Drug · FAERS side-effect profile with label screen
Ferric Gluconate Complex side effects: what 2,139 FDA adverse event reports show
Drug class
Parenteral Iron Replacement
FDA label (Established Pharmacologic Class) of the closest related product
Label matched
Sodium Ferric Gluconate Complex (Ferrlecit)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
2,139 reports · 81% serious · 439 with death outcome · 66% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Ferrlecit is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy. Ferrlecit is an iron.
FDA label, Indications and Usage
What it is
Ferrlecit ® (sodium ferric gluconate complex in sucrose injection), an iron replacement product, is a stable macromolecular complex with an apparent molecular weight on gel chromatography of 289,000–440,000 daltons.
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 5Labeled (related wording) 2Likely indication confounding 1Reporting / coding artifact 4Lab value / disease marker 2Not in label — unassessed 26
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.
- 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.
- 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. 89 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 |
|---|---|---|---|---|---|---|
| Appendicitis | 256 | 277.7 247.1–312.1ROR 315.3 · χ² 68,365 / p <1e-300 | 264.6 EB05 238.5 · IC025 +7.3 3/3 methods agree | Not in label — unassessed | serious PRR 194.5 · ♀ 3% (drug 66%) · 96% clinician | no trial data cached |
| Ventricular fibrillation | 222 | 199.4 175.8–226.2ROR 222.4 · χ² 42,765 / p <1e-300 | 192.2 EB05 171.9 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious PRR 139.1 · ♀ 3% (drug 66%) · 96% clinician | no trial data cached |
| Cardiogenic shock | 251 | 175.5 156.1–197.4ROR 198.7 · χ² 42,639 / p <1e-300 | 170.2 EB05 153.2 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious PRR 122.4 · ♀ 4% (drug 66%) · 96% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 257 | 91.1 81.2–102.3ROR 103.4 · χ² 22,634 / p <1e-300 | 89.7 EB05 80.9 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 64.1 · ♀ 4% (drug 66%) · 96% clinician | no trial data cached |
| Ascites | 260 | 87.4 78.0–98.0ROR 99.4 · χ² 21,958 / p <1e-300 | 86.1 EB05 77.7 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious PRR 62.4 · ♀ 3% (drug 66%) · 96% clinician | no trial data cached |
| Incorrect route of product administration | 127 | 74.6 63.0–88.4ROR 79.3 · χ² 9,091 / p <1e-300 | 73.3 EB05 63.2 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious PRR 105.2 · ♀ 5% (drug 66%) · 98% clinician | no trial data cached |
| Bacterial infection | 137 | 72.8 61.9–85.7ROR 77.8 · χ² 9,572 / p <1e-300 | 71.6 EB05 62.1 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 59.4 · ♀ 6% (drug 66%) · 96% clinician | no trial data cached |
| Neuralgia | 133 | 54.1 45.8–63.8ROR 57.6 · χ² 6,842 / p <1e-300 | 53.4 EB05 46.2 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 56.7 · ♀ 6% (drug 66%) · 97% clinician | no trial data cached |
| Hyperlipidaemia | 63 | 51.8 40.6–66.1ROR 53.3 · χ² 3,073 / p <1e-300 | 50.8 EB05 41.1 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 40.3 · ♀ 11% (drug 66%) · 97% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 258 | 45.2 40.3–50.7ROR 51.3 · χ² 11,086 / p <1e-300 | 44.9 EB05 40.4 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 32.8 · ♀ 4% (drug 66%) · 96% clinician | no trial data cached |
