Drug · FAERS side-effect profile with label screen
Granisetron side effects: what 10,428 FDA adverse event reports show
Drug class
Serotonin-3 Receptor Antagonist
FDA label (Established Pharmacologic Class) · compare the class
Brand names
Sustol
openFDA label
Who reports
10,428 reports · 83% serious · 1,874 with death outcome · 54% female
openFDA FAERS counts, all years, deduplication not applied
Used for
SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens.
FDA label, Indications and Usage
What it is
SUSTOL (granisetron) extended-release injection, contains granisetron, a serotonin-3 (5-HT 3 ) receptor antagonist. Granisetron is 1-methyl-N-[(1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide with a molecular weight of 312.4.
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 1Labeled (related wording) 4Reporting / coding artifact 1Lab value / disease marker 1Not in label — unassessed 33
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. 981 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 |
|---|---|---|---|---|---|---|
| Antithrombin iii decreased | 12 | 94.4 52.9–168.5ROR 94.6 · χ² 972 / p 1e-213 | 79.2 EB05 48.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Restrictive cardiomyopathy | 11 | 75.0 41.1–136.8ROR 75.0 · χ² 704 / p 2e-155 | 64.6 EB05 38.5 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Radiation oesophagitis | 12 | 65.6 36.9–116.5ROR 65.6 · χ² 677 / p 1e-149 | 58.0 EB05 35.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Insulin autoimmune syndrome | 10 | 60.3 32.1–113.1ROR 60.3 · χ² 510 / p 4e-113 | 53.0 EB05 30.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Systemic infection | 39 | 48.3 35.1–66.3ROR 48.4 · χ² 1,716 / p <1e-300 | 46.1 EB05 35.2 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=39 · 100% clinician | no trial data cached |
| Urinary tract infection pseudomonal | 12 | 41.7 23.5–73.8ROR 41.7 · χ² 428 / p 3e-95 | 38.6 EB05 23.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Pseudomonal bacteraemia | 14 | 34.1 20.1–57.8ROR 34.2 · χ² 410 / p 1e-91 | 32.2 EB05 20.4 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Aortitis | 11 | 33.0 18.2–59.8ROR 33.0 · χ² 305 / p 2e-68 | 30.8 EB05 18.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Pharyngeal inflammation | 18 | 30.4 19.1–48.4ROR 30.4 · χ² 475 / p 1e-105 | 29.1 EB05 19.5 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Onychalgia | 12 | 24.4 13.8–43.1ROR 24.4 · χ² 243 / p 4e-55 | 23.2 EB05 13.9 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Product adhesion issue | 399 | 22.9 20.8–25.2ROR 23.7 · χ² 8,245 / p <1e-300 | 22.6 EB05 20.8 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious n=28 | no trial data cached |
| Allergy to chemicals | 14 | 22.9 13.5–38.7ROR 22.9 · χ² 268 / p 2e-60 | 21.9 EB05 13.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Neutropenic colitis | 23 | 22.7 15.1–34.2ROR 22.7 · χ² 450 / p 3e-100 | 22.1 EB05 15.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=23 · 100% clinician | no trial data cached |
| Febrile neutropenia | 737 | 22.6 21.1–24.3ROR 24.3 · χ² 15,085 / p <1e-300 | 22.4 EB05 21.0 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.3 · 96% clinician | no trial data cached |
| Oesophageal haemorrhage | 14 | 21.5 12.7–36.3ROR 21.5 · χ² 250 / p 1e-56 | 20.6 EB05 12.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Neutropenic infection | 10 | 21.0 11.3–39.2ROR 21.0 · χ² 169 / p 5e-39 | 19.6 EB05 10.6 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious n=10 | no trial data cached |
