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Isentress (Raltegravir) - Side Effect Reports to FDA

 
 



Index of reports > All Cases (558)

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

 Reports 1 - 30 of 558   Next >>

Possible Isentress side effects in male

Reported by a physician from France on 2012-08-27

Patient: male

Reactions: Oedema Peripheral, Pyrexia, Erythema, Arthritis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Isentress
    Dosage: 400mg twice per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-04

Olmesartan Medoxomil
    Dosage: 40mg per day
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-11-01

Abacavir Sulfate / Lamivudine
    Dosage: 1tab per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-01-30

Fenofibrate
    Dosage: 300mg per day
    Administration route: Oral
    Indication: Dyslipidaemia
    Start date: 2012-04-05

Other drugs received by patient: Norvir; Prezista



Possible Isentress side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient:

Reactions: Foetal Chromosome Abnormality, Spina Bifida, Foetal Exposure During Pregnancy, Arnold-Chiari Malformation, Vertical Talus

Drug(s) suspected as cause:
Truvada
    Dosage: 1 df, unk
    Start date: 2011-07-13
    End date: 2011-10-27

Reyataz
    Dosage: 300 mg, qd
    Start date: 2011-07-13
    End date: 2011-10-27

Combivir
    Dosage: 2 df, unk
    Start date: 2011-11-21

Norvir
    Dosage: 100 mg, qd
    Start date: 2011-07-13
    End date: 2011-10-27

Isentress
    Dosage: 800 mg, qd
    Start date: 2011-11-21



Possible Isentress side effects in 18 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: 18 year old female

Reactions: Amniotic Fluid Volume Decreased, Maternal Exposure During Pregnancy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prezista
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-11-15
    End date: 2012-05-16

Ritonavir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-11-15
    End date: 2012-05-16

Isentress
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-11-15
    End date: 2012-05-16

Epzicom
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-11-15
    End date: 2012-05-16

Etravirine
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-11-15
    End date: 2012-05-16



Possible Isentress side effects in

Reported by a physician from Japan on 2012-08-27

Patient:

Reactions: Hepatic Function Abnormal, Cardiac Failure

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Kaletra
    Dosage: divided dose frequency unknown
    Administration route: Oral
    Start date: 2004-08-31
    End date: 2006-09-21

Kaletra
    Dosage: divided dose frequency unknown
    Administration route: Oral
    Start date: 2006-10-26
    End date: 2011-07-07

Invirase
    Dosage: divided dose requency u
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-10-26

Kaletra
    Dosage: divided dose frequency unknown
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2002-09-03
    End date: 2004-08-04

Isentress
    Dosage: divided dose frequency unknown
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2008-07-31
    End date: 2011-08-07

Other drugs received by patient: Halcion



Possible Isentress side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-26

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Isentress

Other drugs received by patient: Prezista; Truvada; Norvir



Possible Isentress side effects in male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-24

Patient: male

Reactions: Sepsis, Renal Tubular Necrosis

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Emtricitabine / Tenofovir Disoproxil Fumarate
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-10-20
    End date: 2010-10-27

Isentress
    Dosage: unk, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-10-20
    End date: 2010-10-27

Other drugs received by patient: Meropen / 01250501 /; Zosyn



Possible Isentress side effects in

Reported by a physician from United States on 2012-08-24

Patient:

Reactions: Volvulus, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Isentress

Other drugs received by patient: Lamivudine; Kaletra; Nevirapine; Zidovudine; Tenofovir Disoproxil Fumarate



Possible Isentress side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient:

Reactions: Maternal Exposure During Pregnancy, Adverse Event

Drug(s) suspected as cause:
Isentress

Other drugs received by patient: Zidovudine; Lamivudine; Tenofovir Disoproxil Fumarate; Nevirapine; Kaletra



Possible Isentress side effects in

Reported by a physician from Japan on 2012-08-24

Patient:

Reactions: Sepsis, Renal Tubular Necrosis

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Isentress
    Dosage: 800 mg, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-10-20
    End date: 2010-10-27

Truvada
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-10-20
    End date: 2010-10-27

Isentress
    Dosage: 800 mg, qd
    Administration route: Oral
    Start date: 2010-11-10



