Drug · FAERS side-effect profile with label screen
Rilpivirine side effects: what 7,018 FDA adverse event reports show
Drug class
Not stated in label
Who reports
7,018 reports · 42% serious · 221 with death outcome · 30% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Rilpivirine tablets are a human immunodeficiency virus type 1 (HIV-1) specific, non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve patients 12 years of age and older and weighing at least 35 kg with HIV-1 RNA less than or equal to 100,000 copies/mL. ( 1.1 ).
FDA label, Indications and Usage
What it is
Rilpivirine tablets are a non-nucleoside reverse transcriptase inhibitor (NNRTI) of human immunodeficiency virus type 1 (HIV-1).
FDA label, Description section
Boxed warning
None in the current 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) 4Reporting / coding artifact 16Lab value / disease marker 1Not in label — unassessed 17
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. 107 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 |
|---|---|---|---|---|---|---|
| Injection site nodule | 157 | 43.2 37.0–50.5ROR 44.2 · χ² 6,340 / p <1e-300 | 42.4 EB05 37.1 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Product complaint | 177 | 21.3 18.4–24.6ROR 21.8 · χ² 3,380 / p <1e-300 | 21.1 EB05 18.6 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious n=7 · 97% clinician | no trial data cached |
| Injection site discomfort | 68 | 19.8 15.6–25.0ROR 19.9 · χ² 1,184 / p 8e-260 | 19.5 EB05 15.9 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious n=40 | no trial data cached |
| Drug resistance | 150 | 17.5 14.9–20.5ROR 17.9 · χ² 2,306 / p <1e-300 | 17.4 EB05 15.1 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 25.9 · ♀ 55% (drug 30%) · 90% clinician | no trial data cached |
| Nodule | 63 | 14.4 11.3–18.5ROR 14.6 · χ² 772 / p 4e-170 | 14.3 EB05 11.5 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · ♀ 54% (drug 30%) · 94% clinician | no trial data cached |
| Drug level decreased | 41 | 12.0 8.8–16.3ROR 12.1 · χ² 401 / p 2e-89 | 11.6 EB05 8.7 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 19.9 · 95% clinician | no trial data cached |
| Injection site induration | 42 | 9.7 7.2–13.1ROR 9.7 · χ² 318 / p 2e-71 | 9.2 EB05 6.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=20 | no trial data cached |
| Product administered at inappropriate site | 58 | 9.5 7.4–12.3ROR 9.6 · χ² 434 / p 1e-96 | 9.2 EB05 7.3 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious n=4 | no trial data cached |
| Exposure during pregnancy | 172 | 8.3 7.1–9.6ROR 8.4 · χ² 1,091 / p 2e-239 | 8.1 EB05 7.1 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 8.2 · ♀ 100% (drug 30%) · 94% clinician | no trial data cached |
| Hepatitis c | 32 | 7.8 5.5–11.1ROR 7.9 · χ² 183 / p 5e-42 | 7.2 EB05 5.3 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.4 · 97% clinician | no trial data cached |
| Product dose omission issue | 669 | 7.0 6.5–7.5ROR 7.6 · χ² 3,484 / p <1e-300 | 7.0 EB05 6.5 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 3.1 | no trial data cached |
| Product administration error | 46 | 6.9 5.2–9.2ROR 6.9 · χ² 225 / p 4e-51 | 6.5 EB05 5.0 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 3.0 · 98% clinician | no trial data cached |
| Wrong technique in device usage process | 103 | 6.7 5.6–8.1ROR 6.8 · χ² 496 / p 3e-110 | 6.5 EB05 5.5 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious n=6 · 95% clinician | no trial data cached |
| Injection site pain (pain where injected) | 673 | 6.6 6.2–7.1ROR 7.2 · χ² 3,245 / p <1e-300 | 6.6 EB05 6.2 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 18.4 | no trial data cached |
| Treatment failure | 172 | 6.3 5.4–7.3ROR 6.4 · χ² 756 / p 1e-166 | 6.1 EB05 5.4 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 10.3 · 96% clinician | no trial data cached |
