This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Isentress (Raltegravir) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (558)
Death (108)
Life Threatening Events (46)
Disability (52)
Reports by Reaction Type
Foetal Exposure During Pregnancy (47),
Death (38),
Maternal Exposure During Pregnancy (36),
Anaemia (26),
Pyrexia (24),
Depression (21),
Pneumonia (19),
Cytolytic Hepatitis (19),
Rash (19),
Eosinophilia (19),
Neutropenia (19),
Pancytopenia (17)
Below are a few examples of reports where side effects / adverse reactions may be related to Isentress (Raltegravir). For a complete list or a specific selection of reports, please use the links above.
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 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 2012-08-26
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
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 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 2012-08-23
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 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 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
Possible Isentress side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient: male
Reactions: Volvulus, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Zidovudine
Dosage: unk
Indication: Maternal Exposure During Pregnancy
End date: 2010-06-10
Tenofovir Disoproxil Fumarate
Dosage: unk
Indication: Maternal Exposure During Pregnancy
Start date: 2010-06-10
Isentress
Dosage: 800 mg/day
Indication: Maternal Exposure During Pregnancy
Start date: 2010-06-10
Nevirapine
Dosage: unk
Indication: Maternal Exposure During Pregnancy
End date: 2010-06-10
Kaletra
Dosage: unk
Indication: Maternal Exposure During Pregnancy
Start date: 2010-06-10
Lamivudine
Dosage: unk
Indication: Maternal Exposure During Pregnancy
End date: 2010-06-10
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