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Cesamet (Nabilone) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Cesamet (Nabilone) 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 (5)
Disability (1)

Reports by Reaction Type

Asthenia (4)Drug Interaction (3)Disorientation (3)Headache (3)Somnolence (3)Pulse Pressure Increased (3)Palpitations (3)Balance Disorder (3)Dizziness (3)Hallucination (3)Muscle Spasms (3)Vomiting (3)

Possible Cesamet side effects in 49 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-26

Patient: 49 year old male

Reactions: Brain Injury, Mobility Decreased

Drug(s) suspected as cause:
Cesamet
    Start date: 2011-01-01

Cesamet



Possible Cesamet 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 Cesamet 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 Cesamet side effects in 80 year old male

Reported by a consumer/non-health professional from United States on 2012-07-17

Patient: 80 year old male, weighing 78.0 kg (171.6 pounds)

Reactions: Lung Disorder, Nausea, Pulmonary Oedema, Asthenia

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Cesamet



Possible Cesamet 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

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