Drug · FAERS side-effect profile with label screen
Emtricitabine side effects: what 7,175 FDA adverse event reports show
Drug class
Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
FDA label (Established Pharmacologic Class) · compare the class
Who reports
7,175 reports · 95% serious · 889 with death outcome · 34% 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 — boxed warning 4Labeled adverse reaction 1Labeled (related wording) 4Reporting / coding artifact 8Lab value / disease marker 2Not in label — unassessed 21
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- 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. 228 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug resistance | 437 | 50.6 46.1–55.4ROR 53.8 · χ² 20,844 / p <1e-300 | 49.6 EB05 45.8 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious PRR 33.1 · 95% clinician | no trial data cached |
| Paranoia | 161 | 27.4 23.5–32.0ROR 28.0 · χ² 4,035 / p <1e-300 | 27.1 EB05 23.7 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 20.3 · ♀ 3% (drug 34%) · 95% clinician | no trial data cached |
| Nephropathy toxic | 101 | 26.7 22.0–32.5ROR 27.1 · χ² 2,455 / p <1e-300 | 26.4 EB05 22.3 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 16.4 · 91% clinician | no trial data cached |
| Anhedonia | 204 | 22.7 19.8–26.0ROR 23.3 · χ² 4,177 / p <1e-300 | 22.5 EB05 20.0 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 14.7 · 100% consumer | no trial data cached |
| Foetal exposure during pregnancy | 622 | 22.5 20.9–24.3ROR 24.6 · χ² 12,731 / p <1e-300 | 22.4 EB05 20.9 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious PRR 13.8 · ♀ 62% (drug 34%) · 91% clinician | no trial data cached |
| Economic problem | 110 | 21.0 17.4–25.3ROR 21.3 · χ² 2,062 / p <1e-300 | 20.8 EB05 17.7 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 13.6 · 100% consumer | no trial data cached |
| Renal tubular necrosis | 57 | 17.0 13.1–22.1ROR 17.2 · χ² 840 / p 7e-185 | 16.8 EB05 13.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 · ♀ 12% (drug 34%) · 98% clinician | no trial data cached |
| Abortion induced | 54 | 16.8 12.9–22.0ROR 16.9 · χ² 784 / p 8e-173 | 16.6 EB05 13.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.5 · ♀ 100% (drug 34%) · 94% clinician | no trial data cached |
| Psychotic disorder | 166 | 16.5 14.2–19.2ROR 16.9 · χ² 2,393 / p <1e-300 | 16.4 EB05 14.4 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.8 · ♀ 2% (drug 34%) · 97% clinician | no trial data cached |
| Hyperbilirubinaemia | 57 | 16.3 12.5–21.1ROR 16.4 · χ² 797 / p 2e-175 | 16.0 EB05 12.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 · 94% clinician | no trial data cached |
| Premature delivery | 87 | 16.0 13.0–19.7ROR 16.2 · χ² 1,200 / p 3e-263 | 15.8 EB05 13.2 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 · ♀ 100% (drug 34%) | no trial data cached |
| Osteopenia | 79 | 15.2 12.2–18.9ROR 15.4 · χ² 1,029 / p 4e-226 | 15.0 EB05 12.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 | no trial data cached |
| Hepatic cytolysis | 56 | 13.4 10.4–17.5ROR 13.5 · χ² 630 / p 2e-139 | 13.2 EB05 10.5 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 · ♀ 73% (drug 34%) · 100% clinician | no trial data cached |
| Premature baby | 134 | 13.0 11.0–15.4ROR 13.3 · χ² 1,471 / p <1e-300 | 12.9 EB05 11.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 · ♀ 73% (drug 34%) · 90% clinician | no trial data cached |
| End stage renal disease | 79 | 12.6 10.1–15.7ROR 12.7 · χ² 828 / p 2e-182 | 12.4 EB05 10.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 | no trial data cached |
| Drug interaction | 663 | 12.3 11.4–13.2ROR 13.4 · χ² 6,867 / p <1e-300 | 12.2 EB05 11.4 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 8.0 · 92% clinician | no trial data cached |
