Drug · FAERS side-effect profile with label screen

Emtricitabine, Rilpivirine and Tenofovir Alafenamide side effects: what 3,568 FDA adverse event reports show

Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Alafenamide · 76 reaction terms · 13,416 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

3,568 reports · 76% serious · 70 with death outcome · 28% 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 2Labeled (related wording) 3Reporting / 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. 36 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 density decreased	1,601	313.0 301.3–325.1ROR 566.9 · χ² 472,811 / p <1e-300	296.0 EB05 284.0 · IC025 +8.0 3/3 methods agree	Lab value / disease marker	serious PRR 244.6 · 100% consumer	no trial data cached
Bone loss	746	303.8 284.4–324.5ROR 383.9 · χ² 213,813 / p <1e-300	286.6 EB05 269.8 · IC025 +7.8 3/3 methods agree	Not in label — unassessed	serious PRR 232.6 · 100% consumer	no trial data cached
Skeletal injury	462	271.5 248.8–296.3ROR 311.7 · χ² 118,744 / p <1e-300	256.7 EB05 237.6 · IC025 +7.5 3/3 methods agree	Not in label — unassessed	serious PRR 201.3 · 100% consumer	no trial data cached
Multiple fractures	690	255.4 238.4–273.6ROR 316.4 · χ² 167,356 / p <1e-300	243.0 EB05 228.2 · IC025 +7.6 3/3 methods agree	Not in label — unassessed	serious PRR 196.7 · 100% consumer	no trial data cached
Tooth loss	818	239.7 225.3–255.0ROR 310.7 · χ² 186,671 / p <1e-300	229.0 EB05 216.1 · IC025 +7.5 3/3 methods agree	Not in label — unassessed	serious PRR 180.6 · 99% consumer	no trial data cached
Osteopenia	537	214.4 198.0–232.2ROR 252.3 · χ² 109,893 / p <1e-300	205.3 EB05 191.2 · IC025 +7.3 3/3 methods agree	Not in label — unassessed	serious PRR 152.5 · 100% consumer	no trial data cached
Anhedonia	604	137.2 127.4–147.6ROR 164.9 · χ² 79,717 / p <1e-300	133.4 EB05 124.8 · IC025 +6.8 3/3 methods agree	Not in label — unassessed	serious PRR 99.4 · 100% consumer	no trial data cached
Osteonecrosis (bone death)	711	128.8 120.5–137.7ROR 160.6 · χ² 88,237 / p <1e-300	125.6 EB05 118.1 · IC025 +6.7 3/3 methods agree	Not in label — unassessed	serious PRR 95.9 · 93% consumer	no trial data cached
Osteoporosis	756	109.9 103.1–117.2ROR 139.2 · χ² 80,116 / p <1e-300	107.6 EB05 101.3 · IC025 +6.5 3/3 methods agree	Not in label — unassessed	serious PRR 94.1 · 96% consumer	no trial data cached
Renal injury	524	104.4 96.4–113.1ROR 122.2 · χ² 52,690 / p <1e-300	102.2 EB05 95.1 · IC025 +6.4 3/3 methods agree	Not in label — unassessed	serious PRR 77.7 · 98% consumer	no trial data cached
Economic problem	221	85.5 75.2–97.2ROR 91.1 · χ² 18,117 / p <1e-300	83.7 EB05 74.8 · IC025 +5.9 3/3 methods agree	Reporting / coding artifact	serious PRR 63.6 · 97% consumer	no trial data cached
Vitamin d deficiency	125	76.3 64.2–90.8ROR 79.1 · χ² 9,103 / p <1e-300	74.5 EB05 64.2 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious PRR 57.2	no trial data cached
Chronic kidney disease	870	67.5 63.7–71.5ROR 88.9 · χ² 56,455 / p <1e-300	66.6 EB05 63.0 · IC025 +5.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 51.2 · 98% consumer	no trial data cached
Nephropathy	72	45.4 36.1–57.2ROR 46.3 · χ² 3,062 / p <1e-300	44.6 EB05 36.6 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 36.3	no trial data cached
Emotional distress	692	33.7 31.5–36.0ROR 41.5 · χ² 21,897 / p <1e-300	33.4 EB05 31.4 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 25.3 · 100% consumer	no trial data cached
Foot fracture	101	31.4 25.9–38.1ROR 32.3 · χ² 2,927 / p <1e-300	31.1 EB05 26.3 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious PRR 27.3	no trial data cached
