This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Rozerem (Ramelteon) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (44)
Death (10)
Life Threatening Events (1)
Disability (2)
Reports by Reaction Type
Hepatic Function Abnormal (5),
Liver Disorder (5),
Cardio-Respiratory Arrest (5),
Depressed Level of Consciousness (5),
Tremor (4),
Jaundice (3),
Pyrexia (3),
Overdose (3),
Dizziness (3),
Pneumonia (3),
Nausea (3),
Alanine Aminotransferase Increased (3)
Below are a few examples of reports where side effects / adverse reactions may be related to Rozerem (Ramelteon). For a complete list or a specific selection of reports, please use the links above.
Possible Rozerem side effects in 70 year old female
Reported by a physician from Japan on 2012-08-16
Patient: 70 year old female, weighing 43.0 kg (94.6 pounds)
Reactions: Vomiting, Nausea, Dizziness, Depressed Level of Consciousness, Cognitive Disorder, Altered State of Consciousness, Eating Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Candesartan Cilexetil
Administration route: Oral
Indication: Hypertension
Start date: 2012-05-01
End date: 2012-07-17
Rozerem
Administration route: Oral
Indication: Sleep Disorder
Start date: 2012-07-12
End date: 2012-07-17
Other drugs received by patient: Forsenid; Levofloxacin; Lansoprazole; Norvasc; Threenofen
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 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 2012-07-06
Patient: 78 year old male
Reactions: Cheilitis, Glossitis, LIP Pruritus, LIP Oedema, Rash
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Rozerem
Dosage: 8 mg (8 mg, 1 in -1d), per oral
Administration route: Oral
Indication: Initial Insomnia
Start date: 2012-05-26
End date: 2012-06-01
Aricept
Dosage: per oral
Administration route: Oral
Start date: 2012-05-26
End date: 2012-06-01
Other drugs received by patient: Prednisolone
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 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:
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
Olmesartan Medoxomil
Administration route: Oral
Start date: 2012-05-07
End date: 2012-06-09
Zolpidem
Administration route: Oral
Indication: Insomnia
Start date: 2010-01-01
Rozerem
Administration route: Oral
Start date: 2012-06-07
End date: 2012-06-09
Olmesartan Medoxomil
Administration route: Oral
Indication: Hypertension
Start date: 2009-01-01
End date: 2012-05-06
Possible Rozerem side effects in male
Reported by a individual with unspecified qualification from Japan on 2012-06-21
Patient: male
Reactions: Blood Prolactin Increased, Cardiac Failure, Depressed Level of Consciousness, Thyroid Function Test Abnormal
Adverse event resulted in: death
Drug(s) suspected as cause:
Rozerem
Other drugs received by patient: Invega
Possible Rozerem side effects in 78 year old male
Reported by a individual with unspecified qualification from Japan on 2012-06-21
Patient: 78 year old male
Reactions: Cheilitis, Glossitis, LIP Pruritus, LIP Oedema, Rash
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Rozerem
Dosage: 8 mg (8 mg, 1 in 1 d), per oral
Administration route: Oral
Indication: Insomnia
Start date: 2012-05-26
End date: 2012-06-01
Aricept
Dosage: per oral
Administration route: Oral
Start date: 2012-05-26
End date: 2012-06-01
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 71 year old male
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-06-15
Patient: 71 year old male
Reactions: Eyelid Oedema, Potentiating Drug Interaction, Pyrexia, Skin Swelling, Erythema, Blister
Drug(s) suspected as cause:
Lyrica
Dosage: 75 mg (75 mg,1 in 1 d) per oral
Administration route: Oral
Indication: Neuropathy Peripheral
Start date: 2011-11-30
Rozerem
Dosage: 8 mg (8 mg,1 in 1 d) per oral
Administration route: Oral
Indication: Insomnia
Start date: 2012-03-07
End date: 2012-03-13
