Drug · FAERS side-effect profile with label screen
Rilpivirine Hydrochloride side effects: what 1,909 FDA adverse event reports show
Drug class
Not stated in label
Who reports
1,909 reports · 68% serious · 86 with death outcome · 29% 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 6Lab value / disease marker 2Not in label — unassessed 26
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. 37 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 |
|---|---|---|---|---|---|---|
| Anhedonia | 141 | 58.7 50.1–68.9ROR 63.4 · χ² 7,914 / p <1e-300 | 58.0 EB05 50.4 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 52.7 | no trial data cached |
| Economic problem | 60 | 42.9 33.4–55.1ROR 44.3 · χ² 2,406 / p <1e-300 | 42.2 EB05 34.0 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious PRR 39.1 | no trial data cached |
| Osteopenia | 42 | 30.3 22.5–40.9ROR 31.0 · χ² 1,159 / p 3e-254 | 29.9 EB05 23.0 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 27.5 | no trial data cached |
| End stage renal disease | 43 | 25.7 19.1–34.5ROR 26.3 · χ² 994 / p 2e-218 | 25.4 EB05 19.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 21.8 | no trial data cached |
| Quality of life decreased | 28 | 22.9 15.9–33.1ROR 23.3 · χ² 565 / p 4e-125 | 22.6 EB05 16.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 24.0 | no trial data cached |
| Decreased activity | 19 | 19.5 12.5–30.5ROR 19.7 · χ² 315 / p 1e-70 | 19.0 EB05 12.7 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 24.9 | no trial data cached |
| Bone density decreased | 52 | 18.0 13.8–23.6ROR 18.5 · χ² 820 / p 1e-180 | 17.9 EB05 14.1 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious PRR 17.7 | no trial data cached |
| Hyperlipidaemia | 19 | 17.4 11.1–27.3ROR 17.6 · χ² 278 / p 1e-62 | 16.9 EB05 11.1 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 16.3 | no trial data cached |
| Osteoporosis | 63 | 16.8 13.2–21.4ROR 17.4 · χ² 922 / p 8e-203 | 16.7 EB05 13.5 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 16.5 | no trial data cached |
| Chronic kidney disease | 117 | 16.8 14.1–20.0ROR 17.8 · χ² 1,724 / p <1e-300 | 16.7 EB05 14.3 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 14.5 | no trial data cached |
| Emotional distress | 156 | 14.1 12.1–16.4ROR 15.3 · χ² 1,896 / p <1e-300 | 14.0 EB05 12.3 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 13.0 | no trial data cached |
| Drug resistance | 32 | 13.7 9.7–19.3ROR 13.9 · χ² 364 / p 2e-81 | 13.3 EB05 9.7 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 9.8 | no trial data cached |
| Nephropathy | 11 | 12.9 7.1–23.2ROR 12.9 · χ² 109 / p 9e-26 | 11.1 EB05 5.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.7 | no trial data cached |
| Abortion induced | 11 | 12.8 7.1–23.1ROR 12.9 · χ² 108 / p 1e-25 | 11.1 EB05 5.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 | no trial data cached |
| Psychotic disorder | 34 | 12.6 9.1–17.7ROR 12.9 · χ² 353 / p 4e-79 | 12.2 EB05 8.9 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 11.7 · ♀ 0% (drug 29%) | no trial data cached |
| Vitamin d deficiency | 11 | 12.4 6.9–22.4ROR 12.5 · χ² 104 / p 1e-24 | 10.6 EB05 5.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 12.7 | no trial data cached |
| Tooth loss | 21 | 11.1 7.2–16.9ROR 11.2 · χ² 182 / p 9e-42 | 10.1 EB05 6.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 | no trial data cached |
| Ankle fracture | 15 | 10.6 6.4–17.6ROR 10.7 · χ² 121 / p 2e-28 | 9.3 EB05 5.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 | no trial data cached |
