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Index of reports
> Cases resulting in a serious event (53)
> Cases with Suicidal Ideation (6)
Below is the selection of adverse event reports related to Rozerem (Ramelteon) that includes cases resulting in a serious event where reactions include suicidal ideation.
Adverse event in female receiving Rozerem (Ramelteon)
Reported by a consumer/non-health professional from United States on 2007-06-15
Patient: female
Adverse reactions / side effects: Blood Pressure Decreased, Somnolence, Suicidal Ideation
Suspect drug(s):
Rozerem (Ramelteon)
Adverse event in female receiving Rozerem (Ramelteon)
Reported by a physician from United States on 2007-06-12
Patient: female
Adverse reactions / side effects: Irritability, Road Traffic Accident, Carbon Monoxide Poisoning, Disturbance in Attention, Drug Interaction, Memory Impairment, Morbid Thoughts, Somnolence, Suicidal Ideation
Suspect drug(s):
Rozerem
Dosage: per oral
Administration route: Oral
Seroquel
Adverse event in receiving Rozerem (Ramelteon)
Reported by a physician from United States on 2007-05-11
Patient:
Adverse reactions / side effects: Feeling Abnormal, Suicidal Ideation
Suspect drug(s):
Rozerem (Ramelteon)
Adverse event in 48 year old female receiving Rozerem (Ramelteon)
Reported by a health professional (non-physician/pharmacist) from United States on 2007-05-02
Patient: 48 year old female, weighing 77.1 kg (169.6 pounds)
Adverse reactions / side effects: Economic Problem, Drug Ineffective, Drug Screen Positive, Family Stress, Hallucination, Auditory, General Physical Health Deterioration, Condition Aggravated, Laceration, Intentional Self-Injury, Suicidal Ideation, Anger, Depression
Adverse event resulted in: hospitalization
Suspect drug(s):
Rozerem
Dosage: 8 mg, 1 in 1 d, per oral
Administration route: Oral
Indication: Affective Disorder
Start date: 2006-09-29
End date: 2006-11-29
Rozerem
Dosage: 8 mg, 1 in 1 d, per oral
Administration route: Oral
Indication: Insomnia
Start date: 2006-09-29
End date: 2006-11-29
Rozerem
Dosage: 8 mg, 1 in 1 d, per oral
Administration route: Oral
Indication: Seasonal Affective Disorder
Start date: 2006-09-29
End date: 2006-11-29
Other drugs received by patient: Lamictal; Wellbutrin; Effexor XR; Klonopin
Adverse event in female receiving Rozerem (Ramelteon)
Reported by a individual with unspecified qualification from United States on 2007-04-30
Patient: female
Adverse reactions / side effects: Myalgia, Arthralgia, Insomnia, Depression, Headache, Suicidal Ideation
Suspect drug(s):
Rozerem (Ramelteon)
Other drugs received by patient: Unknown Bipolar Medication (All Other Therapeutic Products); Unknown Depression Medications (All Other Therapeutic Products)
Adverse event in 48 year old female receiving Rozerem (Ramelteon)
Reported by a health professional (non-physician/pharmacist) from United States on 2007-01-26
Patient: 48 year old female, weighing 77.1 kg (169.6 pounds)
Adverse reactions / side effects: Economic Problem, Drug Screen Positive, Hallucination, Auditory, Self Injurious Behaviour, Suicidal Ideation, Cardiac Disorder, Skin Laceration, Anger, Depression
Adverse event resulted in: hospitalization
Suspect drug(s):
Rozerem
Dosage: 8 mg, 1 in 1 d, per oral
Administration route: Oral
Indication: Affective Disorder
Start date: 2006-09-29
End date: 2006-11-29
Rozerem
Dosage: 8 mg, 1 in 1 d, per oral
Administration route: Oral
Indication: Insomnia
Start date: 2006-09-29
End date: 2006-11-29
Rozerem
Dosage: 8 mg, 1 in 1 d, per oral
Administration route: Oral
Indication: Seasonal Affective Disorder
Start date: 2006-09-29
End date: 2006-11-29
Other drugs received by patient: Lamictal; Wellbutrin; Effexor XR; Klonopin
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