| Drug Report: TRUVADA (EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE) | ||||||||
| Primary Suspect Reports: 1,932 Total Reports: 6,789 FDA AERS Reports from 11/01/1997 to 08/27/2012 | ||||||||
| Drug Description : | ||||||||
Truvada (emtricitabine and tenofovir) is a combination of two antiretroviral drugs Emtriva (emtricitabine 200mg) and Viread (tenofovir 300 mg) used for the treatment of HIV. By interfering with the replication process, Truvada as part of a combination regimen lowers the amount of HIV-1 in the blood. Truvada was approved by the FDA on August 2, 2004 and is manufactured by Gilead. |
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| Drug Safety Monitor News : | ||||||||
07/16/2012 - FDA Approves Gilead Sciences’ Truvada for Pre-Exposure Prophylaxis |
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| Other Names : | Generic Name : | Report Info: | ||||||
Emtriva And Viread (Co-Formulation), Emtricitabine And Tenofovir |
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | Average Age: 42 Years |
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FDA Listed Names (155) :
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Manufacturer: | Common Conditions: | ||||||
2ctruvada |
Gilead Sciences, Inc. (1,631) |
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| Top TRUVADA Adverse Events/Side Effects |
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| Side Effects MedDRA Preferred Terms |
TRUVADA Primary Suspect Reports | TRUVADA Total Reports |
ROR Score
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PRR Score
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| Reported Report Outcomes for TRUVADA Adverse Events |
| Report Outcomes |
TRUVADA Primary Suspect (# of Reports) (11/01/1997 to 08/27/2012) |
TRUVADA Total (# of Reports) (11/01/1997 to 08/27/2012) |
| Other | 877 (45%) | 2,856 (42%) |
| Hospitalization - Initial or Prolonged | 807 (42%) | 2,769 (41%) |
| Death | 208 (11%) | 643 (9%) |
| Life-Threatening | 174 (9%) | 547 (8%) |
| Congenital Anomaly | 116 (6%) | 384 (6%) |
| Disability | 76 (4%) | 283 (4%) |
| Required Intervention to Prevent Permanent Impairment/Damage | 10 (1%) | 32 (0%) |
| Most Recent TRUVADA Report Reviews/FDA Reports (Primary Suspect) |
| Report Date | Age | Gender | Conditions | Adverse Events | Outcome |
| 08/27/2012 | 68 YR | M |
Hiv Infection |
Chest Discomfort Supraventricular Tachycardia |
Hospitalization - Initial or Prolonged |
| 08/24/2012 | 48 YR | M |
Hiv Infection |
Sepsis Renal Tubular Necrosis |
Life-Threatening |
| 08/24/2012 | Not Stated | F |
Antiretroviral Therapy Hiv Infection |
Ventricular Septal Defect Patent Ductus Arteriosus Syndactyly Show All |
Congenital Anomaly |
| 08/23/2012 | 30 YR | M |
Prophylaxis Against Hiv Infection |
Lower Respiratory Tract Infection |
Hospitalization - Initial or Prolonged |
| 08/22/2012 | 50 YR | M |
Hiv Infection |
Rheumatoid Arthritis Nephrolithiasis |
Other |
| 08/22/2012 | 23 YR | F |
Prophylaxis Against Hiv Infection |
Pregnancy Abortion Spontaneous Headache Show All |
Life-Threatening Other |
| 08/22/2012 | 45 YR | M |
Prophylaxis Against Hiv Infection |
Nephrolithiasis |
Hospitalization - Initial or Prolonged |
| 08/21/2012 | 49 YR | F |
Hiv Infection |
Orthostatic Hypotension Rash Dehydration Show All |
Hospitalization - Initial or Prolonged |
| 08/21/2012 | Not Stated | M |
Hiv Infection Hypertension |
Cleft Lip And Palate |
Congenital Anomaly |
| 08/21/2012 | 32 YR | F |
Hiv Infection |
Abortion Spontaneous |
Other |
