Drug Report: INTELENCE (ETRAVIRINE)
Primary Suspect Reports: 378 Total Reports: 1,305 FDA AERS Reports from 11/01/1997 to 08/27/2012
Drug Description :

Intelence (etravirine) is an antiretroviral medication indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in treatment-experienced adult patients. Intelence was FDA approved on January 8, 2008 and is marketed by Janssen Therapeutics, Division of Janssen Products, LP.

From 11/01/1997 to 08/27/2012, there have been 378 reports of a serious adverse event where INTELENCE was identified as the primary suspect drug causing that event. During that time period, the top three adverse events reported in cases where INTELENCE was identified as the primary suspect drug were: Rash, Pyrexia and Drug Interaction.

Drug Safety Monitor News :

03/27/2012 - FDA Approves Intelence for Treatment-Experienced Pediatric Patients with HIV-1

Other Names : Generic Name : Report Info:

Etravirine, R165335-TMC125, TMC125

ETRAVIRINE

Average Age: 46 Years
Gender: 71% M, 29% F
Average Duration of Treatment: 783 Days

FDA Listed Names (42) : How to read this section Manufacturer: Common Conditions:

Blinded; Tmc125
Emtravirine
Entravirine
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Tibotec Pharmaceuticals, Ltd. (304)
Johnson & Johnson (64)
McNEIL-PPC, Inc. (2)

HIV INFECTION
DRUG EXPOSURE DURING PREGNANCY
ANTIRETROVIRAL THERAPY

INTELENCE Adverse Event Timeline
Top INTELENCE Adverse Events/Side Effects How to read this section
How to read this section
Side Effects
MedDRA Preferred Terms
INTELENCE Primary Suspect Reports INTELENCE Total Reports ROR Score
How to read this section
PRR Score
How to read this section
Compare Top Drugs
Rash 32 (8%) 68 (5%) Premium Feature Premium Feature
Pyrexia 24 (6%) 68 (5%) Premium Feature Premium Feature
Drug Interaction 14 (4%) 66 (5%) Premium Feature Premium Feature
Nausea 13 (3%) 41 (3%) Premium Feature Premium Feature
Fatigue 11 (3%) 34 (3%) Premium Feature Premium Feature
Immune Reconstitution Syndrome 11 (3%) 44 (3%) Premium Feature Premium Feature
Maternal Exposure During Pregnancy 11 (3%) 60 (5%) Premium Feature Premium Feature
Renal Failure Acute 11 (3%) 49 (4%) Premium Feature Premium Feature
Vomiting 11 (3%) 29 (2%) Premium Feature Premium Feature
Aspartate Aminotransferase Increased 10 (3%) 34 (3%) Premium Feature Premium Feature
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Reported Report Outcomes for INTELENCE Adverse Events
Report Outcomes INTELENCE Primary Suspect
(# of Reports)
(11/01/1997 to 08/27/2012)
INTELENCE Total
(# of Reports)
(11/01/1997 to 08/27/2012)
Other 188 (50%) 572 (44%)
Hospitalization - Initial or Prolonged 160 (42%) 596 (46%)
Life-Threatening 51 (13%) 138 (11%)
Death 29 (8%) 125 (10%)
Disability 23 (6%) 92 (7%)
Congenital Anomaly 4 (1%) 30 (2%)
Required Intervention to Prevent Permanent Impairment/Damage 1 (0%) 1 (0%)
Most Recent INTELENCE Report Reviews/FDA Reports (Primary Suspect)
Report Date Age Gender Conditions Adverse Events Outcome
08/22/2012 54 YR M Hiv Infection
Multi-organ Failure
Renal Failure Acute
Fanconi Syndrome
Death
Hospitalization - Initial or Prolonged
08/21/2012 Not Stated Not Stated Hiv Infection
Creatinine Renal Clearance Decreased
Other
08/10/2012 Not Stated M Cytomegalovirus Infection
Hiv Infection
Tuberculosis
Drug Eruption
Hospitalization - Initial or Prolonged
Other
08/09/2012 54 YR M Hiv Infection
Multi-organ Failure
Renal Failure Acute
Fanconi Syndrome
Death
Hospitalization - Initial or Prolonged
08/03/2012 45 YR M Hiv Infection
Product Coating Issue
Retching
Choking

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Other
07/27/2012 48 YR M Hiv Infection
Pain
Retching
Foreign Body

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Life-Threatening
07/25/2012 55 YR M Antiviral Prophylaxis
Chronic Obstructive Pulmonary Disease
Hiv Infection

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Oedema Peripheral
Osteonecrosis
Gait Disturbance

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Disability
Other
07/20/2012 Not Stated Not Stated Hiv Infection
Cerebral Infarction
Other
07/16/2012 49 YR M Hiv Infection
Idiopathic Thrombocytopenic Purpura
Hospitalization - Initial or Prolonged
07/16/2012 49 YR F Hiv Infection
Oral Candidiasis
Sinusitis
Dystonia
Nightmare
Accidental Overdose
Other

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