Drug class · FAERS comparison
Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor side effects compared: 4 drugs, 30,759 FDA adverse event reports
How to read this page. Report counts are not incidence rates: a drug with more reports is usually older, more widely used or more publicised, not more dangerous.
Signals are screened against each product's FDA label on its own page; a term flagged across most of a class usually reflects the shared mechanism or the shared patient population.
Members
| Drug | FAERS reports | Serious | Death outcome | Boxed warning | Top labeled signals | Unlabeled (unassessed) |
|---|---|---|---|---|---|---|
| Zidovudine | 13,295 | 95% | 1,654 | boxed | Virologic failure; Immune reconstitution syndrome; Vertical infection transmission | Viral mutation identified; Lipodystrophy acquired |
| Emtricitabine | 7,175 | 95% | 889 | boxed | Chronic kidney disease; Renal impairment; Blood creatinine increased | Anhedonia; Psychotic disorder |
| Emtricitabine | 6,721 | 86% | 85 | boxed | Chronic kidney disease; Renal failure; Acute kidney injury | Renal injury; Skeletal injury |
| Emtricitabine | 3,568 | 76% | 70 | boxed | Chronic kidney disease; Pain; Renal failure | Tooth loss; Osteoporosis |
Class-wide signals (flagged in at least 2 of 4 members)
| Reaction | Members flagged | Median PRR | Reports (sum) | In label |
|---|---|---|---|---|
| Osteopenia | 3/4 | 194.7 | 1,512 | 0/3 members' labels |
| Anhedonia | 3/4 | 137.2 | 2,027 | 0/3 members' labels |
| Osteoporosis | 3/4 | 108.5 | 2,281 | 0/3 members' labels |
| Chronic kidney disease | 3/4 | 67.5 | 3,039 | 3/3 members' labels |
| Nephropathy | 3/4 | 45.4 | 390 | 0/3 members' labels |
| End stage renal disease | 3/4 | 12.6 | 249 | 0/3 members' labels |
| Renal impairment | 3/4 | 12.3 | 697 | 3/3 members' labels |
| Proteinuria | 3/4 | 11.6 | 177 | 0/3 members' labels |
| Skeletal injury | 2/4 | 701.1 | 3,237 | 0/2 members' labels |
| Bone loss | 2/4 | 331.4 | 2,311 | 0/2 members' labels |
| Tooth loss | 2/4 | 285.4 | 2,820 | 0/2 members' labels |
| Multiple fractures | 2/4 | 285.1 | 2,208 | 0/2 members' labels |
| Renal injury | 2/4 | 223.2 | 3,486 | 0/2 members' labels |
| Osteonecrosis | 2/4 | 139.3 | 2,228 | 0/2 members' labels |
| Vitamin d deficiency | 2/4 | 101.5 | 505 | 0/2 members' labels |
| Tooth fracture | 2/4 | 36.4 | 205 | 0/2 members' labels |
| Emotional distress | 2/4 | 34.6 | 2,062 | 0/2 members' labels |
| Renal failure | 2/4 | 33.4 | 2,266 | 2/2 members' labels |
| Foot fracture | 2/4 | 31.6 | 293 | 0/2 members' labels |
| Fracture | 2/4 | 30.7 | 294 | 0/2 members' labels |
| Ankle fracture | 2/4 | 28.4 | 215 | 0/2 members' labels |
| Bone disorder | 2/4 | 24.2 | 234 | 0/2 members' labels |
| Wrist fracture | 2/4 | 22.1 | 132 | 0/2 members' labels |
| Rib fracture | 2/4 | 18.2 | 179 | 0/2 members' labels |
| Intervertebral disc degeneration | 2/4 | 16.4 | 84 | 0/2 members' labels |
| Dental caries | 2/4 | 14.1 | 88 | 0/2 members' labels |
| Anxiety | 2/4 | 13.6 | 1,908 | 0/2 members' labels |
| Decreased activity | 2/4 | 12.9 | 66 | 0/2 members' labels |
| Hip arthroplasty | 2/4 | 11.9 | 94 | 0/2 members' labels |
| Quality of life decreased | 2/4 | 11.2 | 72 | 0/2 members' labels |
Member-specific signals (flagged in exactly one drug)
| Reaction | Drug | Reports | PRR | Label screen |
|---|---|---|---|---|
| Pinealoblastoma | Zidovudine | 79 | 8,777.7 | Not in label — unassessed |
| Progressive external ophthalmoplegia | Zidovudine | 100 | 5,363.9 | Not in label — unassessed |
| Human immunodeficiency virus transmission | Zidovudine | 147 | 2,078.8 | Likely indication confounding |
| Csf hiv escape syndrome | Zidovudine | 55 | 1,030.8 | Not in label — unassessed |
| Mitochondrial toxicity | Zidovudine | 240 | 652.7 | Not in label — unassessed |
| Immune reconstitution syndrome | Zidovudine | 303 | 477.1 | Labeled — boxed warning |
| Neutropenia neonatal | Zidovudine | 51 | 461.2 | Likely indication confounding |
| Lipodystrophy acquired | Zidovudine | 436 | 406.1 | Not in label — unassessed |
| Anaemia neonatal | Zidovudine | 77 | 298.7 | Likely indication confounding |
| Viral mutation identified | Zidovudine | 568 | 285.4 | Not in label — unassessed |
| Virologic failure | Zidovudine | 816 | 281.4 | Labeled (related wording) |
| Trisomy 18 | Zidovudine | 51 | 241.9 | Not in label — unassessed |
| Paranoia | Emtricitabine | 161 | 27.4 | Not in label — unassessed |
| Nephropathy toxic | Emtricitabine | 101 | 26.7 | Not in label — unassessed |
| Renal tubular necrosis | Emtricitabine | 57 | 17.0 | Not in label — unassessed |
| Abortion induced | Emtricitabine | 54 | 16.8 | Not in label — unassessed |
| Psychotic disorder | Emtricitabine | 166 | 16.5 | Not in label — unassessed |
| Hyperbilirubinaemia | Emtricitabine | 57 | 16.3 | Not in label — unassessed |
| Premature delivery | Emtricitabine | 87 | 16.0 | Not in label — unassessed |
| Hepatic cytolysis | Emtricitabine | 56 | 13.4 | Not in label — unassessed |
| Premature baby | Emtricitabine | 134 | 13.0 | Not in label — unassessed |
| Tuberculosis | Emtricitabine | 50 | 11.4 | Labeled — boxed warning |
| Acute kidney injury | Emtricitabine | 440 | 9.0 | Labeled (related wording) |
| Abortion spontaneous | Emtricitabine | 122 | 8.9 | Not in label — unassessed |
| Pain | Emtricitabine | 711 | 6.8 | Labeled adverse reaction |
Common questions
Which human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor has the most FDA adverse event reports?
Zidovudine has the most FAERS co-reports in this class (13,295), followed by Emtricitabine (7,175). Report volume tracks how widely and how long a drug has been used, and how much attention it has had, far more than its risk.
Which side effects are shared across human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor drugs?
Reaction terms flagged in at least half of the 4 members include osteopenia, anhedonia, osteoporosis, chronic kidney disease, nephropathy. A term shared across a class usually reflects the shared mechanism (or the shared patient population) rather than one product.
Does a FAERS signal mean the drug causes the reaction?
No. These are disproportionality signals from voluntary reports with no denominator. Each is screened against the FDA label (known vs unlabeled) on the drug pages; causality needs temporality, dose-response, plausibility and trial or cohort evidence.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, seriousness and death counts from openFDA count queries. Generated 2026-10-08. Not medical advice.