Index of reports
> Cases with Jaundice (3)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Rozerem (Ramelteon) where reactions include jaundice. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Rozerem side effects in 76 year old female
Reported by a health professional (non-physician/pharmacist) from Japan on 2011-12-19
Patient: 76 year old female
Reactions: Jaundice, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Liver Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Amlodipine
Dosage: 2.5 mg (2.5 mg, 1 in 1 d)
Administration route: Oral
End date: 2011-11-16
Slow-K
Dosage: 1200 mg (1200 mg, 1 in 1 d)
Administration route: Oral
End date: 2011-11-16
Risperidone
Dosage: 1 mg (1 mg, 1 in 1 d)
Administration route: Oral
End date: 2011-11-16
Chlorpromazine HCL
Dosage: 12.5 mg (12.5 mg, 1 in 1 d)
Administration route: Oral
Start date: 2011-08-01
End date: 2011-11-16
Yokukan-SAN Osugi (Herbal Extract Nos)
Dosage: 7.5 gm (2.5 gm, 3 in 1 d)
End date: 2011-11-16
Rozerem
Dosage: 8 mg (8 mg, 1 in 1 d)
Administration route: Oral
Indication: Insomnia
End date: 2011-11-16
Epinastine Hydrochloride
Dosage: 20 mg (20 mg, 1 in 1 d)
Administration route: Oral
End date: 2011-11-16
Possible Rozerem side effects in 85 year old male
Reported by a health professional (non-physician/pharmacist) from Japan on 2011-12-15
Patient: 85 year old male
Reactions: Jaundice, Flatulence, Prothrombin Time Prolonged, Ascites, Nephrolithiasis, NO Therapeutic Response, Oedema Peripheral, Cholecystitis, Chronic Hepatitis, Splenomegaly, Hepatic Cirrhosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Rozerem
Dosage: 8 mg (8 mg, 1 in 1 d)
Administration route: Oral
Indication: Insomnia
Start date: 2011-07-14
End date: 2011-08-21
Rhythmy (Rilmazafone Hydrochloride)
Dosage: (1 mg, 1 d)
Administration route: Oral
Indication: Insomnia
Start date: 2011-07-11
Other drugs received by patient: Ardephyllin (Theophylline); Selbex (Teprenone); Toughmac E (Enzymes Nos); Tapizol (Lansoprazole); Sawatene (Carbocisteine); Alvesco; Spiriva
Possible Rozerem side effects in 76 year old female
Reported by a health professional (non-physician/pharmacist) from Japan on 2011-12-07
Patient: 76 year old female
Reactions: Jaundice
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Rozerem
Other drugs received by patient: Amlodipine; Slow-K; Chlorpromazine HCL; Helvottz (Epinastine Hydrochloride); Risperidone
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