Drug · FAERS side-effect profile with label screen

Emtricitabine, Rilpivirine and Tenofovir Disoproxil side effects: what 6,721 FDA adverse event reports show

Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate · 89 reaction terms · 32,532 drug–reaction co-reports · data 2026-09-14

Drug class

Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor

FDA label (Established Pharmacologic Class) · compare the class

Who reports

6,721 reports · 86% serious · 85 with death outcome · 30% 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 adverse reaction 1Labeled (related wording) 4Reporting / coding artifact 1Lab value / disease marker 2Not in label — unassessed 32

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
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. 49 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
Skeletal injury	2,775	1,130.6 1,090.3–1,172.5ROR 1,925.1 · χ² 2,290,874 / p <1e-300	822.4 EB05 797.1 · IC025 +9.4 3/3 methods agree	Not in label — unassessed	serious PRR 569.6 · 100% consumer	no trial data cached
Bone density decreased	3,553	394.7 384.7–404.8ROR 836.1 · χ² 1,238,072 / p <1e-300	349.3 EB05 339.7 · IC025 +8.3 3/3 methods agree	Lab value / disease marker	serious PRR 264.6 · 100% consumer	no trial data cached
Bone loss	1,565	359.0 342.6–376.1ROR 467.6 · χ² 500,329 / p <1e-300	320.3 EB05 307.2 · IC025 +8.1 3/3 methods agree	Not in label — unassessed	serious PRR 230.6 · 100% consumer	no trial data cached
Renal injury	2,962	341.9 332.0–352.1ROR 610.5 · χ² 907,131 / p <1e-300	307.2 EB05 298.0 · IC025 +8.1 3/3 methods agree	Not in label — unassessed	serious PRR 206.7 · 100% consumer	no trial data cached
Tooth loss	2,002	331.2 318.4–344.5ROR 471.3 · χ² 595,311 / p <1e-300	298.3 EB05 287.5 · IC025 +8.0 3/3 methods agree	Not in label — unassessed	serious PRR 220.1 · 100% consumer	no trial data cached
Multiple fractures	1,518	314.9 300.4–330.1ROR 406.4 · χ² 430,925 / p <1e-300	284.7 EB05 272.9 · IC025 +7.9 3/3 methods agree	Not in label — unassessed	serious PRR 203.6 · 99% consumer	no trial data cached
Osteopenia	896	194.7 182.8–207.4ROR 224.5 · χ² 162,359 / p <1e-300	182.5 EB05 172.7 · IC025 +7.3 3/3 methods agree	Not in label — unassessed	serious PRR 130.1 · 99% consumer	no trial data cached
Anhedonia	1,219	150.5 142.9–158.6ROR 183.7 · χ² 172,721 / p <1e-300	143.3 EB05 136.6 · IC025 +7.0 3/3 methods agree	Not in label — unassessed	serious PRR 96.4 · 100% consumer	no trial data cached
Osteonecrosis (bone death)	1,517	149.7 143.0–156.7ROR 193.0 · χ² 213,837 / p <1e-300	142.5 EB05 136.6 · IC025 +7.0 3/3 methods agree	Not in label — unassessed	serious PRR 96.3 · 99% consumer	no trial data cached
Vitamin d deficiency	380	126.6 114.6–139.9ROR 134.1 · χ² 45,373 / p <1e-300	120.9 EB05 111.0 · IC025 +6.5 3/3 methods agree	Not in label — unassessed	serious PRR 89.5 · 97% consumer	no trial data cached
Osteoporosis	1,384	108.5 103.4–113.8ROR 136.4 · χ² 142,572 / p <1e-300	104.7 EB05 100.1 · IC025 +6.6 3/3 methods agree	Not in label — unassessed	serious PRR 81.2 · 96% consumer	no trial data cached
Nephropathy	297	102.0 91.1–114.2ROR 106.6 · χ² 28,655 / p <1e-300	98.1 EB05 89.1 · IC025 +6.2 3/3 methods agree	Not in label — unassessed	serious PRR 70.1 · 100% consumer	no trial data cached
Economic problem	406	84.4 76.7–92.9ROR 89.8 · χ² 32,512 / p <1e-300	81.9 EB05 75.4 · IC025 +6.1 3/3 methods agree	Reporting / coding artifact	serious PRR 55.1 · 99% consumer	no trial data cached
Chronic kidney disease	1,993	83.3 80.2–86.5ROR 118.0 · χ² 158,258 / p <1e-300	81.1 EB05 78.1 · IC025 +6.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 55.2 · 100% consumer	no trial data cached
Tooth fracture	149	42.7 36.4–50.2ROR 43.7 · χ² 5,952 / p <1e-300	42.0 EB05 36.6 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 39.1 · 100% consumer	no trial data cached
Renal failure (kidney failure)	1,621	38.3 36.7–39.9ROR 50.1 · χ² 58,438 / p <1e-300	37.8 EB05 36.3 · IC025 +5.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 25.5 · 99% consumer	no trial data cached
