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Buprenorphine (Buprenorphine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Buprenorphine 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 (322)
Death (70)
Life Threatening Events (20)
Disability (6)

Reports by Reaction Type

Nausea (30)Vomiting (27)Maternal Exposure During Pregnancy (27)Hyperhidrosis (24)Dizziness (21)Toxicity To Various Agents (20)Foetal Exposure During Pregnancy (19)Disorientation (18)Ataxia (17)Somnolence (16)Drug Interaction (15)Constipation (15)

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

Possible Buprenorphine side effects in 91 year old female

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-08-20

Patient: 91 year old female

Reactions: Hypoglycaemia, Drug Interaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Buprenorphine
    Dosage: 35 mcg/h
    Indication: Pain

Levofloxacin
    Dosage: 500 mg/d for 7 days
    Administration route: Oral
    Indication: Bacterial Infection

Metformina Glibenclamide Sandoz
    Dosage: 400 mg/2.5 mg
    Administration route: Oral

Nadroparin
    Dosage: 3800 ui/d
    Indication: Cerebrovascular Accident

Tramadol HCL
    Dosage: when required

Other drugs received by patient: Aspirin; Enalapril Maleate; Enalapril Maleate and Hydrochlorothiazide; Lansoprazole; Insulin



Possible Buprenorphine side effects in 82 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-17

Patient: 82 year old female

Reactions: Hallucination, Visual, Disorientation, Delusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Buprenorphine



Possible Buprenorphine 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 Buprenorphine side effects in 62 year old male

Reported by a physician from Japan on 2012-08-17

Patient: 62 year old male

Reactions: Loss of Consciousness, Arrhythmia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Buprenorphine
    Dosage: 15 mcg, q1h
    Start date: 2012-05-07
    End date: 2012-05-14

Buprenorphine
    Dosage: 10 mcg, q1h
    Start date: 2012-04-24
    End date: 2012-05-06

Buprenorphine
    Dosage: 10 mcg, q1h
    Indication: Pain
    End date: 2012-07-05

Buprenorphine
    Dosage: 20 mcg, q1h
    Start date: 2012-05-15
    End date: 2012-05-22

Buprenorphine
    Dosage: 5 mcg, q1h
    Start date: 2012-04-11
    End date: 2012-04-23

Buprenorphine
    Dosage: 10 mcg, q1h
    Start date: 2012-06-05
    End date: 2012-06-25

Pravastatin
    Dosage: 10 mg, daily
    Administration route: Oral

Other drugs received by patient: Carvedilol; Diart; Aldactone; Lisinopril; Omeprazole; Lendormin



Possible Buprenorphine 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 Buprenorphine side effects in male

Reported by a physician from Japan on 2012-08-06

Patient: male, weighing 70.0 kg (154.0 pounds)

Reactions: Vomiting, Interstitial Lung Disease, Nausea

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Buprenorphine

Other drugs received by patient: Celebrex; Zetia; Agaricus; Epinastine Hydrochloride; Lansoprazole; Warfarin Sodium; Livalo; Artist; Plavix; Lasix; Epadel / 01682401 /; Pursennid / 00142207 /; San'o-Shashin-TO; Allopurinol; Denshichi Ginseng



Possible Buprenorphine side effects in 82 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-06

Patient: 82 year old female

Reactions: Hallucination, Visual, Disorientation, Delusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Buprenorphine



Possible Buprenorphine side effects in

Reported by a physician from Italy on 2012-08-03

Patient:

Reactions: Confusional State, Vomiting, Nausea, Inadequate Analgesia, Toxicity To Various Agents, Respiratory Depression, Constipation, Hyperhidrosis, Somnolence, Adverse Reaction, Myoclonus, DRY Mouth

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Buprenorphine
    Indication: Cancer Pain

Fentanyl Citrate
    Dosage: expressed as medican in mg/day
    Indication: Cancer Pain

Hydromorphone HCL
    Administration route: Oral
    Indication: Cancer Pain

Morphine Sulfate
    Dosage: expressed as median in mg/day
    Indication: Cancer Pain

Morphine Sulfate
    Dosage: expressed as median, in mg/day
    Administration route: Oral

Oxycodone HCL
    Dosage: expressed as median, in mg/day
    Administration route: Oral
    Indication: Cancer Pain



