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This is an index of reports of adverse events (side effects, adverse reactions, etc.) related to Rozerem (Ramelteon). Click on the relevant link below to view a selection of reports according to the event's seriousness level and/or the nature of the side effect / adverse reaction. Or scroll down to view a sample of recent reports further on this page.
Our database includes reports from Jan 2007 to Dec 2007. The information is not vetted and should not be cosidered as verified clinical evidence.
All cases (456)
Cases resulting in a serious event (53)
Cases resulting in death (7)
Cases resulting in life threatening events (4)
Cases resulting in hospitalization (20)
Cases resulting in disability (1)
Cases resulting in other serious reactions (33)
Below is a sample of reports where side effects / adverse reactions may be related to Rozerem (Ramelteon). For a complete list and/or a specific selection of reports, please use the links in the index above.
Adverse event in 45 year old male receiving Rozerem (Ramelteon)
Reported by a consumer/non-health professional from United States on 2007-10-31
Patient: 45 year old male
Adverse reactions / side effects: Wrong Drug Administered, Self-Medication
Adverse event resulted in: death
Suspect drug(s):
Rozerem (Ramelteon)
Adverse event in 45 year old male receiving Rozerem (Ramelteon)
Reported by a consumer/non-health professional from United States on 2007-10-31
Patient: 45 year old male, weighing 122.5 kg (269.4 pounds)
Adverse reactions / side effects: Initial Insomnia, Poor Quality Sleep, Heart Rate Increased, Feeling Abnormal
Suspect drug(s):
Rozerem
Dosage: 8 mg, qhs, per oral
Administration route: Oral
Indication: Insomnia
Start date: 2007-09-25
End date: 2007-09-27
Rozerem
Dosage: 8 mg, qhs, per oral
Administration route: Oral
Indication: Insomnia
Start date: 2007-09-28
End date: 2007-10-19
Other drugs received by patient: Cardizem; Zyrtec; Androgel; Aspirin
Adverse event in 51 year old male receiving Rozerem (Ramelteon)
Reported by a physician from United States on 2007-10-26
Patient: 51 year old male, weighing 88.5 kg (194.6 pounds)
Adverse reactions / side effects: Abnormal Dreams, Hallucinations, Mixed, Middle Insomnia, Somnambulism
Suspect drug(s):
Rozerem (Ramelteon)
Other drugs received by patient: Soma; Morphine; Melatonin (Melatonin); Nexium
Adverse event in male receiving Rozerem (Ramelteon)
Reported by a consumer/non-health professional from United States on 2007-10-26
Patient: male
Adverse reactions / side effects: Drug Ineffective, Underdose, Somnolence, Treatment Noncompliance
Suspect drug(s):
Rozerem (Ramelteon)
Adverse event in 43 year old male receiving Rozerem (Ramelteon)
Reported by a consumer/non-health professional from United States on 2007-10-25
Patient: 43 year old male, weighing 77.1 kg (169.6 pounds)
Adverse reactions / side effects: Initial Insomnia, Middle Insomnia, Drug Ineffective, Insomnia, Hangover, Rebound Effect
Suspect drug(s):
Rozerem
Dosage: 8 mg, qhs, per oral
Administration route: Oral
Indication: Insomnia
Start date: 2005-01-01
Rozerem
Dosage: 8 mg, qhs, per oral
Administration route: Oral
Indication: Insomnia
Start date: 2007-10-15
Ambien
Indication: Insomnia
Start date: 2005-01-01
End date: 2006-01-01
Ambien CR
Indication: Insomnia
Start date: 2006-01-01
End date: 2006-01-01
Other drugs received by patient: Lunesta
Adverse event in 80 year old male receiving Rozerem (Ramelteon)
Reported by a consumer/non-health professional from United States on 2007-10-25
Patient: 80 year old male, weighing 81.6 kg (179.6 pounds)
Adverse reactions / side effects: Psychomotor Hyperactivity, Drug Ineffective, Insomnia, Condition Aggravated
Suspect drug(s):
Rozerem
Dosage: 8 mg, qhs, per oral; 12 mg, qhs, per oral; per oral
Administration route: Oral
Indication: Initial Insomnia
Start date: 2007-10-07
End date: 2007-10-09
Rozerem
Dosage: 8 mg, qhs, per oral; 12 mg, qhs, per oral; per oral
Administration route: Oral
Indication: Initial Insomnia
Start date: 2007-10-10
End date: 2007-10-10
Prilosec
Other drugs received by patient: Bupropion HCL; Amitriptyline HCL; Diltiazem; Ambien
Adverse event in 23 year old female receiving Rozerem (Ramelteon)
Reported by a individual with unspecified qualification from United States on 2007-10-22
