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

 
 



Index of reports > All Cases (897)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Suboxone (Buprenorphine / Naloxone) all cases. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 897   Next >>

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 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 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

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 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 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 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 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 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 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 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



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



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