Drug · FAERS side-effect profile with label screen
Ganciclovir Sodium side effects: what 10,521 FDA adverse event reports show
Drug class
Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor, Nucleoside Analog Antiviral
FDA label (Established Pharmacologic Class) · compare the class
Brand names
Zirgan
openFDA label
Who reports
10,521 reports · 98% serious · 3,382 with death outcome · 42% female
openFDA FAERS counts, all years, deduplication not applied
Used for
ZIRGAN is indicated for the treatment of acute herpetic keratitis (dendritic ulcers) in adults and pediatric patients aged 2 years and older. ZIRGAN is a nucleoside analog antiviral indicated for the treatment of acute herpetic keratitis (dendritic ulcers) in adults and pediatric patients aged 2 years and older. ( 1 )
FDA label, Indications and Usage
What it is
ZIRGAN (ganciclovir ophthalmic gel) 0.15% contains ganciclovir, a nucleoside analog antiviral. ZIRGAN is a sterile, preserved, clear, colorless, ophthalmic gel for topical ophthalmic use.
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
Lab value / disease marker 3No label text to screen 37
What the badges mean
- 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.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
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. 992 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 |
|---|---|---|---|---|---|---|
| Encephalitis cytomegalovirus | 175 | 1,365.1 1,126.8–1,654.0ROR 1,388.2 · χ² 139,982 / p <1e-300 | 740.3 EB05 652.7 · IC025 +7.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=175 · 94% clinician | no trial data cached |
| Immune recovery uveitis | 21 | 1,179.5 686.9–2,025.4ROR 1,181.8 · χ² 14,726 / p <1e-300 | 440.4 EB05 303.9 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=21 · 100% clinician | no trial data cached |
| Oesophagopleural fistula | 11 | 1,029.7 496.6–2,135.1ROR 1,030.8 · χ² 6,759 / p <1e-300 | 310.7 EB05 185.1 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | no trial data cached |
| Cytomegalovirus myocarditis | 11 | 982.9 476.7–2,026.4ROR 983.9 · χ² 6,553 / p <1e-300 | 306.3 EB05 182.5 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | no trial data cached |
| Cytomegalovirus syndrome | 46 | 779.5 554.3–1,096.3ROR 783.0 · χ² 25,056 / p <1e-300 | 452.8 EB05 353.3 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=46 | no trial data cached |
| Smooth muscle cell neoplasm | 108 | 705.3 566.6–878.0ROR 712.6 · χ² 55,386 / p <1e-300 | 475.4 EB05 404.8 · IC025 +6.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=108 · ♀ 100% (drug 42%) · 98% clinician | no trial data cached |
| Retinitis viral | 28 | 611.6 400.4–934.3ROR 613.2 · χ² 12,557 / p <1e-300 | 353.7 EB05 256.8 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=28 · ♀ 80% (drug 42%) | no trial data cached |
| Cytomegalovirus gastritis | 37 | 354.8 250.1–503.3ROR 356.1 · χ² 10,760 / p <1e-300 | 260.3 EB05 197.2 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=37 · 97% clinician | no trial data cached |
| Cytomegalovirus gastrointestinal infection | 44 | 343.2 249.3–472.5ROR 344.7 · χ² 12,493 / p <1e-300 | 259.4 EB05 201.3 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=44 · 100% clinician | no trial data cached |
| Necrotising herpetic retinopathy | 10 | 307.2 157.8–598.0ROR 307.4 · χ² 2,381 / p <1e-300 | 176.8 EB05 102.6 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial data cached |
| Disseminated cytomegaloviral infection | 28 | 292.8 196.9–435.3ROR 293.6 · χ² 6,835 / p <1e-300 | 217.3 EB05 157.8 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=28 · 100% clinician | no trial data cached |
| Cytomegalovirus gastroenteritis | 25 | 270.0 177.8–410.0ROR 270.7 · χ² 5,657 / p <1e-300 | 201.2 EB05 143.3 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=24 · 100% clinician | no trial data cached |
| Intracranial infection | 14 | 257.2 147.4–448.8ROR 257.5 · χ² 2,937 / p <1e-300 | 174.0 EB05 110.2 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=14 | no trial data cached |
| Cytomegalovirus chorioretinitis | 215 | 250.2 217.4–288.0ROR 255.4 · χ² 47,128 / p <1e-300 | 217.8 EB05 194.4 · IC025 +7.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=212 · 95% clinician | no trial data cached |
| Cytomegalovirus oesophagitis | 40 | 245.0 176.4–340.1ROR 245.9 · χ² 8,426 / p <1e-300 | 197.5 EB05 151.3 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=40 | no trial data cached |
