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Isentress (Raltegravir) - Cytolytic Hepatitis - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Cytolytic Hepatitis (19)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Isentress (Raltegravir) where reactions include cytolytic hepatitis. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Isentress side effects in

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-10

Patient:

Reactions: Cytolytic Hepatitis, Cholestasis, Pyrexia, Neutropenia, Dermatitis Exfoliative, Eosinophilia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Abacavir Sulfate / Lamivudine
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-11-18
    End date: 2011-12-21

Imatinib Mesylate
    Dosage: 400 mg, qd
    Administration route: Oral
    Indication: Gastrointestinal Neoplasm
    Start date: 2011-11-22
    End date: 2011-12-01

Isentress
    Dosage: 400 mg, bid
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-11-25
    End date: 2011-12-21



Possible Isentress side effects in

Reported by a physician from France on 2012-08-06

Patient:

Reactions: Cytolytic Hepatitis

Drug(s) suspected as cause:
Isentress
    Dosage: 400 mg, bid
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-04-12
    End date: 2012-08-01

Maraviroc
    Dosage: 300 mg, bid
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-04-12
    End date: 2012-08-01

Metformin Hydrochloride
    Dosage: 1000 mg, bid
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2011-11-25
    End date: 2012-08-01



Possible Isentress side effects in 25 year old female

Reported by a individual with unspecified qualification from United Kingdom on 2012-06-29

Patient: 25 year old female

Reactions: Maternal Exposure During Pregnancy, Cytolytic Hepatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Combivir
    Dosage: 2 tab/daily/po
    Administration route: Oral
    Start date: 2012-03-19

Epzicom
    Dosage: 1 tab/daily/po
    Administration route: Oral
    Start date: 2012-03-05
    End date: 2012-03-12

Isentress
    Dosage: 80 mg/daily/po
    Administration route: Oral
    Start date: 2010-07-13
    End date: 2011-11-08

Kaletra
    Dosage: 2 tab/daily/po
    Administration route: Oral
    Start date: 2012-03-05
    End date: 2012-03-12

Norvir
    Dosage: 100 mg/daily/po
    Administration route: Oral
    Start date: 2010-07-13
    End date: 2011-11-08

Prezista
    Dosage: 800 mg/daily/po
    Administration route: Oral
    Start date: 2010-07-13
    End date: 2011-11-08

Selzentry
    Dosage: 300 mg/daily/po
    Administration route: Oral
    Start date: 2010-07-13
    End date: 2011-11-08

Truvada
    Dosage: 1 tab/daily/po
    Administration route: Oral
    Start date: 2010-07-13
    End date: 2011-11-08



Possible Isentress side effects in 25 year old female

Reported by a individual with unspecified qualification from United Kingdom on 2012-06-25

Patient: 25 year old female

Reactions: Maternal Exposure During Pregnancy, Cytolytic Hepatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Combivir

Epzicom
    Start date: 2012-03-05
    End date: 2012-03-19

Isentress
    Dosage: po
    Administration route: Oral
    End date: 2011-11-08

Kaletra
    Start date: 2012-03-05
    End date: 2012-03-19

Norvir
    End date: 2011-11-08

Prezista
    End date: 2011-11-08

Selzentry
    End date: 2011-11-08

Truvada
    Start date: 2010-07-13
    End date: 2011-11-08



Possible Isentress side effects in 41 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-25

Patient: 41 year old male

Reactions: Cytolytic Hepatitis

Drug(s) suspected as cause:
Isentress

Other drugs received by patient: Aspirin Lysine; Pravastatin Sodium; Metformin; Emtricitabine and Tenofovir Disoproxil Fumarate



Possible Isentress side effects in 46 year old female

Reported by a physician from France on 2012-05-31

Patient: 46 year old female, weighing 67.0 kg (147.4 pounds)

