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Index of reports
> Cases resulting in a serious event (53)
> Cases with Drug Ineffective (8)
Below is the selection of adverse event reports related to Rozerem (Ramelteon) that includes cases resulting in a serious event 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 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 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 2007-05-29
Patient: 66 year old female, weighing 59.0 kg (129.7 pounds)
Adverse reactions / side effects: Drug Ineffective, Insomnia, Axillary Pain, Chest Pain, Heart Rate Irregular
Suspect drug(s):
Rozerem (Ramelteon)
Other drugs received by patient: Tylenol PM (Diphenydramine, Paracetamol); Aleve PM (Naproxen Sodium)
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 consumer/non-health professional from United States on 2007-03-16
Patient: 66 year old female, weighing 59.0 kg (129.7 pounds)
Adverse reactions / side effects: Drug Ineffective, Insomnia, Axillary Pain, Chest Pain, Heart Rate Irregular
Suspect drug(s):
Rozerem (Ramelteon)
Other drugs received by patient: Tylenol PM (Diphenhydramine, Paracetamol); Aleve PM (Naproxen Sodium)
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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