Index of reports
> Cases with Cardio-Respiratory Arrest (5)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Rozerem (Ramelteon) where reactions include cardio-respiratory arrest. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Rozerem side effects in 89 year old male
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-26
Patient: 89 year old male
Reactions: Cardio-Respiratory Arrest, Pneumonia, Respiratory Failure
Adverse event resulted in: death
Drug(s) suspected as cause:
Rozerem
Other drugs received by patient: Mucodyne (Carbocisteine); Maglax (Magnesium Oxide); Lendem D ( Brotizolam); Flivas OD (Naftopidil); Wystal (Cefoperazone Sodium, Sulbactam Sodium); Casodex; Sulbacillin (Ampicillin Sodium, Sulbactam Sodium); Losartan Potassium; SOL-Melcort (Methylprednisolone Sodium Succinate); SOL-Melcort (Methylprednisolone Sodium Succinate); SOL-Melcort (Methylprednisolone Sodium Succinate)
Possible Rozerem side effects in 77 year old male
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-06
Patient: 77 year old male
Reactions: Electrocardiogram QT Prolonged, Cardio-Respiratory Arrest
Adverse event resulted in: death
Drug(s) suspected as cause:
Rozerem
Other drugs received by patient: Lorazepam; Grandaxin (Tofisopam); Zolpidem Tartrate; Slow-K; Desyrel; Lendorm; Rize (Clotiazepam); Pimenol (Pirmenol Hydrochloride); Pursennid (Sennoside A+b); Aldactone; Depas (Etizolam)
Possible Rozerem side effects in 89 year old male
Reported by a individual with unspecified qualification from Japan on 2012-06-21
Patient: 89 year old male
Reactions: Cardio-Respiratory Arrest, Pneumonia, Condition Aggravated
Adverse event resulted in: death
Drug(s) suspected as cause:
Rozerem
Other drugs received by patient: Mucodyne (Carbocisteine); Maglax (Magnessium Oxide); Casodex; NU-Lotan (Loartan Potassium); SOL-Melcort (Methylprednisolone Sodium Succinate); Flivas OD (Naftopidil); Lendem D (Brotizolam); Sulbacillin (Ampicillin Sodium, Sulbactam Sodium); Wystal (Cefoperazone Sodium, Sulfactam Sodium)
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
Possible Rozerem side effects in 71 year old male
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-05-25
Patient: 71 year old male
Reactions: Electrocardiogram QT Prolonged, Cardio-Respiratory Arrest
Adverse event resulted in: death
Drug(s) suspected as cause:
Rozerem
Other drugs received by patient: Zolpidem Tartrate; Pursennid (Sennoside A+b); Aldactone; Rize (Clotiazepam)
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