Rohypnol (Flunitrazepam)
Dosage: 1 mg (1 mg,1 in 1 d ) per oral
Administration route: Oral
Indication: Insomnia
Start date: 2009-02-14
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)
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 2012-05-07
Patient:
Reactions: Interstitial Lung Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Rozerem
Dosage: 8 mg (8 mg,1 in 1 d) per oral
Administration route: Oral
Indication: Insomnia
Start date: 2012-03-01
End date: 2012-04-01
Navelbine
Dosage: injection
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 71 year old male
Reported by a individual with unspecified qualification from Japan on 2012-04-19
Patient: 71 year old male
Reactions: Eyelid Oedema, Oculomucocutaneous Syndrome, Haemorrhage, Pain, Pyrexia, Erythema, Face Oedema, Activities of Daily Living Impaired, Skin Swelling, Scar
Drug(s) suspected as cause:
Rozerem
Dosage: 8 mg (8 mg, 1 in 1 d) oral
Administration route: Oral
Indication: Insomnia
Start date: 2012-03-07
End date: 2012-03-13
Rohypnol (Flunitrazepam)
Dosage: 1 mg (1 mg, 1 in 1 d) oral
Administration route: Oral
Indication: Insomnia
Start date: 2009-02-14
Lyrica
Dosage: 75 mg (75 mg, 1 in 1 d) oral
Administration route: Oral
Indication: Neuropathy Peripheral
Start date: 2011-11-30
Possible Rozerem side effects in 89 year old female
Reported by a individual with unspecified qualification from Japan on 2012-04-11
Patient: 89 year old female
Reactions: Blood Alkaline Phosphatase Increased, Hepatic Function Abnormal, C-Reactive Protein Increased, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased, Pyrexia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Flurazepam Hydrochloride
Dosage: 10 mg (10 mg, 1 in 1 d), per oral
Administration route: Oral
Start date: 2012-01-06
End date: 2012-02-03
Rozerem
Dosage: 8 mg (8 mg 1 in 1 d), per oral
Administration route: Oral
Indication: Sleep Disorder
Start date: 2011-12-27
End date: 2012-02-07
Sediel (Tandospirone Citrate)
Dosage: 20 mg (10 mg, 2 in 1 d) per oral; 30 mg (10 mg, 3 in 1 d), per oral
Administration route: Oral
Start date: 2011-12-29
End date: 2012-02-03
Sediel (Tandospirone Citrate)
Dosage: 20 mg (10 mg, 2 in 1 d) per oral; 30 mg (10 mg, 3 in 1 d), per oral
Administration route: Oral
Start date: 2011-12-27
End date: 2011-12-28
Other drugs received by patient: Magmitt (Magnesium Oxide); Zolpidem Tartrate; Furosemide; Apatya (Isosorbide Dinitrate); Aldactone; Trazodone HCL
Possible Rozerem side effects in male
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-04-10
Patient: male
Reactions: Acute Myocardial Infarction
Adverse event resulted in: death
Drug(s) suspected as cause:
Rozerem
Other drugs received by patient: Seroquel
Possible Rozerem side effects in 81 year old male
Reported by a individual with unspecified qualification from United States on 2012-04-06
Patient: 81 year old male
Reactions: Myocardial Infarction
Adverse event resulted in: death
Drug(s) suspected as cause:
Rozerem
Other drugs received by patient: Paxil; Zolpidem Tartrate
Possible Rozerem side effects in 76 year old female
Reported by a physician from Japan on 2012-04-04
Patient: 76 year old female
Reactions: Liver Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Slow-K
Dosage: unk ukn, unk
Administration route: Oral
Rozerem
Administration route: Oral
Amlodipine
Administration route: Oral
Risperidone
Administration route: Oral
Promazine Hydrochloride
Administration route: Oral
Epinastine Hydrochloride
Administration route: Oral
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:
Zoloft
Dosage: 100 mg/day
Administration route: Oral
Start date: 2012-02-21
Rozerem
Dosage: 8 mg/day
Administration route: Oral
Indication: Sleep Disorder
Start date: 2012-02-20
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 76 year old female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-02-10