Possible Isentress side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-24

Patient: male

Reactions: Renal Failure, Coma, Convulsion

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Rifabutin
    Administration route: Oral
    Indication: Atypical Mycobacterium Pericarditis
    Start date: 2012-07-11

Prazepam
    Dosage: 1 unit
    Administration route: Oral
    Start date: 2012-07-10

Olanzapine
    Dosage: 1 unit
    Administration route: Oral
    Start date: 2012-01-01

Truvada
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-03-01

Leucovorin Calcium
    Administration route: Oral
    Start date: 2012-07-10

Acetaminophen
    Indication: Pain
    Start date: 2012-07-11

Kaletra
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-03-01

Acupan
    Indication: Pain
    Start date: 2012-07-16
    End date: 2012-07-27

Potassium Chloride
    Administration route: Oral
    Start date: 2012-07-10

Clarithromycin
    Administration route: Oral
    Indication: Atypical Mycobacterium Pericarditis
    Start date: 2012-07-11

Amikacin
    Indication: Atypical Mycobacterium Pericarditis
    Start date: 2012-07-11

Cernevit-12
    Indication: Vitamin Supplementation
    Start date: 2012-07-10
    End date: 2012-08-02

Perikabiven
    Indication: Parenteral Nutrition
    Start date: 2012-07-10

Isentress
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-05-01

Bactrim
    Administration route: Oral
    Indication: Atypical Mycobacterium Pericarditis
    Start date: 2012-07-13

Myambutol
    Dosage: 2 units
    Administration route: Oral
    Start date: 2012-07-11



Possible Isentress side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient:

Reactions: Dysphagia

Drug(s) suspected as cause:
Isentress



Possible Isentress side effects in

Reported by a physician from United States on 2012-08-23

Patient:

Reactions: Inappropriate Schedule of Drug Administration, NO Adverse Event

Drug(s) suspected as cause:
Isentress
    Dosage: 400 mg, bid
    Administration route: Oral

Isentress
    Dosage: 800 mg, qd
    Administration route: Oral



Possible Isentress side effects in

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-23

Patient:

Reactions: Arthritis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Isentress
    Dosage: 400 mg, bid
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-04

Fenofibrate
    Dosage: 300 mg, qd
    Administration route: Oral
    Indication: Dyslipidaemia
    Start date: 2012-04-05

Abacavir Sulfate / Lamivudine
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-01-30

Olmesartan Medoxomil
    Dosage: 40 mg, qd
    Indication: Hypertension
    Start date: 2011-11-01



Possible Isentress side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Isentress

Other drugs received by patient: Truvada; Norvir; Prezista



Possible Isentress side effects in

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-23

Patient:

Reactions: Cholestasis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epivir
    Dosage: 150 mg, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-05-22
    End date: 2012-06-12

Viramune
    Dosage: 200 mg, bid
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-05-22
    End date: 2012-06-12

Isentress
    Dosage: 400 mg, bid
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-05-22
    End date: 2012-06-12



Possible Isentress side effects in

Reported by a pharmacist from United States on 2012-08-23

Patient:

Reactions: Hospitalisation, Gastrointestinal Tube Insertion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Isentress



Possible Isentress side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23

Patient:

Reactions: Septic Shock

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Isentress



Possible Isentress side effects in

Reported by a physician from France on 2012-08-23

Patient:

Reactions: Diarrhoea, Pyrexia, Rash

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Isentress
    Dosage: 400 mg, bid
    Indication: HIV Infection
    Start date: 2012-07-10

Maraviroc
    Dosage: 300 mg, bid
    Start date: 2012-07-10



Possible Isentress side effects in

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-23

Patient:

Reactions: Gastric Haemorrhage

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Isentress

Other drugs received by patient: Hepsal; Omeprazole; Bisoprolol Fumarate; Dexamethasone; Nystatin; Rifampicin; Thiamin HCL TAB; Truvada; Cacit Vitamine D3; Gentamicin; Mirtazapine; Acetaminophen; Omeprazole; Zopiclone; Sulfamethoxazole Trimethoprim; Meropenem; Valcyte; Galfer; Moxifloxacin Hydrochloride; Galfer; Targocid; Trizivir



Possible Isentress side effects in

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-23

Patient:

