Drug · FAERS side-effect profile with label screen
Vorinostat side effects: what 2,146 FDA adverse event reports show
Drug class
FDA label (Established Pharmacologic Class) · compare the class
Brand names
Zolinza
openFDA label
Who reports
2,146 reports · 87% serious · 420 with death outcome · 48% female
openFDA FAERS counts, all years, deduplication not applied
Used for
ZOLINZA ® is indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent or recurrent disease on or following two systemic therapies. ZOLINZA is a histone deacetylase (HDAC) inhibi.
FDA label, Indications and Usage
What it is
ZOLINZA contains vorinostat, which is described chemically as N- hydroxy- N'- phenyloctanediamide.
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 9Labeled (related wording) 6Likely indication confounding 1Reporting / coding artifact 3Lab value / disease marker 1Not in label — unassessed 20
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.
- 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. 23 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 |
|---|---|---|---|---|---|---|
| Febrile neutropenia | 239 | 35.4 31.4–39.9ROR 39.7 · χ² 7,948 / p <1e-300 | 35.2 EB05 31.6 · IC025 +4.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 23.5 | no trial data cached |
| Lymphopenia | 42 | 29.3 21.7–39.5ROR 29.8 · χ² 1,115 / p 8e-245 | 28.8 EB05 22.2 · IC025 +3.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 20.9 · ♀ 4% (drug 48%) · 100% clinician | no trial data cached |
| Acute myeloid leukaemia | 40 | 25.2 18.5–34.2ROR 25.6 · χ² 902 / p 1e-198 | 24.8 EB05 19.0 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 16.8 · 95% clinician | no trial data cached |
| Electrocardiogram qt prolonged | 68 | 18.5 14.6–23.4ROR 19.1 · χ² 1,108 / p 4e-243 | 18.4 EB05 15.0 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 · ♀ 72% (drug 48%) · 94% clinician | no trial data cached |
| Haematotoxicity | 17 | 17.9 11.2–28.8ROR 18.1 · χ² 255 / p 1e-57 | 17.4 EB05 11.1 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 11.5 | no trial data cached |
| Lung infection | 28 | 17.4 12.0–25.1ROR 17.6 · χ² 416 / p 1e-92 | 17.1 EB05 12.3 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 12.4 | no trial data cached |
| Mucosal inflammation | 39 | 14.6 10.7–20.0ROR 14.9 · χ² 482 / p 4e-107 | 14.4 EB05 10.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 10.1 · ♀ 83% (drug 48%) · 95% clinician | no trial data cached |
| Device related infection | 22 | 13.9 9.2–21.1ROR 14.1 · χ² 251 / p 6e-57 | 13.4 EB05 8.9 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 9.5 | no trial data cached |
| Myelodysplastic syndrome | 20 | 13.5 8.7–20.9ROR 13.6 · χ² 219 / p 6e-50 | 12.8 EB05 8.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 · 95% clinician | no trial data cached |
| Hyperbilirubinaemia | 14 | 13.3 7.9–22.4ROR 13.4 · χ² 147 / p 4e-34 | 12.1 EB05 6.9 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | no trial data cached |
| Thrombocytopenia (low platelets) | 151 | 13.2 11.4–15.5ROR 14.2 · χ² 1,704 / p <1e-300 | 13.2 EB05 11.5 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.9 · 94% clinician | no trial data cached |
| Hypocalcaemia (low calcium) | 25 | 13.0 8.8–19.1ROR 13.1 · χ² 264 / p 1e-59 | 12.4 EB05 8.5 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Neutrophil count decreased | 52 | 12.6 9.6–16.4ROR 12.8 · χ² 542 / p 4e-120 | 12.3 EB05 9.6 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.7 | no trial data cached |
| Hypokalaemia (low potassium) | 52 | 11.1 8.5–14.5ROR 11.3 · χ² 467 / p 6e-104 | 10.8 EB05 8.4 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.5 | no trial data cached |
| Bacteraemia | 13 | 10.8 6.3–18.6ROR 10.9 · χ² 106 / p 4e-25 | 9.2 EB05 5.3 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.2 | no trial data cached |
