Drug · FAERS side-effect profile with label screen

Emtricitabine and Tenofovir Alafenamide side effects: what 11,270 FDA adverse event reports show

Emtricitabine And Tenofovir Alafenamide · 949 reaction terms · 55,312 drug–reaction co-reports · data 2026-09-14

Drug class

Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor

FDA label (Established Pharmacologic Class) of the closest related product

Label matched

Emtricitabine (Emtricitabine)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

11,270 reports · 76% serious · 364 with death outcome · 23% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Emtricitabine capsules are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Emtricitabine, a nucleoside analog HIV-1 reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. ( 1 )

FDA label, Indications and Usage

What it is

Emtricitabine (FTC) is a synthetic nucleoside analog with activity against human immunodeficiency virus type 1 (HIV-1) reverse transcriptase.

FDA label, Description section

Boxed warning

POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B (HBV) have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued emtricitabine. Hepatic functi.

FDA label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled (related wording) 3Reporting / coding artifact 1Lab value / disease marker 8Not in label — unassessed 28

What the badges mean

Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 909 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Bone demineralisation	240	545.0 472.4–628.7ROR 556.8 · χ² 100,058 / p <1e-300	406.7 EB05 365.3 · IC025 +7.6 3/3 methods agree	Not in label — unassessed	serious n=213	not reported in cached trials
Bone loss	2,636	391.7 377.2–406.8ROR 510.9 · χ² 846,781 / p <1e-300	322.2 EB05 312.0 · IC025 +8.2 3/3 methods agree	Not in label — unassessed	serious PRR 263.2 · 99% consumer	not reported in cached trials
Skeletal injury	1,628	343.3 326.7–360.7ROR 401.1 · χ² 467,999 / p <1e-300	288.4 EB05 276.8 · IC025 +8.0 3/3 methods agree	Not in label — unassessed	serious PRR 225.6 · 100% consumer	not reported in cached trials
Bone density decreased	4,845	336.5 328.4–344.8ROR 589.4 · χ² 1,371,298 / p <1e-300	284.2 EB05 277.5 · IC025 +8.1 3/3 methods agree	Lab value / disease marker	serious PRR 245.3 · 100% consumer	not reported in cached trials
Multiple fractures	2,435	320.9 308.7–333.7ROR 409.1 · χ² 661,232 / p <1e-300	272.7 EB05 263.7 · IC025 +7.9 3/3 methods agree	Not in label — unassessed	serious PRR 221.6 · 100% consumer	not reported in cached trials
Tooth loss	2,318	232.5 223.6–241.8ROR 292.5 · χ² 474,562 / p <1e-300	206.1 EB05 199.2 · IC025 +7.6 3/3 methods agree	Not in label — unassessed	serious PRR 171.6 · 100% consumer	not reported in cached trials
Osteopenia	1,508	204.2 194.3–214.7ROR 235.6 · χ² 274,414 / p <1e-300	183.4 EB05 175.8 · IC025 +7.4 3/3 methods agree	Not in label — unassessed	serious PRR 143.4 · 98% consumer	not reported in cached trials
Bone density abnormal	337	182.5 163.4–203.8ROR 188.1 · χ² 55,172 / p <1e-300	164.5 EB05 150.3 · IC025 +6.9 3/3 methods agree	Lab value / disease marker	serious n=280 · 100% consumer	not reported in cached trials
