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Index of reports
> Cases resulting in a serious event (53)
Below is the selection of adverse event reports related to Rozerem (Ramelteon) that includes cases resulting in a serious event.
Reports 1 - 25 of 53 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
Adverse reactions / side effects: Wrong Drug Administered, Self-Medication
Adverse event resulted in: death
Suspect drug(s):
Rozerem (Ramelteon)
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):
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
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
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 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):
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
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
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 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):
Cymbalta
Dosage: 30 mg, qhs
Indication: Pain
Hydrocodone Bitartrate
Lortab
Dosage: 10/500, q12-24 hrs
Indication: Pain
Methadone HCL
Dosage: 10 mg, 2 in 1 d, per oral
Administration route: Oral
Rozerem
Dosage: per oral
Administration route: Oral
Indication: Insomnia
Start date: 2007-07-18
End date: 2007-07-24
Other drugs received by patient: Aleve; Omega 3 Fish OIL (Fish Oil); Decadron
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 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 female receiving Rozerem (Ramelteon)
Reported by a physician from United States on 2007-07-06
Patient: female, weighing 47.6 kg (104.8 pounds)
Adverse reactions / side effects: Blood Corticotrophin Increased, Adrenal Insufficiency, Adrenal Neoplasm
Suspect drug(s):
Rozerem (Ramelteon)
Other drugs received by patient: Antihypertensive (Antihypertensives)
Adverse event in 36 year old female receiving Rozerem (Ramelteon)
Reported by a health professional (non-physician/pharmacist) from United States on 2007-07-06
Patient: 36 year old female
Adverse reactions / side effects: Drug Eruption, Asthma, Condition Aggravated
Suspect drug(s):
Rozerem (Ramelteon)
Other drugs received by patient: Topamax; Paroxetine
Adverse event in 56 year old female receiving Rozerem (Ramelteon)
Reported by a physician from United States on 2007-06-26
Patient: 56 year old female
Adverse reactions / side effects: Palpitations
Suspect drug(s):
Rozerem (Ramelteon)
Adverse event in 39 year old female receiving Rozerem (Ramelteon)
Reported by a physician from United States on 2007-06-20
Patient: 39 year old female
Adverse reactions / side effects: Overdose, Intentional Self-Injury, Joint Injury
Adverse event resulted in: hospitalization
Suspect drug(s):
Rozerem (Ramelteon)
Adverse event in male receiving Rozerem (Ramelteon)
Reported by a physician from United States on 2007-06-20
Patient: male
Adverse reactions / side effects: NO Adverse Drug Effect, Drug Dispensing Error
Suspect drug(s):
Razadyne ER
Administration route: Oral
Indication: Drug USE FOR Unknown Indication
Rozerem
Indication: Insomnia
Adverse event in female receiving Rozerem (Ramelteon)
Reported by a consumer/non-health professional from United States on 2007-06-15
Patient: female
Adverse reactions / side effects: Blood Pressure Decreased, Somnolence, Suicidal Ideation
Suspect drug(s):
Rozerem (Ramelteon)
Adverse event in female receiving Rozerem (Ramelteon)
Reported by a physician from United States on 2007-06-12
Patient: female
Adverse reactions / side effects: Irritability, Road Traffic Accident, Carbon Monoxide Poisoning, Disturbance in Attention, Drug Interaction, Memory Impairment, Morbid Thoughts, Somnolence, Suicidal Ideation
Suspect drug(s):
Rozerem
Dosage: per oral
Administration route: Oral
Seroquel
Adverse event in 52 year old female receiving Rozerem (Ramelteon)
Reported by a health professional (non-physician/pharmacist) from United States on 2007-06-04
Patient: 52 year old female, weighing 99.8 kg (219.5 pounds)
Adverse reactions / side effects: Heart Rate Decreased, Palpitations
Adverse event resulted in: life threatening event
Suspect drug(s):
Rozerem
Dosage: 8 mg once hs po
Administration route: Oral
Indication: Insomnia
Start date: 2007-04-26
Rozerem
Dosage: 8 mg once hs po
Administration route: Oral
Indication: Insomnia
Start date: 2007-04-27
Adverse event in 39 year old female receiving Rozerem (Ramelteon)
Reported by a physician from United States on 2007-05-30
Patient: 39 year old female
Adverse reactions / side effects: Intentional Overdose, Laceration, Intentional Self-Injury
Adverse event resulted in: hospitalization
Suspect drug(s):
Rozerem (Ramelteon)
Adverse event in 51 year old male receiving Rozerem (Ramelteon)
Reported by a physician from United States on 2007-05-30
Patient: 51 year old male
Adverse reactions / side effects: Speech Disorder, Movement Disorder, Fear, Catatonia
Suspect drug(s):
Rozerem (Ramelteon)
Other drugs received by patient: Vitamin (Vitamins) (Unknown)
Adverse event in 66 year old female receiving Rozerem (Ramelteon)
Reported by a physician from United States on 2007-05-29
Patient: 66 year old female, weighing 59.0 kg (129.7 pounds)
Adverse reactions / side effects: Drug Ineffective, Insomnia, Axillary Pain, Chest Pain, Heart Rate Irregular
Suspect drug(s):
Rozerem (Ramelteon)
Other drugs received by patient: Tylenol PM (Diphenydramine, Paracetamol); Aleve PM (Naproxen Sodium)
Adverse event in female receiving Rozerem (Ramelteon)
Reported by a physician from United States on 2007-05-24
Patient: female
Adverse reactions / side effects: Convulsion
Suspect drug(s):
Rozerem (Ramelteon)
Other drugs received by patient: Multiple Unknown Medication (All Other NON-Therapeutic Products)
Adverse event in receiving Rozerem (Ramelteon)
Reported by a physician from United States on 2007-05-23
Patient:
Adverse reactions / side effects: Death
Adverse event resulted in: death
Suspect drug(s):
Rozerem (Ramelteon)
Adverse event in 67 year old male receiving Rozerem (Ramelteon)
Reported by a consumer/non-health professional from United States on 2007-05-22
Patient: 67 year old male
Adverse reactions / side effects: Homicide, Suicide Attempt
Adverse event resulted in: life threatening event
Suspect drug(s):
Ambien
Cymbalta
Indication: Depression
Rozerem
Dosage: per oral
Administration route: Oral
Other drugs received by patient: Lunesta
Adverse event in 50 year old female receiving Rozerem (Ramelteon)
Reported by a health professional (non-physician/pharmacist) from United States on 2007-05-21
Patient: 50 year old female
Adverse reactions / side effects: Abnormal Behaviour, Sleep Walking
Suspect drug(s):
Rozerem (Ramelteon)
Other drugs received by patient: UNK Medications (All Other Therapeutic Products)
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