| Drug Report: VIREAD (TENOFOVIR DISOPROXIL FUMARATE) | ||||||||
| Primary Suspect Reports: 2,282 Total Reports: 8,143 FDA AERS Reports from 11/01/1997 to 08/27/2012 | ||||||||
| Drug Description : | ||||||||
Viread (tenofovir) is an antiretroviral medication used to treat HIV. It is in a class of medications called reverse transcriptase inhibitors and is typically used in combination with other antiviral medications. Manufactured by Gilead, Viread was approved by the FDA on October 26, 2001. |
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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: | ||||||
Tenofovir Disoproxil Fumarate, Tenofovir DF, TDF |
TENOFOVIR DISOPROXIL FUMARATE | Average Age: 43 Years |
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FDA Listed Names (206) :
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Manufacturer: | Common Conditions: | ||||||
(tenofir) |
Gilead Sciences, Inc. (1,974) |
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| Top VIREAD Adverse Events/Side Effects |
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| Side Effects MedDRA Preferred Terms |
VIREAD Primary Suspect Reports | VIREAD Total Reports |
ROR Score
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PRR Score
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Compare Top Drugs |
| Renal Failure Acute | 228 (10%) | 513 (6%) | Premium Feature | Premium Feature |
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| Renal Failure | 170 (7%) | 394 (5%) | Premium Feature | Premium Feature |
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| Blood Creatinine Increased | 154 (7%) | 285 (3%) | Premium Feature | Premium Feature |
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| Fanconi Syndrome Acquired | 141 (6%) | 182 (2%) | Premium Feature | Premium Feature |
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| Abortion Spontaneous | 120 (5%) | 259 (3%) | Premium Feature | Premium Feature |
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| Vomiting | 120 (5%) | 465 (6%) | Premium Feature | Premium Feature |
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| Nausea | 115 (5%) | 438 (5%) | Premium Feature | Premium Feature |
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| Pyrexia | 110 (5%) | 590 (7%) | Premium Feature | Premium Feature |
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| Weight Decreased | 108 (5%) | 307 (4%) | Premium Feature | Premium Feature |
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| Asthenia | 106 (5%) | 324 (4%) | Premium Feature | Premium Feature |
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| Reported Report Outcomes for VIREAD Adverse Events |
| Report Outcomes |
VIREAD Primary Suspect (# of Reports) (11/01/1997 to 08/27/2012) |
VIREAD Total (# of Reports) (11/01/1997 to 08/27/2012) |
| Other | 1,012 (44%) | 3,225 (40%) |
| Hospitalization - Initial or Prolonged | 981 (43%) | 3,729 (46%) |
| Death | 220 (10%) | 993 (12%) |
| Life-Threatening | 168 (7%) | 666 (8%) |
| Disability | 123 (5%) | 389 (5%) |
| Congenital Anomaly | 70 (3%) | 247 (3%) |
| Required Intervention to Prevent Permanent Impairment/Damage | 38 (2%) | 219 (3%) |
| Most Recent VIREAD Report Reviews/FDA Reports (Primary Suspect) |
| Report Date | Age | Gender | Conditions | Adverse Events | Outcome |
| 08/27/2012 | Not Stated | F |
Hiv Infection |
Congenital Anomaly |
Congenital Anomaly |
| 08/24/2012 | 31 YR | M |
Hiv Infection Tuberculosis |
Deep Vein Thrombosis |
Hospitalization - Initial or Prolonged |
| 08/23/2012 | 57 YR | M |
Hepatitis B |
Arrhythmia |
Death Hospitalization - Initial or Prolonged |
| 08/23/2012 | 62 YR | M |
Hepatitis B |
Squamous Cell Carcinoma |
Other |
| 08/23/2012 | 43 YR | M |
Hiv Infection |
Death |
Death |
| 08/23/2012 | 53 YR | M |
Hiv Infection |
Fanconi Syndrome Acquired Cd4 Lymphocytes Decreased Osteomalacia |
Other |
| 08/23/2012 | 42 YR | M |
Hiv Infection |
Osteosclerosis Osteonecrosis Osteomalacia Show All |
Other |
| 08/22/2012 | 42 YR | M |
Diabetes Mellitus Hiv Infection Hypercholesterolaemia |
Drug Interaction |
Life-Threatening |
| 08/21/2012 | 69 YR | F |
Hiv Infection |
Diarrhoea Renal Impairment Dehydration |
Hospitalization - Initial or Prolonged |
| 08/17/2012 | Not Stated | M |
Hiv Infection |
Renal Failure Acute |
Other |