Reactions: Fanconi Syndrome, Renal Failure Acute

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Prezista
    Dosage: 400 mg, bid
    Administration route: Oral
    End date: 2011-06-01

Isentress
    Dosage: 400 mg, bid
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-05-27
    End date: 2011-06-01

Videx
    Dosage: unk
    Administration route: Oral
    End date: 2011-05-27

Viread
    Dosage: unk
    Administration route: Oral
    Indication: HIV Infection
    End date: 2011-05-27

Intelence
    Dosage: 200 mg, bid
    Administration route: Oral

Norvir
    Dosage: unk
    Administration route: Oral
    End date: 2011-06-01

Other drugs received by patient: [composition Unspecified]; Aspirin; Crestor; Clomipramine Hydrochloride; Omeprazole



Possible Isentress side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23

Patient:

Reactions: Maternal Exposure During Pregnancy, Adverse Event

Drug(s) suspected as cause:
Isentress

Other drugs received by patient: Zidovudine; Nevirapine; Tenofovir Disoproxil Fumarate; Lamivudine; Kaletra



Possible Isentress side effects in

Reported by a pharmacist from United States on 2012-08-23

Patient:

Reactions: Drug Dose Omission, Dysphagia

Drug(s) suspected as cause:
Isentress



Possible Isentress side effects in

Reported by a physician from France on 2012-08-23

Patient:

Reactions: Renal Failure, Malaise, Vision Blurred

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vimpat
    Dosage: 100 mg, bid
    Indication: Neuropathy Peripheral
    Start date: 2012-06-18

Vitamin D
    Dosage: 2 df, qd
    Indication: Hypovitaminosis
    Start date: 2009-09-21

Isentress
    Dosage: 400 mg, bid
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-02-23

Olmesartan Medoxomil and Hydrochlorothizide
    Dosage: 20 mg, qd
    Indication: Hypertension
    Start date: 2008-06-23
    End date: 2012-07-23

Maraviroc
    Dosage: 300 mg, bid
    Indication: HIV Infection
    Start date: 2012-02-23



Possible Isentress side effects in 54 year old male

Reported by a physician from France on 2012-08-23

Patient: 54 year old male

Reactions: Fanconi Syndrome, Mitochondrial Cytopathy, Drug Interaction

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Norvir
    Administration route: Oral
    Start date: 2011-06-01

Prezista
    Administration route: Oral
    End date: 2011-06-01

Isentress
    Dosage: film coated
    Administration route: Oral
    Start date: 2011-05-27
    End date: 2011-06-01

Other drugs received by patient possibly interacting with the suspect drug:
Videx
    Administration route: Oral
    Indication: HIV Infection
    End date: 2011-05-27

Viread
    Administration route: Oral
    Indication: HIV Infection
    End date: 2011-05-27

Other drugs received by patient: Sertraline Hydrochloride; Clomipramine HCL; Aspirin; Crestor; Omeprazole



Possible Isentress side effects in

Reported by a physician from United States on 2012-08-23

Patient:

Reactions: Malabsorption, Gastrointestinal Disorder

Drug(s) suspected as cause:
Isentress



Possible Isentress side effects in

Reported by a physician from Japan on 2012-08-22

Patient:

Reactions: Diabetes Mellitus, Hypertriglyceridaemia

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Epivir
    Dosage: 150 mg, bid
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2003-09-16
    End date: 2006-02-28

Isentress
    Dosage: 800 mg divided dose frequency u
    Administration route: Oral
    Start date: 2008-08-05

Epivir
    Dosage: 150 mg, bid
    Administration route: Oral
    Start date: 2008-12-16

Intelence
    Dosage: 200 mg, bid
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-02-11

Kaletra
    Dosage: 4 df
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2007-07-04
    End date: 2008-01-08

Zerit
    Dosage: 60 mg divided dose frequency u
    Administration route: Oral
    Start date: 2008-12-16
    End date: 2009-02-10

Truvada
    Dosage: 1 df, unk
    Administration route: Oral
    Start date: 2008-08-05
    End date: 2008-12-15

Zerit
    Dosage: 80 mg
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2003-09-16
    End date: 2006-02-28

Prezista
    Dosage: 1200 mg
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2008-01-09
    End date: 2008-05-01