| Injection site mass | 77 | 6.2 5.0–7.8ROR 6.3 · χ² 333 / p 1e-74 | 6.0 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 | no trial data cached |
| Product storage error | 176 | 6.1 5.2–7.0ROR 6.2 · χ² 742 / p 1e-163 | 6.0 EB05 5.3 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 1.5 · 94% clinician | no trial data cached |
| Treatment noncompliance | 103 | 5.7 4.7–6.9ROR 5.7 · χ² 391 / p 3e-87 | 5.5 EB05 4.7 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 8.4 · 93% clinician | no trial data cached |
| Nephropathy toxic | 20 | 5.4 3.5–8.3ROR 5.4 · χ² 67 / p 2e-16 | 4.8 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 · 100% clinician | no trial data cached |
| Erectile dysfunction | 45 | 5.2 3.9–7.0ROR 5.2 · χ² 149 / p 1e-34 | 5.0 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 · ♀ 0% (drug 30%) | no trial data cached |
| Abscess | 27 | 5.1 3.5–7.4ROR 5.1 · χ² 84 / p 3e-20 | 4.7 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 · 96% clinician | no trial data cached |
| Glomerular filtration rate decreased | 20 | 4.9 3.2–7.6ROR 4.9 · χ² 59 / p 9e-15 | 4.5 EB05 3.1 · IC025 +1.4 3/3 methods agree | Lab value / disease marker | serious PRR 7.6 | no trial data cached |
| Sciatica | 26 | 4.9 3.3–7.2ROR 4.9 · χ² 77 / p 1e-18 | 4.5 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Tuberculosis | 21 | 4.9 3.2–7.5ROR 4.9 · χ² 61 / p 3e-15 | 4.4 EB05 3.1 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.9 | no trial data cached |
| Injection site warmth | 31 | 4.5 3.2–6.4ROR 4.5 · χ² 81 / p 1e-19 | 4.2 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Incorrect route of product administration | 24 | 4.3 2.9–6.4ROR 4.3 · χ² 57 / p 3e-14 | 4.0 EB05 2.8 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 4.9 | no trial data cached |
| Abortion spontaneous | 54 | 4.0 3.1–5.2ROR 4.0 · χ² 119 / p 6e-28 | 3.9 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 · ♀ 100% (drug 30%) · 98% clinician | no trial data cached |
| Product dispensing error | 29 | 4.0 2.8–5.7ROR 4.0 · χ² 62 / p 2e-15 | 3.8 EB05 2.8 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Psychotic disorder | 38 | 3.8 2.8–5.3ROR 3.9 · χ² 77 / p 9e-19 | 3.7 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 · ♀ 3% (drug 30%) | no trial data cached |
| Injection site reaction | 87 | 3.8 3.1–4.7ROR 3.8 · χ² 176 / p 2e-40 | 3.7 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Neurotoxicity | 21 | 3.6 2.4–5.5ROR 3.6 · χ² 37 / p 6e-10 | 3.4 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 · 100% clinician | no trial data cached |
| Liver function test increased | 24 | 3.4 2.3–5.0ROR 3.4 · χ² 37 / p 5e-10 | 3.2 EB05 2.3 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.9 · ♀ 50% (drug 30%) · 92% clinician | no trial data cached |
| Poor quality product administered | 11 | 3.2 1.8–5.8ROR 3.2 · χ² 15 / p 7e-5 | 2.9 EB05 1.8 · IC025 +0.5 | Labeled (related wording) related wording | – | no trial data cached |
| Gait inability | 35 | 3.2 2.3–4.4ROR 3.2 · χ² 49 / p 1e-12 | 3.0 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Weight fluctuation | 11 | 3.1 1.7–5.7ROR 3.2 · χ² 14 / p 9e-5 | 2.9 EB05 1.7 · IC025 +0.5 | Not in label — unassessed | serious n=9 | no trial data cached |
| Musculoskeletal pain | 55 | 3.1 2.4–4.0ROR 3.1 · χ² 77 / p 1e-18 | 3.0 EB05 2.4 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Inappropriate schedule of product administration | 184 | 3.1 2.7–3.6ROR 3.2 · χ² 262 / p 3e-59 | 3.1 EB05 2.7 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 3.6 | no trial data cached |
| Exposure via skin contact | 23 | 3.0 2.0–4.6ROR 3.0 · χ² 29 / p 3e-8 | 2.9 EB05 2.0 · IC025 +0.8 3/3 methods agree | Reporting / coding artifact | serious n=3 · 100% clinician | no trial data cached |
| Drug interaction | 155 | 2.9 2.5–3.4ROR 3.0 · χ² 194 / p 2e-44 | 2.9 EB05 2.5 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 4.3 · 97% clinician | no trial data cached |
