Drug · FAERS side-effect profile with label screen

Granules For side effects: what 593 FDA adverse event reports show

Granules For Oral Solution · 15 reaction terms · 113 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Granules For Oral Solution (Fosfomycin Tromethamine)

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

Who reports

593 reports · 91% serious · 29 with death outcome · 83% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Fosfomycin Tromethamine is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis . Fosfomycin Tromethamine is not indicated for the treatment of pyelonephritis or perinephric abscess.

FDA label, Indications and Usage

What it is

DESCRIPTION Fosfomycin Tromethamine Granules for Oral Solution contains fosfomycin tromethamine, a synthetic, broad spectrum, bactericidal antibiotic for oral administration. It is available a.

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 10 strongest signals

Likely indication confounding 1Reporting / coding artifact 1Not in label — unassessed 8

What the badges mean

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.
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. 5 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
Coordination abnormal	10	25.1 13.6–46.5ROR 25.6 · χ² 208 / p 2e-47	23.9 EB05 13.5 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 22.2	no trial data cached
Agranulocytosis (severe loss of white cells)	13	24.8 14.5–42.5ROR 25.4 · χ² 274 / p 7e-62	24.0 EB05 14.7 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 15.8	no trial data cached
Cystitis	22	24.3 16.1–36.6ROR 25.2 · χ² 469 / p 2e-104	23.8 EB05 16.6 · IC025 +3.3 3/3 methods agree	Likely indication confounding term in indications	serious PRR 21.1	no trial data cached
Sputum discoloured	6	22.4 10.1–49.7ROR 22.6 · χ² 102 / p 2e-24	19.4 EB05 7.4 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 18.6	no trial data cached
Polyneuropathy	7	20.8 9.9–43.4ROR 21.0 · χ² 113 / p 1e-26	18.5 EB05 7.8 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 13.4	no trial data cached
Pharyngeal swelling	5	18.4 7.7–44.2ROR 18.6 · χ² 66 / p 2e-16	14.1 EB05 4.5 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious n=5	no trial data cached
Serotonin syndrome	9	16.6 8.7–31.8ROR 16.9 · χ² 117 / p 1e-27	14.8 EB05 7.0 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 10.6	no trial data cached
Tooth fracture	5	16.0 6.7–38.3ROR 16.1 · χ² 56 / p 3e-14	11.5 EB05 3.9 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 15.4	no trial data cached
Drug reaction with eosinophilia and systemic symptoms	6	8.3 3.7–18.4ROR 8.4 · χ² 32 / p 1e-8	5.6 EB05 2.7 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 5.3	no trial data cached
Foetal exposure during pregnancy	12	5.2 3.0–9.1ROR 5.3 · χ² 37 / p 6e-10	4.4 EB05 2.7 · IC025 +1.2 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
Cystitis	22	24.3 16.1–36.6ROR 25.2 · χ² 469 / p 2e-104	23.8 EB05 16.6 · IC025 +3.3 3/3 methods agree	Likely indication confounding term in indications	serious PRR 21.1	no trial data cached
Agranulocytosis (severe loss of white cells)	13	24.8 14.5–42.5ROR 25.4 · χ² 274 / p 7e-62	24.0 EB05 14.7 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 15.8	no trial data cached
Foetal exposure during pregnancy	12	5.2 3.0–9.1ROR 5.3 · χ² 37 / p 6e-10	4.4 EB05 2.7 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 3.4	no trial data cached
Coordination abnormal	10	25.1 13.6–46.5ROR 25.6 · χ² 208 / p 2e-47	23.9 EB05 13.5 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 22.2	no trial data cached
Serotonin syndrome	9	16.6 8.7–31.8ROR 16.9 · χ² 117 / p 1e-27	14.8 EB05 7.0 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 10.6	no trial data cached
Polyneuropathy	7	20.8 9.9–43.4ROR 21.0 · χ² 113 / p 1e-26	18.5 EB05 7.8 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 13.4	no trial data cached
Drug reaction with eosinophilia and systemic symptoms	6	8.3 3.7–18.4ROR 8.4 · χ² 32 / p 1e-8	5.6 EB05 2.7 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 5.3	no trial data cached
Sputum discoloured	6	22.4 10.1–49.7ROR 22.6 · χ² 102 / p 2e-24	19.4 EB05 7.4 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 18.6	no trial data cached
Tooth fracture	5	16.0 6.7–38.3ROR 16.1 · χ² 56 / p 3e-14	11.5 EB05 3.9 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 15.4	no trial data cached
Pharyngeal swelling	5	18.4 7.7–44.2ROR 18.6 · χ² 66 / p 2e-16	14.1 EB05 4.5 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious n=5	no trial data cached
Drug exposure during pregnancy	4	4.1 1.5–10.9ROR 4.1 · χ² 7 / p 0.005	3.0 EB05 1.4 · IC025 -0.2 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 2.2	no trial data cached
Pulmonary arterial hypertension	4	9.7 3.7–25.8ROR 9.8 · χ² 23 / p 8e-7	5.6 EB05 2.2 · IC025 +0.5 3/3 methods agree	Not in label — unassessed	serious PRR 6.3	no trial data cached
Pulmonary thrombosis	4	12.9 4.9–34.3ROR 13.0 · χ² 33 / p 5e-9	7.7 EB05 2.7 · IC025 +0.7 3/3 methods agree	Not in label — unassessed	serious PRR 8.3	no trial data cached
Thyroid cancer	3	8.7 2.8–27.0ROR 8.8 · χ² 14 / p 1e-4	4.6 EB05 1.7 · IC025 -0.0 PRR-only: not supported by EBGM or IC	Not in label — unassessed	serious PRR 5.6	no trial data cached
Caesarean section	3	9.0 2.9–27.8ROR 9.0 · χ² 14 / p 9e-5	4.7 EB05 1.7 · IC025 +0.0	Likely indication confounding shares a disease stem with the indications wording	serious PRR 5.9	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: Minoxidil (oral) ↔ Pericardial effusion.

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 Granules For?

In FDA FAERS, the most frequently co-reported reaction terms for Granules For are cystitis, agranulocytosis, coordination abnormal, serotonin syndrome, polyneuropathy, drug reaction with eosinophilia and systemic symptoms. 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 Granules For have an FDA boxed warning?

No. The FDA label retrieved for Granules For has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Granules For 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 c3ba67e7-aaca-e682-277a-94e20b0abad7, effective 20201111; matched on openfda.generic_name.exact:"GRANULES FOR ORAL SOLUTION")
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, 15 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.