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Index of reports
> Cases resulting in a serious event (53)
> Cases with Insomnia (9)
Below is the selection of adverse event reports related to Rozerem (Ramelteon) that includes cases resulting in a serious event where reactions include insomnia.
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 57 year old male receiving Rozerem (Ramelteon)
Reported by a pharmacist from United States on 2007-10-12
Patient: 57 year old male, weighing 92.5 kg (203.6 pounds)
Adverse reactions / side effects: Blood Pressure Increased, Pneumonia, Incorrect Dose Administered, Benign Prostatic Hyperplasia, Disorientation, Abnormal Dreams, Dysarthria, Lung Disorder, Fatigue, Insomnia, Vision Blurred, Arthritis, Feeling Abnormal, Scar
Adverse event resulted in: hospitalization
Suspect drug(s):
Rozerem
Dosage: 8 mg, qhs, per oral; 2 tablets, qhs, per oral; 8 mg, 1 tablet, qhs, per oral
Administration route: Oral
Indication: Insomnia
Start date: 2006-01-01
End date: 2007-09-06
Rozerem
Dosage: 8 mg, qhs, per oral; 2 tablets, qhs, per oral; 8 mg, 1 tablet, qhs, per oral
Administration route: Oral
Indication: Insomnia
End date: 2007-10-01
Rozerem
Dosage: 8 mg, qhs, per oral; 2 tablets, qhs, per oral; 8 mg, 1 tablet, qhs, per oral
Administration route: Oral
Indication: Insomnia
Start date: 2007-09-07
Other drugs received by patient: Citracal D (Ergocalciferol, Calcium Citrate); Atarax; Flomax; Zyrtec-D 12 Hour; Omega 6 (Omega-6 Fatty Acids); Benazepril HCL
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 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 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 female receiving Rozerem (Ramelteon)
Reported by a physician from United States on 2007-03-09
Patient: female, weighing 114.8 kg (252.5 pounds)
Adverse reactions / side effects: Incontinence, Medication Error, Insomnia, Headache, Drug Dispensing Error
Suspect drug(s):
Razadyne
Administration route: Oral
Indication: Drug USE FOR Unknown Indication
Rozerem
Indication: Insomnia
Other drugs received by patient: Topamax; Topamax; Nyaspan; Synthroid; Yasmin; Singulair
Adverse event in female receiving Rozerem (Ramelteon)
Reported by a consumer/non-health professional from United States on 2007-02-16
Patient: female, weighing 114.8 kg (252.5 pounds)
Adverse reactions / side effects: Incontinence, Medication Error, Insomnia, Headache, Drug Dispensing Error
Suspect drug(s):
Razadyne
Administration route: Oral
Indication: Drug USE FOR Unknown Indication
Rozerem
Indication: Insomnia
Other drugs received by patient: Topamax; Nyaspan; Synthroid; Yasmin
Adverse event in 69 year old male receiving Rozerem (Ramelteon)
Reported by a physician from United States on 2007-01-26
Patient: 69 year old male
Adverse reactions / side effects: Blood Bilirubin Increased, Alanine Aminotransferase Increased, International Normalised Ratio Increased, Liver Disorder, Blood Acid Phosphatase Increased, Brain Natriuretic Peptide Increased, Insomnia, Liver Function Test Abnormal
Adverse event resulted in: hospitalization
Suspect drug(s):
Rozerem
Dosage: per oral
Administration route: Oral
Start date: 2006-11-13
Ambien
Other drugs received by patient: Lasix (Furosemide) (40 Milligram); Aspirin; Zocort (Simvastatin)
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