| Tuberculosis | 50 | 11.4 8.6–15.0ROR 11.5 · χ² 463 / p 7e-103 | 11.0 EB05 8.6 · IC025 +2.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 7.0 | no trial data cached |
| Exposure during pregnancy | 227 | 10.7 9.4–12.2ROR 11.0 · χ² 1,986 / p <1e-300 | 10.6 EB05 9.5 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 9.1 · ♀ 95% (drug 34%) · 93% clinician | no trial data cached |
| Osteoporosis | 141 | 10.0 8.5–11.8ROR 10.2 · χ² 1,136 / p 2e-249 | 9.9 EB05 8.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Adrenal insufficiency | 40 | 9.8 7.2–13.3ROR 9.8 · χ² 306 / p 7e-69 | 9.3 EB05 7.0 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · 90% clinician | no trial data cached |
| Treatment noncompliance | 168 | 9.1 7.8–10.5ROR 9.3 · χ² 1,196 / p 2e-262 | 8.9 EB05 7.8 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 8.3 · 97% clinician | no trial data cached |
| Hepatomegaly | 30 | 8.9 6.2–12.7ROR 8.9 · χ² 202 / p 4e-46 | 8.2 EB05 5.9 · IC025 +2.4 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.8 · 100% clinician | no trial data cached |
| Abortion spontaneous | 122 | 8.9 7.4–10.6ROR 9.0 · χ² 845 / p 5e-186 | 8.7 EB05 7.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 · ♀ 92% (drug 34%) · 96% clinician | no trial data cached |
| Pneumocystis jirovecii pneumonia | 30 | 8.8 6.1–12.6ROR 8.8 · χ² 199 / p 2e-45 | 8.1 EB05 5.8 · IC025 +2.4 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.3 · 97% clinician | no trial data cached |
| Splenomegaly | 34 | 8.5 6.1–11.9ROR 8.5 · χ² 217 / p 2e-49 | 7.9 EB05 5.8 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · ♀ 7% (drug 34%) · 97% clinician | no trial data cached |
| Caesarean section | 34 | 8.5 6.1–11.8ROR 8.5 · χ² 216 / p 3e-49 | 7.8 EB05 5.8 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 · ♀ 78% (drug 34%) | no trial data cached |
| Bone density decreased | 87 | 8.0 6.5–9.9ROR 8.1 · χ² 529 / p 2e-117 | 7.8 EB05 6.5 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious PRR 6.0 | no trial data cached |
| Proteinuria | 51 | 7.9 6.0–10.4ROR 8.0 · χ² 301 / p 1e-67 | 7.5 EB05 5.9 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 · 92% clinician | no trial data cached |
| Oral candidiasis (oral thrush) | 35 | 7.9 5.7–11.0ROR 7.9 · χ² 203 / p 2e-46 | 7.3 EB05 5.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Glomerular filtration rate decreased | 31 | 7.5 5.3–10.7ROR 7.5 · χ² 168 / p 1e-38 | 6.9 EB05 5.0 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious PRR 5.2 · 96% clinician | no trial data cached |
| Neurotoxicity | 44 | 7.4 5.5–10.0ROR 7.5 · χ² 237 / p 7e-54 | 7.0 EB05 5.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 · 100% clinician | no trial data cached |
| Hepatitis c | 29 | 7.0 4.8–10.0ROR 7.0 · χ² 142 / p 6e-33 | 6.3 EB05 4.6 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.0 · 92% clinician | no trial data cached |
| Chronic kidney disease | 176 | 6.7 5.8–7.8ROR 6.9 · χ² 853 / p 9e-188 | 6.6 EB05 5.8 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.1 | no trial data cached |
| Nephropathy | 21 | 6.6 4.3–10.0ROR 6.6 · χ² 93 / p 2e-22 | 5.8 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Drug level increased | 37 | 6.5 4.7–9.0ROR 6.6 · χ² 168 / p 1e-38 | 6.1 EB05 4.6 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 4.2 · 94% clinician | no trial data cached |
| Lactic acidosis | 71 | 6.5 5.1–8.2ROR 6.5 · χ² 323 / p 2e-72 | 6.2 EB05 5.1 · IC025 +2.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 3.9 · 94% clinician | no trial data cached |
| Maternal exposure during pregnancy | 189 | 6.3 5.4–7.2ROR 6.4 · χ² 834 / p 1e-183 | 6.2 EB05 5.5 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 4.4 · ♀ 97% (drug 34%) | no trial data cached |
| Acute hepatic failure | 29 | 6.2 4.3–9.0ROR 6.3 · χ² 122 / p 1e-28 | 5.7 EB05 4.2 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.8 · ♀ 10% (drug 34%) · 93% clinician | no trial data cached |