Reactions: Phlebitis, Vitamin D Deficiency, Diabetes Mellitus, Cytolytic Hepatitis, Urinary Tract Infection, Alopecia, Tendonitis, Hypertriglyceridaemia, Bursa Calcification

Drug(s) suspected as cause:
Isentress

Other drugs received by patient: Abacavir Sulfate and Lamivudine



Possible Isentress side effects in 54 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-04-12

Patient: 54 year old female

Reactions: Cytolytic Hepatitis

Drug(s) suspected as cause:
Darunavir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-04-01
    End date: 2012-01-15

Isentress
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-04-01
    End date: 2012-01-15

Ofloxacin
    Administration route: Oral
    Indication: Urinary Tract Infection
    Start date: 2011-12-01

Other drugs received by patient: Venlafaxine Hydrochloride; Lithium; Cyamemazine; Zopiclone; Ritonavir



Possible Isentress side effects in 54 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-04-05

Patient: 54 year old female

Reactions: Cytolytic Hepatitis

Drug(s) suspected as cause:
Ciprofloxacin Hydrochloride
    Indication: Urinary Tract Infection

Darunavir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-04-01
    End date: 2012-01-15

Isentress
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-04-01
    End date: 2012-01-15

Other drugs received by patient: Cyamemazine; Ritonavir; Venlafaxine Hydrochloride; Zopiclone; Lithium



Possible Isentress side effects in 39 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-03-27

Patient: 39 year old male

Reactions: Cytolytic Hepatitis, Pyrexia, Rash Pruritic

Drug(s) suspected as cause:
Isentress

Other drugs received by patient: Ritonavir; Darunavir



Possible Isentress side effects in 54 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-03-15

Patient: 54 year old female

Reactions: Cytolytic Hepatitis

Drug(s) suspected as cause:
Ciprofloxacin
    Dosage: unk
    Indication: Urinary Tract Infection
    Start date: 2011-12-01

Darunavir Hydrate
    Dosage: unk
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-04-01
    End date: 2012-01-15

Isentress
    Dosage: unk
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-04-01
    End date: 2012-01-15

Other drugs received by patient: Norvir; Tercian; Imovane; Effexor; Lithium Carbonate



Possible Isentress side effects in 63 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-03-06

Patient: 63 year old male

Reactions: Tubulointerstitial Nephritis, Cytolytic Hepatitis, Cholestasis, Glomerulonephritis Membranous, Nephrotic Syndrome, Eosinophilia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Isentress
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-04-27
    End date: 2011-12-09

Norvir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-04-27

Reyataz
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-04-27

Sustiva
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-04-27

Other drugs received by patient: Clopidogrel Bisulfate; Aspirin Lysine; Pravastatin Sodium; Acebutolol Hydrochloride; Aspirin Lysine; Sulfamethoxazole and Trimethoprim



Possible Isentress side effects in 61 year old male

Reported by a physician from France on 2012-03-06

Patient: 61 year old male

Reactions: Tubulointerstitial Nephritis, Cytolytic Hepatitis, Cholestasis, Eosinophilia, Glomerulonephritis Membranous, Nephrotic Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bactrim

Isentress
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-04-27
    End date: 2011-12-09

Norvir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-04-27

Reyataz
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-04-27

Sustiva
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-04-27

Other drugs received by patient: Pravastatin; Plavix; Aspegic 1000; Aspirin; Perindopril Erbumine; Sectral



Possible Isentress side effects in 54 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-02-10

Patient: 54 year old female

Reactions: Cytolytic Hepatitis

Drug(s) suspected as cause:
Ciprofloxacin HCL
    Indication: Urinary Tract Infection

Darunavir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-04-01
    End date: 2012-01-15

Isentress
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-04-01
    End date: 2012-01-15

Other drugs received by patient: Cyamemazine; Zopiclone; Venlafaxine Hydrochloride; Ritonavir; Lithium



Possible Isentress side effects in 54 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-02-08