| End stage renal disease | 83 | 44.4 35.9–54.8ROR 46.1 · χ² 3,462 / p <1e-300 | 43.8 EB05 36.4 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 31.4 · ♀ 12% (drug 66%) · 96% clinician | no trial data cached |
| Ulcer | 68 | 42.0 33.2–53.1ROR 43.4 · χ² 2,672 / p <1e-300 | 41.4 EB05 33.8 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 37.5 · ♀ 11% (drug 66%) · 94% clinician | no trial data cached |
| Gout | 69 | 37.8 29.9–47.7ROR 39.0 · χ² 2,427 / p <1e-300 | 37.3 EB05 30.5 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 40.4 · ♀ 13% (drug 66%) · 99% clinician | no trial data cached |
| Stress | 255 | 34.9 31.1–39.1ROR 39.5 · χ² 8,356 / p <1e-300 | 34.7 EB05 31.2 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 41.0 · ♀ 4% (drug 66%) · 94% clinician | no trial data cached |
| Blood test abnormal | 48 | 33.6 25.4–44.5ROR 34.4 · χ² 1,483 / p <1e-300 | 33.1 EB05 26.0 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 36.5 · ♀ 14% (drug 66%) · 96% clinician | no trial data cached |
| Blood cholesterol increased | 145 | 30.6 26.1–35.8ROR 32.7 · χ² 4,114 / p <1e-300 | 30.4 EB05 26.4 · IC025 +4.5 3/3 methods agree | Lab value / disease marker | serious PRR 32.9 · ♀ 5% (drug 66%) · 97% clinician | no trial data cached |
| Infusion related reaction (reaction during infusion) | 196 | 29.2 25.5–33.3ROR 32.0 · χ² 5,305 / p <1e-300 | 29.0 EB05 25.8 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 22.2 · ♀ 93% (drug 66%) · 97% clinician | no trial data cached |
| Aspiration | 30 | 27.2 19.1–38.8ROR 27.6 · χ² 730 / p 5e-161 | 26.7 EB05 19.6 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 19.8 · ♀ 12% (drug 66%) · 100% clinician | no trial data cached |
| Sepsis (blood infection) | 293 | 25.8 23.2–28.7ROR 29.7 · χ² 6,980 / p <1e-300 | 25.7 EB05 23.3 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.4 · ♀ 12% (drug 66%) · 96% clinician | no trial data cached |
| Abdominal distension (bloating) | 269 | 25.4 22.7–28.4ROR 28.9 · χ² 6,303 / p <1e-300 | 25.3 EB05 22.9 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 31.4 · ♀ 5% (drug 66%) · 95% clinician | no trial data cached |
| Chronic obstructive pulmonary disease | 130 | 24.5 20.7–29.0ROR 26.0 · χ² 2,907 / p <1e-300 | 24.4 EB05 21.0 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 20.3 · ♀ 6% (drug 66%) · 97% clinician | no trial data cached |
| General physical health deterioration | 285 | 24.4 21.9–27.2ROR 28.0 · χ² 6,385 / p <1e-300 | 24.3 EB05 22.0 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious PRR 20.1 · ♀ 10% (drug 66%) · 94% clinician | no trial data cached |
| Dry mouth | 174 | 21.1 18.3–24.3ROR 22.9 · χ² 3,318 / p <1e-300 | 21.0 EB05 18.5 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 29.0 · ♀ 11% (drug 66%) · 94% clinician | no trial data cached |
| Micturition urgency | 24 | 20.8 14.0–31.0ROR 21.0 · χ² 432 / p 3e-96 | 20.4 EB05 14.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 24.4 · ♀ 15% (drug 66%) · 100% clinician | no trial data cached |
| Iron deficiency anaemia | 19 | 20.3 13.0–31.8ROR 20.5 · χ² 329 / p 7e-74 | 19.8 EB05 13.3 · IC025 +3.0 3/3 methods agree | Likely indication confounding term in indications | serious PRR 13.7 | no trial data cached |
| Full blood count abnormal | 21 | 19.6 12.8–30.0ROR 19.7 · χ² 351 / p 1e-78 | 19.1 EB05 13.1 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious PRR 18.4 · 100% clinician | no trial data cached |
| Swelling | 181 | 19.0 16.6–21.9ROR 20.7 · χ² 3,083 / p <1e-300 | 19.0 EB05 16.8 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 19.4 · ♀ 29% (drug 66%) · 94% clinician | no trial data cached |