Patient: 23 year old female, weighing 48.1 kg (105.8 pounds)
Adverse reactions / side effects: Drug Ineffective, Insomnia, Somnolence
Suspect drug(s):
Rozerem
Dosage: 8 mg, qhs, per oral
Administration route: Oral
Indication: Insomnia
Start date: 2007-10-07
End date: 2007-10-07
Rozerem
Dosage: 8 mg, qhs, per oral
Administration route: Oral
Indication: Insomnia
Start date: 2007-09-01
Other drugs received by patient: Cytoplasm(all Other Therapeutic Products); Repliva(mineral Supplements); Flonase
Adverse event in 85 year old female receiving Rozerem (Ramelteon)
Reported by a individual with unspecified qualification from United States on 2007-10-19
Patient: 85 year old female, weighing 61.7 kg (135.7 pounds)
Adverse reactions / side effects: Fatigue, Drug Ineffective, Incorrect Dose Administered, Insomnia, Somnolence
Suspect drug(s):
Rozerem
Dosage: 8 mg, qhs, per oral; 16 mg, qhs, per oral
Administration route: Oral
Indication: Insomnia
Start date: 2007-10-07
End date: 2007-10-08
Rozerem
Dosage: 8 mg, qhs, per oral; 16 mg, qhs, per oral
Administration route: Oral
Indication: Insomnia
Start date: 2007-10-09
End date: 2007-10-09
Other drugs received by patient: Aspirin; Metoprolol Tartrate; Verapamil
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 female receiving Rozerem (Ramelteon)
Reported by a health professional (non-physician/pharmacist) from United States on 2007-10-12
Patient: female
Adverse reactions / side effects: Tachycardia, Self-Medication
Suspect drug(s):
Rozerem (Ramelteon)
Other drugs received by patient: Unknown Anti-Hypertensive Medications (Antihypertensives)
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 37 year old male receiving Rozerem (Ramelteon)
Reported by a individual with unspecified qualification from United States on 2007-10-12
Patient: 37 year old male, weighing 96.2 kg (211.6 pounds)
Adverse reactions / side effects: Abnormal Dreams, Unevaluable Event
Suspect drug(s):
Rozerem (Ramelteon)
Other drugs received by patient: Lunesta
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 2007-10-09
Patient: 66 year old female, weighing 65.8 kg (144.7 pounds)
Adverse reactions / side effects: Initial Insomnia, Colon Cancer, Middle Insomnia, Drug Ineffective, Sleep Disorder
Adverse event resulted in: hospitalization
Suspect drug(s):
Rozerem
Dosage: 8 mg, qhs, per oral; 8 mg, per oral
Administration route: Oral
Indication: Insomnia
Start date: 2007-01-05
End date: 2007-01-05
Rozerem
Dosage: 8 mg, qhs, per oral; 8 mg, per oral
Administration route: Oral
Indication: Insomnia
Start date: 2007-01-16
End date: 2007-01-16
Other drugs received by patient: Zyrtec; Premarin; Flonase Nasal Spray (Fluticasone Propionate)
Adverse event in receiving Rozerem (Ramelteon)
Reported by a health professional (non-physician/pharmacist) from United States on 2007-10-05
Patient:
Adverse reactions / side effects: Aggression
Suspect drug(s):
Rozerem (Ramelteon)
Adverse event in 70 year old male receiving Rozerem (Ramelteon)
Reported by a consumer/non-health professional from United States on 2007-10-05
Patient: 70 year old male, weighing 72.6 kg (159.7 pounds)
Adverse reactions / side effects: Myocardial Infarction
Adverse event resulted in: hospitalization
Suspect drug(s):
Rozerem
Dosage: 8 mg, hs, per oral
Administration route: Oral
Indication: Middle Insomnia
Start date: 2007-06-02
End date: 2007-06-09
Rozerem
Dosage: 8 mg, hs, per oral
Administration route: Oral
Indication: Middle Insomnia
Start date: 2007-08-03
Other drugs received by patient: Diovan HCT; Caduet (Atorvastatin Calcium, Amlodipine Besilate); Lorazepam
Adverse event in 39 year old male receiving Rozerem (Ramelteon)
Reported by a physician from United States on 2007-10-03
Patient: 39 year old male, weighing 88.0 kg (193.6 pounds)
Adverse reactions / side effects: Drug Effect Decreased, Treatment Noncompliance
Suspect drug(s):
Rozerem
Dosage: 8 mg, hs, per oral; 16 mg, hs, per oral
Administration route: Oral
Indication: Insomnia
Start date: 2007-01-01
Rozerem
Dosage: 8 mg, hs, per oral; 16 mg, hs, per oral
Administration route: Oral
Indication: Insomnia
Start date: 2007-06-03
Other drugs received by patient: Multiple Medications (All Other Therapeutic Products)
Adverse event in 54 year old male receiving Rozerem (Ramelteon)
Reported by a physician from United States on 2007-10-02
Patient: 54 year old male, weighing 104.3 kg (229.5 pounds)