Patient: 76 year old female
Reactions: Hepatic Necrosis, Drug Ineffective, Cholestasis, Hepatitis, Liver Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Risperidone
Dosage: see image
Administration route: Oral
Start date: 2011-09-28
Risperidone
Dosage: see image
Administration route: Oral
End date: 2011-11-16
Risperidone
Dosage: see image
Administration route: Oral
Start date: 2010-08-11
End date: 2011-09-20
Risperidone
Dosage: see image
Administration route: Oral
Start date: 2011-09-21
End date: 2011-09-27
Rozerem
Dosage: 8 mg (8 mg, 1 in 1 d)
Administration route: Oral
Indication: Insomnia
Start date: 2011-09-21
End date: 2011-11-16
Slow-K
Dosage: 1200 mg (1200 mg, 1 in 1 d)
Administration route: Oral
Start date: 2011-07-20
End date: 2011-11-16
Yokukan-SAN Osugi (Herbal Extract Nos)
Dosage: 7.5 gm (2.5 gm, 3 in 1 d)
Administration route: Oral
Start date: 2008-02-06
End date: 2011-11-16
Chlorpromazine HCL
Dosage: 12.5 mg (12.5 mg, 1 in 1 d)
Administration route: Oral
Start date: 2011-09-28
End date: 2011-11-16
Amlodipine
Dosage: 2.5 mg(2.5 mg, 1 in 1 d)
Administration route: Oral
Start date: 2010-11-20
End date: 2011-11-16
Epinastine Hydrochloride
Dosage: 20 mg (20 mg, 1in 1 d)
Administration route: Oral
Start date: 2008-12-30
End date: 2011-11-16
Possible Rozerem side effects in 42 year old male
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-02-07
Patient: 42 year old male
Reactions: Hepatic Function Abnormal, Delirium Tremens, Nausea, Condition Aggravated, Hepatic Steatosis, Aggression, Eating Disorder, Tremor, Alcohol Use, Hepatomegaly, Depressed Level of Consciousness, Hallucination
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Rozerem
Other drugs received by patient: Crestor; Rohypnol (Flunitrazepam); Omeprazole; CO-DIO (Hydrochlorothiazide, Valsartan); Loxonin (Loxoprofen Sodium); Amlodin OD (Amlodipine Besilate); Tenorimin (Atenolol); Allopurinol; Myonal (Eperisone Hydrochloride); Novamine 15%
Possible Rozerem side effects in
Reported by a individual with unspecified qualification from Japan on 2012-01-31
Patient:
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Rozerem
Possible Rozerem side effects in 76 year old female
Reported by a individual with unspecified qualification from Japan on 2012-01-25
Patient: 76 year old female
Reactions: Hepatic Necrosis, Cholestasis, Hepatitis, Liver Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Chlorpromazine HCL
Dosage: 12.5 mg (12.5 mg, 1 in 1 d), per oral
Administration route: Oral
Start date: 2011-08-01
End date: 2011-11-16
Rozerem
Dosage: 8 mg (8 mg, 1 in 1 d), per oral
Administration route: Oral
Indication: Insomnia
End date: 2011-11-16
Slow-K
Dosage: 1200 mg (1200 mg, 1 in 1 d), per oral
Administration route: Oral
End date: 2011-11-16
Epinastine Hydrochloride
Dosage: 20 mg (20 mg, 1 in 1 d) per oral
Administration route: Oral
End date: 2011-11-16
Risperidone
Dosage: 1 mg (1 mg, 1 in 1 d), per oral
Administration route: Oral
End date: 2011-11-16
Amlodipine
Dosage: 2.5 mg (2.5 mg, 1 in 1 d), per oral
Administration route: Oral
End date: 2011-11-16
Yokukan-SAN Osugi (Herbal Extract Nos)
Dosage: 7.5 gm (2.5 gm, 3 in 1 d), per oral
Administration route: Oral
End date: 2011-11-16
Possible Rozerem side effects in
Reported by a individual with unspecified qualification from Japan on 2012-01-17
Patient:
Reactions: Nightmare, Completed Suicide
Adverse event resulted in: death
Drug(s) suspected as cause:
Rozerem
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 2012-01-05
Patient: 53 year old male
Reactions: Convulsion
Drug(s) suspected as cause:
Herbal Preparation
Dosage: oral
Administration route: Oral
Urinorm (Benzbromarone)
Dosage: oral
Administration route: Oral
Alprazolam
Dosage: oral
Administration route: Oral
Rozerem
Dosage: oral
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