| Hypercholesterolaemia | 18 | 18.5 11.7–29.3ROR 18.6 · χ² 280 / p 4e-63 | 18.0 EB05 11.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 13.9 | no trial data cached |
| Diabetes mellitus | 138 | 17.7 15.1–20.8ROR 18.8 · χ² 2,161 / p <1e-300 | 17.6 EB05 15.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 13.6 · ♀ 4% (drug 66%) · 97% clinician | no trial data cached |
| Abdominal pain | 407 | 17.2 15.8–18.8ROR 21.0 · χ² 6,248 / p <1e-300 | 17.1 EB05 15.8 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.8 · ♀ 37% (drug 66%) · 94% clinician | no trial data cached |
| Thrombosis | 139 | 16.9 14.4–19.9ROR 18.0 · χ² 2,070 / p <1e-300 | 16.8 EB05 14.6 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.4 · ♀ 5% (drug 66%) · 96% clinician | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 93 | 16.6 13.6–20.3ROR 17.3 · χ² 1,351 / p 4e-296 | 16.5 EB05 13.9 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.3 | no trial data cached |
| Sleep disorder | 118 | 16.6 13.9–19.7ROR 17.5 · χ² 1,712 / p <1e-300 | 16.5 EB05 14.1 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 19.4 · ♀ 7% (drug 66%) · 97% clinician | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 24 | 15.6 10.5–23.3ROR 15.8 · χ² 314 / p 2e-70 | 15.2 EB05 10.5 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 11.1 · ♀ 100% (drug 66%) · 100% clinician | no trial data cached |
| Intentional product misuse | 133 | 15.0 12.7–17.7ROR 16.0 · χ² 1,733 / p <1e-300 | 15.0 EB05 12.9 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 24.2 · ♀ 5% (drug 66%) · 97% clinician | no trial data cached |
| Obstructive airways disorder | 17 | 15.0 9.3–24.0ROR 15.1 · χ² 207 / p 3e-47 | 14.2 EB05 8.8 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 | no trial data cached |
| Liver function test increased | 32 | 14.7 10.4–20.8ROR 14.9 · χ² 396 / p 2e-88 | 14.4 EB05 10.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 15.8 · ♀ 25% (drug 66%) · 91% clinician | no trial data cached |
| Joint range of motion decreased | 20 | 14.7 9.5–22.7ROR 14.8 · χ² 241 / p 1e-54 | 14.1 EB05 9.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 13.3 | no trial data cached |
| Sputum discoloured | 14 | 14.5 8.6–24.5ROR 14.6 · χ² 163 / p 1e-37 | 13.5 EB05 7.8 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 13.5 | no trial data cached |
| Blood pressure decreased | 96 | 14.2 11.7–17.3ROR 14.8 · χ² 1,168 / p 3e-256 | 14.1 EB05 11.9 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.9 · ♀ 91% (drug 66%) · 92% 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 |
|---|---|---|---|---|---|---|
| Nausea | 508 | 6.3 5.9–6.8ROR 8.0 · χ² 2,355 / p <1e-300 | 6.3 EB05 5.8 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.5 · 94% clinician | no trial data cached |
| Vomiting | 455 | 9.5 8.8–10.3ROR 11.8 · χ² 3,538 / p <1e-300 | 9.5 EB05 8.8 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.1 · ♀ 43% (drug 66%) · 93% clinician | no trial data cached |
| Abdominal pain | 407 | 17.2 15.8–18.8ROR 21.0 · χ² 6,248 / p <1e-300 | 17.1 EB05 15.8 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.8 · ♀ 37% (drug 66%) · 94% clinician | no trial data cached |
| Dyspnoea (shortness of breath) | 385 | 6.7 6.1–7.3ROR 7.9 · χ² 1,903 / p <1e-300 | 6.6 EB05 6.1 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 · 91% clinician | no trial data cached |
