Maraviroc side effects: what 2,286 FDA adverse event reports show
Drug class
CCR5 Co-receptor Antagonist
Brand names
Selzentry
Who reports
2,286 reports · 86% serious · 264 with death outcome · 28% female
Used for
SELZENTRY is indicated in combination with other antiretroviral agents for the treatment of only CCR5‑tropic human immunodeficiency virus type 1 (HIV‑1) infection in adult and pediatric patients weighing at least 2 kg. Limitations of Use • SELZENTRY is not recommended in patients with dual/mixed- or CXCR4-tropic HIV-1 .
What it is
SELZENTRY (maraviroc) is a selective, slowly reversible, small molecule antagonist of the interaction between human CCR5 and HIV-1 gp120. Blocking this interaction prevents CCR5-tropic HIV-1 entry into cells.
Boxed warning
HEPATOTOXICITY Hepatotoxicity has been reported with use of SELZENTRY. Severe rash or evidence of a systemic allergic reaction (e.g., fever, eosinophilia, or elevated IgE) prior to the development of hepatotoxicity may occur.
Causality screen of the 40 strongest signals
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.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- 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. 44 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug resistance | 85 | 30.4 24.7–37.5ROR 31.6 · χ² 2,385 / p <1e-300 | 30.1 EB05 25.1 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious PRR 22.2 · 91% clinician | no trial data cached |
| Anhedonia | 62 | 21.5 16.8–27.5ROR 22.1 · χ² 1,190 / p 4e-261 | 21.3 EB05 17.2 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 14.9 | no trial data cached |
| Osteopenia | 28 | 16.8 11.7–24.4ROR 17.0 · χ² 401 / p 1e-89 | 16.5 EB05 11.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.5 | no trial data cached |
| Economic problem | 28 | 16.7 11.5–24.1ROR 16.9 · χ² 397 / p 1e-88 | 16.4 EB05 11.7 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 11.8 | no trial data cached |
| Squamous cell carcinoma | 15 | 14.6 8.8–24.2ROR 14.7 · χ² 177 / p 1e-40 | 13.7 EB05 8.1 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.1 | no trial data cached |
| Hyperlipidaemia | 16 | 12.2 7.5–20.0ROR 12.3 · χ² 154 / p 1e-35 | 11.1 EB05 6.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Hyperbilirubinaemia | 13 | 11.6 6.7–19.9ROR 11.6 · χ² 115 / p 4e-27 | 10.0 EB05 5.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Treatment noncompliance | 57 | 9.6 7.4–12.4ROR 9.8 · χ² 433 / p 2e-96 | 9.3 EB05 7.3 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 9.6 · 100% clinician | no trial data cached |
| Bone density decreased | 33 | 9.6 6.8–13.4ROR 9.7 · χ² 244 / p 2e-55 | 8.9 EB05 6.5 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious PRR 7.8 | no trial data cached |
| Parkinsonism | 10 | 9.4 5.1–17.5ROR 9.4 · χ² 67 / p 1e-16 | 7.4 EB05 4.0 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Immunodeficiency | 15 | 9.3 5.6–15.5ROR 9.4 · χ² 103 / p 1e-24 | 7.9 EB05 4.9 · IC025 +2.0 3/3 methods agree | Likely indication confounding term in indications | serious PRR 6.8 | no trial data cached |
| Exposure during pregnancy | 62 | 9.1 7.2–11.7ROR 9.4 · χ² 443 / p 2e-98 | 8.8 EB05 7.0 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 8.8 · ♀ 100% (drug 28%) | no trial data cached |
| Hepatitis c | 12 | 9.0 5.1–15.8ROR 9.1 · χ² 78 / p 6e-19 | 7.3 EB05 4.3 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.5 | no trial data cached |
| Abortion spontaneous | 39 | 8.9 6.5–12.1ROR 9.0 · χ² 266 / p 5e-60 | 8.3 EB05 6.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · ♀ 100% (drug 28%) · 92% clinician | no trial data cached |
| Brain oedema | 12 | 8.7 5.0–15.3ROR 8.8 · χ² 74 / p 3e-18 | 7.1 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Oral candidiasis (oral thrush) | 12 | 8.5 4.8–14.9ROR 8.5 · χ² 72 / p 1e-17 | 6.9 EB05 4.0 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Lymphoma | 14 | 8.3 4.9–14.0ROR 8.3 · χ² 83 / p 5e-20 | 6.9 EB05 4.2 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 | no trial data cached |
