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Index of reports
> Cases resulting in hospitalization (20)
> Cases with Drug Ineffective (6)
Below is the selection of adverse event reports related to Rozerem (Ramelteon) that includes cases resulting in hospitalization where reactions include drug ineffective.
Adverse event in 54 year old female receiving Rozerem (Ramelteon)
Reported by a consumer/non-health professional from United States on 2007-10-16
Patient: 54 year old female, weighing 68.0 kg (149.7 pounds)
Adverse reactions / side effects: Drug Ineffective, Drug Hypersensitivity, Headache, Swollen Tongue, Ill-Defined Disorder, Pharyngeal Oedema, Hallucinations, Mixed, Insomnia, Thyroid Disorder
Adverse event resulted in: hospitalization
Suspect drug(s):
Rozerem
Dosage: 8 mg, qhs, per oral; 8 mg, qhs, per oral; 8 mg, qhs, per oral
Administration route: Oral
Indication: Insomnia
Start date: 2007-09-01
End date: 2007-09-01
Rozerem
Dosage: 8 mg, qhs, per oral; 8 mg, qhs, per oral; 8 mg, qhs, per oral
Administration route: Oral
Indication: Insomnia
Start date: 2007-08-01
Rozerem
Dosage: 8 mg, qhs, per oral; 8 mg, qhs, per oral; 8 mg, qhs, per oral
Administration route: Oral
Indication: Insomnia
Start date: 2007-09-01
Ambien CR
Dosage: qhs, per oral
Administration route: Oral
Indication: Insomnia
Start date: 2006-01-01
End date: 2007-09-01
Imitrex
Dosage: 50 mg, as required, per oral; 50 mg, as required, per oral
Administration route: Oral
Indication: Headache
Start date: 2003-01-01
End date: 2007-09-01
Imitrex
Dosage: 50 mg, as required, per oral; 50 mg, as required, per oral
Administration route: Oral
Indication: Headache
Start date: 2007-09-01
Unknown Sleep Medication (All Other Therapeutic Products)
Indication: Sleep Disorder Therapy
Start date: 2007-08-01
End date: 2007-08-01
Other drugs received by patient: Vicodin; Flexeril; Unknown Anti-Inflammatory (All Other Therapeutic Products); Unknown Anti-Depressant (Antidepressants)
Adverse event in 54 year old female receiving Rozerem (Ramelteon)
Reported by a consumer/non-health professional from United States on 2007-10-09
Patient: 54 year old female, weighing 68.0 kg (149.7 pounds)
Adverse reactions / side effects: Drug Ineffective, Drug Hypersensitivity, Headache, Swollen Tongue, Ill-Defined Disorder, Pharyngeal Oedema, Hallucinations, Mixed, Insomnia, Thyroid Disorder
Adverse event resulted in: hospitalization
Suspect drug(s):
Rozerem
Dosage: 8 mg, qhs, per oral; 8 mg, qhs, per oral; 8 mg, qhs, per oral
Administration route: Oral
Indication: Insomnia
Start date: 2007-09-01
End date: 2007-09-01
Rozerem
Dosage: 8 mg, qhs, per oral; 8 mg, qhs, per oral; 8 mg, qhs, per oral
Administration route: Oral
Indication: Insomnia
Start date: 2007-08-01
Rozerem
Dosage: 8 mg, qhs, per oral; 8 mg, qhs, per oral; 8 mg, qhs, per oral
Administration route: Oral
Indication: Insomnia
Start date: 2007-09-01
Ambien CR
Dosage: qhs, per oral
Administration route: Oral
Indication: Insomnia
Start date: 2006-01-01
End date: 2007-09-01
Imitrex
Dosage: 50 mg, as required, per oral; 50 mg, as required, oral; 50 mg, as required, per oral
Administration route: Oral
Indication: Headache
Start date: 2003-01-01
End date: 2007-09-01
Imitrex
Dosage: 50 mg, as required, per oral; 50 mg, as required, oral; 50 mg, as required, per oral
Administration route: Oral
Indication: Headache
Start date: 2007-09-01
Unknown Sleep Medication (All Other Therapeutic Products)
Indication: Sleep Disorder Therapy
Start date: 2007-08-01
End date: 2007-08-01
Other drugs received by patient: Vicodin; Flexeril; Unknown Anti-Inflammatory (All Other Therapeutic Products); Unknown Anti-Depressant (Antidepressants)
Adverse event in 66 year old female receiving Rozerem (Ramelteon)
Reported by a physician from United States on 2007-10-09
Patient: 66 year old female, weighing 65.8 kg (144.7 pounds)
Adverse reactions / side effects: Initial Insomnia, Colon Cancer, Middle Insomnia, Drug Ineffective, Sleep Disorder
Adverse event resulted in: hospitalization
Suspect drug(s):
Rozerem
Dosage: 8 mg, qhs, per oral; 8 mg, per oral
Administration route: Oral
Indication: Insomnia
Start date: 2007-01-05
End date: 2007-01-05
Rozerem
Dosage: 8 mg, qhs, per oral; 8 mg, per oral
Administration route: Oral
Indication: Insomnia
Start date: 2007-01-16
End date: 2007-01-16
Other drugs received by patient: Zyrtec; Premarin; Flonase Nasal Spray (Fluticasone Propionate)
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 51 year old female receiving Rozerem (Ramelteon)
Reported by a consumer/non-health professional from United States on 2007-04-04
Patient: 51 year old female, weighing 63.0 kg (138.7 pounds)
Adverse reactions / side effects: Weight Increased, Initial Insomnia, Laboratory Test Abnormal, Drug Ineffective, Thyroid Cancer, Somnolence
Adverse event resulted in: hospitalization
Suspect drug(s):
Rozerem (Ramelteon)
Other drugs received by patient: Synthroid
Adverse event in 66 year old female receiving Rozerem (Ramelteon)
Reported by a individual with unspecified qualification from United States on 2007-01-26
Patient: 66 year old female, weighing 65.8 kg (144.7 pounds)
Adverse reactions / side effects: Initial Insomnia, Colon Cancer, Middle Insomnia, Drug Ineffective
Adverse event resulted in: hospitalization
Suspect drug(s):
Rozerem
Dosage: 8 mg, qhs, per oral
Administration route: Oral
Indication: Insomnia
Start date: 2007-01-05
End date: 2007-01-05
Rozerem
Dosage: 8 mg, qhs, per oral
Administration route: Oral
Indication: Insomnia
Start date: 2007-01-16
End date: 2007-01-16
Other drugs received by patient: Zyrtec; Premarin; Flonase Nasal Spray (Fluticasone Propionate)
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