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Index of reports
> Cases with Somnolence (14)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Butrans (Buprenorphine) where reactions include somnolence. The selected reports were submitted to the FDA during the sample period of about a year.
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 consumer/non-health professional from United States on 2012-06-28
Patient: male, weighing 105.2 kg (231.5 pounds)
Reactions: Nausea, Headache, Somnolence, Exposure To Toxic Agent
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Acetone
Indication: Accidental Exposure
Benzocain
Dosage: unk, bid
Indication: Proctalgia
Butrans
Indication: Pain
Butrans
Dosage: 10 mcg/hr, unk
Indication: Psoriatic Arthropathy
Start date: 2012-04-12
Other drugs received by patient: Probiotic; Fexofenadine HCL; Terazosin HCL; Hydrocodone Bitartrate + Acetaminophen; Cymbalta; Nuvigil; Lycopene; Folic Acid; Tramadol HCL; Fexofenadine HCL; Vitamin B 12 Lichtenstein; Hydrocortisone Acetate; Metamucil / 00029101 /; Clobex / 00337102 /; Sulfasalazine; Hydrocodone Bitartrate + Acetaminophen; Flonase; Methotrexate; Cinnamon / 01647501 /; Focalin; Fish OIL W / Tocopherol / Borago Officinalis OIL; Hydroxyzine; Simponi
Possible Butrans side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-07
Patient: male, weighing 104.3 kg (229.5 pounds)
Reactions: Nausea, Headache, Somnolence, Exposure To Toxic Agent
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Acetone
Indication: Accidental Exposure
Butrans
Dosage: 10 mcg/hr, unk
Indication: Psoriatic Arthropathy
Start date: 2012-04-01
Possible Butrans side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-29
Patient: female, weighing 70.3 kg (154.6 pounds)
Reactions: Confusional State, Pain, Inadequate Analgesia, Delirium, Somnolence, Incoherent, Syncope, Dizziness, Feeling Abnormal
Drug(s) suspected as cause:
Butrans
Dosage: 10 mcg/hr, unk
Indication: Pain
Start date: 2012-03-01
End date: 2012-03-01
Dilaudid
Dosage: 4 mg, unk
Administration route: Oral
Indication: Pain
Pristiq
Indication: Pain
Pristiq
Dosage: 50 mg, daily
Indication: Fibromyalgia
Other drugs received by patient: Hiprex; Lyrica; Norco; Levoxyl; Crestor; Pantoprazole; Oxybutynin; Midodrine Hydrochloride
Possible Butrans side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-14
Patient: male, weighing 104.3 kg (229.5 pounds)
Reactions: Nausea, Headache, Somnolence, Exposure To Toxic Agent
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Acetone
Indication: Accidental Exposure
Butrans
Dosage: 10 mcg/hr, unk
Indication: Psoriatic Arthropathy
Start date: 2012-04-01
Possible Butrans side effects in 55 year old female
Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-04-12
Patient: 55 year old female
Reactions: Drug Interaction, Disorientation, Headache, Somnolence, Pulse Pressure Increased, Balance Disorder, Palpitations, Dizziness, Hallucination, Muscle Spasms, Vomiting, Dyspnoea, Urinary Tract Infection, Anxiety, Euphoric Mood, Diarrhoea, Hypopnoea, Disturbance in Attention, Gait Disturbance, Asthenia
Drug(s) suspected as cause:
Baclofen
Dosage: 60 mg
Butrans
Dosage: 240 mcg
Butrans
Dosage: 360 mcg
Butrans
Dosage: 120 mcg
Butrans
Dosage: 480 mcg
Cesamet
Administration route: Oral
Clonazepam
Dosage: 3 mg
Administration route: Oral
Escitalopram
Dosage: 20 mg
Administration route: Oral
Other drugs received by patient: Cipro XR
Possible Butrans side effects in female
Reported by a physician from United Kingdom on 2012-02-03
Patient: female
Reactions: Nausea, Drug Interaction, Left Ventricular Hypertrophy, Pyrexia, Somnolence, Fatigue, Dizziness, Feeling of Body Temperature Change
Adverse event resulted in: death
Drug(s) suspected as cause:
Butrans
Other drugs received by patient possibly interacting with the suspect drug:
Butrans
Dosage: 10 mcg, q1h
Indication: Arthralgia
Start date: 2011-03-24
End date: 2011-08-04
Meptazinol Hydrochloride
