Drug · FAERS side-effect profile with label screen

Valganciclovir Powder side effects: what 12,124 FDA adverse event reports show

Valganciclovir Hydrochloride Powder, · 1,041 reaction terms · 47,473 drug–reaction co-reports · data 2026-09-14

Drug class

Deoxynucleoside analogue cytomegalovirus (cmv) dna polymerase inhibitor

FDA label, Indications wording of the closest related product

Label matched

Valganciclovir Hydrochloride Powder, (Valganciclovir)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

12,124 reports · 95% serious · 2,085 with death outcome · 40% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Valganciclovir hydrochloride is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for: Adult Patients (1.1 ) Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk.

FDA label, Indications and Usage

What it is

Valganciclovir for oral solution, USP contains valganciclovir hydrochloride USP, a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV.

FDA label, Description section

Boxed warning

HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS Hematologic Toxicity: Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, and bone marrow failure including aplastic anemia have been reported in patients treated with valganciclovir hydrochloride [see Warnings and Precautions ( 5.1 )].

FDA 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) 3Likely indication confounding 16Not in label — unassessed 21

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.
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.
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. 1,001 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Pseudoaneurysm infection	40	5,247.6 2,807.5–9,808.6ROR 5,265.0 · χ² 50,187 / p <1e-300	794.5 EB05 608.6 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious n=40 · ♀ 0% (drug 40%) · 100% clinician	no trial data cached
Oesophagopleural fistula	12	1,023.3 500.3–2,092.8ROR 1,024.3 · χ² 7,034 / p <1e-300	316.7 EB05 193.1 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=12	no trial data cached
Cytomegalovirus syndrome	60	1,003.2 729.7–1,379.3ROR 1,008.2 · χ² 37,195 / p <1e-300	525.5 EB05 423.1 · IC025 +6.2 3/3 methods agree	Likely indication confounding term in indications	serious n=60 · ♀ 10% (drug 40%) · 95% clinician	no trial data cached
Cytomegalovirus nephritis	18	902.9 510.1–1,598.2ROR 904.2 · χ² 10,021 / p <1e-300	362.6 EB05 242.7 · IC025 +4.3 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=18	no trial data cached
Cytomegalovirus myocarditis	11	852.7 413.6–1,758.1ROR 853.5 · χ² 5,684 / p <1e-300	286.1 EB05 170.5 · IC025 +3.4 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=11	no trial data cached
Pericarditis fungal	19	689.4 404.8–1,174.3ROR 690.5 · χ² 8,817 / p <1e-300	328.6 EB05 222.3 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=19	no trial data cached
Cytomegalovirus gastrointestinal infection	80	631.7 489.0–815.9ROR 635.8 · χ² 36,300 / p <1e-300	415.2 EB05 344.3 · IC025 +6.5 3/3 methods agree	Labeled (related wording) related wording	serious n=80 · 97% clinician	no trial data cached
Encephalitis cytomegalovirus	115	628.6 508.0–777.9ROR 634.6 · χ² 52,197 / p <1e-300	426.8 EB05 365.3 · IC025 +7.0 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=115 · 95% clinician	no trial data cached
Pyelonephritis fungal	17	527.1 306.1–907.9ROR 527.9 · χ² 6,423 / p <1e-300	277.3 EB05 183.4 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious n=17	no trial data cached
Immune recovery uveitis	13	515.6 277.3–958.6ROR 516.2 · χ² 4,739 / p <1e-300	250.5 EB05 155.8 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=13	no trial data cached
Human ehrlichiosis	43	473.1 337.7–663.0ROR 474.8 · χ² 15,492 / p <1e-300	318.1 EB05 246.0 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious n=43 · 100% clinician	no trial data cached
Choriomeningitis lymphocytic	14	442.2 245.7–795.7ROR 442.7 · χ² 4,549 / p <1e-300	237.7 EB05 150.5 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=14	no trial data cached
Granulomatous rosacea	10	437.3 218.4–875.8ROR 437.7 · χ² 3,126 / p <1e-300	209.5 EB05 121.6 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=10	no trial data cached
Vascular pseudoaneurysm ruptured	44	405.6 292.1–563.2ROR 407.1 · χ² 14,022 / p <1e-300	287.0 EB05 222.6 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious n=44 · ♀ 0% (drug 40%) · 100% clinician	no trial data cached
Cerebral nocardiosis	39	386.7 273.3–547.2ROR 388.0 · χ² 11,918 / p <1e-300	273.2 EB05 208.5 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=39 · 100% clinician	no trial data cached
Cytomegalovirus oesophagitis	60	340.0 257.8–448.3ROR 341.6 · χ² 16,626 / p <1e-300	260.1 EB05 209.4 · IC025 +6.0 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=60	no trial data cached
Cutaneous mucormycosis	26	295.6 195.0–448.1ROR 296.2 · χ² 6,258 / p <1e-300	212.8 EB05 152.6 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious n=26 · ♀ 0% (drug 40%) · 96% clinician	no trial data cached
New onset diabetes after transplantation	24	286.2 185.8–440.9ROR 286.8 · χ² 5,600 / p <1e-300	205.3 EB05 145.2 · IC025 +4.7 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=24 · 100% clinician	no trial data cached
Cytomegalovirus duodenitis	10	284.2 145.6–555.1ROR 284.5 · χ² 2,182 / p <1e-300	166.8 EB05 96.9 · IC025 +3.2 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=10	no trial data cached
Cutaneous nocardiosis	18	281.6 171.1–463.6ROR 282.1 · χ² 4,083 / p <1e-300	192.7 EB05 129.0 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious n=18	no trial data cached
Cytomegalovirus viraemia	606	278.4 255.9–302.7ROR 292.9 · χ² 143,764 / p <1e-300	237.6 EB05 222.2 · IC025 +7.5 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=597 · 97% clinician	no trial data cached
Delayed graft function	96	272.0 219.4–337.1ROR 274.1 · χ² 22,120 / p <1e-300	224.3 EB05 189.1 · IC025 +6.4 3/3 methods agree	Not in label — unassessed	serious n=96 · 92% clinician	no trial data cached
Cytomegalovirus enteritis	45	254.1 185.9–347.4ROR 255.1 · χ² 9,655 / p <1e-300	202.4 EB05 157.4 · IC025 +5.5 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=45 · 98% clinician	no trial data cached