| Bone loss | 13 | 9.4 5.5–16.2ROR 9.5 · χ² 89 / p 2e-21 | 7.8 EB05 4.6 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 | no trial data cached |
| Spinal pain | 10 | 9.4 5.1–17.4ROR 9.4 · χ² 67 / p 2e-16 | 7.4 EB05 4.0 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 | no trial data cached |
| Multiple fractures | 14 | 9.3 5.5–15.6ROR 9.3 · χ² 95 / p 8e-23 | 7.8 EB05 4.7 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | no trial data cached |
| Glomerular filtration rate decreased | 10 | 9.1 4.9–16.8ROR 9.1 · χ² 64 / p 6e-16 | 7.1 EB05 3.9 · IC025 +1.6 3/3 methods agree | Lab value / disease marker | serious PRR 8.6 | no trial data cached |
| Blood creatinine increased | 52 | 8.7 6.7–11.4ROR 8.9 · χ² 349 / p 3e-78 | 8.3 EB05 6.5 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.4 | no trial data cached |
| Renal failure (kidney failure) | 103 | 8.5 7.0–10.2ROR 8.9 · χ² 674 / p 8e-149 | 8.2 EB05 7.0 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.2 | no trial data cached |
| Foetal exposure during pregnancy | 62 | 8.4 6.6–10.7ROR 8.6 · χ² 397 / p 1e-88 | 8.0 EB05 6.4 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 7.3 · 94% clinician | no trial data cached |
| Loss of personal independence in daily activities | 36 | 8.3 6.0–11.5ROR 8.5 · χ² 225 / p 4e-51 | 7.7 EB05 5.8 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Exposure during pregnancy | 47 | 8.3 6.3–11.0ROR 8.5 · χ² 295 / p 2e-66 | 7.9 EB05 6.1 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 9.3 · ♀ 100% (drug 29%) | no trial data cached |
| Renal impairment | 63 | 8.3 6.5–10.5ROR 8.5 · χ² 397 / p 1e-88 | 7.9 EB05 6.4 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.3 | no trial data cached |
| Aggression | 36 | 7.9 5.7–10.9ROR 8.0 · χ² 210 / p 7e-48 | 7.3 EB05 5.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 · ♀ 0% (drug 29%) | no trial data cached |
| Nightmare | 23 | 7.3 4.8–10.9ROR 7.3 · χ² 118 / p 8e-28 | 6.5 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Anxiety | 186 | 7.2 6.2–8.2ROR 7.8 · χ² 993 / p 3e-218 | 7.1 EB05 6.2 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.9 | no trial data cached |
| Blood triglycerides increased | 11 | 6.8 3.8–12.3ROR 6.8 · χ² 49 / p 1e-12 | 5.5 EB05 3.2 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.8 | no trial data cached |
| Product administration error | 12 | 6.6 3.8–11.6ROR 6.6 · χ² 52 / p 3e-13 | 5.4 EB05 3.3 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Rib fracture | 12 | 6.4 3.7–11.3ROR 6.5 · χ² 50 / p 9e-13 | 5.3 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Proteinuria | 11 | 6.4 3.6–11.6ROR 6.4 · χ² 45 / p 1e-11 | 5.2 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Foot fracture | 11 | 6.4 3.5–11.5ROR 6.4 · χ² 44 / p 1e-11 | 5.2 EB05 3.1 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Abortion spontaneous | 23 | 6.3 4.2–9.4ROR 6.3 · χ² 97 / p 3e-23 | 5.6 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 · ♀ 100% (drug 29%) | no trial data cached |
| Treatment noncompliance | 30 | 6.1 4.3–8.6ROR 6.1 · χ² 122 / p 1e-28 | 5.6 EB05 4.1 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 4.8 | no trial data cached |
| Osteonecrosis (bone death) | 18 | 6.0 3.8–9.4ROR 6.0 · χ² 70 / p 4e-17 | 5.2 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Dysstasia | 15 | 5.6 3.4–9.3ROR 5.7 · χ² 53 / p 2e-13 | 4.9 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | 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 |
