Respiratory Arrest, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Acetaminophen
    Dosage: unk
    Administration route: Oral

Methadone
    Dosage: unk
    Administration route: Oral

Alprazolam
    Dosage: unk
    Administration route: Oral



Possible Methadone side effects in 60 year old female

Reported by a physician from United States on 2011-12-23

Patient: 60 year old female

Reactions: Completed Suicide, Respiratory Arrest, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Zolpidem
    Administration route: Oral

Pantoprazole
    Administration route: Oral

Duloxetine
    Administration route: Oral

Methadone
    Dosage: unk
    Administration route: Oral



Possible Methadone side effects in 29 year old male

Reported by a physician from United States on 2011-12-22

Patient: 29 year old male

Reactions: Respiratory Arrest, Drug Abuse, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Cocaine
    Dosage: unk
    Administration route: Oral

Alprazolam
    Dosage: unk
    Administration route: Oral

Methadone
    Dosage: unk
    Administration route: Oral



Possible Methadone side effects in 54 year old male

Reported by a physician from United States on 2011-12-22

Patient: 54 year old male

Reactions: Completed Suicide, Respiratory Arrest, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Nadolol

Oxycodone Hydrochloride

Methadone

Ibuprofen

Acetaminophen and Oxycodone HCL



Possible Methadone side effects in 27 year old male

Reported by a physician from United States on 2011-12-22

Patient: 27 year old male

Reactions: Death, Respiratory Arrest, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Alprazolam
    Dosage: unk

Acetaminophen and Oxycodone HCL
    Dosage: unk

Methadone
    Dosage: unk

Carisoprodol
    Dosage: unk



Possible Methadone side effects in 24 year old male

Reported by a physician from United States on 2011-12-22

Patient: 24 year old male

Reactions: Death, Respiratory Arrest, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Alprazolam
    Dosage: unk

Oxycodone Hydrochloride
    Dosage: unk

Oxymorphone
    Dosage: unk

Methadone
    Dosage: unk

Codeine
    Dosage: unk



Possible Methadone side effects in 51 year old female

Reported by a physician from United States on 2011-12-22

Patient: 51 year old female

Reactions: Intentional Drug Misuse

Adverse event resulted in: death

Drug(s) suspected as cause:
Ibuprofen

Methadone

Aripiprazole



Possible Methadone side effects in 51 year old male

Reported by a physician from United States on 2011-12-22

Patient: 51 year old male

Reactions: Drug Abuse

Adverse event resulted in: death

Drug(s) suspected as cause:
Diphenhydramine
    Dosage: unk
    Administration route: Oral

Alprazolam
    Dosage: unk
    Administration route: Oral

Methadone
    Dosage: unk
    Administration route: Oral



Possible Methadone side effects in 82 year old male

Reported by a physician from United States on 2011-12-22

Patient: 82 year old male

Reactions: Completed Suicide, Toxicity To Various Agents

Adverse event resulted in: death

Drug(s) suspected as cause:
Pregabalin
    Dosage: unk
    Administration route: Oral

Cyclobenzaprine
    Dosage: unk
    Administration route: Oral

Acetaminophen and Hydrocodone Bitartrate
    Dosage: unk
    Administration route: Oral

Warfarin
    Dosage: unk
    Administration route: Oral

Amlodipine Besylate
    Dosage: unk
    Administration route: Oral

Methadone
    Dosage: unk
    Administration route: Oral

Hydroxychloroquine
    Dosage: unk
    Administration route: Oral



Possible Methadone side effects in 17 year old male

Reported by a physician from United States on 2011-12-22

Patient: 17 year old male

Reactions: Death, Respiratory Arrest, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Meprobamate
    Dosage: unk

Methadone
    Dosage: unk

Alprazolam
    Dosage: unk



Possible Methadone side effects in 31 year old female

Reported by a physician from United States on 2011-12-22

Patient: 31 year old female

Reactions: Completed Suicide, Respiratory Arrest, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Methadone
    Dosage: unk
    Administration route: Oral

Alprazolam
    Dosage: unk
    Administration route: Oral



Possible Methadone side effects in 46 year old female

Reported by a physician from United States on 2011-12-22

Patient: 46 year old female

Reactions: Respiratory Arrest, Drug Abuse, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Carisoprodol
    Dosage: unk
    Administration route: Oral

Methadone
    Dosage: unk
    Administration route: Oral

Ethanol
    Dosage: unk
    Administration route: Oral

Acetaminophen and Hydrocodone Bitartrate
    Dosage: unk
    Administration route: Oral

Alprazolam
    Dosage: unk
    Administration route: Oral

Clonazepam
    Dosage: unk
    Administration route: Oral



Possible Methadone side effects in 29 year old male

Reported by a physician from United States on 2011-12-22

Patient: 29 year old male

Reactions: Respiratory Arrest, Drug Abuse, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Acetaminophen and Hydrocodone Bitartrate
    Dosage: unk
    Administration route: Oral

Alprazolam
    Dosage: unk
    Administration route: Oral

Methadone
    Dosage: unk
    Administration route: Oral

Codeine
    Dosage: unk
    Administration route: Oral



Possible Methadone side effects in 39 year old male

Reported by a pharmacist from United Kingdom on 2011-12-02

Patient: 39 year old male

Reactions: Epilepsy

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Carbamazepine
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Heroin
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Xanax
    Dosage: unk

Methadone
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Gabapentin
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Dihydrocodeine Bitartrate
    Dosage: 30 mg, 2x/day
    Administration route: Oral
    Indication: Pain

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