| Osteochondrosis | 11 | 19.1 10.5–34.5ROR 19.1 · χ² 169 / p 6e-39 | 17.8 EB05 9.8 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Tooth erosion | 10 | 17.8 9.5–33.1ROR 17.8 · χ² 141 / p 9e-33 | 16.3 EB05 8.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Drug clearance decreased | 11 | 17.7 9.8–32.1ROR 17.7 · χ² 156 / p 5e-36 | 16.4 EB05 8.8 · IC025 +2.3 3/3 methods agree | Lab value / disease marker | serious n=11 | no trial data cached |
| Febrile infection | 10 | 17.6 9.4–32.8ROR 17.6 · χ² 139 / p 2e-32 | 16.1 EB05 8.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Hepatic infection | 10 | 15.9 8.6–29.7ROR 16.0 · χ² 125 / p 3e-29 | 14.2 EB05 7.1 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Venous thrombosis limb | 16 | 15.5 9.5–25.3ROR 15.5 · χ² 201 / p 7e-46 | 14.6 EB05 8.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Pulmonary sepsis | 11 | 15.4 8.5–27.9ROR 15.4 · χ² 133 / p 5e-31 | 13.9 EB05 7.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Jugular vein thrombosis | 13 | 14.9 8.6–25.7ROR 14.9 · χ² 154 / p 1e-35 | 13.7 EB05 7.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Electrocardiogram st segment elevation | 24 | 14.6 9.8–21.9ROR 14.7 · χ² 289 / p 3e-65 | 14.1 EB05 9.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=24 · ♀ 27% (drug 54%) · 90% clinician | no trial data cached |
| Venoocclusive disease | 18 | 14.5 9.1–23.1ROR 14.6 · χ² 212 / p 2e-48 | 13.7 EB05 8.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Subileus | 14 | 13.5 8.0–22.8ROR 13.5 · χ² 149 / p 1e-34 | 12.2 EB05 7.0 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Injection site cellulitis | 12 | 13.2 7.5–23.3ROR 13.2 · χ² 122 / p 9e-29 | 11.6 EB05 6.3 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious n=8 | no trial data cached |
| Aplastic anaemia | 33 | 12.7 9.0–17.9ROR 12.8 · χ² 343 / p 8e-77 | 12.2 EB05 8.9 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=33 · 97% clinician | no trial data cached |
| Periodontitis | 13 | 12.3 7.1–21.2ROR 12.3 · χ² 123 / p 8e-29 | 10.7 EB05 6.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Vena cava thrombosis | 10 | 12.1 6.5–22.6ROR 12.1 · χ² 91 / p 8e-22 | 10.0 EB05 5.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Dermatitis acneiform | 35 | 11.7 8.4–16.3ROR 11.7 · χ² 330 / p 5e-74 | 11.2 EB05 8.2 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=35 | no trial data cached |
| Mucosal inflammation | 149 | 11.6 9.8–13.6ROR 11.7 · χ² 1,420 / p <1e-300 | 11.4 EB05 9.9 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 · 95% clinician | no trial data cached |
| Peripheral sensory neuropathy | 33 | 11.4 8.1–16.1ROR 11.4 · χ² 301 / p 8e-68 | 10.8 EB05 7.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=30 | no trial data cached |
| Polyneuropathy | 67 | 11.4 9.0–14.5ROR 11.5 · χ² 621 / p 2e-137 | 11.1 EB05 8.9 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 · 94% clinician | no trial data cached |
| Mitral valve disease | 10 | 11.4 6.1–21.2ROR 11.4 · χ² 84 / p 3e-20 | 9.2 EB05 4.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Ileus | 69 | 11.3 9.0–14.3ROR 11.4 · χ² 637 / p 9e-141 | 11.1 EB05 8.9 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.8 · 91% clinician | no trial data cached |
| Hyperaemia | 11 | 11.2 6.2–20.3ROR 11.3 · χ² 92 / p 4e-22 | 9.3 EB05 5.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Neutrophil count decreased | 225 | 11.2 9.9–12.8ROR 11.5 · χ² 2,078 / p <1e-300 | 11.1 EB05 9.9 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.6 | no trial data cached |
| Pneumonia klebsiella | 10 | 11.0 5.9–20.5ROR 11.0 · χ² 81 / p 1e-19 | 8.9 EB05 4.6 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=10 | 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 |