Tooth injury	375	174.5 157.2–193.7ROR 180.5 · χ² 58,924 / p <1e-300	158.2 EB05 145.2 · IC025 +6.9 3/3 methods agree	Not in label — unassessed	serious n=368 · 100% consumer	not reported in cached trials
Protein total abnormal	111	172.7 142.3–209.7ROR 174.4 · χ² 17,166 / p <1e-300	153.8 EB05 131.3 · IC025 +6.2 3/3 methods agree	Lab value / disease marker	serious n=109	not reported in cached trials
Osteonecrosis (bone death)	2,607	158.9 153.3–164.6ROR 206.4 · χ² 376,868 / p <1e-300	146.1 EB05 141.5 · IC025 +7.1 3/3 methods agree	Not in label — unassessed	serious PRR 112.3 · 97% consumer	not reported in cached trials
Anhedonia	1,701	127.7 122.0–133.7ROR 150.2 · χ² 200,053 / p <1e-300	119.3 EB05 114.6 · IC025 +6.8 3/3 methods agree	Not in label — unassessed	serious PRR 93.1 · 100% consumer	not reported in cached trials
Renal injury	1,882	124.5 119.2–129.9ROR 149.2 · χ² 216,037 / p <1e-300	116.5 EB05 112.1 · IC025 +6.7 3/3 methods agree	Not in label — unassessed	serious PRR 89.1 · 96% consumer	not reported in cached trials
Degenerative bone disease	26	116.1 78.1–172.4ROR 116.3 · χ² 2,682 / p <1e-300	101.3 EB05 72.6 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=26	not reported in cached trials
Osteoporosis	2,273	108.7 104.6–112.9ROR 135.9 · χ² 229,317 / p <1e-300	102.6 EB05 99.1 · IC025 +6.6 3/3 methods agree	Not in label — unassessed	serious PRR 90.4 · 92% consumer	not reported in cached trials
Syphilis	36	96.8 69.3–135.3ROR 97.2 · χ² 3,153 / p <1e-300	87.9 EB05 66.3 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious n=34 · 92% clinician	NCT00557245: 27/1,579 (1.7%) on Emtricitabine and Tenofovir Alafenamide; 23/1,584 (1.5%) control
Fanconi syndrome acquired	70	77.5 61.0–98.3ROR 77.9 · χ² 4,997 / p <1e-300	72.9 EB05 59.7 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious n=70	not reported in cached trials
Glomerular filtration rate abnormal	54	74.3 56.6–97.4ROR 74.6 · χ² 3,682 / p <1e-300	69.7 EB05 55.5 · IC025 +5.0 3/3 methods agree	Lab value / disease marker	serious n=52	not reported in cached trials
Economic problem	589	73.9 68.2–80.1ROR 77.9 · χ² 40,684 / p <1e-300	70.9 EB05 66.3 · IC025 +5.9 3/3 methods agree	Reporting / coding artifact	serious PRR 55.5 · 99% consumer	not reported in cached trials
Chronic kidney disease	2,873	72.4 70.1–74.8ROR 96.9 · χ² 195,364 / p <1e-300	69.7 EB05 67.6 · IC025 +6.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 53.9 · 97% consumer	not reported in cached trials
Blood hiv rna increased	66	71.1 55.6–90.8ROR 71.5 · χ² 4,322 / p <1e-300	67.2 EB05 54.6 · IC025 +5.1 3/3 methods agree	Lab value / disease marker	serious n=55	not reported in cached trials
Vitamin d deficiency	351	69.5 62.6–77.2ROR 71.7 · χ² 22,770 / p <1e-300	66.7 EB05 61.1 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious PRR 52.3 · 94% consumer	not reported in cached trials
Osteomalacia	54	66.7 50.9–87.5ROR 67.0 · χ² 3,310 / p <1e-300	63.0 EB05 50.2 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious n=54	not reported in cached trials
Nephropathy	289	59.1 52.6–66.3ROR 60.6 · χ² 15,941 / p <1e-300	57.1 EB05 51.8 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious PRR 45.7 · 93% consumer	not reported in cached trials
