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Index of reports
> Cases resulting in hospitalization (20)
Below is the selection of adverse event reports related to Rozerem (Ramelteon) that includes cases resulting in hospitalization.
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 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 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 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 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 48 year old female receiving Rozerem (Ramelteon)
Reported by a health professional (non-physician/pharmacist) from United States on 2007-05-02
Patient: 48 year old female, weighing 77.1 kg (169.6 pounds)
Adverse reactions / side effects: Economic Problem, Drug Ineffective, Drug Screen Positive, Family Stress, Hallucination, Auditory, General Physical Health Deterioration, Condition Aggravated, Laceration, Intentional Self-Injury, Suicidal Ideation, Anger, Depression
Adverse event resulted in: hospitalization
Suspect drug(s):
Rozerem
Dosage: 8 mg, 1 in 1 d, per oral
Administration route: Oral
Indication: Affective Disorder
Start date: 2006-09-29
End date: 2006-11-29
Rozerem
Dosage: 8 mg, 1 in 1 d, per oral
Administration route: Oral
Indication: Insomnia
Start date: 2006-09-29
End date: 2006-11-29
Rozerem
Dosage: 8 mg, 1 in 1 d, per oral
Administration route: Oral
Indication: Seasonal Affective Disorder
Start date: 2006-09-29
End date: 2006-11-29
Other drugs received by patient: Lamictal; Wellbutrin; Effexor XR; Klonopin
Adverse event in female receiving Rozerem (Ramelteon)
Reported by a physician from United States on 2007-05-01
Patient: female
Adverse reactions / side effects: Completed Suicide
Adverse event resulted in: death, hospitalization
Suspect drug(s):
Rozerem
Dosage: per oral
Administration route: Oral
Indication: Anxiety
Start date: 2007-04-01
End date: 2007-04-01
Rozerem
Dosage: per oral
Administration route: Oral
Indication: Divorced
Start date: 2007-04-01
End date: 2007-04-01
Rozerem
Dosage: per oral
Administration route: Oral
Indication: Insomnia
Start date: 2007-04-01
End date: 2007-04-01
Rozerem
Dosage: per oral
Administration route: Oral
Indication: Mental Disorder
Start date: 2007-04-01
End date: 2007-04-01
Rozerem
Dosage: per oral
Administration route: Oral
Indication: Stress
Start date: 2007-04-01
End date: 2007-04-01
Adverse event in female receiving Rozerem (Ramelteon)
Reported by a physician from United States on 2007-04-26
Patient: female
Adverse reactions / side effects: Completed Suicide
Adverse event resulted in: death, hospitalization
Suspect drug(s):
Rozerem
Dosage: per oral
Administration route: Oral
Indication: Anxiety
Start date: 2007-04-01
End date: 2007-04-01
Rozerem
Dosage: per oral
Administration route: Oral
Indication: Insomnia
Start date: 2007-04-01
End date: 2007-04-01
Rozerem
Dosage: per oral
Administration route: Oral
Indication: Stress
Start date: 2007-04-01
End date: 2007-04-01
Adverse event in male receiving Rozerem (Ramelteon)
Reported by a health professional (non-physician/pharmacist) from United States on 2007-04-24
Patient: male
Adverse reactions / side effects: Anxiety, Cardiac Disorder
Adverse event resulted in: hospitalization
Suspect drug(s):
Rozerem
Dosage: per oral
Administration route: Oral
Clonazepam
Dosage: 0.25 mg, per oral
Administration route: Oral
Indication: Anxiety
Other drugs received by patient: Trazodone HCL
Adverse event in 51 year old female receiving Rozerem (Ramelteon)
Reported by a consumer/non-health professional from United States on 2007-04-04
Patient: 51 year old female, weighing 63.0 kg (138.7 pounds)
Adverse reactions / side effects: Weight Increased, Initial Insomnia, Laboratory Test Abnormal, Drug Ineffective, Thyroid Cancer, Somnolence
Adverse event resulted in: hospitalization
Suspect drug(s):
Rozerem (Ramelteon)
Other drugs received by patient: Synthroid
Adverse event in 81 year old male receiving Rozerem (Ramelteon)
Reported by a pharmacist from United States on 2007-03-29
Patient: 81 year old male
Adverse reactions / side effects: Partial Seizures, Dystonia, Dyskinesia
Adverse event resulted in: hospitalization
Suspect drug(s):
Rozerem (Ramelteon)
Other drugs received by patient: Docusate; Furosemide; Aspirin; Ferrous Sulfate; Zocor; Prilosec; Coumadin; Doxycycline; Clonazepam; Carvedilol; Flomax; Diovan; Lantus; Sprinolactone; Potassium Chloride; M.v.i.; Zyrtec; Novolog; Levaquin; Vicodin
Adverse event in 69 year old male receiving Rozerem (Ramelteon)
Reported by a physician from United States on 2007-03-21