Cytomegalovirus gastroenteritis	26	245.0 162.5–369.4ROR 245.5 · χ² 5,313 / p <1e-300	185.3 EB05 132.9 · IC025 +4.8 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=26 · 100% clinician	no trial data cached
Deafness congenital	25	242.3 159.4–368.2ROR 242.8 · χ² 5,050 / p <1e-300	182.8 EB05 130.2 · IC025 +4.7 3/3 methods agree	Labeled (related wording) related wording	serious n=25 · 100% clinician	no trial data cached
Congenital cytomegalovirus infection	18	239.8 146.5–392.7ROR 240.2 · χ² 3,547 / p <1e-300	172.3 EB05 115.3 · IC025 +4.2 3/3 methods agree	Labeled (related wording) related wording	serious n=18	no trial data cached
Cytomegalovirus gastritis	29	232.2 157.6–342.1ROR 232.8 · χ² 5,674 / p <1e-300	180.4 EB05 131.7 · IC025 +4.9 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=29	no trial data cached
Trichophytosis	25	229.2 151.0–347.9ROR 229.7 · χ² 4,809 / p <1e-300	175.3 EB05 124.9 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=24 · ♀ 0% (drug 40%) · 100% clinician	no trial data cached
Gastritis fungal	12	224.9 123.2–410.5ROR 225.1 · χ² 2,169 / p <1e-300	151.5 EB05 92.3 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=12	no trial data cached
Smooth muscle cell neoplasm	47	221.4 163.5–299.9ROR 222.3 · χ² 8,934 / p <1e-300	181.7 EB05 142.1 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=47 · ♀ 89% (drug 40%) · 96% clinician	no trial data cached
Retinitis viral	13	211.2 118.7–375.6ROR 211.4 · χ² 2,236 / p <1e-300	147.7 EB05 91.9 · IC025 +3.6 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=13	no trial data cached
Renal graft infection	24	199.7 130.9–304.6ROR 200.1 · χ² 4,071 / p <1e-300	156.8 EB05 110.9 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=24 · ♀ 77% (drug 40%) · 100% clinician	no trial data cached
Teratogenicity	31	197.3 136.1–286.0ROR 197.8 · χ² 5,252 / p <1e-300	159.7 EB05 117.8 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious n=31 · 100% clinician	no trial data cached
Pulmonary nocardiosis	82	192.9 153.6–242.2ROR 194.2 · χ² 13,892 / p <1e-300	166.7 EB05 138.6 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious n=82 · 100% clinician	no trial data cached
Cytomegalovirus colitis	223	189.0 164.8–216.8ROR 192.5 · χ² 37,381 / p <1e-300	167.8 EB05 150.1 · IC025 +6.7 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=223 · 90% clinician	no trial data cached
Disseminated cytomegaloviral infection	21	183.7 117.1–288.0ROR 184.0 · χ² 3,281 / p <1e-300	144.4 EB05 99.6 · IC025 +4.4 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=21 · 100% clinician	no trial data cached
Polyomavirus viraemia	94	179.5 145.3–221.9ROR 180.9 · χ² 14,938 / p <1e-300	157.4 EB05 132.4 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious n=92 · 90% clinician	no trial data cached
Drug resistance mutation	16	172.7 103.3–288.7ROR 172.9 · χ² 2,327 / p <1e-300	132.5 EB05 86.5 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=15	no trial data cached
Cytomegalovirus chorioretinitis	171	168.3 144.0–196.7ROR 170.7 · χ² 25,732 / p <1e-300	150.7 EB05 132.7 · IC025 +6.5 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=169 · 96% clinician	no trial data cached
Cytomegalovirus infection reactivation	376	167.1 150.6–185.5ROR 172.4 · χ² 56,408 / p <1e-300	151.1 EB05 138.7 · IC025 +6.8 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=375 · 94% 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)	1,968	3.9 3.8–4.1ROR 4.5 · χ² 4,468 / p <1e-300	3.9 EB05 3.8 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 4.0 · 93% clinician	no trial data cached
Cytomegalovirus infection	1,252	140.8 133.3–148.7ROR 156.9 · χ² 160,543 / p <1e-300	129.9 EB05 124.0 · IC025 +6.9 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 76.7 · 93% clinician	no trial data cached
Drug ineffective (drug did not work)	1,164	1.5 1.4–1.6ROR 1.6 · χ² 227 / p 2e-51	1.5 EB05 1.5 · IC025 +0.5	Reporting / coding artifact	serious PRR 2.6 · 95% clinician	no trial data cached
Neutropenia (low neutrophils (infection-fighting cells))	836	10.7 10.0–11.5ROR 11.5 · χ² 7,369 / p <1e-300	10.7 EB05 10.1 · IC025 +3.3 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 6.7 · 96% clinician	no trial data cached
Leukopenia (low white blood cells)	687	24.1 22.4–26.0ROR 25.5 · χ² 15,035 / p <1e-300	23.8 EB05 22.3 · IC025 +4.4 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 14.7 · 96% clinician	no trial data cached
Acute kidney injury (sudden kidney damage)	616	7.0 6.5–7.6ROR 7.3 · χ² 3,183 / p <1e-300	7.0 EB05 6.5 · IC025 +2.7 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 4.2 · 92% clinician	no trial data cached
Cytomegalovirus viraemia	606	278.4 255.9–302.7ROR 292.9 · χ² 143,764 / p <1e-300	237.6 EB05 222.2 · IC025 +7.5 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=597 · 97% clinician	no trial data cached
Drug resistance	571	39.3 36.2–42.6ROR 41.2 · χ² 20,823 / p <1e-300	38.4 EB05 35.8 · IC025 +5.1 3/3 methods agree	Reporting / coding artifact	serious PRR 24.6 · 95% clinician	no trial data cached
Pyrexia (fever)	564	2.8 2.6–3.1ROR 2.9 · χ² 671 / p 4e-148	2.8 EB05 2.6 · IC025 +1.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.1	no trial data cached
Diarrhoea (diarrhea)	546	1.5 1.4–1.6ROR 1.5 · χ² 84 / p 3e-20	1.5 EB05 1.4 · IC025 +0.4	Labeled adverse reaction exact term	serious PRR 1.5	no trial data cached
Product use in unapproved indication	483	3.4 3.1–3.7ROR 3.5 · χ² 834 / p 9e-184	3.4 EB05 3.2 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 4.3 · 92% clinician	no trial data cached
Pancytopenia (all blood cells low)	481	15.0 13.8–16.4ROR 15.6 · χ² 6,256 / p <1e-300	14.9 EB05 13.8 · IC025 +3.7 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 9.0 · 97% clinician	no trial data cached
Transplant rejection	462	105.9 96.5–116.1ROR 110.0 · χ² 45,108 / p <1e-300	99.3 EB05 92.0 · IC025 +6.3 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 60.3 · 92% clinician	no trial data cached
Thrombocytopenia (low platelets)	456	7.1 6.5–7.8ROR 7.3 · χ² 2,385 / p <1e-300	7.0 EB05 6.5 · IC025 +2.7 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 4.4 · 96% clinician	no trial data cached
Anaemia (low red blood cells)	429	3.9 3.5–4.3ROR 4.0 · χ² 926 / p 1e-203	3.9 EB05 3.6 · IC025 +1.8 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 2.6 · 94% 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.