Teeth brittle	31	56.3 39.4–80.5ROR 56.5 · χ² 1,581 / p <1e-300	53.0 EB05 39.1 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=25	not reported in cached trials
Hiv test positive	19	54.5 34.5–85.9ROR 54.6 · χ² 917 / p 9e-202	50.4 EB05 34.1 · IC025 +3.7 3/3 methods agree	Lab value / disease marker	serious n=10	not reported in cached trials
Congenital hydrocephalus	13	48.4 27.9–83.9ROR 48.4 · χ² 542 / p 3e-120	44.3 EB05 27.6 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=13	not reported in cached trials
Glomerular filtration rate increased	20	46.9 30.1–73.1ROR 47.0 · χ² 832 / p 3e-183	44.0 EB05 30.1 · IC025 +3.7 3/3 methods agree	Lab value / disease marker	serious n=17	not reported in cached trials
Protein total increased	58	41.6 32.1–53.9ROR 41.8 · χ² 2,206 / p <1e-300	40.2 EB05 32.2 · IC025 +4.5 3/3 methods agree	Lab value / disease marker	serious n=45	not reported in cached trials
Fracture	342	34.2 30.8–38.0ROR 35.2 · χ² 10,798 / p <1e-300	33.5 EB05 30.7 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious PRR 28.0 · 97% consumer	NCT00557245: 1/1,579 (0.1%) on Emtricitabine and Tenofovir Alafenamide (serious AE)
Hand fracture	124	33.1 27.8–39.5ROR 33.5 · χ² 3,763 / p <1e-300	32.4 EB05 27.9 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=122	not reported in cached trials
Renal failure (kidney failure)	2,249	31.8 30.6–33.0ROR 39.5 · χ² 66,339 / p <1e-300	31.3 EB05 30.2 · IC025 +4.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 24.0 · 90% consumer	NCT00557245: 1/1,584 (0.1%) on Emtricitabine and Tenofovir Alafenamide (serious AE)
Emotional distress	1,925	29.9 28.7–31.2ROR 35.9 · χ² 53,259 / p <1e-300	29.5 EB05 28.4 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious PRR 23.4 · 100% consumer	not reported in cached trials
Ulna fracture	15	28.5 17.1–47.5ROR 28.6 · χ² 366 / p 9e-82	27.2 EB05 17.5 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=15	not reported in cached trials
Chronic kidney disease-mineral and bone disorder	16	28.1 17.1–46.0ROR 28.1 · χ² 385 / p 5e-86	26.9 EB05 17.5 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=16	not reported in cached trials
Fibula fracture	43	28.0 20.7–37.8ROR 28.1 · χ² 1,075 / p 4e-236	27.3 EB05 21.1 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=43	NCT00557245: 1/1,584 (0.1%) on Emtricitabine and Tenofovir Alafenamide (serious AE)
Foot fracture	278	27.6 24.5–31.0ROR 28.3 · χ² 6,999 / p <1e-300	27.2 EB05 24.6 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious PRR 24.0	not reported in cached trials
Tooth fracture	151	25.8 22.0–30.3ROR 26.2 · χ² 3,531 / p <1e-300	25.4 EB05 22.2 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 26.3	not reported in cached trials
Immune reconstitution inflammatory syndrome	68	25.6 20.2–32.5ROR 25.8 · χ² 1,562 / p <1e-300	25.1 EB05 20.5 · IC025 +4.0 3/3 methods agree	Labeled (related wording) related wording	serious n=68	not reported in cached trials
Osteoporotic fracture	26	25.4 17.3–37.4ROR 25.5 · χ² 578 / p 4e-128	24.7 EB05 17.7 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=26	not reported in cached trials