Adverse reactions / side effects: Impaired Driving Ability, Legal Problem, Drug Interaction, Imprisonment, Amnesia, Feeling Abnormal
Adverse event resulted in: life threatening event, hospitalization
Suspect drug(s):
Rozerem
Dosage: per oral
Administration route: Oral
Indication: Insomnia
Start date: 2007-07-18
End date: 2007-07-24
Methadone HCL
Dosage: 10 mg, 2 in 1 d, per oral
Administration route: Oral
Hydrocodone Bitartrate
Cymbalta
Dosage: 30 mg, qhs
Indication: Pain
Lortab
Dosage: 10/500, q12-24 hrs
Indication: Pain
Other drugs received by patient: Aleve; Omega 3 Fish OIL (Fish Oil); Decadron
Adverse event in female receiving Rozerem (Ramelteon)
Reported by a individual with unspecified qualification from United States on 2007-10-02
Patient: female
Adverse reactions / side effects: Fatigue, Nausea, Dizziness, Self-Medication
Suspect drug(s):
Rozerem (Ramelteon)
Adverse event in 60 year old female receiving Rozerem (Ramelteon)
Reported by a consumer/non-health professional from United States on 2007-10-01
Patient: 60 year old female, weighing 59.0 kg (129.7 pounds)
Adverse reactions / side effects: Middle Insomnia, Drug Ineffective, Headache, Self-Medication
Suspect drug(s):
Rozerem (Ramelteon)
Other drugs received by patient: Lipitor
Adverse event in 27 year old male receiving Rozerem (Ramelteon)
Reported by a consumer/non-health professional from United States on 2007-07-27
Patient: 27 year old male, weighing 81.6 kg (179.6 pounds)
Adverse reactions / side effects: Middle Insomnia
Suspect drug(s):
Rozerem
Dosage: 8 mg, qhs, per oral; 16 mg, qhs, per oral; 24 mg, qhs, per oral
Administration route: Oral
Indication: Insomnia
End date: 2007-07-18
Rozerem
Dosage: 8 mg, qhs, per oral; 16 mg, qhs, per oral; 24 mg, qhs, per oral
Administration route: Oral
Indication: Insomnia
Start date: 2007-07-01
Other drugs received by patient: Clonazepam
Adverse event in 67 year old female receiving Rozerem (Ramelteon)
Reported by a physician from United States on 2007-07-26
Patient: 67 year old female, weighing 72.6 kg (159.7 pounds)
Adverse reactions / side effects: Impaired Driving Ability, Pollakiuria, Polyuria, Somnolence, Feeling Abnormal
Suspect drug(s):
Rozerem (Ramelteon)
Other drugs received by patient: Prevacid; Aspirin; Ultram ER (Tramadol Hydrochloride); Folic Acid / B12 / B6 (Vitamin B12 and Folic Acid); Hydrochlorothiazide; Lipitor (Atorastatin Calcium); Lisinopril; Protonix
Adverse event in 53 year old receiving Rozerem (Ramelteon)
Reported by a individual with unspecified qualification from United States on 2007-07-19
Patient: 53 year old , weighing 60.8 kg (133.7 pounds)
Adverse reactions / side effects: Initial Insomnia, Thyroid Cancer, Recurrent Cancer
Suspect drug(s):
Rozerem (Ramelteon)
Other drugs received by patient: Synthroid
Adverse event in 51 year old male receiving Rozerem (Ramelteon)
Reported by a physician from United States on 2007-07-17
Patient: 51 year old male
Adverse reactions / side effects: Hypokinesia, Fear, Lack of Spontaneous Speech, Catatonia
Suspect drug(s):
Rozerem
Dosage: 8 mg, once, per oral
Administration route: Oral
Indication: Circadian Rhythm Sleep Disorder
Rozerem
Dosage: 8 mg, once, per oral
Administration route: Oral
Indication: Insomnia
Other drugs received by patient: Vitamin (Vitamins)
Adverse event in 44 year old male receiving Rozerem (Ramelteon)
Reported by a consumer/non-health professional from United States on 2007-07-13
Patient: 44 year old male, weighing 88.5 kg (194.6 pounds)
Adverse reactions / side effects: Drug Effect Decreased, Drug Ineffective, Cognitive Disorder, Amnesia, Abnormal Dreams, Dysgeusia, Poor Quality Sleep, Rebound Effect
Suspect drug(s):
Lunesta
Dosage: 3 mg;oral
Administration route: Oral
Indication: Rapid Eye Movements Sleep Abnormal
Start date: 2005-01-01
End date: 2007-03-27
Lunesta
Dosage: 3 mg;oral
Administration route: Oral
Indication: Rapid Eye Movements Sleep Abnormal
Start date: 2007-03-31
End date: 2007-04-07
Lunesta
Dosage: 3 mg;oral
Administration route: Oral
Indication: Rapid Eye Movements Sleep Abnormal
Start date: 2007-04-18
Rozerem
Dosage: oral
Administration route: Oral
Indication: Rapid Eye Movements Sleep Abnormal
Start date: 2007-03-01
End date: 2007-04-01
Other drugs received by patient: Nexium; Crestor
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