Emotional distress	1,370	35.6 33.9–37.3ROR 44.4 · χ² 45,739 / p <1e-300	35.2 EB05 33.6 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious PRR 24.1 · 100% consumer	no trial data cached
Fracture	209	34.8 30.4–39.8ROR 35.9 · χ² 6,759 / p <1e-300	34.3 EB05 30.6 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious PRR 24.9 · 98% consumer	no trial data cached
Foot fracture	192	31.8 27.7–36.6ROR 32.7 · χ² 5,647 / p <1e-300	31.4 EB05 27.9 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 24.8 · 100% consumer	no trial data cached
Bone disorder	178	30.5 26.4–35.3ROR 31.3 · χ² 5,006 / p <1e-300	30.1 EB05 26.6 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 24.0 · 97% consumer	no trial data cached
Ankle fracture	141	28.6 24.3–33.7ROR 29.2 · χ² 3,700 / p <1e-300	28.3 EB05 24.6 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious PRR 21.2	no trial data cached
Wrist fracture	90	23.6 19.2–29.0ROR 23.9 · χ² 1,911 / p <1e-300	23.3 EB05 19.5 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 18.0	no trial data cached
Intervertebral disc degeneration	69	23.3 18.4–29.5ROR 23.5 · χ² 1,440 / p <1e-300	23.0 EB05 18.8 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 17.5	no trial data cached
End stage renal disease	132	22.5 19.0–26.7ROR 22.9 · χ² 2,675 / p <1e-300	22.3 EB05 19.3 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious PRR 15.0	no trial data cached
Dental caries	75	21.3 17.0–26.7ROR 21.5 · χ² 1,423 / p <1e-300	21.1 EB05 17.4 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 21.4	no trial data cached
Blood creatinine increased	413	19.8 18.0–21.8ROR 21.0 · χ² 7,336 / p <1e-300	19.7 EB05 18.1 · IC025 +4.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 14.4 · 87% consumer	no trial data cached
Rib fracture	111	17.0 14.1–20.4ROR 17.2 · χ² 1,643 / p <1e-300	16.8 EB05 14.3 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 12.2	no trial data cached
Proteinuria	89	14.8 12.0–18.2ROR 15.0 · χ² 1,126 / p 3e-247	14.6 EB05 12.2 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 9.9	no trial data cached
Hip arthroplasty	70	14.4 11.4–18.2ROR 14.6 · χ² 859 / p 4e-189	14.3 EB05 11.6 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 9.9	no trial data cached
Anxiety	1,263	13.9 13.2–14.6ROR 16.8 · χ² 15,210 / p <1e-300	13.8 EB05 13.2 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 12.3 · 97% consumer	no trial data cached
Renal impairment	330	12.3 11.1–13.7ROR 12.9 · χ² 3,431 / p <1e-300	12.3 EB05 11.2 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.2 · 88% consumer	no trial data cached
Decreased activity	41	12.0 8.8–16.3ROR 12.0 · χ² 400 / p 2e-89	11.6 EB05 8.7 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 11.2	no trial data cached
Osteoarthritis	158	11.6 10.0–13.6ROR 11.9 · χ² 1,524 / p <1e-300	11.5 EB05 10.1 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 8.5 · 100% consumer	no trial data cached
Glomerular filtration rate decreased	44	11.4 8.5–15.3ROR 11.4 · χ² 405 / p 3e-90	11.0 EB05 8.3 · IC025 +2.8 3/3 methods agree	Lab value / disease marker	serious PRR 8.8	no trial data cached
Upper limb fracture	69	10.8 8.5–13.7ROR 10.9 · χ² 602 / p 4e-133	10.5 EB05 8.5 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 8.1	no trial data cached
Quality of life decreased	45	10.5 7.8–14.0ROR 10.5 · χ² 375 / p 6e-84	10.0 EB05 7.7 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 8.1	no trial data cached
Lower limb fracture	59	9.7 7.5–12.5ROR 9.7 · χ² 449 / p 7e-100	9.3 EB05 7.4 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 6.7	no trial data cached
Acute kidney injury (sudden kidney damage)	440	9.0 8.3–9.9ROR 9.6 · χ² 3,151 / p <1e-300	9.0 EB05 8.3 · IC025 +3.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.1 · 92% consumer	no trial data cached
Hip fracture	86	8.4 6.8–10.3ROR 8.5 · χ² 551 / p 4e-122	8.1 EB05 6.7 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 5.7	no trial data cached
Tooth extraction	32	8.0 5.7–11.4ROR 8.1 · χ² 190 / p 2e-43	7.4 EB05 5.4 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 6.5	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