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Emtricitabine and Tenofovir Alafenamide as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (4 of 40 signal terms matched).

NCT00557245 — Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples (N=4758, PHASE3; 172 AE terms posted; arms: Tenofovir Disoproxil Fumarate (TDF); Emtricitabine/Tenofovir Disoproxil Fumar; Placebo)

Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Bone density decreased	4,845	336.5 328.4–344.8ROR 589.4 · χ² 1,371,298 / p <1e-300	284.2 EB05 277.5 · IC025 +8.1 3/3 methods agree	Lab value / disease marker	serious PRR 245.3 · 100% consumer	not reported in cached trials
Chronic kidney disease	2,873	72.4 70.1–74.8ROR 96.9 · χ² 195,364 / p <1e-300	69.7 EB05 67.6 · IC025 +6.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 53.9 · 97% consumer	not reported in cached trials
Bone loss	2,636	391.7 377.2–406.8ROR 510.9 · χ² 846,781 / p <1e-300	322.2 EB05 312.0 · IC025 +8.2 3/3 methods agree	Not in label — unassessed	serious PRR 263.2 · 99% consumer	not reported in cached trials
Osteonecrosis (bone death)	2,607	158.9 153.3–164.6ROR 206.4 · χ² 376,868 / p <1e-300	146.1 EB05 141.5 · IC025 +7.1 3/3 methods agree	Not in label — unassessed	serious PRR 112.3 · 97% consumer	not reported in cached trials
Multiple fractures	2,435	320.9 308.7–333.7ROR 409.1 · χ² 661,232 / p <1e-300	272.7 EB05 263.7 · IC025 +7.9 3/3 methods agree	Not in label — unassessed	serious PRR 221.6 · 100% consumer	not reported in cached trials
Tooth loss	2,318	232.5 223.6–241.8ROR 292.5 · χ² 474,562 / p <1e-300	206.1 EB05 199.2 · IC025 +7.6 3/3 methods agree	Not in label — unassessed	serious PRR 171.6 · 100% consumer	not reported in cached trials
Osteoporosis	2,273	108.7 104.6–112.9ROR 135.9 · χ² 229,317 / p <1e-300	102.6 EB05 99.1 · IC025 +6.6 3/3 methods agree	Not in label — unassessed	serious PRR 90.4 · 92% consumer	not reported in cached trials
Renal failure (kidney failure)	2,249	31.8 30.6–33.0ROR 39.5 · χ² 66,339 / p <1e-300	31.3 EB05 30.2 · IC025 +4.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 24.0 · 90% consumer	NCT00557245: 1/1,584 (0.1%) on Emtricitabine and Tenofovir Alafenamide (serious AE)
Pain	2,015	6.1 5.9–6.4ROR 7.2 · χ² 8,836 / p <1e-300	6.1 EB05 5.9 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.7 · 88% consumer	NCT00557245: 2/1,579 (0.1%) on Emtricitabine and Tenofovir Alafenamide; 2/1,584 (0.1%) control (serious AE)
Emotional distress	1,925	29.9 28.7–31.2ROR 35.9 · χ² 53,259 / p <1e-300	29.5 EB05 28.4 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious PRR 23.4 · 100% consumer	not reported in cached trials
Renal injury	1,882	124.5 119.2–129.9ROR 149.2 · χ² 216,037 / p <1e-300	116.5 EB05 112.1 · IC025 +6.7 3/3 methods agree	Not in label — unassessed	serious PRR 89.1 · 96% consumer	not reported in cached trials
Anxiety	1,783	11.7 11.2–12.2ROR 13.7 · χ² 17,555 / p <1e-300	11.6 EB05 11.2 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 11.9 · 95% consumer	NCT00557245: 1/1,579 (0.1%) on Emtricitabine and Tenofovir Alafenamide (serious AE)
Anhedonia	1,701	127.7 122.0–133.7ROR 150.2 · χ² 200,053 / p <1e-300	119.3 EB05 114.6 · IC025 +6.8 3/3 methods agree	Not in label — unassessed	serious PRR 93.1 · 100% consumer	not reported in cached trials
Skeletal injury	1,628	343.3 326.7–360.7ROR 401.1 · χ² 467,999 / p <1e-300	288.4 EB05 276.8 · IC025 +8.0 3/3 methods agree	Not in label — unassessed	serious PRR 225.6 · 100% consumer	not reported in cached trials
Osteopenia	1,508	204.2 194.3–214.7ROR 235.6 · χ² 274,414 / p <1e-300	183.4 EB05 175.8 · IC025 +7.4 3/3 methods agree	Not in label — unassessed	serious PRR 143.4 · 98% consumer	not reported in cached trials

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Bone demineralisation — n=240, PRR 545.0
Bone loss — n=2,636, PRR 391.7
Skeletal injury — n=1,628, PRR 343.3
Multiple fractures — n=2,435, PRR 320.9
Tooth loss — n=2,318, PRR 232.5
Osteopenia — n=1,508, PRR 204.2
Tooth injury — n=375, PRR 174.5
Osteonecrosis — n=2,607, PRR 158.9
Anhedonia — n=1,701, PRR 127.7
Renal injury — n=1,882, PRR 124.5

✓ A hand-written Bradford Hill causality assessment exists for this drug: Tenofovir disoproxil fumarate ↔ Bone loss.

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Emtricitabine and Tenofovir Alafenamide?

In FDA FAERS, the most frequently co-reported reaction terms for Emtricitabine and Tenofovir Alafenamide are bone density decreased, chronic kidney disease, bone loss, osteonecrosis, multiple fractures, tooth loss. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Emtricitabine and Tenofovir Alafenamide have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B (HBV) have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued emtricitabine. Hepatic functi.

Do FAERS signals prove that Emtricitabine and Tenofovir Alafenamide causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID cdfb7868-3eba-46e1-a286-ca40760fd98d, effective 20240207; matched on openfda.generic_name.exact:"EMTRICITABINE")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 949 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath
ClinicalTrials.gov API v2 (query EMTRICITABINE, results-bearing studies sorted by enrollment)

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.