Pseudoaneurysm infection — n=40, PRR 5,247.6
Human ehrlichiosis — n=43, PRR 473.1
Vascular pseudoaneurysm ruptured — n=44, PRR 405.6
Cerebral nocardiosis — n=39, PRR 386.7
Cutaneous mucormycosis — n=26, PRR 295.6
Delayed graft function — n=96, PRR 272.0
Trichophytosis — n=25, PRR 229.2
Smooth muscle cell neoplasm — n=47, PRR 221.4
Renal graft infection — n=24, PRR 199.7
Teratogenicity — n=31, PRR 197.3

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 Valganciclovir Powder?

In FDA FAERS, the most frequently co-reported reaction terms for Valganciclovir Powder are cytomegalovirus infection, neutropenia, leukopenia, acute kidney injury, cytomegalovirus viraemia, pyrexia. 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 Valganciclovir Powder have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS Hematologic Toxicity: Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, and bone marrow failure including aplastic anemia have been reported in patients treated with valganciclovir hydrochloride [see Warnings and Precautions ( 5.1 )].

Do FAERS signals prove that Valganciclovir Powder 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 1e08a87f-624a-4993-a773-8c660c27b6af, effective 20251224; matched on openfda.generic_name.exact:"VALGANCICLOVIR HYDROCHLORIDE POWDER,")
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, field patient.drug.openfda.generic_name.exact, 1,041 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.