This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Butrans (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 (320)
Death (66)
Life Threatening Events (13)
Disability (9)
Reports by Reaction Type
Death (27),
Vomiting (22),
Nausea (22),
Pain (21),
Dyspnoea (20),
Headache (19),
Inadequate Analgesia (18),
Dizziness (16),
Drug Ineffective (14),
Somnolence (14),
Myocardial Infarction (14),
Application Site Pruritus (13)
Below are a few examples of reports where side effects / adverse reactions may be related to Butrans (Buprenorphine). For a complete list or a specific selection of reports, please use the links above.
Possible Butrans side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female
Reactions: Hepatic Failure
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Butrans
Possible Butrans side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: female
Reactions: Hospitalisation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Butrans
Other drugs received by patient: Opioids
Possible Butrans side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: female
Reactions: Tooth Loss, Neoplasm Malignant
Drug(s) suspected as cause:
Butrans
Possible Butrans side effects in female
Reported by a pharmacist from United States on 2012-08-24
Patient: female
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Butrans
Possible Butrans side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: male
Reactions: Application Site Burn
Drug(s) suspected as cause:
Butrans
Possible Butrans side effects in 52 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23
Patient: 52 year old female
Reactions: Respiratory Depression
Adverse event resulted in: death
Drug(s) suspected as cause:
Butrans
Indication: Product Used FOR Unknown Indication
Hydrocodone Bitartrate
Indication: Chronic Obstructive Pulmonary Disease
Other drugs received by patient: Butrans
Possible Butrans side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient: female
Reactions: Pancreatic Carcinoma
Adverse event resulted in: death
Drug(s) suspected as cause:
Butrans
Possible Butrans side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-21
Patient: male, weighing 108.8 kg (239.4 pounds)
Reactions: Panic Attack
Drug(s) suspected as cause:
Butrans
Other drugs received by patient: Celebrex; Hydrocodone; Flexeril
Possible Butrans side effects in 45 year old female
Reported by a consumer/non-health professional from United States on 2012-08-21
Patient: 45 year old female, weighing 90.7 kg (199.5 pounds)
Reactions: Application Site Swelling, Headache, Application Site Pain, Stress, Hyperhidrosis, Feeling Cold, Application Site Pruritus, Insomnia, Application Site Burn, Application Site Dryness, Neck Surgery, Muscle Spasms, Application Site Irritation
Drug(s) suspected as cause:
Butrans
Indication: Complex Regional Pain Syndrome
Butrans
Indication: Pain
Butrans
Dosage: 10 mcg/hr, weekly
Indication: Neuralgia
Start date: 2011-01-01
Other drugs received by patient: Nucynta; Baclofen; Ambien; Keppra; Xyzal
Possible Butrans side effects in female
Reported by a pharmacist from United States on 2012-08-21
Patient: female
Reactions: Death, Grief Reaction, Depression
Adverse event resulted in: death
Drug(s) suspected as cause:
Butrans
Possible Butrans side effects in male
Reported by a pharmacist from United States on 2012-08-16
Patient: male
Reactions: Drug Abuse
Drug(s) suspected as cause:
Butrans
Dosage: 20 mcg, q1h
Indication: Product Used FOR Unknown Indication
Morphine Sulfate
Dosage: unk
Indication: Drug Abuse
Possible Butrans side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-15
Patient: male, weighing 144.2 kg (317.3 pounds)
Reactions: Road Traffic Accident
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Butrans
Other drugs received by patient: MS Contin; Metoprolol / 00376902 /; Lisinopril; Zoloft; Nsaid's; Flexeril; Medrol
Possible Butrans side effects in female
Reported by a physician from United States on 2012-08-10
Patient: female
Reactions: Renal Impairment
Drug(s) suspected as cause:
Butrans
Indication: Pain
Tramadol HCL
Dosage: 50 mg upto 6 times per day
Indication: Pain
Possible Butrans side effects in male
Reported by a physician from United States on 2012-08-08
Patient: male
Reactions: Hospitalisation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Butrans
Possible Butrans side effects in 55 year old female
Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-08-07
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, Hypopnoea, Diarrhoea, Disturbance in Attention, Gait Disturbance, Asthenia
Drug(s) suspected as cause:
Baclofen
Dosage: 60 mg as needed
Indication: Muscle Spasms
Butrans
Dosage: 240 i?g
Start date: 2011-01-01
