| 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. |
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| Drug Safety Monitor News : | ||||||||
03/27/2012 - FDA Approves Intelence for Treatment-Experienced Pediatric Patients with HIV-1 |
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| Other Names : | Generic Name : | Report Info: | ||||||
Etravirine, R165335-TMC125, TMC125 |
ETRAVIRINE | Average Age: 46 Years |
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FDA Listed Names (42) :
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Manufacturer: | Common Conditions: | ||||||
Blinded; Tmc125 |
Tibotec Pharmaceuticals, Ltd. (304) |
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| Top INTELENCE Adverse Events/Side Effects |
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| Side Effects MedDRA Preferred Terms |
INTELENCE Primary Suspect Reports | INTELENCE Total Reports |
ROR Score
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PRR Score
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| Rash | 32 (8%) | 68 (5%) | Premium Feature | Premium Feature |
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| Pyrexia | 24 (6%) | 68 (5%) | Premium Feature | Premium Feature |
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| Drug Interaction | 14 (4%) | 66 (5%) | Premium Feature | Premium Feature |
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| Nausea | 13 (3%) | 41 (3%) | Premium Feature | Premium Feature |
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| Fatigue | 11 (3%) | 34 (3%) | Premium Feature | Premium Feature |
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| Immune Reconstitution Syndrome | 11 (3%) | 44 (3%) | Premium Feature | Premium Feature |
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| Maternal Exposure During Pregnancy | 11 (3%) | 60 (5%) | Premium Feature | Premium Feature |
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| Renal Failure Acute | 11 (3%) | 49 (4%) | Premium Feature | Premium Feature |
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| Vomiting | 11 (3%) | 29 (2%) | Premium Feature | Premium Feature |
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| 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 Show All |
Other |
| 07/27/2012 | 48 YR | M |
Hiv Infection |
Pain Retching Foreign Body Show All |
Life-Threatening |
| 07/25/2012 | 55 YR | M |
Antiviral Prophylaxis Chronic Obstructive Pulmonary Disease Hiv Infection Show All |
Oedema Peripheral Osteonecrosis Gait Disturbance Show All |
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 |