Patient: 69 year old male
Adverse reactions / side effects: Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased, Vomiting, Chest Discomfort, International Normalised Ratio Increased, Alanine Aminotransferase Increased, Brain Natriuretic Peptide Increased, Sleep Disorder, Bilirubin Conjugated Increased
Adverse event resulted in: hospitalization
Suspect drug(s):
Rozerem
Dosage: per oral
Administration route: Oral
Start date: 2006-11-13
Ambien
Zocor
Dosage: 40 mg, 1 in 1 d
Other drugs received by patient: Lasix (Furosemide) (40 Milligram); Aspirin
Adverse event in 69 year old female receiving Rozerem (Ramelteon)
Reported by a health professional (non-physician/pharmacist) from United States on 2007-02-07
Patient: 69 year old female, weighing 113.4 kg (249.5 pounds)
Adverse reactions / side effects: Vomiting, Blood Pressure Systolic Increased, Nausea, Sinus Bradycardia, Diarrhoea, Dizziness, Gait Disturbance, Vertigo Positional
Adverse event resulted in: hospitalization
Suspect drug(s):
Rozerem
Dosage: 8 mg, qhs, per oral
Administration route: Oral
Indication: Insomnia
Start date: 2006-04-20
End date: 2006-04-25
Paxil
Dosage: 20 mg, 1 in 1 d, per oral
Administration route: Oral
Indication: Affective Disorder
Hyzaar
Dosage: 1 in 1 d, per oral
Administration route: Oral
Indication: Blood Pressure
Synthroid
Dosage: 125 mcg, 1 in 1 d, per oral
Administration route: Oral
Indication: Hypothyroidism
Other drugs received by patient: Aleve; Calcium (Calcium); Fish OIL (Fish Oil); Glucosamine (Glucosamine)
Adverse event in 21 year old female receiving Rozerem (Ramelteon)
Reported by a physician from United States on 2007-02-02
Patient: 21 year old female, weighing 59.0 kg (129.7 pounds)
Adverse reactions / side effects: Nephritis Interstitial, Hepatitis Acute, Renal Failure Acute
Adverse event resulted in: hospitalization
Suspect drug(s):
Rozerem
Dosage: 8 mg, unknown, per oral
Administration route: Oral
Indication: Insomnia
Start date: 2005-10-24
End date: 2005-11-04
Lithium (Lithium) (900 Milligram)
Dosage: 900 mg, qhs, per oral
Administration route: Oral
Indication: Bipolar Disorder
Start date: 2003-09-01
End date: 2005-11-01
Tylenol
Other drugs received by patient: Unspecified Prescription Medications (All Other Therapeutic Products); Diazepam; Lamictal; Risperdal
Adverse event in 48 year old female receiving Rozerem (Ramelteon)
Reported by a health professional (non-physician/pharmacist) from United States on 2007-01-26
Patient: 48 year old female, weighing 77.1 kg (169.6 pounds)
Adverse reactions / side effects: Economic Problem, Drug Screen Positive, Hallucination, Auditory, Self Injurious Behaviour, Suicidal Ideation, Cardiac Disorder, Skin Laceration, Anger, Depression
Adverse event resulted in: hospitalization
Suspect drug(s):
Rozerem
Dosage: 8 mg, 1 in 1 d, per oral
Administration route: Oral
Indication: Affective Disorder
Start date: 2006-09-29
End date: 2006-11-29
Rozerem
Dosage: 8 mg, 1 in 1 d, per oral
Administration route: Oral
Indication: Insomnia
Start date: 2006-09-29
End date: 2006-11-29
Rozerem
Dosage: 8 mg, 1 in 1 d, per oral
Administration route: Oral
Indication: Seasonal Affective Disorder
Start date: 2006-09-29
End date: 2006-11-29
Other drugs received by patient: Lamictal; Wellbutrin; Effexor XR; Klonopin
Adverse event in 66 year old female receiving Rozerem (Ramelteon)
Reported by a individual with unspecified qualification from United States on 2007-01-26
Patient: 66 year old female, weighing 65.8 kg (144.7 pounds)
Adverse reactions / side effects: Initial Insomnia, Colon Cancer, Middle Insomnia, Drug Ineffective
Adverse event resulted in: hospitalization
Suspect drug(s):
Rozerem
Dosage: 8 mg, qhs, per oral
Administration route: Oral
Indication: Insomnia
Start date: 2007-01-05
End date: 2007-01-05
Rozerem
Dosage: 8 mg, qhs, 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 69 year old male receiving Rozerem (Ramelteon)
Reported by a physician from United States on 2007-01-26
Patient: 69 year old male
Adverse reactions / side effects: Blood Bilirubin Increased, Alanine Aminotransferase Increased, International Normalised Ratio Increased, Liver Disorder, Blood Acid Phosphatase Increased, Brain Natriuretic Peptide Increased, Insomnia, Liver Function Test Abnormal
Adverse event resulted in: hospitalization
Suspect drug(s):
Rozerem
Dosage: per oral
Administration route: Oral
Start date: 2006-11-13
Ambien
Other drugs received by patient: Lasix (Furosemide) (40 Milligram); Aspirin; Zocort (Simvastatin)
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