DOLUTEGRAVIR for Hiv infection: Side Effects & Safety Data
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There are 7,207 adverse event reports in the FDA FAERS database where DOLUTEGRAVIR was used for Hiv infection.
Most Reported Side Effects for DOLUTEGRAVIR
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Foetal exposure during pregnancy | 1,036 | 9.6% | 93 | 66 |
| Exposure during pregnancy | 776 | 7.2% | 110 | 95 |
| Virologic failure | 770 | 7.2% | 16 | 61 |
| Pathogen resistance | 586 | 5.4% | 2 | 13 |
| Maternal exposure during pregnancy | 517 | 4.8% | 14 | 41 |
| Viral mutation identified | 510 | 4.7% | 4 | 11 |
| Treatment failure | 453 | 4.2% | 96 | 11 |
| Drug ineffective | 447 | 4.2% | 133 | 55 |
| Off label use | 413 | 3.8% | 116 | 48 |
| Blood hiv rna increased | 410 | 3.8% | 12 | 28 |
| Treatment noncompliance | 409 | 3.8% | 20 | 90 |
| Immune reconstitution inflammatory syndrome | 403 | 3.7% | 58 | 208 |
| Headache | 401 | 3.7% | 102 | 76 |
| Pyrexia | 398 | 3.7% | 122 | 154 |
| Death | 397 | 3.7% | 392 | 29 |
Other Indications for DOLUTEGRAVIR
Product used for unknown indication (2,252)
Antiretroviral therapy (241)
Acquired immunodeficiency syndrome (149)
Prophylaxis against hiv infection (95)
Hiv test positive (77)
Maternal exposure timing unspecified (49)
Hepatitis b (30)
Antiviral treatment (24)
Acute hiv infection (23)
Hiv test (23)
Other Drugs Used for Hiv infection
EMTRICITABINE\TENOFOVIR DISOPROXIL (27,672)
TENOFOVIR DISOPROXIL (19,662)
EFAVIRENZ\EMTRICITABINE\TENOFOVIR DISOPROXIL (15,794)
LAMIVUDINE (8,963)
COBICISTAT\ELVITEGRAVIR\EMTRICITABINE\TENOFOVIR DISOPROXIL (6,874)
RITONAVIR (6,739)
EMTRICITABINE\RILPIVIRINE\TENOFOVIR DISOPROXIL (5,840)
EFAVIRENZ (5,261)
BICTEGRAVIR\EMTRICITABINE\TENOFOVIR ALAFENAMIDE (4,854)
RALTEGRAVIR (4,566)