Drug · FAERS side-effect profile with label screen
Granisetron Hydrochloride side effects: what 10,384 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
10,384 reports · 91% serious · 1,893 with death outcome · 53% 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 (related wording) 3Lab value / disease marker 3Not in label — unassessed 34
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.
- 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. 996 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 | 16 | 128.5 77.5–213.0ROR 128.7 · χ² 1,784 / p <1e-300 | 105.9 EB05 69.1 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Restrictive cardiomyopathy | 11 | 75.3 41.3–137.4ROR 75.4 · χ² 707 / p 4e-156 | 64.8 EB05 38.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Tumour perforation | 10 | 67.1 35.7–125.9ROR 67.1 · χ² 567 / p 1e-125 | 58.1 EB05 33.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Insulin autoimmune syndrome | 10 | 60.5 32.3–113.6ROR 60.6 · χ² 512 / p 1e-113 | 53.2 EB05 30.9 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Systemic infection | 39 | 48.5 35.3–66.5ROR 48.6 · χ² 1,724 / p <1e-300 | 46.3 EB05 35.4 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=39 · 100% clinician | no trial data cached |
| Aortitis | 15 | 45.4 27.2–75.7ROR 45.5 · χ² 594 / p 1e-131 | 42.2 EB05 27.2 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Urinary tract infection pseudomonal | 12 | 41.9 23.6–74.1ROR 41.9 · χ² 430 / p 1e-95 | 38.7 EB05 23.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Pulpitis dental | 18 | 40.1 25.1–63.9ROR 40.1 · χ² 634 / p 3e-140 | 37.9 EB05 25.3 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Pseudomonal bacteraemia | 14 | 34.3 20.2–58.1ROR 34.3 · χ² 412 / p 6e-92 | 32.4 EB05 20.5 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Pharyngeal inflammation | 19 | 32.2 20.5–50.7ROR 32.3 · χ² 536 / p 8e-119 | 30.9 EB05 20.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Malignant ascites | 12 | 32.1 18.1–56.7ROR 32.1 · χ² 326 / p 4e-73 | 30.2 EB05 18.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Mucous membrane disorder | 21 | 30.9 20.1–47.6ROR 31.0 · χ² 570 / p 3e-126 | 29.7 EB05 20.5 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Ileal perforation | 10 | 30.8 16.5–57.5ROR 30.8 · χ² 255 / p 9e-58 | 28.8 EB05 16.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Tooth erosion | 16 | 28.7 17.6–47.1ROR 28.8 · χ² 395 / p 3e-88 | 27.5 EB05 17.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Febrile neutropenia | 858 | 26.5 24.8–28.3ROR 28.8 · χ² 20,817 / p <1e-300 | 26.2 EB05 24.7 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 16.3 · 96% clinician | no trial data cached |
| Neutropenic colitis | 26 | 25.8 17.5–38.0ROR 25.9 · χ² 588 / p 4e-130 | 25.1 EB05 18.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=26 | no trial data cached |
| Onychalgia | 12 | 24.5 13.9–43.3ROR 24.5 · χ² 244 / p 2e-55 | 23.3 EB05 13.9 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Cytomegalovirus test positive | 21 | 24.2 15.8–37.2ROR 24.3 · χ² 439 / p 8e-98 | 23.5 EB05 16.2 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious n=20 · 100% clinician | no trial data cached |
| Allergy to chemicals | 14 | 23.0 13.6–38.9ROR 23.0 · χ² 269 / p 8e-61 | 22.0 EB05 13.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Acute graft versus host disease in skin | 31 | 22.9 16.1–32.7ROR 23.0 · χ² 621 / p 2e-137 | 22.4 EB05 16.5 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=31 · 100% clinician | no trial data cached |
| Venous thrombosis limb | 23 | 22.4 14.9–33.8ROR 22.5 · χ² 444 / p 6e-99 | 21.8 EB05 15.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=22 · ♀ 75% (drug 53%) · 91% clinician | no trial data cached |
| Enterocolitis infectious | 10 | 21.9 11.8–40.9ROR 22.0 · χ² 177 / p 9e-41 | 20.5 EB05 11.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Blast cell count increased | 11 | 21.4 11.8–38.7ROR 21.4 · χ² 192 / p 7e-44 | 20.1 EB05 11.4 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious n=11 | no trial data cached |
| Neutropenic infection | 10 | 21.1 11.3–39.3ROR 21.1 · χ² 170 / p 4e-39 | 19.7 EB05 10.6 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious n=10 | no trial data cached |
| Drug clearance decreased | 13 | 21.1 12.2–36.3ROR 21.1 · χ² 226 / p 2e-51 | 20.1 EB05 12.1 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious n=12 | no trial data cached |
| Oesophageal haemorrhage | 13 | 20.0 11.6–34.5ROR 20.0 · χ² 214 / p 9e-49 | 19.0 EB05 11.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Periodontitis | 21 | 20.0 13.0–30.7ROR 20.0 · χ² 356 / p 8e-80 | 19.4 EB05 13.3 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=21 · 100% clinician | no trial data cached |