| Pneumonia cytomegaloviral | 194 | 224.2 193.5–259.8ROR 228.4 · χ² 38,498 / p <1e-300 | 197.5 EB05 175.2 · IC025 +6.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=194 · 95% clinician | no trial data cached |
| Cytomegalovirus viraemia | 438 | 221.9 201.4–244.4ROR 231.4 · χ² 86,352 / p <1e-300 | 197.7 EB05 182.7 · IC025 +7.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=434 · 92% clinician | no trial data cached |
| Epstein-barr viraemia | 105 | 213.2 174.5–260.6ROR 215.4 · χ² 19,819 / p <1e-300 | 186.0 EB05 158.0 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=105 · ♀ 15% (drug 42%) · 95% clinician | no trial data cached |
| Cytomegalovirus colitis | 210 | 203.9 177.1–234.7ROR 208.0 · χ² 38,229 / p <1e-300 | 181.8 EB05 162.0 · IC025 +6.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=209 · 92% clinician | no trial data cached |
| Cytomegalovirus antigen positive | 17 | 201.3 122.3–331.5ROR 201.6 · χ² 2,895 / p <1e-300 | 151.9 EB05 100.4 · IC025 +4.1 3/3 methods agree | Lab value / disease marker | serious n=17 | no trial data cached |
| Cytomegalovirus infection reactivation | 388 | 199.4 180.0–221.0ROR 207.0 · χ² 69,376 / p <1e-300 | 179.5 EB05 165.0 · IC025 +7.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=387 · 94% clinician | no trial data cached |
| Acanthamoeba infection | 16 | 182.9 109.6–305.1ROR 183.1 · χ² 2,484 / p <1e-300 | 139.8 EB05 91.3 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=16 | no trial data cached |
| Neutrophil pelger-huet anomaly present | 15 | 171.4 101.2–290.5ROR 171.7 · χ² 2,184 / p <1e-300 | 131.7 EB05 84.7 · IC025 +3.8 3/3 methods agree | Lab value / disease marker | serious n=15 | no trial data cached |
| Cytomegalovirus enteritis | 27 | 165.9 112.0–245.5ROR 166.3 · χ² 3,930 / p <1e-300 | 138.3 EB05 99.8 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=27 · 96% clinician | no trial data cached |
| Cytomegalovirus infection | 1,266 | 164.3 155.6–173.4ROR 186.6 · χ² 189,598 / p <1e-300 | 151.3 EB05 144.5 · IC025 +7.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 90.2 · 92% clinician | no trial data cached |
| Drug resistance mutation | 13 | 158.7 90.2–279.2ROR 158.9 · χ² 1,742 / p <1e-300 | 121.2 EB05 75.4 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | no trial data cached |
| Adenovirus reactivation | 10 | 154.8 81.3–294.6ROR 154.9 · χ² 1,277 / p 5e-280 | 113.2 EB05 65.7 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial data cached |
| Mesangioproliferative glomerulonephritis | 11 | 152.3 82.5–281.1ROR 152.4 · χ² 1,397 / p <1e-300 | 114.0 EB05 67.9 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | no trial data cached |
| Viral haemorrhagic cystitis | 50 | 151.9 114.0–202.4ROR 152.6 · χ² 6,819 / p <1e-300 | 134.0 EB05 105.6 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=49 · ♀ 65% (drug 42%) · 100% clinician | no trial data cached |
| Cytomegalovirus hepatitis | 25 | 151.7 101.0–227.7ROR 152.0 · χ² 3,336 / p <1e-300 | 127.4 EB05 90.7 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=25 · 92% clinician | no trial data cached |
| Cytomegalovirus enterocolitis | 53 | 149.1 112.8–196.9ROR 149.8 · χ² 7,108 / p <1e-300 | 132.1 EB05 104.9 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=53 | no trial data cached |
| Gastrointestinal mucormycosis | 11 | 148.1 80.3–273.3ROR 148.3 · χ² 1,361 / p 3e-298 | 111.7 EB05 66.5 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | no trial data cached |
| Necrotising retinitis | 41 | 136.8 99.8–187.7ROR 137.4 · χ² 5,043 / p <1e-300 | 120.9 EB05 92.9 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=41 · 95% clinician | no trial data cached |
| Cytomegalovirus test positive | 106 | 126.9 104.4–154.3ROR 128.2 · χ² 12,321 / p <1e-300 | 116.8 EB05 99.3 · IC025 +5.9 3/3 methods agree | Lab value / disease marker | serious n=104 · 90% clinician | no trial data cached |
| Rhegmatogenous retinal detachment | 12 | 120.4 67.2–215.5ROR 120.5 · χ² 1,228 / p 2e-269 | 96.5 EB05 58.8 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | no trial data cached |
| Infected neoplasm | 14 | 120.2 70.1–206.1ROR 120.3 · χ² 1,449 / p <1e-300 | 98.5 EB05 62.3 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=14 | no trial data cached |
| Human herpesvirus 8 infection | 34 | 118.1 83.6–166.8ROR 118.5 · χ² 3,614 / p <1e-300 | 105.0 EB05 78.6 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=34 · ♀ 9% (drug 42%) · 94% clinician | no trial data cached |