Dosage: 200 mg, qid
Other drugs received by patient: Amlodipine; Aspirin; Epilim Chrono / 00228502 /; Candesartan Cilexetil; Diazepam; Diazepam; Simvastatin; Procyclidine Hydrochloride 2MG TAB; Haloperidol; Lansoprazole; Fexofenadine; Bisacodyl; Novorapid; Citalopram Hydrobromide
Possible Butrans side effects in 47 year old female
Reported by a consumer/non-health professional from United States on 2012-01-27
Patient: 47 year old female, weighing 84.4 kg (185.6 pounds)
Reactions: Pruritus Generalised, Hypoaesthesia Oral, Paraesthesia Oral, Somnolence, Contraindication To Medical Treatment, Convulsion
Drug(s) suspected as cause:
Butrans
Possible Butrans side effects in female
Reported by a consumer/non-health professional from United States on 2012-01-19
Patient: female, weighing 59.0 kg (129.7 pounds)
Reactions: Humerus Fracture, Unresponsive To Stimuli, Incorrect Dose Administered, Hand Fracture, Cerebrovascular Accident, Fall, Somnolence
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Butrans
Possible Butrans side effects in 88 year old female
Reported by a consumer/non-health professional from United States on 2011-12-21
Patient: 88 year old female
Reactions: Incorrect Dose Administered, Cerebrovascular Accident, Somnolence
Drug(s) suspected as cause:
Butrans
Possible Butrans side effects in 55 year old female
Reported by a consumer/non-health professional from Canada on 2011-12-21
Patient: 55 year old female
Reactions: Drug Interaction, Disorientation, Headache, Somnolence, Pulse Pressure Increased, Palpitations, Balance Disorder, Dizziness, Hallucination, Muscle Spasms, Vomiting, Dyspnoea, Urinary Tract Infection, Anxiety, Euphoric Mood, Diarrhoea, Hypopnoea, Disturbance in Attention, Gait Disturbance, Asthenia
Drug(s) suspected as cause:
Baclofen
Dosage: 20 mg, tid prn
Indication: Muscle Spasms
Butrans
Dosage: 20 mcg, q1h
Indication: Back Pain
Butrans
Dosage: 5 mcg, q1h
End date: 2011-01-01
Butrans
Dosage: 15 mcg, q1h
Start date: 2011-01-01
End date: 2011-01-01
Butrans
Dosage: 10 mcg, q1h
End date: 2011-01-01
Clonazepam
Dosage: 1 mg, tid prn
Administration route: Oral
Indication: Anxiety
Start date: 2011-12-11
Escitalopram
Dosage: 20 mg, daily
Administration route: Oral
Indication: Depression
End date: 2011-08-01
Nabilone
Dosage: .25 mg, unk
Administration route: Oral
Indication: Back Pain
End date: 2011-08-01
Other drugs received by patient: Cipro XR
Possible Butrans side effects in 86 year old female
Reported by a consumer/non-health professional from United States on 2011-12-20
Patient: 86 year old female
Reactions: Fatigue, Knee Arthroplasty, Somnolence
Drug(s) suspected as cause:
Butrans
Possible Butrans side effects in female
Reported by a physician from United Kingdom on 2011-11-15
Patient: female
Reactions: Nausea, Drug Interaction, Pyrexia, Somnolence, Death, Fatigue, Dizziness, Feeling of Body Temperature Change
Adverse event resulted in: death
Drug(s) suspected as cause:
Butrans
Other drugs received by patient possibly interacting with the suspect drug:
Butrans
Dosage: 10 mcg, q1h
Indication: Arthralgia
Start date: 2011-03-24
End date: 2011-08-04
Meptazinol Hydrochloride
Dosage: 200 mg, qid
Other drugs received by patient: Simvastatin; Lansoprazole; Candesartan Cilexetil; Bisacodyl; Epilim Chrono / 00228502 /; Amlodipine; Fexofenadine; Diazepam; Aspirin; Citalopram Hydrobromide; Procyclidine Hydrochloride 2MG TAB; Haloperidol; Novorapid; Diazepam
Possible Butrans side effects in 48 year old female
Reported by a physician from United Kingdom on 2011-10-31
Patient: 48 year old female
Reactions: Death, Fatigue, Drug Interaction, Feeling of Body Temperature Change, Somnolence
Adverse event resulted in: death
Drug(s) suspected as cause:
Butrans
Other drugs received by patient possibly interacting with the suspect drug:
Antipsychotics
Indication: Product Used FOR Unknown Indication
Butrans
Dosage: 20 mcg, q1h
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