| Hepatic failure | 26 | 7.9 5.4–11.6ROR 8.0 · χ² 150 / p 1e-34 | 7.1 EB05 5.0 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 · ♀ 5% (drug 28%) · 96% clinician | no trial data cached |
| Bacteraemia | 10 | 7.8 4.2–14.5ROR 7.8 · χ² 53 / p 2e-13 | 6.1 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Proteinuria | 16 | 7.8 4.8–12.7ROR 7.8 · χ² 88 / p 3e-21 | 6.6 EB05 4.2 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Osteoporosis | 34 | 7.6 5.4–10.6ROR 7.7 · χ² 188 / p 5e-43 | 7.0 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Treatment failure | 64 | 7.2 5.6–9.1ROR 7.3 · χ² 334 / p 8e-75 | 6.8 EB05 5.5 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 8.5 · 98% clinician | no trial data cached |
| Multiple fractures | 12 | 6.6 3.8–11.7ROR 6.7 · χ² 52 / p 3e-13 | 5.4 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Chronic kidney disease | 55 | 6.6 5.1–8.5ROR 6.7 · χ² 255 / p 8e-58 | 6.3 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Gamma-glutamyltransferase increased | 15 | 6.2 3.7–10.3ROR 6.2 · χ² 60 / p 4e-15 | 5.3 EB05 3.4 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious PRR 3.5 | no trial data cached |
| Acute myocardial infarction | 20 | 6.2 4.0–9.6ROR 6.2 · χ² 82 / p 7e-20 | 5.5 EB05 3.7 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.2 · ♀ 0% (drug 28%) | no trial data cached |
| Stevens-johnson syndrome (severe blistering skin reaction) | 15 | 6.2 3.7–10.2ROR 6.2 · χ² 60 / p 5e-15 | 5.3 EB05 3.4 · IC025 +1.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.2 | no trial data cached |
| Cytomegalovirus infection | 11 | 6.1 3.4–10.9ROR 6.1 · χ² 42 / p 6e-11 | 4.9 EB05 2.9 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.1 | no trial data cached |
| Blood creatine phosphokinase increased | 18 | 5.6 3.6–8.9ROR 5.7 · χ² 64 / p 6e-16 | 5.0 EB05 3.3 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious PRR 3.8 | no trial data cached |
| Drug level increased | 10 | 5.5 3.0–10.3ROR 5.6 · χ² 33 / p 5e-9 | 4.5 EB05 2.6 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 4.1 | no trial data cached |
| Emotional distress | 73 | 5.5 4.4–6.9ROR 5.7 · χ² 266 / p 4e-60 | 5.3 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Foetal exposure during pregnancy | 48 | 5.4 4.1–7.2ROR 5.5 · χ² 169 / p 6e-39 | 5.2 EB05 4.0 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 3.6 | no trial data cached |
| Skin lesion | 16 | 5.4 3.3–8.8ROR 5.4 · χ² 53 / p 2e-13 | 4.7 EB05 3.1 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.1 | no trial data cached |
| Pancytopenia (all blood cells low) | 30 | 4.9 3.5–7.0ROR 5.0 · χ² 90 / p 1e-21 | 4.6 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 · 97% clinician | no trial data cached |
| Renal failure acute | 23 | 4.9 3.3–7.4ROR 4.9 · χ² 68 / p 1e-16 | 4.5 EB05 3.2 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.3 · 90% clinician | no trial data cached |
| Rash maculo-papular | 11 | 4.6 2.5–8.2ROR 4.6 · χ² 27 / p 1e-7 | 3.9 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 | no trial data cached |
| Laboratory test abnormal | 14 | 4.4 2.6–7.3ROR 4.4 · χ² 33 / p 5e-9 | 3.9 EB05 2.5 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 7.0 | no trial data cached |
| Osteonecrosis (bone death) | 15 | 4.1 2.5–6.9ROR 4.2 · χ² 33 / p 5e-9 | 3.7 EB05 2.4 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 | no trial data cached |
| Maternal exposure during pregnancy | 37 | 3.8 2.8–5.3ROR 3.9 · χ² 75 / p 2e-18 | 3.7 EB05 2.8 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 2.6 · ♀ 100% (drug 28%) | no trial data cached |
