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Suboxone (Buprenorphine / Naloxone) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Suboxone (Buprenorphine / Naloxone) 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 (897)
Death (64)
Life Threatening Events (70)
Disability (14)

Reports by Reaction Type

Maternal Exposure During Pregnancy (128)Drug Withdrawal Syndrome (101)Foetal Exposure During Pregnancy (97)Wrong Technique in Drug Usage Process (86)Convulsion (69)Substance Abuse (67)Underdose (58)Suicidal Ideation (57)Pain (54)Drug Withdrawal Syndrome Neonatal (49)Nausea (46)Off Label Use (45)

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

Possible Suboxone side effects in male

Reported by a physician from United States on 2012-08-24

Patient: male

Reactions: Delirium

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ativan
    Dosage: unknown dosing details
    Indication: Product Used FOR Unknown Indication

Suboxone
    Dosage: dosing details unknown
    Indication: Drug Dependence
    Start date: 2012-07-01



Possible Suboxone side effects in

Reported by a physician from United States on 2012-08-24

Patient:

Reactions: Foetal Growth Restriction, LOW Birth Weight Baby, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Suboxone



Possible Suboxone side effects in male

Reported by a physician from United States on 2012-08-24

Patient: male, weighing 70.3 kg (154.7 pounds)

Reactions: Pruritus, Erythema

Drug(s) suspected as cause:
Suboxone



Possible Suboxone side effects in 62 year old male

Reported by a physician from United States on 2012-08-24

Patient: 62 year old male, weighing 55.0 kg (121.0 pounds)

Reactions: Performance Status Decreased, Nausea, Headache, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Paclitaxel
    Start date: 2012-07-30
    End date: 2012-08-03

Paclitaxel
    Start date: 2012-07-23
    End date: 2012-07-27

Ridaforolimus
    Dosage: 10 mg po day 12-5
    Administration route: Oral

Suboxone
    Dosage: 135/m2/auc 5
    Start date: 2012-07-23
    End date: 2012-07-23



Possible Suboxone side effects in

Reported by a physician from United States on 2012-08-23

Patient:

Reactions: Premature Baby, Foetal Exposure During Pregnancy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amphetamines
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Barbiturates
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Benzodiazepines
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Cocaine
    Indication: Product Used FOR Unknown Indication

Hydroxyzine
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Lorazepam
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Methylphenidate
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Nifedipine
    Dosage: dosing details unknown
    Indication: Premature Labour

Seroquel
    Dosage: unknown dosing details
    Indication: Product Used FOR Unknown Indication

Suboxone
    Dosage: dosing details unknown
    Indication: Drug Dependence

Subutex
    Dosage: dosing details unknown
    Indication: Drug Dependence

Terbutaline
    Indication: Premature Labour



Possible Suboxone side effects in 26 year old female

Reported by a physician from United States on 2012-08-23

Patient: 26 year old female, weighing 86.2 kg (189.6 pounds)

Reactions: Oedema Peripheral, Fluid Retention

Drug(s) suspected as cause:
Suboxone

Other drugs received by patient: Lyrica; Metformin Hydrochloride



Possible Suboxone side effects in 60 year old female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: 60 year old female

Reactions: Back Pain, Wrong Technique in Drug Usage Process, Underdose, Drug Withdrawal Syndrome, Depression, Feeling Abnormal, Suicidal Ideation

Drug(s) suspected as cause:
Suboxone
    Start date: 2011-01-01
    End date: 2012-05-01

Suboxone
    Dosage: varies
    Indication: Drug Dependence
    Start date: 2012-05-01
    End date: 2012-07-01



Possible Suboxone side effects in 60 year old female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: 60 year old female

Reactions: Feeling of Despair, Depression, Suicidal Ideation

Drug(s) suspected as cause:
Suboxone



Possible Suboxone side effects in male

Reported by a physician from United States on 2012-08-23

Patient: male, weighing 69.9 kg (153.7 pounds)

Reactions: Small Intestinal Obstruction, Fatigue, Pyrexia, White Blood Cell Count Increased

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Suboxone

Other drugs received by patient: Imuran; Prednisolone



Possible Suboxone side effects in 27 year old female

Reported by a physician from United States on 2012-08-23

Patient: 27 year old female

Reactions: Agitation, Maternal Exposure During Pregnancy, Drug Abuse, Premature Labour, Vaginal Haemorrhage, Anxiety, Psychotic Disorder, Labour Pain, Heart Rate Increased, Eye Movement Disorder, Premature Delivery, Muscle Spasms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Barbiturates
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Benzodiazepines
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Cocaine
    Indication: Product Used FOR Unknown Indication

Generic Amphetamine Salts
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Methylphenidate
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Seroquel
    Dosage: unknown dosing details
    Indication: Product Used FOR Unknown Indication

Suboxone
    Dosage: dosing details unknown
    Indication: Drug Dependence

Subutex
    Dosage: dosing details unknown
    Indication: Drug Dependence



Possible Suboxone side effects in 72 year old female

Reported by a physician from United States on 2012-08-23

Patient: 72 year old female

Reactions: Oedema Peripheral, Anger, Mood Swings, Suicidal Ideation

Drug(s) suspected as cause:
Suboxone
    Indication: Pain
    Start date: 2012-07-01

Suboxone
    Start date: 2012-07-01



Possible Suboxone side effects in male

Reported by a physician from United States on 2012-08-23

Patient: male, weighing 85.7 kg (188.6 pounds)

Reactions: Convulsion

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Suboxone



Possible Suboxone side effects in 47 year old male

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: 47 year old male

Reactions: Off Label Use, Wrong Technique in Drug Usage Process, Pneumonia, Intentional Drug Misuse