Possible Buprenorphine side effects in 4 month old female

Reported by a pharmacist from United States on 2012-08-03

Patient: 4 month old female

Reactions: Agitation, Mydriasis, Psychomotor Hyperactivity, Yawning, Exposure During Breast Feeding, Foetal Exposure During Pregnancy, Drug Withdrawal Syndrome, Hyperhidrosis, Tremor, Myoclonus, Insomnia, Sneezing

Drug(s) suspected as cause:
Buprenorphine



Possible Buprenorphine side effects in 26 year old female

Reported by a consumer/non-health professional from United States on 2012-08-01

Patient: 26 year old female

Reactions: Maternal Exposure During Pregnancy, Abortion Induced

Drug(s) suspected as cause:
Buprenorphine

Other drugs received by patient: Biotin; Zoloft



Possible Buprenorphine side effects in 55 year old male

Reported by a physician from United States on 2012-08-01

Patient: 55 year old male

Reactions: Renal Failure

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Buprenorphine

Other drugs received by patient: Xanax; Ambien



Possible Buprenorphine side effects in 80 year old female

Reported by a pharmacist from Japan on 2012-08-01

Patient: 80 year old female

Reactions: Application Site Erythema, Lumbar Spinal Stenosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Buprenorphine



Possible Buprenorphine side effects in male

Reported by a physician from Japan on 2012-08-01

Patient: male, weighing 50.7 kg (111.5 pounds)

Reactions: Dysphagia, Pneumonia Aspiration, Abnormal Behaviour, Hallucination

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Buprenorphine
    Dosage: 5 mcg, q1h
    Start date: 2012-06-13
    End date: 2012-06-28

Buprenorphine
    Dosage: 5 mcg, q1h
    Indication: Pain
    Start date: 2012-07-10

Buprenorphine
    Dosage: 10 mcg, q1h
    Indication: Spinal Compression Fracture
    Start date: 2012-06-29
    End date: 2012-07-09

Other drugs received by patient: Vitamin B12; Mucosta; Lyrica; Opalmon; Gasmotin; Calblock; Motilium; Olmesartan Medoxomil; Dogmatyl; Aricept; Mohrus L



Possible Buprenorphine side effects in 26 year old female

Reported by a consumer/non-health professional from United States on 2012-07-31

Patient: 26 year old female

Reactions: Procedural Pain, Foetal Growth Restriction, Maternal Exposure During Pregnancy, Drug Withdrawal Syndrome, Hypertension, Foetal Heart Rate Decreased, Postpartum Depression

Drug(s) suspected as cause:
Buprenorphine
    Indication: Drug Dependence
    Start date: 2010-01-01
    End date: 2011-11-01

Buprenorphine
    Start date: 2011-11-01
    End date: 2011-11-01

Buprenorphine
    Start date: 2011-11-01

Pitocin
    Dosage: unknown dosage details
    Indication: Induced Labour
    Start date: 2011-11-02
    End date: 2011-11-02

Other drugs received by patient: Zoloft; Multi-Vitamins; Biotin; Fish OIL



Possible Buprenorphine side effects in 55 year old female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-07-31

Patient: 55 year old female

Reactions: Drug Interaction, Headache, Disorientation, Somnolence, Pulse Pressure Increased, Balance Disorder, Palpitations, Dizziness, Hallucination, Muscle Spasms, Dyspnoea, Vomiting, Urinary Tract Infection, Anxiety, Euphoric Mood, Diarrhoea, Hypopnoea, Disturbance in Attention, Gait Disturbance, Asthenia

Drug(s) suspected as cause:
Baclofen
    Dosage: 60 mg (20 mg,3 in 1 d)

Buprenorphine
    Dosage: 240 mcg(10mcg,1 in 1 hr),360 mcg(15mcg,1 in 1 hr),480 mcg (20mcg,1 in 1 hr),120 mcg (5 mcg,1 in 1 hr

Cesamet
    Dosage: (0.25 mg), oral
    Administration route: Oral

Clonazepam
    Dosage: 3 mg (1 mg,3 in 1 d), oral
    Administration route: Oral

Escitalopram Oxalate
    Dosage: 20 mg (20 mg, 1 in 1 d),oral
    Administration route: Oral