| Febrile infection | 11 | 19.5 10.7–35.2ROR 19.5 · χ² 173 / p 9e-40 | 18.2 EB05 10.1 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Hepatic infection | 12 | 19.2 10.9–34.0ROR 19.3 · χ² 188 / p 5e-43 | 18.2 EB05 10.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Osteochondrosis | 11 | 19.2 10.6–34.7ROR 19.2 · χ² 170 / p 4e-39 | 17.9 EB05 9.8 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Subileus | 18 | 17.5 11.0–27.8ROR 17.5 · χ² 261 / p 5e-59 | 16.8 EB05 10.9 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Jugular vein thrombosis | 14 | 16.1 9.5–27.3ROR 16.2 · χ² 182 / p 7e-42 | 15.1 EB05 8.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Cystitis haemorrhagic | 31 | 15.7 11.0–22.3ROR 15.7 · χ² 409 / p 4e-91 | 15.3 EB05 11.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=31 · 97% clinician | no trial data cached |
| Pulmonary sepsis | 11 | 15.5 8.5–28.0ROR 15.5 · χ² 134 / p 3e-31 | 13.9 EB05 7.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Neutrophil count decreased | 298 | 15.0 13.4–16.7ROR 15.4 · χ² 3,846 / p <1e-300 | 14.8 EB05 13.5 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.5 | no trial data cached |
| Venoocclusive disease | 18 | 14.6 9.2–23.2ROR 14.6 · χ² 213 / p 1e-48 | 13.8 EB05 8.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Peripheral motor neuropathy | 10 | 14.6 7.8–27.1ROR 14.6 · χ² 112 / p 2e-26 | 12.7 EB05 6.3 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Enterocolitis | 40 | 14.2 10.4–19.4ROR 14.3 · χ² 476 / p 8e-106 | 13.9 EB05 10.5 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=40 · 95% clinician | no trial data cached |
| Mitral valve disease | 12 | 13.7 7.8–24.2ROR 13.7 · χ² 128 / p 5e-30 | 12.2 EB05 6.6 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Vena cava thrombosis | 11 | 13.4 7.4–24.3ROR 13.4 · χ² 113 / p 9e-27 | 11.6 EB05 6.1 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=11 | 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 | 1,204 | 3.1 2.9–3.3ROR 3.4 · χ² 1,758 / p <1e-300 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.1 | no trial data cached |
| Febrile neutropenia | 858 | 26.5 24.8–28.3ROR 28.8 · χ² 20,817 / p <1e-300 | 26.2 EB05 24.7 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 16.3 · 96% clinician | no trial data cached |
| Diarrhoea (diarrhea) | 789 | 2.5 2.3–2.7ROR 2.6 · χ² 716 / p 5e-158 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 | no trial data cached |
| Vomiting | 762 | 3.3 3.1–3.5ROR 3.5 · χ² 1,235 / p 7e-271 | 3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 2.8 | no trial data cached |
| Pyrexia (fever) | 759 | 4.4 4.1–4.7ROR 4.7 · χ² 2,045 / p <1e-300 | 4.4 EB05 4.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Dyspnoea (shortness of breath) | 651 | 2.3 2.2–2.5ROR 2.4 · χ² 504 / p 7e-112 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.0 | no trial data cached |
| Fatigue (tiredness) | 563 | 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) | 547 | 5.8 5.3–6.3ROR 6.1 · χ² 2,183 / p <1e-300 | 5.8 EB05 5.4 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 · 90% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 534 | 8.0 7.4–8.7ROR 8.4 · χ² 3,265 / p <1e-300 | 7.9 EB05 7.4 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.0 · 91% clinician | no trial data cached |
| Off label use (used outside approved label) | 515 | 1.2 1.1–1.3ROR 1.2 · χ² 17 / p 1e-5 | 1.2 EB05 1.1 · IC025 +0.1 | Reporting / coding artifact | serious PRR 1.3 | no trial data cached |
| Decreased appetite (loss of appetite) | 423 | 3.7 3.4–4.1ROR 3.8 · χ² 836 / p 4e-184 | 3.7 EB05 3.4 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Pneumonia (lung infection) | 414 | 2.6 2.4–2.8ROR 2.7 · χ² 408 / p 5e-91 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 1.7 | no trial data cached |
| Death | 401 | 0.9 0.9–1.0ROR 0.9 · χ² 2 / p 0.109 | 0.9 EB05 0.9 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 0.6 | no trial data cached |
| Constipation | 397 | 3.7 3.4–4.1ROR 3.8 · χ² 790 / p 4e-174 | 3.7 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 | no trial data cached |
| General physical health deterioration | 381 | 6.7 6.1–7.4ROR 6.9 · χ² 1,852 / p <1e-300 | 6.6 EB05 6.1 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 4.9 · 93% clinician | 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 48.5
- Mucous membrane disorder — n=21, PRR 30.9
- Neutropenic colitis — n=26, PRR 25.8
- Acute graft versus host disease in skin — n=31, PRR 22.9
- Venous thrombosis limb — n=23, PRR 22.4
- Periodontitis — n=21, PRR 20.0
- Cystitis haemorrhagic — n=31, PRR 15.7
- Enterocolitis — n=40, PRR 14.2
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, febrile neutropenia, diarrhoea, vomiting, 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, 1,036 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.