| Sepsis (blood infection) | 293 | 25.8 23.2–28.7ROR 29.7 · χ² 6,980 / p <1e-300 | 25.7 EB05 23.3 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.4 · ♀ 12% (drug 66%) · 96% clinician | no trial data cached |
| General physical health deterioration | 285 | 24.4 21.9–27.2ROR 28.0 · χ² 6,385 / p <1e-300 | 24.3 EB05 22.0 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious PRR 20.1 · ♀ 10% (drug 66%) · 94% clinician | no trial data cached |
| Abdominal distension (bloating) | 269 | 25.4 22.7–28.4ROR 28.9 · χ² 6,303 / p <1e-300 | 25.3 EB05 22.9 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 31.4 · ♀ 5% (drug 66%) · 95% clinician | no trial data cached |
| Ascites | 260 | 87.4 78.0–98.0ROR 99.4 · χ² 21,958 / p <1e-300 | 86.1 EB05 77.7 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious PRR 62.4 · ♀ 3% (drug 66%) · 96% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 258 | 45.2 40.3–50.7ROR 51.3 · χ² 11,086 / p <1e-300 | 44.9 EB05 40.4 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 32.8 · ♀ 4% (drug 66%) · 96% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 257 | 91.1 81.2–102.3ROR 103.4 · χ² 22,634 / p <1e-300 | 89.7 EB05 80.9 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 64.1 · ♀ 4% (drug 66%) · 96% clinician | no trial data cached |
| Appendicitis | 256 | 277.7 247.1–312.1ROR 315.3 · χ² 68,365 / p <1e-300 | 264.6 EB05 238.5 · IC025 +7.3 3/3 methods agree | Not in label — unassessed | serious PRR 194.5 · ♀ 3% (drug 66%) · 96% clinician | no trial data cached |
| Stress | 255 | 34.9 31.1–39.1ROR 39.5 · χ² 8,356 / p <1e-300 | 34.7 EB05 31.2 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 41.0 · ♀ 4% (drug 66%) · 94% clinician | no trial data cached |
| Constipation | 252 | 11.4 10.2–12.8ROR 12.8 · χ² 2,410 / p <1e-300 | 11.4 EB05 10.2 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 14.5 · ♀ 6% (drug 66%) · 95% clinician | no trial data cached |
| Cardiogenic shock | 251 | 175.5 156.1–197.4ROR 198.7 · χ² 42,639 / p <1e-300 | 170.2 EB05 153.2 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious PRR 122.4 · ♀ 4% (drug 66%) · 96% clinician | no trial data cached |
| Ventricular fibrillation | 222 | 199.4 175.8–226.2ROR 222.4 · χ² 42,765 / p <1e-300 | 192.2 EB05 171.9 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious PRR 139.1 · ♀ 3% (drug 66%) · 96% 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.
- Appendicitis — n=256, PRR 277.7
- Ventricular fibrillation — n=222, PRR 199.4
- Cardiogenic shock — n=251, PRR 175.5
- Multiple organ dysfunction syndrome — n=257, PRR 91.1
- Ascites — n=260, PRR 87.4
- Bacterial infection — n=137, PRR 72.8
- Neuralgia — n=133, PRR 54.1
- Hyperlipidaemia — n=63, PRR 51.8
- Hyponatraemia — n=258, PRR 45.2
- End stage renal disease — n=83, PRR 44.4
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 Ferric Gluconate Complex?
In FDA FAERS, the most frequently co-reported reaction terms for Ferric Gluconate Complex are nausea, vomiting, abdominal pain, dyspnoea, sepsis, abdominal distension. 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 Ferric Gluconate Complex have an FDA boxed warning?
No. The FDA label retrieved for Ferric Gluconate Complex has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ferric Gluconate Complex 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 1fe028ff-42ac-4329-b1a5-a9dadfcb79f6, effective 20251007; matched on
openfda.generic_name.exact:"SODIUM FERRIC GLUCONATE COMPLEX") - 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, 129 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.