| Blood creatinine increased | 139 | 6.2 5.3–7.3ROR 6.3 · χ² 604 / p 1e-133 | 6.1 EB05 5.3 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.2 | no trial data cached |
| Renal impairment | 176 | 6.2 5.3–7.1ROR 6.3 · χ² 757 / p 8e-167 | 6.1 EB05 5.3 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 | 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 |
|---|---|---|---|---|---|---|
| Drug interaction | 663 | 12.3 11.4–13.2ROR 13.4 · χ² 6,867 / p <1e-300 | 12.2 EB05 11.4 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 8.0 · 92% clinician | no trial data cached |
| Foetal exposure during pregnancy | 622 | 22.5 20.9–24.3ROR 24.6 · χ² 12,731 / p <1e-300 | 22.4 EB05 20.9 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious PRR 13.8 · ♀ 62% (drug 34%) · 91% clinician | no trial data cached |
| Drug resistance | 437 | 50.6 46.1–55.4ROR 53.8 · χ² 20,844 / p <1e-300 | 49.6 EB05 45.8 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious PRR 33.1 · 95% clinician | no trial data cached |
| Anxiety | 432 | 4.4 4.0–4.9ROR 4.6 · χ² 1,158 / p 4e-254 | 4.4 EB05 4.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Emotional distress | 239 | 5.8 5.1–6.5ROR 5.9 · χ² 938 / p 2e-206 | 5.7 EB05 5.1 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 · 92% consumer | no trial data cached |
| Depression | 233 | 3.0 2.6–3.4ROR 3.0 · χ² 308 / p 3e-69 | 3.0 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 · ♀ 13% (drug 34%) | no trial data cached |
| Exposure during pregnancy | 227 | 10.7 9.4–12.2ROR 11.0 · χ² 1,986 / p <1e-300 | 10.6 EB05 9.5 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 9.1 · ♀ 95% (drug 34%) · 93% clinician | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 212 | 4.1 3.6–4.6ROR 4.2 · χ² 491 / p 4e-109 | 4.0 EB05 3.6 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.5 · 93% clinician | no trial data cached |
| Renal failure (kidney failure) | 205 | 4.5 3.9–5.1ROR 4.6 · χ² 554 / p 8e-123 | 4.4 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.7 | no trial data cached |
| Anhedonia | 204 | 22.7 19.8–26.0ROR 23.3 · χ² 4,177 / p <1e-300 | 22.5 EB05 20.0 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 14.7 · 100% consumer | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 191 | 6.1 5.3–7.0ROR 6.2 · χ² 811 / p 1e-178 | 6.0 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 · ♀ 8% (drug 34%) | no trial data cached |
| Maternal exposure during pregnancy | 189 | 6.3 5.4–7.2ROR 6.4 · χ² 834 / p 1e-183 | 6.2 EB05 5.5 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 4.4 · ♀ 97% (drug 34%) | no trial data cached |
| Anaemia (low red blood cells) | 183 | 2.8 2.4–3.2ROR 2.9 · χ² 212 / p 2e-48 | 2.8 EB05 2.5 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Renal impairment | 176 | 6.2 5.3–7.1ROR 6.3 · χ² 757 / p 8e-167 | 6.1 EB05 5.3 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 | no trial data cached |
| Chronic kidney disease | 176 | 6.7 5.8–7.8ROR 6.9 · χ² 853 / p 9e-188 | 6.6 EB05 5.8 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.1 | 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.
- Paranoia — n=161, PRR 27.4
- Nephropathy toxic — n=101, PRR 26.7
- Anhedonia — n=204, PRR 22.7
- Renal tubular necrosis — n=57, PRR 17.0
- Abortion induced — n=54, PRR 16.8
- Psychotic disorder — n=166, PRR 16.5
- Hyperbilirubinaemia — n=57, PRR 16.3
- Premature delivery — n=87, PRR 16.0
- Osteopenia — n=79, PRR 15.2
- Hepatic cytolysis — n=56, PRR 13.4
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 anxiety, emotional distress, depression, acute kidney injury, renal failure, anhedonia. 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, fieldpatient.drug.openfda.generic_name.exact, 268 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.