Possible Buprenorphine side effects in 23 year old female

Reported by a consumer/non-health professional from United States on 2012-07-31

Patient: 23 year old female

Reactions: Postpartum Haemorrhage, Maternal Exposure During Pregnancy, PRE-Eclampsia, Hypertension

Drug(s) suspected as cause:
Buprenorphine
    Indication: Drug Dependence
    Start date: 2011-07-01
    End date: 2012-01-01

Suboxone
    Indication: Drug Dependence
    Start date: 2012-01-01

Other drugs received by patient: Celexa; Multi-Vitamins



Possible Buprenorphine side effects in female

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

Patient: female

Reactions: Umbilical Cord Abnormality, Abortion Threatened, Hepatitis C RNA Increased, Maternal Exposure During Pregnancy, Underdose, Premature Delivery, Premature Labour, Foetal Hypokinesia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Buprenorphine
    Indication: Drug Dependence
    End date: 2011-09-20

Nicotine
    Dosage: 1/2 pack daily
    Indication: Nicotine Dependence

Suboxone
    Indication: Drug Dependence

Other drugs received by patient: Multi-Vitamins



Possible Buprenorphine side effects in male

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

Patient: male, weighing 2.5 kg (5.5 pounds)

Reactions: LOW Birth Weight Baby, Exposure During Breast Feeding, Premature Baby, Foetal Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Buprenorphine
    Indication: Drug Dependence
    End date: 2011-09-20

Buprenorphine
    Start date: 2011-09-20
    End date: 2011-09-22

Multi-Vitamins
    Dosage: one daily
    Indication: Pregnancy
    End date: 2011-09-20

Nicotine
    Dosage: 1/2 pack per day
    Start date: 2011-09-20
    End date: 2011-09-22

Nicotine
    Dosage: 1/2 pack daily
    Indication: Nicotine Dependence
    End date: 2011-09-20

Suboxone
    Indication: Drug Dependence
    Start date: 2011-01-01



Possible Buprenorphine side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-27

Patient: male

Reactions: Wrong Technique in Drug Usage Process, Tonic Clonic Movements, Hyperhidrosis

Drug(s) suspected as cause:
Buprenorphine
    Indication: Drug Abuse

Seroquel XR
    Administration route: Oral



Possible Buprenorphine side effects in

Reported by a consumer/non-health professional from United States on 2012-07-27

Patient:

Reactions: Fatigue, Drug Interaction, Intentional Drug Misuse, Pallor, Amnesia, Somnolence

Drug(s) suspected as cause:
Buprenorphine
    Dosage: 1 mg;total;iv
    Indication: Product Used FOR Unknown Indication

Clonazepam
    Dosage: 4 mg;total
    Indication: Product Used FOR Unknown Indication

Diazepam
    Dosage: 10 mg;total
    Indication: Product Used FOR Unknown Indication

Midazolam
    Dosage: 15 mg;total
    Indication: Product Used FOR Unknown Indication



Possible Buprenorphine side effects in 4 month old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-27

Patient: 4 month old female

Reactions: Agitation, Mydriasis, Exposure During Breast Feeding, Yawning, Foetal Exposure During Pregnancy, Hyperreflexia, Hyperhidrosis, Tremor, Myoclonus, Insomnia, Sneezing

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Buprenorphine

Buprenorphine



Possible Buprenorphine side effects in 86 year old male

Reported by a physician from Japan on 2012-07-24

Patient: 86 year old male

Reactions: Pneumonia, Dizziness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Buprenorphine
    Dosage: 10 mcg, q1h
    Start date: 2012-03-31
    End date: 2012-04-27

Buprenorphine
    Dosage: 20 mcg, q1h
    Start date: 2012-02-18
    End date: 2012-03-30

Buprenorphine
    Dosage: 10 mcg, q1h
    Start date: 2011-12-03
    End date: 2012-02-17

Buprenorphine
    Dosage: 5 mcg, q1h
    Start date: 2011-11-12
    End date: 2011-12-02

Buprenorphine
    Dosage: 5 mcg, q1h
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-28
    End date: 2012-04-28



Possible Buprenorphine side effects in 54 year old female

Reported by a physician from United States on 2012-07-24

Patient: 54 year old female

Reactions: Weight Decreased, Psychotic Disorder, Oedema Peripheral, Headache, Rash, Blister

