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Methadose (Methadone) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Methadose (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 (677)
Death (54)
Life Threatening Events (5)
Disability (1)

Reports by Reaction Type

Drug Withdrawal Syndrome Neonatal (374)Foetal Exposure During Pregnancy (371)Maternal Exposure During Pregnancy (176)Premature Delivery (169)Premature Baby (84)Completed Suicide (25)Cardio-Respiratory Arrest (22)Nystagmus (22)Maternal Drugs Affecting Foetus (21)Strabismus (16)Overdose (11)Toxicity To Various Agents (11)

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

Possible Methadose side effects in female

Reported by a physician from United States on 2012-08-21

Patient: female

Reactions: Maternal Exposure During Pregnancy, Premature Delivery

Drug(s) suspected as cause:
Methadose



Possible Methadose side effects in 63 year old

Reported by a individual with unspecified qualification from Italy on 2012-08-21

Patient: 63 year old

Reactions: Intestinal Obstruction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Methadose

Other drugs received by patient: Opioids



Possible Methadose side effects in 63 year old

Reported by a individual with unspecified qualification from Italy on 2012-08-20

Patient: 63 year old

Reactions: Intestinal Obstruction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Methadose

Other drugs received by patient: Opioids



Possible Methadose side effects in male

Reported by a physician from United States on 2012-08-13

Patient: male

Reactions: Epidermolysis Bullosa, Premature Baby, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Methadose



Possible Methadose side effects in

Reported by a physician from United States on 2012-08-13

Patient:

Reactions: Hypoxic-Ischaemic Encephalopathy

Drug(s) suspected as cause:
Methadose



Possible Methadose side effects in 24 year old male

Reported by a physician from United States on 2012-08-13

Patient: 24 year old male

Reactions: Hypoxic-Ischaemic Encephalopathy, Accidental Overdose

Adverse event resulted in: hospitalization

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

Methadose
    Dosage: unk



Possible Methadose side effects in

Reported by a physician from United States on 2012-08-13

Patient:

Reactions: Hypoxic-Ischaemic Encephalopathy

Drug(s) suspected as cause:
Methadose



Possible Methadose side effects in 56 year old female

Reported by a physician from United States on 2012-08-13

Patient: 56 year old female

Reactions: Rhabdomyolysis, Multiple Drug Overdose Intentional, Leukoencephalopathy, Renal Failure Acute

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Benzodiazepine Derivatives
    Dosage: unk

Fentanyl Citrate
    Dosage: unk

Methadose
    Dosage: unk



Possible Methadose side effects in 19 year old male

Reported by a physician from United States on 2012-08-13

Patient: 19 year old male

Reactions: Drug Diversion, Overdose, Leukoencephalopathy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Methadose



Possible Methadose side effects in 51 year old female

Reported by a physician from United States on 2012-08-13

Patient: 51 year old female

Reactions: Overdose, Leukoencephalopathy

Drug(s) suspected as cause:
Methadose

Other drugs received by patient: Fentanyl Citrate



Possible Methadose side effects in

Reported by a physician from United States on 2012-08-13

Patient:

Reactions: Hypoxic-Ischaemic Encephalopathy

Drug(s) suspected as cause:
Methadose



Possible Methadose side effects in 17 year old female

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: 17 year old female

Reactions: Death

Adverse event resulted in: death

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

Hydrocodone Bitartrate
    Dosage: unk

Methadose
    Dosage: unk

Oxycodone HCL
    Dosage: unk



Possible Methadose side effects in 19 year old female

Reported by a physician from Belgium on 2012-08-09

Patient: 19 year old female

Reactions: Leukoencephalopathy, Drug Abuse

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amphetamines
    Dosage: unk
    Indication: Substance Use

Benzodiazepine Derivatives
    Dosage: unk
    Indication: Substance Use

Cocaine
    Dosage: unk
    Indication: Substance Use

Ethanol
    Dosage: unk
    Indication: Substance Use

LSD
    Dosage: unk
    Indication: Substance Abuse

Methadose
    Dosage: unk
    Indication: Substance Abuse



Possible Methadose side effects in 30 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-09

Patient: 30 year old female

Reactions: Amniotic Fluid Volume Decreased, Maternal Exposure During Pregnancy, Premature Delivery

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lisinopril
    Dosage: unk
    Indication: Hypertension
    End date: 2011-12-01

Methadose
    Dosage: 160 mg, qd
    Administration route: Oral
    Indication: Substance Abuse