| Haemorrhage intracranial | 16 | 10.4 6.4–17.0ROR 10.5 · χ² 127 / p 9e-30 | 9.1 EB05 5.6 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Sinus bradycardia | 10 | 10.1 5.4–18.7ROR 10.1 · χ² 73 / p 6e-18 | 8.0 EB05 4.3 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Platelet count decreased | 106 | 9.7 8.1–11.7ROR 10.2 · χ² 825 / p 9e-182 | 9.5 EB05 8.1 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.4 | no trial data cached |
| Sepsis (blood infection) | 111 | 9.7 8.1–11.7ROR 10.2 · χ² 864 / p 3e-190 | 9.5 EB05 8.1 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.5 | no trial data cached |
| Small intestinal obstruction | 12 | 9.6 5.4–16.8ROR 9.6 · χ² 84 / p 3e-20 | 7.8 EB05 4.5 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.4 | no trial data cached |
| Bone marrow failure | 20 | 9.6 6.2–14.8ROR 9.6 · χ² 145 / p 1e-33 | 8.5 EB05 5.6 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Hyperglycaemia (high blood sugar) | 35 | 9.4 6.8–13.1ROR 9.6 · χ² 255 / p 9e-58 | 8.8 EB05 6.5 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.9 · 91% clinician | no trial data cached |
| Pneumonitis | 26 | 9.4 6.4–13.8ROR 9.5 · χ² 187 / p 7e-43 | 8.6 EB05 6.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 · 92% clinician | no trial data cached |
| Lymphocyte count decreased | 17 | 9.4 5.9–15.1ROR 9.5 · χ² 119 / p 4e-28 | 8.2 EB05 5.2 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 7.6 | no trial data cached |
| Hypercalcaemia | 11 | 8.7 4.8–15.7ROR 8.8 · χ² 68 / p 1e-16 | 7.0 EB05 4.0 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Hypoxia (low oxygen) | 31 | 8.6 6.1–12.3ROR 8.8 · χ² 202 / p 4e-46 | 8.0 EB05 5.8 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Candida infection (yeast infection) | 14 | 8.2 4.9–13.8ROR 8.3 · χ² 82 / p 9e-20 | 6.8 EB05 4.2 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 | no trial data cached |
| Dehydration | 102 | 7.5 6.2–9.0ROR 7.8 · χ² 569 / p 5e-126 | 7.3 EB05 6.2 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 | no trial data cached |
| Hyponatraemia (low sodium) | 42 | 7.3 5.4–9.9ROR 7.4 · χ² 223 / p 1e-50 | 6.8 EB05 5.2 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 | no trial data cached |
| Colitis | 28 | 7.3 5.0–10.5ROR 7.4 · χ² 145 / p 9e-34 | 6.6 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Choking | 14 | 7.0 4.2–11.9ROR 7.1 · χ² 67 / p 2e-16 | 5.9 EB05 3.7 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Respiratory failure | 52 | 7.0 5.3–9.1ROR 7.1 · χ² 260 / p 7e-59 | 6.6 EB05 5.2 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.6 | no trial data cached |
| Anaemia (low red blood cells) | 135 | 6.9 5.9–8.1ROR 7.3 · χ² 683 / p 7e-151 | 6.8 EB05 5.9 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 | no trial data cached |
| Sinus tachycardia | 10 | 6.9 3.7–12.8ROR 6.9 · χ² 45 / p 1e-11 | 5.4 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 93 | 6.7 5.5–8.2ROR 7.0 · χ² 449 / p 6e-100 | 6.5 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.6 · 93% clinician | no trial data cached |
| Respiratory arrest | 16 | 5.6 3.5–9.2ROR 5.7 · χ² 56 / p 3e-14 | 4.9 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Renal failure acute | 24 | 5.5 3.7–8.1ROR 5.5 · χ² 83 / p 4e-20 | 5.0 EB05 3.5 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.7 | no trial data cached |
| Product use in unapproved indication | 130 | 5.2 4.4–6.1ROR 5.5 · χ² 442 / p 2e-98 | 5.1 EB05 4.4 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 4.5 · 98% clinician | no trial data cached |
| Pericardial effusion | 12 | 5.1 2.9–9.0ROR 5.1 · χ² 36 / p 1e-9 | 4.3 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Malignant neoplasm progression | 53 | 5.1 3.9–6.6ROR 5.2 · χ² 171 / p 3e-39 | 4.9 EB05 3.9 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | 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 |
