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 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 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 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
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
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
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