Drug(s) suspected as cause:
Suboxone
    Dosage: suboxone film; 6-8 mg/daily
    Indication: Pain
    Start date: 2012-04-01
    End date: 2012-08-06

Suboxone
    Dosage: suboxone film; 6-8 mg/daily
    Start date: 2012-04-01
    End date: 2012-08-06

Suboxone
    Dosage: 6-8 mg/daily
    Indication: Pain
    Start date: 2012-08-07

Suboxone
    Dosage: 6-8 mg/daily
    Indication: Drug Dependence
    Start date: 2012-08-07



Possible Suboxone side effects in 36 year old female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 36 year old female

Reactions: Laceration, Lower Limb Fracture, Drug Abuse, Grand MAL Convulsion, Road Traffic Accident, Visual Impairment, Insomnia, Gait Disturbance, Feeling Abnormal

Drug(s) suspected as cause:
Buprenorphine
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Klonopin
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Phenobarbital TAB
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Suboxone
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Valium
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Xanax
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication



Possible Suboxone side effects in 62 year old male

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: 62 year old male

Reactions: Narcolepsy, Restless Legs Syndrome, Agoraphobia, Fatigue, Road Traffic Accident, Overdose, Dizziness, Depression, Hallucination, Nausea, Paranoia, Drug Withdrawal Syndrome, Renal Failure, Dehydration, Asthenia, Sleep Apnoea Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Oxycontin
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Suboxone
    Indication: Drug Dependence
    Start date: 2008-01-01

Suboxone
    Dosage: tapered down to 16 mg daily
    Indication: Drug Dependence



Possible Suboxone side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient: male

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

Drug(s) suspected as cause:
Suboxone



Possible Suboxone side effects in 33 year old female

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient: 33 year old female

Reactions: Clavicle Fracture, Wrist Fracture, Pain, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Suboxone



Possible Suboxone side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient: female

Reactions: Maternal Exposure During Pregnancy, Premature Delivery

Drug(s) suspected as cause:
Suboxone



Possible Suboxone side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient: female

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

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Suboxone



Possible Suboxone side effects in 40 year old male

Reported by a pharmacist from United States on 2012-08-15

Patient: 40 year old male

Reactions: Abdominal Pain, Colitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Suboxone



Possible Suboxone side effects in 53 year old male

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: 53 year old male

Reactions: Off Label Use, Pneumonia, Unresponsive To Stimuli, Drug Withdrawal Syndrome

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Buprenex
    Dosage: 4 times per day
    Indication: Drug Dependence
    Start date: 2012-05-21
    End date: 2012-01-01

Suboxone
    Dosage: 16 mg
    Indication: Drug Dependence
    Start date: 2007-01-01
    End date: 2012-05-20

Other drugs received by patient: Klonopin



Possible Suboxone side effects in 23 year old female

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: 23 year old female

Reactions: Pelvic Fracture, Road Traffic Accident, Spinal Fracture, Substance Abuse

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Suboxone



Possible Suboxone side effects in 40 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-13

Patient: 40 year old male

Reactions: Depression, Suicidal Ideation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Suboxone



Possible Suboxone side effects in female

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

Patient: female, weighing 63.5 kg (139.7 pounds)

Reactions: Skin Lesion, Scar

Drug(s) suspected as cause:
Suboxone



Possible Suboxone side effects in 34 year old female

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

Patient: 34 year old female

Reactions: Hepatitis C, Weight Increased, Diplopia, Fatigue, Arthralgia, Oedema Peripheral, Dizziness, Musculoskeletal Stiffness, Brain Oedema, Intracranial Pressure Increased, Fluid Retention

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Buprenorphine
    Dosage: unit dose unknown
    Indication: Product Used FOR Unknown Indication

Suboxone
    Dosage: 12-16 mg daily
    Indication: Product Used FOR Unknown Indication

Suboxone
    Dosage: suboxone film: unit dose unknown
    Indication: Product Used FOR Unknown Indication



Possible Suboxone side effects in 29 year old female

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

Patient: 29 year old female

Reactions: Migraine, Drug Withdrawal Syndrome, Suicidal Ideation, Abdominal Pain Upper, Anxiety, Malaise, Gastrointestinal Disorder, Pancreatitis, Gallbladder Disorder, Feeling Abnormal

Drug(s) suspected as cause:
Suboxone



Possible Suboxone side effects in 23 year old female

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

Patient: 23 year old female

Reactions: NO Adverse Event, Maternal Exposure During Pregnancy

Drug(s) suspected as cause:
Suboxone
    Dosage: suboxone film
    Indication: Drug Dependence
    Start date: 2012-03-01
    End date: 2012-06-04

Subutex
    Indication: Drug Dependence
    Start date: 2012-06-05

Other drugs received by patient: Multi-Vitamins



Possible Suboxone side effects in

Reported by a physician from United States on 2012-08-10

Patient:

Reactions: Rhabdomyolysis, Intentional Drug Misuse

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Suboxone



Possible Suboxone side effects in 28 year old male

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

Patient: 28 year old male

Reactions: Limb Crushing Injury, Hypoaesthesia Oral, Road Traffic Accident, Drug Ineffective, Tendon Rupture, Substance Abuse

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Suboxone
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Suboxone
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Subutex
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication



Possible Suboxone side effects in 30 year old male

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

Patient: 30 year old male

Reactions: Impaired Driving Ability, Road Traffic Accident, Upper Limb Fracture, Laceration, Splenic Injury, Internal Injury

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Freon GAS
    Dosage: unknown dosage details
    Indication: Product Used FOR Unknown Indication

Suboxone
    Dosage: unknown dosage details
    Indication: Product Used FOR Unknown Indication

Xanax
    Dosage: unknown dosage details
    Indication: Product Used FOR Unknown Indication

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