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Index of reports
> All cases (456)
Below is the selection of adverse event reports related to Rozerem (Ramelteon) that includes all cases.
Reports 1 - 25 of 456 Next >>
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 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 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 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 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 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 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 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 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 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 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 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 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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