Possible Methadose side effects in 39 year old female

Reported by a physician from United States on 2012-08-09

Patient: 39 year old female

Reactions: Pneumonia Aspiration, Hypotension, Mental Status Changes, Overdose, Affect Lability, Fatigue, Disturbance in Attention, Depressed Level of Consciousness, Gait Disturbance, Leukoencephalopathy

Adverse event resulted in: hospitalization

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

Methadose



Possible Methadose side effects in

Reported by a physician from United States on 2012-08-09

Patient:

Reactions: Hypoxic-Ischaemic Encephalopathy

Drug(s) suspected as cause:
Methadose



Possible Methadose side effects in 38 year old male

Reported by a physician from United States on 2012-08-09

Patient: 38 year old male

Reactions: Pneumonia Aspiration, Rhabdomyolysis, Hepatic Enzyme Increased, Loss of Consciousness, Drug Diversion, Hypoxic-Ischaemic Encephalopathy, Blood Pressure Decreased, Hallucination, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amantadine HCL
    Dosage: unk
    Indication: Hypoxic-Ischaemic Encephalopathy

Diazepam
    Indication: Neck Pain

Diazepam
    Indication: Back Pain

Methadose
    Dosage: unk
    Indication: Back Pain

Methadose
    Indication: Neck Pain

Methylin
    Dosage: unk
    Indication: Rehabilitation Therapy



Possible Methadose side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-09

Patient: female, weighing 2.8 kg (6.2 pounds)

Reactions: Premature Baby, Foetal Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal

Drug(s) suspected as cause:
Methadose



Possible Methadose side effects in 42 year old female

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: 42 year old female

Reactions: Sedation, Multiple Drug Overdose, Amnesia

Adverse event resulted in: death

Drug(s) suspected as cause:
Hydrocodone
    Indication: Product Used FOR Unknown Indication

Ibuprofen
    Indication: Product Used FOR Unknown Indication

Methadose
    Indication: Product Used FOR Unknown Indication

Morphine Sulfate
    Dosage: unk
    Indication: Product Used FOR Unknown Indication



Possible Methadose side effects in 30 year old male

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

Patient: 30 year old male

Reactions: Multiple Drug Overdose

Adverse event resulted in: death

Drug(s) suspected as cause:
Methadose

Morphine Sulfate

Oxycodone HCL



Possible Methadose side effects in 30 year old male

Reported by a consumer/non-health professional from United States on 2012-07-11

Patient: 30 year old male

Reactions: Multiple Drug Overdose

Adverse event resulted in: death

Drug(s) suspected as cause:
Methadose

Morphine

Oxycodone HCL



Possible Methadose side effects in 21 year old male

Reported by a consumer/non-health professional from United States on 2012-07-11

Patient: 21 year old male

Reactions: Toxicity To Various Agents

Adverse event resulted in: death

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

Oxycodone HCL
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Soma
    Indication: Product Used FOR Unknown Indication

Valium
    Dosage: unk
    Indication: Product Used FOR Unknown Indication



Possible Methadose side effects in

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-10

Patient:

Reactions: Overdose, Leukoencephalopathy

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

Methadose
    Dosage: unk
    Indication: Product Used FOR Unknown Indication



Possible Methadose side effects in

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-10

Patient:

Reactions: Leukoencephalopathy

Drug(s) suspected as cause:
Methadose



Possible Methadose side effects in

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-10

Patient:

Reactions: Leukoencephalopathy

Drug(s) suspected as cause:
Benzodiazepine Related Drugs

Fentanyl Citrate

Methadose
    Dosage: unk



Possible Methadose side effects in

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-10

Patient:

Reactions: Leukoencephalopathy

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

Methadose
    Dosage: unk
    Indication: Product Used FOR Unknown Indication



Possible Methadose side effects in 43 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-10

Patient: 43 year old female

Reactions: Pneumonia Aspiration, Hypoglycaemia, Hepatic Failure, Drug Diversion, Overdose, Brain Hypoxia, Leukoencephalopathy, Hypoperfusion, Renal Tubular Necrosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Alprazolam
    Dosage: 15 mg

Methadose
    Dosage: 180 mg



Possible Methadose side effects in 71 year old male

Reported by a pharmacist on 2012-07-03

Patient: 71 year old male

Reactions: Intestinal Perforation, Acute Respiratory Failure, Faecaloma, Infectious Peritonitis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Methadose



Possible Methadose side effects in 39 year old

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-18

Patient: 39 year old

Reactions: Bronchospasm, Oxygen Saturation Decreased

Drug(s) suspected as cause:
Methadose



Possible Methadose side effects in

Reported by a health professional (non-physician/pharmacist) from Ireland on 2012-06-05

Patient:

Reactions: Foetal Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal

Drug(s) suspected as cause:
Methadose

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