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Index of reports
> Life Threatening Events (1)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Rozerem (Ramelteon) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Rozerem side effects in 77 year old female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-06-13
Patient: 77 year old female, weighing 57.5 kg (126.5 pounds)
Reactions: Disseminated Intravascular Coagulation, Unresponsive To Stimuli, Continuous Haemodiafiltration, Acidosis, Treatment Noncompliance, Fall, Cardio-Respiratory Arrest, Overdose, Arteriosclerosis, Oxygen Saturation Decreased, Pupillary Reflex Impaired, Hypotension, Cerebral Atrophy, Body Temperature Decreased, Toxicity To Various Agents, Renal Atrophy, Miosis, Bradycardia, Altered State of Consciousness
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Rozerem
Dosage: 8 mg (8 mg, 1 in 1 d), per oral
Administration route: Oral
Indication: Insomnia
End date: 2012-05-05
Carvedilol
Dosage: 10 mg (10 mg, 1 in 1 d), per oral
Administration route: Oral
Indication: Hypertension
End date: 2012-05-05
Olmesartan Medoxomil
Dosage: 40 mg (40 mg, 1 in 1 d), per oral
Administration route: Oral
Indication: Hypertension
End date: 2012-05-05
Noxtal (Brotizolam) (Tablet)
Dosage: 8.5 mg 99.5 mg, 1 in 1 d), per oral
Administration route: Oral
Indication: Insomnia
Start date: 2012-05-05
End date: 2012-05-05
Enalapril Maleate
Dosage: 2.5 mg (2.5 mg, 1 in 1 d), per oral
Administration route: Oral
Indication: Hypertension
End date: 2012-05-05
Amoban (Zopiclone) (Tablet)
Dosage: 7.5 mg (7.5 mg, 1 in 1 d), per oral
Administration route: Oral
Indication: Hypertension
End date: 2012-05-05
Coniel (Benidipine Hydrochloride) (Tablet)
Dosage: 4 mg (4 mg, 1 in 1 d), per oral
Administration route: Oral
Indication: Hypertension
End date: 2012-05-05
Other drugs received by patient: Lansoprazole; Allopurinol; Aspirin
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