| Rash generalised | 11 | 3.8 2.1–6.9ROR 3.9 · χ² 20 / p 3e-6 | 3.4 EB05 2.0 · IC025 +0.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 resistance | 85 | 30.4 24.7–37.5ROR 31.6 · χ² 2,385 / p <1e-300 | 30.1 EB05 25.1 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious PRR 22.2 · 91% clinician | no trial data cached |
| Emotional distress | 73 | 5.5 4.4–6.9ROR 5.7 · χ² 266 / p 4e-60 | 5.3 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Treatment failure | 64 | 7.2 5.6–9.1ROR 7.3 · χ² 334 / p 8e-75 | 6.8 EB05 5.5 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 8.5 · 98% clinician | no trial data cached |
| Exposure during pregnancy | 62 | 9.1 7.2–11.7ROR 9.4 · χ² 443 / p 2e-98 | 8.8 EB05 7.0 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 8.8 · ♀ 100% (drug 28%) | no trial data cached |
| Anhedonia | 62 | 21.5 16.8–27.5ROR 22.1 · χ² 1,190 / p 4e-261 | 21.3 EB05 17.2 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 14.9 | no trial data cached |
| Treatment noncompliance | 57 | 9.6 7.4–12.4ROR 9.8 · χ² 433 / p 2e-96 | 9.3 EB05 7.3 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 9.6 · 100% clinician | no trial data cached |
| Chronic kidney disease | 55 | 6.6 5.1–8.5ROR 6.7 · χ² 255 / p 8e-58 | 6.3 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Foetal exposure during pregnancy | 48 | 5.4 4.1–7.2ROR 5.5 · χ² 169 / p 6e-39 | 5.2 EB05 4.0 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 3.6 | no trial data cached |
| Myocardial infarction (heart attack) | 40 | 2.1 1.5–2.8ROR 2.1 · χ² 22 / p 2e-6 | 2.1 EB05 1.6 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.4 · 97% clinician | no trial data cached |
| Abortion spontaneous | 39 | 8.9 6.5–12.1ROR 9.0 · χ² 266 / p 5e-60 | 8.3 EB05 6.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · ♀ 100% (drug 28%) · 92% clinician | no trial data cached |
| Maternal exposure during pregnancy | 37 | 3.8 2.8–5.3ROR 3.9 · χ² 75 / p 2e-18 | 3.7 EB05 2.8 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 2.6 · ♀ 100% (drug 28%) | no trial data cached |
| Osteoporosis | 34 | 7.6 5.4–10.6ROR 7.7 · χ² 188 / p 5e-43 | 7.0 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Bone density decreased | 33 | 9.6 6.8–13.4ROR 9.7 · χ² 244 / p 2e-55 | 8.9 EB05 6.5 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious PRR 7.8 | no trial data cached |
| Pancytopenia (all blood cells low) | 30 | 4.9 3.5–7.0ROR 5.0 · χ² 90 / p 1e-21 | 4.6 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 · 97% clinician | no trial data cached |
| Economic problem | 28 | 16.7 11.5–24.1ROR 16.9 · χ² 397 / p 1e-88 | 16.4 EB05 11.7 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 11.8 | 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=62, PRR 21.5
- Osteopenia — n=28, PRR 16.8
- Abortion spontaneous — n=39, PRR 8.9
- Osteoporosis — n=34, PRR 7.6
- Chronic kidney disease — n=55, PRR 6.6
- Emotional distress — n=73, PRR 5.5
- Pancytopenia — n=30, PRR 4.9
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 Maraviroc?
In FDA FAERS, the most frequently co-reported reaction terms for Maraviroc are emotional distress, anhedonia, chronic kidney disease, myocardial infarction, abortion spontaneous, osteoporosis. 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 Maraviroc have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: HEPATOTOXICITY Hepatotoxicity has been reported with use of SELZENTRY. Severe rash or evidence of a systemic allergic reaction (e.g., fever, eosinophilia, or elevated IgE) prior to the development of hepatotoxicity may occur.
Do FAERS signals prove that Maraviroc 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 3c52dddd-0457-41cd-99e0-d30d4fd00ec5, effective 20231110; matched on
openfda.generic_name.exact:"MARAVIROC") - 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, 84 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.