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Index of reports
> Serious Reactions (11)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Rozerem (Ramelteon) serious reactions. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Rozerem side effects in 93 year old female
Reported by a individual with unspecified qualification from Japan on 2012-07-26
Patient: 93 year old female
Reactions: Hyperkalaemia, Lack of Spontaneous Speech, Hyporesponsive To Stimuli, Depressed Level of Consciousness
Drug(s) suspected as cause:
Rozerem
Other drugs received by patient: Zyrtec; Marzulene S (Levoglutamide, Sodium Gualenate); Amoban (Zopiclone); Forsenid (Sennoside A+B Calcium); Magnesium Oxide
Possible Rozerem side effects in
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-18
Patient:
Reactions: Rhabdomyolysis, Anaemia
Drug(s) suspected as cause:
Olmesartan Medoxomil
Dosage: 10 mg (10 mg, 1 d)
Administration route: Oral
Rozerem
Dosage: 8 mg (8 mg, 1 in 1 d)
Administration route: Oral
Indication: Insomnia
Start date: 2012-05-26
Other drugs received by patient: Zolpidem Tartrate
Possible Rozerem side effects in 78 year old male
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-02
Patient: 78 year old male
Reactions: Atelectasis, Pneumonia, Hypotension, Respiratory Arrest, Bradycardia, Chest X-RAY Abnormal
Drug(s) suspected as cause:
Rozerem
Dosage: 8 mg (8 mg, 1 in 1 d) per oral, 8 mg (8 mg, 1 in 1 d) per oral, 4 mg (4 mg, 1 in 1 d) per oral
Administration route: Oral
Indication: Insomnia
Start date: 2012-05-09
End date: 2012-05-11
Rozerem
Dosage: 8 mg (8 mg, 1 in 1 d) per oral, 8 mg (8 mg, 1 in 1 d) per oral, 4 mg (4 mg, 1 in 1 d) per oral
Administration route: Oral
Indication: Insomnia
Start date: 2012-04-13
End date: 2012-04-25
Rozerem
Dosage: 8 mg (8 mg, 1 in 1 d) per oral, 8 mg (8 mg, 1 in 1 d) per oral, 4 mg (4 mg, 1 in 1 d) per oral
Administration route: Oral
Indication: Insomnia
Start date: 2012-05-07
End date: 2012-05-08
Other drugs received by patient: Midazolam; Aminophylline; Funguard (Micafungin Sodium); Brotizolam; Famotidine; Vfend; Bactrim
Possible Rozerem side effects in 85 year old female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-06-25
Patient: 85 year old female
Reactions: Blood Creatine Phosphokinase Increased
Drug(s) suspected as cause:
Olmesartan Medoxomil
Administration route: Oral
Start date: 2012-05-07
End date: 2012-06-09
Olmesartan Medoxomil
Administration route: Oral
Indication: Hypertension
Start date: 2009-01-01
End date: 2012-05-06
Rozerem
Administration route: Oral
Start date: 2012-06-07
End date: 2012-06-09
Zolpidem
Administration route: Oral
Start date: 2012-05-07
End date: 2012-06-06
Zolpidem
Administration route: Oral
Start date: 2012-06-07
End date: 2012-06-09
Zolpidem
Administration route: Oral
Indication: Insomnia
Start date: 2010-01-01
Possible Rozerem side effects in 87 year old male
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-05-23
Patient: 87 year old male
Reactions: Nightmare, Subarachnoid Haemorrhage, Sudden Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Rozerem
Other drugs received by patient: Pollakisu (Oxybutynin Hydrochloride); Urief (Silodosin)
Possible Rozerem side effects in
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-04-27
Patient:
Reactions: Convulsion
Drug(s) suspected as cause:
Rozerem
Possible Rozerem side effects in 75 year old male
Reported by a pharmacist from Japan on 2012-03-05
Patient: 75 year old male
Reactions: Cogwheel Rigidity, Extrapyramidal Disorder, Muscle Rigidity, Tremor
Drug(s) suspected as cause:
Rozerem
Dosage: 8 mg/day
Administration route: Oral
Indication: Sleep Disorder
Start date: 2012-02-20
Zoloft
Dosage: 100 mg/day
Administration route: Oral
Start date: 2012-02-21
Zoloft
Dosage: 25 mg/day
Administration route: Oral
Indication: Depression
End date: 2012-02-19
Zoloft
Dosage: 50 mg/day
Administration route: Oral
Start date: 2012-02-20
End date: 2012-02-20
Possible Rozerem side effects in 82 year old male
Reported by a consumer/non-health professional from United States on 2012-01-12
Patient: 82 year old male, weighing 65.8 kg (144.7 pounds)
Reactions: Poor Quality Sleep
Drug(s) suspected as cause:
Rozerem
Possible Rozerem side effects in 53 year old male
Reported by a individual with unspecified qualification from Japan on 2011-12-22
Patient: 53 year old male
Reactions: Convulsion
Drug(s) suspected as cause:
Alprazolam
Dosage: per oral
Administration route: Oral
Herbal Preparation
Dosage: per oral
Administration route: Oral
Rozerem
Dosage: per oral
Administration route: Oral
Urinorm (Benzbromarone)
Dosage: per oral
Administration route: Oral
Possible Rozerem side effects in female
Reported by a physician from Japan on 2011-11-17
Patient: female
Reactions: Overdose, Decubitus Ulcer
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Fentanyl-100
Indication: Pain
Start date: 2011-07-15
End date: 2011-07-23
Halcion
Administration route: Oral
Indication: Insomnia
Morphine HCL Elixir
Administration route: Oral
Indication: Pain
Start date: 2011-02-18
Rozerem
Administration route: Oral
Indication: Insomnia
Start date: 2011-04-18
Other drugs received by patient: Pregabalin
Possible Rozerem side effects in female
Reported by a physician from Japan on 2011-10-27
Patient: female
Reactions: Overdose, Decubitus Ulcer, Somnolence
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Fentanyl-100
Indication: Pain
Start date: 2011-07-15
End date: 2011-07-23
Halcion
Administration route: Oral
Indication: Insomnia
Morphine HCL Elixir
Administration route: Oral
Indication: Pain
Start date: 2011-02-18
Rozerem
Administration route: Oral
Indication: Insomnia
Start date: 2011-04-18
Other drugs received by patient: Pregabalin
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