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Rozerem (Ramelteon) - Jaundice - Suspected Cause - Side Effect Reports

 
 



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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