DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Butrans (Buprenorphine) - Side Effect Reports to FDA

 
 



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: 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 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 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 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 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 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

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017