Tooth fracture	56	30.0 23.1–38.9ROR 30.5 · χ² 1,534 / p <1e-300	29.6 EB05 23.6 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious PRR 28.7	no trial data cached
Renal failure (kidney failure)	645	28.5 26.5–30.5ROR 34.5 · χ² 17,094 / p <1e-300	28.3 EB05 26.5 · IC025 +4.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 21.5 · 88% consumer	no trial data cached
Ankle fracture	74	28.2 22.5–35.3ROR 28.8 · χ² 1,905 / p <1e-300	27.9 EB05 22.9 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 23.0	no trial data cached
Fracture	85	26.5 21.5–32.7ROR 27.1 · χ² 2,052 / p <1e-300	26.2 EB05 21.9 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 21.3 · 100% consumer	no trial data cached
Wrist fracture	42	20.7 15.3–27.9ROR 20.9 · χ² 764 / p 2e-168	20.4 EB05 15.7 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 17.0	no trial data cached
Rib fracture	68	19.5 15.4–24.7ROR 19.9 · χ² 1,174 / p 1e-257	19.4 EB05 15.8 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 15.8	no trial data cached
Bone disorder	56	18.0 13.8–23.3ROR 18.2 · χ² 878 / p 3e-193	17.8 EB05 14.2 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 15.0	no trial data cached
Blood creatinine increased	173	15.6 13.5–18.0ROR 16.3 · χ² 2,347 / p <1e-300	15.5 EB05 13.7 · IC025 +3.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 12.7 · 76% consumer	no trial data cached
Decreased activity	25	13.7 9.3–20.3ROR 13.8 · χ² 282 / p 1e-63	13.2 EB05 9.1 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 14.4	no trial data cached
Renal impairment	191	13.4 11.7–15.4ROR 14.1 · χ² 2,191 / p <1e-300	13.4 EB05 11.8 · IC025 +3.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.2	no trial data cached
Anxiety	645	13.3 12.4–14.3ROR 16.0 · χ² 7,419 / p <1e-300	13.3 EB05 12.4 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 13.0 · 89% consumer	no trial data cached
End stage renal disease	38	12.1 8.9–16.7ROR 12.3 · χ² 377 / p 3e-84	11.7 EB05 8.7 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 9.2	no trial data cached
Quality of life decreased	27	11.8 8.1–17.2ROR 11.9 · χ² 257 / p 5e-58	11.2 EB05 7.8 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 9.8	no trial data cached
Proteinuria	37	11.6 8.4–15.9ROR 11.7 · χ² 346 / p 2e-77	11.1 EB05 8.2 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 8.2	no trial data cached
Lower limb fracture	36	11.1 8.0–15.4ROR 11.2 · χ² 320 / p 6e-72	10.6 EB05 7.8 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 9.2	no trial data cached
Glomerular filtration rate decreased	22	10.7 7.0–16.2ROR 10.7 · χ² 183 / p 4e-42	9.8 EB05 6.5 · IC025 +2.4 3/3 methods agree	Lab value / disease marker	serious PRR 8.6	no trial data cached
Upper limb fracture	35	10.3 7.4–14.3ROR 10.4 · χ² 284 / p 5e-64	9.7 EB05 7.1 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 8.4	no trial data cached
Osteoarthritis	69	9.6 7.6–12.1ROR 9.7 · χ² 521 / p 2e-115	9.3 EB05 7.5 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 7.5	no trial data cached
Intervertebral disc degeneration	15	9.5 5.7–15.7ROR 9.5 · χ² 105 / p 5e-25	8.1 EB05 4.9 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 7.7	no trial data cached
Hip arthroplasty	24	9.3 6.2–13.9ROR 9.4 · χ² 169 / p 5e-39	8.4 EB05 5.8 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 7.2	no trial data cached
Dysstasia	38	7.6 5.6–10.5ROR 7.7 · χ² 212 / p 2e-48	7.1 EB05 5.4 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 7.0	no trial data cached
Hip fracture	38	7.0 5.1–9.6ROR 7.0 · χ² 188 / p 4e-43	6.5 EB05 4.9 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 5.3	no trial data cached
Dental caries	13	6.9 4.0–11.9ROR 6.9 · χ² 60 / p 5e-15	5.7 EB05 3.5 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 7.5	no trial data cached