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	3,553	394.7 384.7–404.8ROR 836.1 · χ² 1,238,072 / p <1e-300	349.3 EB05 339.7 · IC025 +8.3 3/3 methods agree	Lab value / disease marker	serious PRR 264.6 · 100% consumer	no trial data cached
Renal injury	2,962	341.9 332.0–352.1ROR 610.5 · χ² 907,131 / p <1e-300	307.2 EB05 298.0 · IC025 +8.1 3/3 methods agree	Not in label — unassessed	serious PRR 206.7 · 100% consumer	no trial data cached
Skeletal injury	2,775	1,130.6 1,090.3–1,172.5ROR 1,925.1 · χ² 2,290,874 / p <1e-300	822.4 EB05 797.1 · IC025 +9.4 3/3 methods agree	Not in label — unassessed	serious PRR 569.6 · 100% consumer	no trial data cached
Tooth loss	2,002	331.2 318.4–344.5ROR 471.3 · χ² 595,311 / p <1e-300	298.3 EB05 287.5 · IC025 +8.0 3/3 methods agree	Not in label — unassessed	serious PRR 220.1 · 100% consumer	no trial data cached
Chronic kidney disease	1,993	83.3 80.2–86.5ROR 118.0 · χ² 158,258 / p <1e-300	81.1 EB05 78.1 · IC025 +6.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 55.2 · 100% consumer	no trial data cached
Renal failure (kidney failure)	1,621	38.3 36.7–39.9ROR 50.1 · χ² 58,438 / p <1e-300	37.8 EB05 36.3 · IC025 +5.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 25.5 · 99% consumer	no trial data cached
Bone loss	1,565	359.0 342.6–376.1ROR 467.6 · χ² 500,329 / p <1e-300	320.3 EB05 307.2 · IC025 +8.1 3/3 methods agree	Not in label — unassessed	serious PRR 230.6 · 100% consumer	no trial data cached
Multiple fractures	1,518	314.9 300.4–330.1ROR 406.4 · χ² 430,925 / p <1e-300	284.7 EB05 272.9 · IC025 +7.9 3/3 methods agree	Not in label — unassessed	serious PRR 203.6 · 99% consumer	no trial data cached
Osteonecrosis (bone death)	1,517	149.7 143.0–156.7ROR 193.0 · χ² 213,837 / p <1e-300	142.5 EB05 136.6 · IC025 +7.0 3/3 methods agree	Not in label — unassessed	serious PRR 96.3 · 99% consumer	no trial data cached
Pain	1,390	7.1 6.7–7.4ROR 8.6 · χ² 7,429 / p <1e-300	7.0 EB05 6.7 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.8 · 98% consumer	no trial data cached
Osteoporosis	1,384	108.5 103.4–113.8ROR 136.4 · χ² 142,572 / p <1e-300	104.7 EB05 100.1 · IC025 +6.6 3/3 methods agree	Not in label — unassessed	serious PRR 81.2 · 96% consumer	no trial data cached
Emotional distress	1,370	35.6 33.9–37.3ROR 44.4 · χ² 45,739 / p <1e-300	35.2 EB05 33.6 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious PRR 24.1 · 100% consumer	no trial data cached
Anxiety	1,263	13.9 13.2–14.6ROR 16.8 · χ² 15,210 / p <1e-300	13.8 EB05 13.2 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 12.3 · 97% consumer	no trial data cached
Anhedonia	1,219	150.5 142.9–158.6ROR 183.7 · χ² 172,721 / p <1e-300	143.3 EB05 136.6 · IC025 +7.0 3/3 methods agree	Not in label — unassessed	serious PRR 96.4 · 100% consumer	no trial data cached
Osteopenia	896	194.7 182.8–207.4ROR 224.5 · χ² 162,359 / p <1e-300	182.5 EB05 172.7 · IC025 +7.3 3/3 methods agree	Not in label — unassessed	serious PRR 130.1 · 99% consumer	no trial data cached

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.

Skeletal injury — n=2,775, PRR 1,130.6
Bone loss — n=1,565, PRR 359.0
Renal injury — n=2,962, PRR 341.9
Tooth loss — n=2,002, PRR 331.2
Multiple fractures — n=1,518, PRR 314.9
Osteopenia — n=896, PRR 194.7
Anhedonia — n=1,219, PRR 150.5
Osteonecrosis — n=1,517, PRR 149.7
Vitamin d deficiency — n=380, PRR 126.6
Osteoporosis — n=1,384, PRR 108.5

✓ 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?

In FDA FAERS, the most frequently co-reported reaction terms for Emtricitabine are bone density decreased, renal injury, skeletal injury, tooth loss, chronic kidney disease, renal failure. 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 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 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, 89 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

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.