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 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 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 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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