|---|---|---|---|---|---|---|
| Anxiety | 186 | 7.2 6.2–8.2ROR 7.8 · χ² 993 / p 3e-218 | 7.1 EB05 6.2 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.9 | no trial data cached |
| Emotional distress | 156 | 14.1 12.1–16.4ROR 15.3 · χ² 1,896 / p <1e-300 | 14.0 EB05 12.3 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 13.0 | no trial data cached |
| Anhedonia | 141 | 58.7 50.1–68.9ROR 63.4 · χ² 7,914 / p <1e-300 | 58.0 EB05 50.4 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 52.7 | no trial data cached |
| Chronic kidney disease | 117 | 16.8 14.1–20.0ROR 17.8 · χ² 1,724 / p <1e-300 | 16.7 EB05 14.3 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 14.5 | no trial data cached |
| Renal failure (kidney failure) | 103 | 8.5 7.0–10.2ROR 8.9 · χ² 674 / p 8e-149 | 8.2 EB05 7.0 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.2 | no trial data cached |
| Product dose omission issue | 100 | 3.9 3.2–4.7ROR 4.0 · χ² 212 / p 3e-48 | 3.8 EB05 3.2 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 6.4 | no trial data cached |
| Renal impairment | 63 | 8.3 6.5–10.5ROR 8.5 · χ² 397 / p 1e-88 | 7.9 EB05 6.4 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.3 | no trial data cached |
| Osteoporosis | 63 | 16.8 13.2–21.4ROR 17.4 · χ² 922 / p 8e-203 | 16.7 EB05 13.5 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 16.5 | no trial data cached |
| Foetal exposure during pregnancy | 62 | 8.4 6.6–10.7ROR 8.6 · χ² 397 / p 1e-88 | 8.0 EB05 6.4 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 7.3 · 94% clinician | no trial data cached |
| Economic problem | 60 | 42.9 33.4–55.1ROR 44.3 · χ² 2,406 / p <1e-300 | 42.2 EB05 34.0 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious PRR 39.1 | no trial data cached |
| Inappropriate schedule of product administration | 58 | 3.6 2.8–4.6ROR 3.7 · χ² 107 / p 2e-25 | 3.5 EB05 2.8 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 5.0 | no trial data cached |
| Blood creatinine increased | 52 | 8.7 6.7–11.4ROR 8.9 · χ² 349 / p 3e-78 | 8.3 EB05 6.5 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.4 | no trial data cached |
| Bone density decreased | 52 | 18.0 13.8–23.6ROR 18.5 · χ² 820 / p 1e-180 | 17.9 EB05 14.1 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious PRR 17.7 | no trial data cached |
| Injection site pain (pain where injected) | 49 | 1.8 1.3–2.3ROR 1.8 · χ² 16 / p 3e-5 | 1.8 EB05 1.4 · IC025 +0.3 | Labeled (related wording) related wording | serious PRR 4.0 | no trial data cached |
| Exposure during pregnancy | 47 | 8.3 6.3–11.0ROR 8.5 · χ² 295 / p 2e-66 | 7.9 EB05 6.1 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 9.3 · ♀ 100% (drug 29%) | 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.
- Anhedonia — n=141, PRR 58.7
- Osteopenia — n=42, PRR 30.3
- End stage renal disease — n=43, PRR 25.7
- Quality of life decreased — n=28, PRR 22.9
- Osteoporosis — n=63, PRR 16.8
- Chronic kidney disease — n=117, PRR 16.8
- Emotional distress — n=156, PRR 14.1
- Psychotic disorder — n=34, PRR 12.6
- Tooth loss — n=21, PRR 11.1
- Loss of personal independence in daily activities — n=36, PRR 8.3
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 anxiety, emotional distress, anhedonia, chronic kidney disease, renal failure, renal impairment. 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, 77 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.