Truvada
    Dosage: 1df
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2007-07-04
    End date: 2008-05-01

Other drugs received by patient: Rhythmy



Possible Isentress side effects in 52 year old male

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 52 year old male, weighing 94.3 kg (207.5 pounds)

Reactions: Abdominal Pain, Blood Urine Present, Wrong Technique in Drug Usage Process, Hypersensitivity, LIP Disorder, Drug Ineffective, Urinary Tract Infection, Erectile Dysfunction, Somnolence, Neuropathy Peripheral, Prostatomegaly

Drug(s) suspected as cause:
Gabapentin
    Dosage: unk
    Indication: Neuropathy Peripheral
    Start date: 2010-01-01

Vicodin
    Dosage: unk
    Indication: Pain in Extremity

Alcohol
    Dosage: unk

Norvir
    Dosage: unk
    Indication: HIV Infection
    End date: 2007-01-01

Isentress
    Dosage: 400 mg, 2x/day
    Indication: HIV Infection

Flomax
    Dosage: 0.4 mg, daily
    Indication: Prostatomegaly

Tramadol HCL
    Dosage: 50 mg, unk
    Indication: Migraine

Vicodin
    Indication: Back Pain

Intelence
    Dosage: 100 mg, 4x/day
    Indication: HIV Infection

Intelence
    Dosage: 200 mg, 2x/day

Other drugs received by patient: Ibuprofen



Possible Isentress side effects in

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-22

Patient:

Reactions: Multi-Organ Failure, Metabolic Acidosis, Fanconi Syndrome, Renal Failure Acute

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Isentress
    Dosage: 400 mg, bid
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-05-27
    End date: 2011-06-01

Intelence
    Dosage: 200 mg, bid
    Administration route: Oral

Norvir
    Dosage: unk
    Administration route: Oral
    End date: 2011-06-01

Videx
    Dosage: unk
    Administration route: Oral
    End date: 2011-05-27

Viread
    Dosage: unk
    Administration route: Oral
    Indication: HIV Infection
    End date: 2011-05-27

Prezista
    Dosage: 400 mg, bid
    Administration route: Oral
    End date: 2011-06-01

Other drugs received by patient: Crestor; Omeprazole; [composition Unspecified]; Aspirin; Clomipramine Hydrochloride



Possible Isentress side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: female

Reactions: Maternal Exposure During Pregnancy, Pregnancy, Congenital Anomaly in Offspring

Drug(s) suspected as cause:
Lamivudine
    Dosage: unk
    Administration route: Oral
    Indication: Antiretroviral Therapy
    End date: 2010-06-10

Zidovudine
    Dosage: unk
    Administration route: Oral
    Indication: Antiretroviral Therapy
    End date: 2010-06-10

Nevirapine
    Dosage: unk
    Administration route: Oral
    Indication: Antiretroviral Therapy
    End date: 2010-06-10

Kaletra
    Dosage: unk
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2010-06-10

Tenofovir Disoproxil Fumarate
    Dosage: unk
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2010-06-10

Isentress
    Dosage: 800 mg/day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2010-06-10



Possible Isentress side effects in male

Reported by a physician from Japan on 2012-08-22

Patient: male

Reactions: Hypophosphataemia, Diarrhoea, Cardiac Failure, Lactic Acidosis, Liver Disorder

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Kaletra
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2002-09-03
    End date: 2004-08-04

Kaletra
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-10-26
    End date: 2011-08-07

Abacavir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2004-08-31
    End date: 2006-09-21

Kaletra
    Administration route: Oral
    Start date: 2004-08-31
    End date: 2006-09-21

Didanosine
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2002-09-03
    End date: 2004-08-04

Didanosine
    Administration route: Oral
    Start date: 2004-08-31
    End date: 2006-09-21

Didanosine
    Administration route: Oral
    Start date: 2006-10-26

Tenofovir Disoproxil Fumarate
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2004-08-31
    End date: 2006-09-21

Isentress
    Dosage: 800mg daily
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-08-07

Stavudine
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2002-04-01
    End date: 2004-08-04

Other drugs received by patient: Glycyron; Saquinavir; Allopurinol; Bifidobacterium; Loperamide HCL; Allopurinol



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