|---|---|---|---|---|---|---|
| Febrile neutropenia | 239 | 35.4 31.4–39.9ROR 39.7 · χ² 7,948 / p <1e-300 | 35.2 EB05 31.6 · IC025 +4.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 23.5 | no trial data cached |
| Thrombocytopenia (low platelets) | 151 | 13.2 11.4–15.5ROR 14.2 · χ² 1,704 / p <1e-300 | 13.2 EB05 11.5 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.9 · 94% clinician | no trial data cached |
| Anaemia (low red blood cells) | 135 | 6.9 5.9–8.1ROR 7.3 · χ² 683 / p 7e-151 | 6.8 EB05 5.9 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 | no trial data cached |
| Product use in unapproved indication | 130 | 5.2 4.4–6.1ROR 5.5 · χ² 442 / p 2e-98 | 5.1 EB05 4.4 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 4.5 · 98% clinician | no trial data cached |
| Sepsis (blood infection) | 111 | 9.7 8.1–11.7ROR 10.2 · χ² 864 / p 3e-190 | 9.5 EB05 8.1 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.5 | no trial data cached |
| Platelet count decreased | 106 | 9.7 8.1–11.7ROR 10.2 · χ² 825 / p 9e-182 | 9.5 EB05 8.1 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.4 | no trial data cached |
| Dehydration | 102 | 7.5 6.2–9.0ROR 7.8 · χ² 569 / p 5e-126 | 7.3 EB05 6.2 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 93 | 6.7 5.5–8.2ROR 7.0 · χ² 449 / p 6e-100 | 6.5 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.6 · 93% clinician | no trial data cached |
| Electrocardiogram qt prolonged | 68 | 18.5 14.6–23.4ROR 19.1 · χ² 1,108 / p 4e-243 | 18.4 EB05 15.0 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 · ♀ 72% (drug 48%) · 94% clinician | no trial data cached |
| Disease progression | 61 | 5.1 3.9–6.5ROR 5.2 · χ² 195 / p 1e-44 | 4.9 EB05 3.9 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 3.7 | no trial data cached |
| Malignant neoplasm progression | 53 | 5.1 3.9–6.6ROR 5.2 · χ² 171 / p 3e-39 | 4.9 EB05 3.9 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 | no trial data cached |
| Respiratory failure | 52 | 7.0 5.3–9.1ROR 7.1 · χ² 260 / p 7e-59 | 6.6 EB05 5.2 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.6 | no trial data cached |
| Hypokalaemia (low potassium) | 52 | 11.1 8.5–14.5ROR 11.3 · χ² 467 / p 6e-104 | 10.8 EB05 8.4 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.5 | no trial data cached |
| Neutrophil count decreased | 52 | 12.6 9.6–16.4ROR 12.8 · χ² 542 / p 4e-120 | 12.3 EB05 9.6 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.7 | no trial data cached |
| White blood cell count decreased | 46 | 4.1 3.1–5.5ROR 4.2 · χ² 107 / p 2e-25 | 4.0 EB05 3.1 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.9 | 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.
- Acute myeloid leukaemia — n=40, PRR 25.2
- Electrocardiogram qt prolonged — n=68, PRR 18.5
- Lung infection — n=28, PRR 17.4
- Mucosal inflammation — n=39, PRR 14.6
- Myelodysplastic syndrome — n=20, PRR 13.5
- Hypocalcaemia — n=25, PRR 13.0
- Bone marrow failure — n=20, PRR 9.6
- Pneumonitis — n=26, PRR 9.4
- Hypoxia — n=31, PRR 8.6
- Colitis — n=28, PRR 7.3
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 Vorinostat?
In FDA FAERS, the most frequently co-reported reaction terms for Vorinostat are febrile neutropenia, thrombocytopenia, anaemia, sepsis, platelet count decreased, dehydration. 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 Vorinostat have an FDA boxed warning?
No. The FDA label retrieved for Vorinostat has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Vorinostat 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 cd86ee78-2781-468b-930c-3c4677bcc092, effective 20241112; matched on
openfda.generic_name.exact:"VORINOSTAT") - 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, 63 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.