| Injection site swelling | 74 | 2.9 2.3–3.7ROR 2.9 · χ² 91 / p 6e-22 | 2.9 EB05 2.4 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | 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 |
|---|---|---|---|---|---|---|
| Injection site pain (pain where injected) | 673 | 6.6 6.2–7.1ROR 7.2 · χ² 3,245 / p <1e-300 | 6.6 EB05 6.2 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 18.4 | no trial data cached |
| Product dose omission issue | 669 | 7.0 6.5–7.5ROR 7.6 · χ² 3,484 / p <1e-300 | 7.0 EB05 6.5 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 3.1 | no trial data cached |
| Pain | 319 | 1.5 1.4–1.7ROR 1.6 · χ² 63 / p 1e-15 | 1.5 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.1 | no trial data cached |
| Inappropriate schedule of product administration | 184 | 3.1 2.7–3.6ROR 3.2 · χ² 262 / p 3e-59 | 3.1 EB05 2.7 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 3.6 | no trial data cached |
| Product complaint | 177 | 21.3 18.4–24.6ROR 21.8 · χ² 3,380 / p <1e-300 | 21.1 EB05 18.6 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious n=7 · 97% clinician | no trial data cached |
| Product storage error | 176 | 6.1 5.2–7.0ROR 6.2 · χ² 742 / p 1e-163 | 6.0 EB05 5.3 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 1.5 · 94% clinician | no trial data cached |
| Treatment failure | 172 | 6.3 5.4–7.3ROR 6.4 · χ² 756 / p 1e-166 | 6.1 EB05 5.4 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 10.3 · 96% clinician | no trial data cached |
| Exposure during pregnancy | 172 | 8.3 7.1–9.6ROR 8.4 · χ² 1,091 / p 2e-239 | 8.1 EB05 7.1 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 8.2 · ♀ 100% (drug 30%) · 94% clinician | no trial data cached |
| Injection site nodule | 157 | 43.2 37.0–50.5ROR 44.2 · χ² 6,340 / p <1e-300 | 42.4 EB05 37.1 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Drug interaction | 155 | 2.9 2.5–3.4ROR 3.0 · χ² 194 / p 2e-44 | 2.9 EB05 2.5 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 4.3 · 97% clinician | no trial data cached |
| Drug resistance | 150 | 17.5 14.9–20.5ROR 17.9 · χ² 2,306 / p <1e-300 | 17.4 EB05 15.1 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 25.9 · ♀ 55% (drug 30%) · 90% clinician | no trial data cached |
| Depression | 142 | 1.9 1.6–2.2ROR 1.9 · χ² 55 / p 5e-14 | 1.8 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
| Myalgia (muscle pain) | 107 | 1.9 1.6–2.3ROR 1.9 · χ² 43 / p 2e-11 | 1.9 EB05 1.6 · IC025 +0.6 | Not in label — unassessed | serious PRR 2.5 | no trial data cached |
| Treatment noncompliance | 103 | 5.7 4.7–6.9ROR 5.7 · χ² 391 / p 3e-87 | 5.5 EB05 4.7 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 8.4 · 93% clinician | no trial data cached |
| Wrong technique in device usage process | 103 | 6.7 5.6–8.1ROR 6.8 · χ² 496 / p 3e-110 | 6.5 EB05 5.5 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious n=6 · 95% clinician | 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.
- Injection site nodule — n=157, PRR 43.2
- Nodule — n=63, PRR 14.4
- Injection site induration — n=42, PRR 9.7
- Injection site mass — n=77, PRR 6.2
- Nephropathy toxic — n=20, PRR 5.4
- Erectile dysfunction — n=45, PRR 5.2
- Abscess — n=27, PRR 5.1
- Sciatica — n=26, PRR 4.9
- Injection site warmth — n=31, PRR 4.5
- Abortion spontaneous — n=54, PRR 4.0
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 Rilpivirine?
In FDA FAERS, the most frequently co-reported reaction terms for Rilpivirine are injection site pain, pain, injection site nodule, depression, myalgia. 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 Rilpivirine have an FDA boxed warning?
No. The FDA label retrieved for Rilpivirine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Rilpivirine 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 dadbf50d-6b7d-4fb5-bd9f-7769b048e764, effective 20260715; matched on
openfda.generic_name.exact:"RILPIVIRINE") - 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, 147 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.