Pain	711	6.8 6.4–7.3ROR 8.2 · χ² 3,612 / p <1e-300	6.8 EB05 6.4 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.1 · 92% consumer	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	1,601	313.0 301.3–325.1ROR 566.9 · χ² 472,811 / p <1e-300	296.0 EB05 284.0 · IC025 +8.0 3/3 methods agree	Lab value / disease marker	serious PRR 244.6 · 100% consumer	no trial data cached
Chronic kidney disease	870	67.5 63.7–71.5ROR 88.9 · χ² 56,455 / p <1e-300	66.6 EB05 63.0 · IC025 +5.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 51.2 · 98% consumer	no trial data cached
Tooth loss	818	239.7 225.3–255.0ROR 310.7 · χ² 186,671 / p <1e-300	229.0 EB05 216.1 · IC025 +7.5 3/3 methods agree	Not in label — unassessed	serious PRR 180.6 · 99% consumer	no trial data cached
Osteoporosis	756	109.9 103.1–117.2ROR 139.2 · χ² 80,116 / p <1e-300	107.6 EB05 101.3 · IC025 +6.5 3/3 methods agree	Not in label — unassessed	serious PRR 94.1 · 96% consumer	no trial data cached
Bone loss	746	303.8 284.4–324.5ROR 383.9 · χ² 213,813 / p <1e-300	286.6 EB05 269.8 · IC025 +7.8 3/3 methods agree	Not in label — unassessed	serious PRR 232.6 · 100% consumer	no trial data cached
Pain	711	6.8 6.4–7.3ROR 8.2 · χ² 3,612 / p <1e-300	6.8 EB05 6.4 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.1 · 92% consumer	no trial data cached
Osteonecrosis (bone death)	711	128.8 120.5–137.7ROR 160.6 · χ² 88,237 / p <1e-300	125.6 EB05 118.1 · IC025 +6.7 3/3 methods agree	Not in label — unassessed	serious PRR 95.9 · 93% consumer	no trial data cached
Emotional distress	692	33.7 31.5–36.0ROR 41.5 · χ² 21,897 / p <1e-300	33.4 EB05 31.4 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 25.3 · 100% consumer	no trial data cached
Multiple fractures	690	255.4 238.4–273.6ROR 316.4 · χ² 167,356 / p <1e-300	243.0 EB05 228.2 · IC025 +7.6 3/3 methods agree	Not in label — unassessed	serious PRR 196.7 · 100% consumer	no trial data cached
Anxiety	645	13.3 12.4–14.3ROR 16.0 · χ² 7,419 / p <1e-300	13.3 EB05 12.4 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 13.0 · 89% consumer	no trial data cached
Renal failure (kidney failure)	645	28.5 26.5–30.5ROR 34.5 · χ² 17,094 / p <1e-300	28.3 EB05 26.5 · IC025 +4.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 21.5 · 88% consumer	no trial data cached
Anhedonia	604	137.2 127.4–147.6ROR 164.9 · χ² 79,717 / p <1e-300	133.4 EB05 124.8 · IC025 +6.8 3/3 methods agree	Not in label — unassessed	serious PRR 99.4 · 100% consumer	no trial data cached
Osteopenia	537	214.4 198.0–232.2ROR 252.3 · χ² 109,893 / p <1e-300	205.3 EB05 191.2 · IC025 +7.3 3/3 methods agree	Not in label — unassessed	serious PRR 152.5 · 100% consumer	no trial data cached
Renal injury	524	104.4 96.4–113.1ROR 122.2 · χ² 52,690 / p <1e-300	102.2 EB05 95.1 · IC025 +6.4 3/3 methods agree	Not in label — unassessed	serious PRR 77.7 · 98% consumer	no trial data cached
Skeletal injury	462	271.5 248.8–296.3ROR 311.7 · χ² 118,744 / p <1e-300	256.7 EB05 237.6 · IC025 +7.5 3/3 methods agree	Not in label — unassessed	serious PRR 201.3 · 100% 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.

Bone loss — n=746, PRR 303.8
Skeletal injury — n=462, PRR 271.5
Multiple fractures — n=690, PRR 255.4
Tooth loss — n=818, PRR 239.7
Osteopenia — n=537, PRR 214.4
Anhedonia — n=604, PRR 137.2
Osteonecrosis — n=711, PRR 128.8
Osteoporosis — n=756, PRR 109.9
Renal injury — n=524, PRR 104.4
Vitamin d deficiency — n=125, PRR 76.3

✓ 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, chronic kidney disease, tooth loss, osteoporosis, bone loss, pain. 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, 76 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.