|---|---|---|---|---|---|---|
| Nausea | 1,336 | 3.4 3.2–3.6ROR 3.8 · χ² 2,357 / p <1e-300 | 3.4 EB05 3.3 · IC025 +1.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.2 | no trial data cached |
| Vomiting | 768 | 3.3 3.1–3.5ROR 3.5 · χ² 1,253 / p 8e-275 | 3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 2.9 | no trial data cached |
| Febrile neutropenia | 737 | 22.6 21.1–24.3ROR 24.3 · χ² 15,085 / p <1e-300 | 22.4 EB05 21.0 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.3 · 96% clinician | no trial data cached |
| Diarrhoea (diarrhea) | 722 | 2.3 2.1–2.4ROR 2.4 · χ² 521 / p 2e-115 | 2.3 EB05 2.1 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 | no trial data cached |
| Pyrexia (fever) | 659 | 3.8 3.6–4.1ROR 4.0 · χ² 1,397 / p <1e-300 | 3.8 EB05 3.6 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Death | 607 | 1.4 1.3–1.5ROR 1.4 · χ² 77 / p 7e-19 | 1.4 EB05 1.3 · IC025 +0.4 | Outcome field, not a reaction | serious PRR 1.0 | no trial data cached |
| Dyspnoea (shortness of breath) | 599 | 2.1 2.0–2.3ROR 2.2 · χ² 368 / p 3e-82 | 2.1 EB05 2.0 · IC025 +1.0 | Not in label — unassessed | serious PRR 2.0 | no trial data cached |
| Fatigue (tiredness) | 565 | 1.5 1.4–1.6ROR 1.5 · χ² 85 / p 1e-20 | 1.5 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.6 | no trial data cached |
| Anaemia (low red blood cells) | 488 | 5.2 4.7–5.6ROR 5.4 · χ² 1,640 / p <1e-300 | 5.1 EB05 4.7 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 484 | 7.2 6.6–7.9ROR 7.5 · χ² 2,588 / p <1e-300 | 7.1 EB05 6.6 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.9 · 91% clinician | no trial data cached |
| Off label use (used outside approved label) | 458 | 1.1 1.0–1.2ROR 1.1 · χ² 2 / p 0.101 | 1.1 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.2 | no trial data cached |
| Constipation | 401 | 3.7 3.4–4.1ROR 3.8 · χ² 806 / p 1e-177 | 3.7 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 | no trial data cached |
| Product adhesion issue | 399 | 22.9 20.8–25.2ROR 23.7 · χ² 8,245 / p <1e-300 | 22.6 EB05 20.8 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious n=28 | no trial data cached |
| Pneumonia (lung infection) | 375 | 2.3 2.1–2.6ROR 2.4 · χ² 289 / p 4e-65 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 1.7 | no trial data cached |
| Decreased appetite (loss of appetite) | 375 | 3.3 3.0–3.6ROR 3.3 · χ² 591 / p 9e-131 | 3.2 EB05 3.0 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 | 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.
- Systemic infection — n=39, PRR 48.3
- Neutropenic colitis — n=23, PRR 22.7
- Electrocardiogram st segment elevation — n=24, PRR 14.6
- Aplastic anaemia — n=33, PRR 12.7
- Dermatitis acneiform — n=35, PRR 11.7
- Mucosal inflammation — n=149, PRR 11.6
- Peripheral sensory neuropathy — n=33, PRR 11.4
- Polyneuropathy — n=67, PRR 11.4
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 Granisetron?
In FDA FAERS, the most frequently co-reported reaction terms for Granisetron are nausea, vomiting, febrile neutropenia, diarrhoea, pyrexia, dyspnoea. 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 Granisetron have an FDA boxed warning?
No. The FDA label retrieved for Granisetron has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Granisetron 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 f7c7ffdd-8270-4030-bc1e-a1cb28a6de56, effective 20260430; matched on
openfda.generic_name.exact:"GRANISETRON") - 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, 1,021 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.