| Scedosporium infection | 37 | 112.4 80.8–156.5ROR 112.8 · χ² 3,760 / p <1e-300 | 101.0 EB05 76.5 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=37 · 92% clinician | no trial data cached |
| Post transplant lymphoproliferative disorder | 267 | 112.0 99.1–126.5ROR 114.8 · χ² 27,681 / p <1e-300 | 105.2 EB05 95.0 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=267 · ♀ 69% (drug 42%) · 95% clinician | no trial data cached |
| Bk virus infection | 176 | 110.5 95.1–128.5ROR 112.4 · χ² 17,986 / p <1e-300 | 103.6 EB05 91.3 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=176 · 93% clinician | 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 |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 1,806 | 4.2 4.0–4.3ROR 4.8 · χ² 4,499 / p <1e-300 | 4.1 EB05 4.0 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 4.4 · 96% clinician | no trial data cached |
| Drug ineffective (drug did not work) | 1,533 | 2.3 2.2–2.4ROR 2.5 · χ² 1,228 / p 2e-269 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 3.8 · 95% clinician | no trial data cached |
| Cytomegalovirus infection | 1,266 | 164.3 155.6–173.4ROR 186.6 · χ² 189,598 / p <1e-300 | 151.3 EB05 144.5 · IC025 +7.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 90.2 · 92% clinician | no trial data cached |
| Drug resistance | 731 | 58.4 54.4–62.7ROR 62.7 · χ² 40,027 / p <1e-300 | 56.6 EB05 53.3 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious PRR 35.5 · 96% clinician | no trial data cached |
| Pyrexia (fever) | 615 | 3.5 3.3–3.8ROR 3.7 · χ² 1,138 / p 1e-249 | 3.5 EB05 3.3 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.6 · 93% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 597 | 8.8 8.2–9.5ROR 9.3 · χ² 4,138 / p <1e-300 | 8.7 EB05 8.2 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.3 · 95% clinician | no trial data cached |
| Product use in unapproved indication | 573 | 4.7 4.3–5.1ROR 4.9 · χ² 1,672 / p <1e-300 | 4.7 EB05 4.3 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 6.0 · 94% clinician | no trial data cached |
| Pancytopenia (all blood cells low) | 554 | 20.0 18.4–21.7ROR 21.1 · χ² 9,909 / p <1e-300 | 19.8 EB05 18.5 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.8 · 96% clinician | no trial data cached |
| Diarrhoea (diarrhea) | 463 | 1.4 1.3–1.6ROR 1.5 · χ² 62 / p 1e-15 | 1.4 EB05 1.3 · IC025 +0.4 | No label text to screen label has no adverse-reaction text | serious PRR 1.5 · 92% clinician | no trial data cached |
| Cytomegalovirus viraemia | 438 | 221.9 201.4–244.4ROR 231.4 · χ² 86,352 / p <1e-300 | 197.7 EB05 182.7 · IC025 +7.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=434 · 92% clinician | no trial data cached |
| Pneumonia (lung infection) | 433 | 2.7 2.4–2.9ROR 2.7 · χ² 458 / p 7e-102 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 1.6 · 94% clinician | no trial data cached |
| Sepsis (blood infection) | 430 | 7.7 7.0–8.5ROR 8.0 · χ² 2,506 / p <1e-300 | 7.6 EB05 7.0 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.6 · 95% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 417 | 30.2 27.5–33.2ROR 31.4 · χ² 11,591 / p <1e-300 | 29.7 EB05 27.4 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.6 · 95% clinician | no trial data cached |
| Respiratory failure | 413 | 11.3 10.3–12.5ROR 11.8 · χ² 3,874 / p <1e-300 | 11.2 EB05 10.4 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.7 · 93% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 389 | 7.0 6.3–7.7ROR 7.2 · χ² 1,988 / p <1e-300 | 6.9 EB05 6.3 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.2 · 96% clinician | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
✓ A hand-written Bradford Hill causality assessment exists for this drug: Ganciclovir ↔ Neutropenia / bone-marrow suppression.
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 Ganciclovir?
In FDA FAERS, the most frequently co-reported reaction terms for Ganciclovir are cytomegalovirus infection, pyrexia, neutropenia, pancytopenia, diarrhoea, cytomegalovirus viraemia. 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 Ganciclovir have an FDA boxed warning?
No. The FDA label retrieved for Ganciclovir has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ganciclovir 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 ea25e7ac-7a93-4ec8-975b-2cec197e1c27, effective 20260518; matched on
openfda.generic_name.exact:"GANCICLOVIR" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - 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, 1,032 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.