Drug(s) suspected as cause:
Buprenorphine
    Dosage: tablet dosage unknown. dose tapered to 4mg daily
    Indication: Drug Dependence
    Start date: 2012-06-01

Suboxone
    Indication: Drug Dependence
    Start date: 2012-05-29
    End date: 2012-06-01



Possible Buprenorphine side effects in 45 year old female

Reported by a consumer/non-health professional from United States on 2012-07-23

Patient: 45 year old female

Reactions: HIP Fracture, Femur Fracture

Drug(s) suspected as cause:
Buprenorphine



Possible Buprenorphine side effects in 37 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-23

Patient: 37 year old female

Reactions: Dyskinesia, Toxicity To Various Agents, Multiple Drug Overdose, Drug Abuse, Convulsion

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Acetaminophen

Acetaminophen
    Indication: Product Used FOR Unknown Indication

Acetylsalicylic Acid SRT
    Indication: Product Used FOR Unknown Indication

Anticonvulsant
    Indication: Product Used FOR Unknown Indication

Buprenorphine
    Dosage: 3/4
    Indication: Product Used FOR Unknown Indication

Ethanol
    Indication: Product Used FOR Unknown Indication

Ultram
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Suboxone



Possible Buprenorphine side effects in male

Reported by a physician from Germany on 2012-07-20

Patient: male, weighing 98.5 kg (216.7 pounds)

Reactions: Weight Decreased, Vomiting, Nausea, Intervertebral Discitis, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Buprenorphine
    Dosage: 52 mcg per hour
    Indication: Back Pain
    Start date: 2011-12-23

Zemplar
    Dosage: 5mcg on monday and friday after dialysis
    Indication: Mesangioproliferative Glomerulonephritis
    Start date: 2011-12-02
    End date: 2012-01-23

Other drugs received by patient: Diclofenac; Concor; Pantoprazole; Abstral; Duragesic-100; Ferrlecit; Clindamycin; Aquaphor; Dekristol; Lercanidipine; Cefazolin; Carenal; Duragesic-100; Torsemide; Metoclopramide; Vergentan; Insuman; Allopurinol



Possible Buprenorphine side effects in 87 year old female

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-07-19

Patient: 87 year old female

Reactions: Epilepsy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Buprenorphine

Other drugs received by patient: Acetaminophen



Possible Buprenorphine side effects in 85 year old male

Reported by a physician from Japan on 2012-07-19

Patient: 85 year old male

Reactions: Agitation, Pneumonia Aspiration, Dysphagia

Drug(s) suspected as cause:
Buprenorphine
    Dosage: 5 mcg, q1h
    Indication: Pain
    Start date: 2012-07-10

Buprenorphine
    Dosage: 10 mcg, q1h
    Start date: 2012-06-29
    End date: 2012-07-09

Buprenorphine
    Dosage: 5 mcg, q1h
    Start date: 2012-06-13
    End date: 2012-06-28

Other drugs received by patient: Dogmatyl; Mucosta; Aricept; Lyrica; Calblock; Vitamin B12; Olmesartan Medoxomil; Motilium; Gasmotin; Opalmon; Mohrus L



Possible Buprenorphine side effects in 55 year old female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-07-17

Patient: 55 year old female

Reactions: Impaired Gastric Emptying, Constipation

Drug(s) suspected as cause:
Buprenorphine
    Indication: Back Pain

Buprenorphine

Buprenorphine HCL
    Dosage: 0.8 mg
    Administration route: Oral
    Indication: Back Pain

Fentanyl
    Indication: Back Pain

Tilidin
    Dosage: 150 mg
    Administration route: Oral
    Indication: Back Pain



Possible Buprenorphine side effects in 86 year old female

Reported by a physician from Japan on 2012-07-16

Patient: 86 year old female

Reactions: Back Pain, Abdominal Pain, Occult Blood, Vomiting, Diarrhoea, Urinary Retention, Constipation

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Buprenorphine
    Dosage: 10 mcg, q1h
    Indication: Intervertebral Discitis
    Start date: 2012-01-19
    End date: 2012-03-28

Buprenorphine
    Dosage: 5 mcg, q1h
    Start date: 2012-01-12
    End date: 2012-01-18

Other drugs received by patient: Primperan TAB

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