Doravirine side effects: what 762 FDA adverse event reports show

Doravirine · Pifeltro · 28 reaction terms · 439 drug–reaction co-reports · data 2026-09-14

Drug class

Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Pifeltro

openFDA label

Who reports

762 reports · 79% serious · 73 with death outcome · 24% female

openFDA FAERS counts, all years, deduplication not applied

Used for

PIFELTRO ® is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg: with no prior antiretroviral treatment history; OR to replace the current antiretrovi.

FDA label, Indications and Usage

What it is

PIFELTRO is a film-coated tablet containing doravirine for oral administration. Doravirine is an HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI).

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 19 strongest signals

Labeled (related wording) 1Reporting / coding artifact 3Lab value / disease marker 1Not in label — unassessed 14

What the badges mean

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. 9 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
Anhedonia	53	55.2 42.5–71.5ROR 59.2 · χ² 2,763 / p <1e-300	54.0 EB05 42.9 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 43.8	no trial data cached
Drug resistance	44	47.2 35.4–62.9ROR 50.1 · χ² 1,944 / p <1e-300	46.3 EB05 35.9 · IC025 +4.5 3/3 methods agree	Reporting / coding artifact	serious PRR 37.1 · 95% clinician	no trial data cached
Economic problem	20	35.8 23.2–55.1ROR 36.7 · χ² 641 / p 1e-141	34.6 EB05 23.7 · IC025 +3.5 3/3 methods agree	Reporting / coding artifact	serious PRR 27.1	no trial data cached
Osteopenia	17	30.7 19.2–49.1ROR 31.4 · χ² 459 / p 4e-102	29.7 EB05 19.7 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 24.9	no trial data cached
Bone density decreased	24	20.9 14.1–30.9ROR 21.5 · χ² 435 / p 8e-97	20.5 EB05 14.4 · IC025 +3.2 3/3 methods agree	Lab value / disease marker	serious PRR 18.3	no trial data cached
Hepatic cytolysis	9	20.3 10.6–38.8ROR 20.5 · χ² 146 / p 6e-34	18.8 EB05 9.5 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 14.8	no trial data cached
Treatment noncompliance	37	18.8 13.7–25.7ROR 19.7 · χ² 605 / p 6e-134	18.6 EB05 14.0 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious PRR 19.7 · ♀ 50% (drug 24%) · 95% clinician	no trial data cached
End stage renal disease	12	17.9 10.2–31.5ROR 18.2 · χ² 175 / p 2e-40	17.0 EB05 9.5 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 13.1	no trial data cached
Proteinuria	12	17.5 10.0–30.7ROR 17.8 · χ² 171 / p 2e-39	16.5 EB05 9.2 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 14.3	no trial data cached
Chronic kidney disease	48	17.2 13.1–22.7ROR 18.3 · χ² 720 / p 5e-159	17.1 EB05 13.4 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 12.8	no trial data cached
Osteoporosis	25	16.7 11.4–24.6ROR 17.2 · χ² 354 / p 2e-79	16.4 EB05 11.5 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 14.1	no trial data cached
Emotional distress	65	14.7 11.7–18.6ROR 16.0 · χ² 822 / p 4e-181	14.6 EB05 11.8 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 12.0	no trial data cached
Decreased activity	5	12.8 5.4–30.8ROR 12.9 · χ² 43 / p 2e-11	8.5 EB05 3.2 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 11.3	no trial data cached
Multiple fractures	7	11.6 5.6–24.3ROR 11.7 · χ² 58 / p 1e-14	8.6 EB05 3.9 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 9.1	no trial data cached
Paranoia	6	9.5 4.3–21.2ROR 9.6 · χ² 38 / p 4e-10	6.5 EB05 3.0 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 8.8	no trial data cached
Apathy	5	9.5 4.0–22.7ROR 9.5 · χ² 30 / p 2e-8	6.0 EB05 2.6 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 10.0	no trial data cached
Drug reaction with eosinophilia and systemic symptoms	8	8.6 4.3–17.2ROR 8.7 · χ² 47 / p 4e-12	6.4 EB05 3.3 · IC025 +1.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.3	no trial data cached