End date: 2011-01-01
Butrans
Dosage: 480 i?g
Butrans
Dosage: 480 i?g
Indication: Pain
Start date: 2011-08-01
End date: 2011-01-01
Butrans
Dosage: 360 i?g
Start date: 2011-01-01
End date: 2011-01-01
Butrans
Dosage: 120 i?g
Start date: 2011-01-01
End date: 2011-01-01
Cesamet
Dosage: 0.5 mg
Administration route: Oral
Indication: Back Pain
End date: 2011-08-01
Clonazepam
Dosage: 3 mg
Administration route: Oral
Indication: Anxiety
Start date: 2011-12-11
Escitalopram
Dosage: 20 mg
Administration route: Oral
Indication: Anxiety
End date: 2011-08-01
Other drugs received by patient: Cipro XR
Possible Butrans side effects in male
Reported by a pharmacist from United States on 2012-08-06
Patient: male
Reactions: Drug Abuse
Drug(s) suspected as cause:
Butrans
Dosage: 20 mcg, q1h
Morphine Sulfate
Dosage: unk
Possible Butrans side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-02
Patient: female
Reactions: Insomnia, Headache, Application Site Pain, Stress, Muscle Spasms, Neck Surgery, Application Site Irritation
Drug(s) suspected as cause:
Butrans
Possible Butrans side effects in female
Reported by a individual with unspecified qualification from United States on 2012-08-02
Patient: female
Reactions: Speech Disorder, Sleep Terror, Disorientation, Asthenia, Fall, Enuresis, Amnesia
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Butrans
Other drugs received by patient: Neruotin,; Trazodone HCL; Paxil; Clazapam,
Possible Butrans side effects in 80 year old male
Reported by a consumer/non-health professional from United States on 2012-08-02
Patient: 80 year old male
Reactions: Drug Ineffective, Cardiac Failure Congestive
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Butrans
Dosage: 10 mcg, q1h
Indication: Product Used FOR Unknown Indication
Oxycontin
Dosage: 60 mg, see text
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Possible Butrans side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-01
Patient: female
Reactions: Vomiting, Diarrhoea, Nausea, Hepatic Lesion, Change of Bowel Habit
Drug(s) suspected as cause:
Butrans
Possible Butrans side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-30
Patient: male
Reactions: Cardiac Failure
Drug(s) suspected as cause:
Butrans
Dosage: 10 mcg/hr, see text
Indication: Product Used FOR Unknown Indication
Oxycontin
Dosage: 60 mg, see text
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Possible Butrans side effects in female
Reported by a physician from United States on 2012-07-30
Patient: female
Reactions: Renal Impairment
Drug(s) suspected as cause:
Butrans
Indication: Pain
Tramadol Hydrochloride
Dosage: 50 mg upto 6 times per day
Indication: Pain
Possible Butrans side effects in 94 year old female
Reported by a pharmacist from United States on 2012-07-30
Patient: 94 year old female
Reactions: Death, Grief Reaction
Adverse event resulted in: death
Drug(s) suspected as cause:
Butrans
Possible Butrans side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-30
Patient: male
Reactions: Drug Ineffective, Incorrect Dose Administered, Drug Withdrawal Syndrome, Suicidal Ideation
Drug(s) suspected as cause:
Butrans
Possible Butrans side effects in female
Reported by a physician from United States on 2012-07-30
Patient: female
Reactions: Renal Impairment
Drug(s) suspected as cause:
Butrans
Indication: Pain
Tramadol Hydrochloride
Dosage: 6 times a day
Indication: Pain
Possible Butrans side effects in 53 year old female
Reported by a consumer/non-health professional from United States on 2012-07-27
Patient: 53 year old female, weighing 62.6 kg (137.7 pounds)
Reactions: Vomiting, Nausea, Pain in Extremity, Headache, Loss of Consciousness, Application Site Pruritus, Blood Glucose Decreased, Malaise, Chest Pain, Myocardial Infarction, Application Site Vesicles, Cold Sweat
Drug(s) suspected as cause:
Butrans
Other drugs received by patient: Ranitidine; Omeprazole; Insulin / 00646001 /; Hormones; Domperidone
Possible Butrans side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-27
Patient: male
Reactions: Heart Rate Increased
Drug(s) suspected as cause:
Butrans
Possible Butrans side effects in female
Reported by a physician from United States on 2012-07-27
Patient: female
Reactions: Hypothyroidism
Drug(s) suspected as cause:
Butrans
Possible Butrans side effects in female
Reported by a physician from United States on 2012-07-25
Patient: female
Reactions: Neoplasm Malignant
Adverse event resulted in: death
Drug(s) suspected as cause:
Butrans
Possible Butrans side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-25
Patient: male
Reactions: Hospitalisation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Butrans
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