Patient: 54 year old female

Reactions: Cytolytic Hepatitis

Drug(s) suspected as cause:
Ciprofloxacin
    Dosage: unk
    Indication: Urinary Tract Infection
    Start date: 2011-12-01

Darunavir
    Dosage: unk
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-04-01
    End date: 2012-01-15

Isentress
    Dosage: unk
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-04-01
    End date: 2012-01-15

Other drugs received by patient: Lithium Carbonate; Effexor; Tercian; Imovane; Norvir



Possible Isentress side effects in 40 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-01-27

Patient: 40 year old female

Reactions: Cytolytic Hepatitis, Cholestasis, Neutropenia, Pyrexia, Dermatitis Exfoliative, Drug Rash With Eosinophilia and Systemic Symptoms, Eosinophilia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Abacavir Sulfate and Lamivudine
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-11-18
    End date: 2011-12-21

Imatinib Mesylate
    Administration route: Oral
    Indication: Gastrointestinal Neoplasm
    Start date: 2011-11-22
    End date: 2011-12-01

Isentress
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-11-25
    End date: 2011-12-21



Possible Isentress side effects in 63 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-01-23

Patient: 63 year old male

Reactions: Tubulointerstitial Nephritis, Cytolytic Hepatitis, General Physical Health Deterioration, Cholestasis, Eosinophilia, Glomerulonephritis Membranous, Nephrotic Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atazanavir Sulfate
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-04-27

Efavirenz
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-04-27

Isentress
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-04-27
    End date: 2011-12-09

Ritonavir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-04-27

Other drugs received by patient: Acebutolol Hydrochloride; Pravastatin Sodium; Aspirin Lysine; Aspirin Lysine; Sulfamethoxazole and Trimethoprim; Clopidogrel Bisulfate



Possible Isentress side effects in 61 year old male

Reported by a physician from France on 2012-01-23

Patient: 61 year old male

Reactions: Tubulointerstitial Nephritis, Cytolytic Hepatitis, Cholestasis, Glomerulonephritis Membranous, Nephrotic Syndrome, Eosinophilia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bactrim

Isentress
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-04-27
    End date: 2011-12-09

Norvir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-04-27

Reyataz
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-04-27

Sustiva
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-04-27

Other drugs received by patient: Sectral; Perindopril Erbumine; Plavix; Aspegic 325; Aspirin; Pravastatin



Possible Isentress side effects in 61 year old male

Reported by a consumer/non-health professional from France on 2012-01-16

Patient: 61 year old male

Reactions: Tubulointerstitial Nephritis, Cytolytic Hepatitis, Cholestasis, Glomerulonephritis Membranous, Eosinophilia, Nephrotic Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bactrim

Isentress
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-04-27
    End date: 2011-12-09

Norvir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-04-27

Reyataz
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-04-27

Sustiva
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-04-27

Other drugs received by patient: Sectral; Perindopril Erbumine; Plavix; Aspegic 325; Pravastatin; Aspirin



Possible Isentress side effects in 55 year old female

Reported by a individual with unspecified qualification from France on 2011-11-21

Patient: 55 year old female

Reactions: Hepatic Artery Thrombosis, Peritoneal Haemorrhage, Hepatic Necrosis, Drug Intolerance, Cytolytic Hepatitis, Pyrexia, Liver Transplant, Peritonitis Bacterial, Staphylococcal Infection, Enterococcus Test Positive, Hepatitis Fulminant

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Isentress

Other drugs received by patient: Chondroitin Sulfate Sodium; Aspirin; Enoxaparin Sodium; Esomeprazole; Atovastatin Calcium; Moxifloxacin Hydrochloride; Prednisone; Valacyclovir Hydrochloride; Tramadol HCL; Mycophenolate Mofetil; Tacrolimus; Amlodipine; Lansoprazole; Emtricitabine + Tenofovir Disoproxil FUM; Ethambutol Hydrochloride

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