Tooth loss	5	6.6 2.8–15.8ROR 6.6 · χ² 18 / p 9e-6	4.4 EB05 2.1 · IC025 +0.6 3/3 methods agree	Not in label — unassessed	serious PRR 6.0	no trial data cached
Oesophageal carcinoma	5	4.6 1.9–11.0ROR 4.6 · χ² 11 / p 5e-4	3.4 EB05 1.6 · IC025 +0.2	Not in label — unassessed	serious PRR 3.4	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
Emotional distress	65	14.7 11.7–18.6ROR 16.0 · χ² 822 / p 4e-181	14.6 EB05 11.8 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 12.0	no trial data cached
Anhedonia	53	55.2 42.5–71.5ROR 59.2 · χ² 2,763 / p <1e-300	54.0 EB05 42.9 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 43.8	no trial data cached
Chronic kidney disease	48	17.2 13.1–22.7ROR 18.3 · χ² 720 / p 5e-159	17.1 EB05 13.4 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 12.8	no trial data cached
Drug resistance	44	47.2 35.4–62.9ROR 50.1 · χ² 1,944 / p <1e-300	46.3 EB05 35.9 · IC025 +4.5 3/3 methods agree	Reporting / coding artifact	serious PRR 37.1 · 95% clinician	no trial data cached
Treatment noncompliance	37	18.8 13.7–25.7ROR 19.7 · χ² 605 / p 6e-134	18.6 EB05 14.0 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious PRR 19.7 · ♀ 50% (drug 24%) · 95% clinician	no trial data cached
Osteoporosis	25	16.7 11.4–24.6ROR 17.2 · χ² 354 / p 2e-79	16.4 EB05 11.5 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 14.1	no trial data cached
Bone density decreased	24	20.9 14.1–30.9ROR 21.5 · χ² 435 / p 8e-97	20.5 EB05 14.4 · IC025 +3.2 3/3 methods agree	Lab value / disease marker	serious PRR 18.3	no trial data cached
Economic problem	20	35.8 23.2–55.1ROR 36.7 · χ² 641 / p 1e-141	34.6 EB05 23.7 · IC025 +3.5 3/3 methods agree	Reporting / coding artifact	serious PRR 27.1	no trial data cached
Osteopenia	17	30.7 19.2–49.1ROR 31.4 · χ² 459 / p 4e-102	29.7 EB05 19.7 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 24.9	no trial data cached
Proteinuria	12	17.5 10.0–30.7ROR 17.8 · χ² 171 / p 2e-39	16.5 EB05 9.2 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 14.3	no trial data cached
End stage renal disease	12	17.9 10.2–31.5ROR 18.2 · χ² 175 / p 2e-40	17.0 EB05 9.5 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 13.1	no trial data cached
Hepatic cytolysis	9	20.3 10.6–38.8ROR 20.5 · χ² 146 / p 6e-34	18.8 EB05 9.5 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 14.8	no trial data cached
Drug reaction with eosinophilia and systemic symptoms	8	8.6 4.3–17.2ROR 8.7 · χ² 47 / p 4e-12	6.4 EB05 3.3 · IC025 +1.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.3	no trial data cached
Multiple fractures	7	11.6 5.6–24.3ROR 11.7 · χ² 58 / p 1e-14	8.6 EB05 3.9 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 9.1	no trial data cached
Paranoia	6	9.5 4.3–21.2ROR 9.6 · χ² 38 / p 4e-10	6.5 EB05 3.0 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 8.8	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=53, PRR 55.2
Chronic kidney disease — n=48, PRR 17.2
Osteoporosis — n=25, PRR 16.7
Emotional distress — n=65, PRR 14.7

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 Doravirine?

In FDA FAERS, the most frequently co-reported reaction terms for Doravirine are emotional distress, anhedonia, chronic kidney disease, osteoporosis, bone density decreased, osteopenia. 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 Doravirine have an FDA boxed warning?

No. The FDA label retrieved for Doravirine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Doravirine 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 76ce1f00-28c0-4314-bd2c-d473fe3d0970, effective 20260708; matched on openfda.generic_name.exact:"DORAVIRINE")
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, 28 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.