Drug · FAERS side-effect profile with label screen
Polycarbophil side effects: what 2,950 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Calcium Polycarbophil (Rite Aid Fiber Caplets)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
2,950 reports · 63% serious · 241 with death outcome · 64% female
openFDA FAERS counts, all years, deduplication not applied
Used for
▪ relieves occasional constipation to help restore and maintain regularity ▪ this product generally produces bowel movement in 12 to 72 hours
FDA label, Indications and Usage
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 4No label text to screen 36
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. 163 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 |
|---|---|---|---|---|---|---|
| Blood calcium decreased | 69 | 43.7 34.6–55.2ROR 44.7 · χ² 2,821 / p <1e-300 | 43.0 EB05 35.1 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious PRR 50.0 · ♀ 98% (drug 64%) | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 70 | 28.6 22.7–36.1ROR 29.3 · χ² 1,832 / p <1e-300 | 28.3 EB05 23.2 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.8 · ♀ 100% (drug 64%) · 90% clinician | no trial data cached |
| Sedation | 74 | 20.2 16.1–25.3ROR 20.7 · χ² 1,331 / p 1e-291 | 20.1 EB05 16.5 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.6 · ♀ 97% (drug 64%) | no trial data cached |
| Cognitive disorder | 87 | 13.3 10.8–16.4ROR 13.7 · χ² 979 / p 4e-215 | 13.2 EB05 11.0 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.9 · ♀ 95% (drug 64%) | no trial data cached |
| Depressed level of consciousness | 69 | 12.4 9.9–15.7ROR 12.7 · χ² 715 / p 1e-157 | 12.2 EB05 9.9 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.7 · ♀ 100% (drug 64%) | no trial data cached |
| Bladder disorder | 14 | 10.0 5.9–16.9ROR 10.1 · χ² 105 / p 7e-25 | 8.5 EB05 5.0 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | no trial data cached |
| Seasonal allergy | 19 | 9.6 6.1–15.0ROR 9.6 · χ² 137 / p 5e-32 | 8.5 EB05 5.5 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=14 | no trial data cached |
| Balance disorder | 103 | 8.5 7.0–10.2ROR 8.7 · χ² 672 / p 2e-148 | 8.2 EB05 7.0 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.1 · ♀ 88% (drug 64%) | no trial data cached |
| Mobility decreased | 81 | 8.0 6.5–10.0ROR 8.2 · χ² 494 / p 1e-109 | 7.8 EB05 6.4 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.6 · ♀ 95% (drug 64%) | no trial data cached |
| Hiatus hernia | 14 | 7.7 4.5–12.9ROR 7.7 · χ² 75 / p 3e-18 | 6.4 EB05 4.0 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.4 | no trial data cached |
| Choking | 20 | 7.3 4.7–11.3ROR 7.4 · χ² 103 / p 2e-24 | 6.4 EB05 4.3 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.1 | no trial data cached |
| Nocturia (night-time urination) | 12 | 7.0 4.0–12.4ROR 7.1 · χ² 56 / p 3e-14 | 5.7 EB05 3.5 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.6 | no trial data cached |
| Cardiomegaly | 12 | 6.9 3.9–12.1ROR 6.9 · χ² 55 / p 8e-14 | 5.6 EB05 3.4 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.5 | no trial data cached |
| Constipation | 206 | 6.8 5.9–7.7ROR 7.2 · χ² 1,017 / p 2e-223 | 6.7 EB05 5.9 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.4 | no trial data cached |
| Haemorrhoids | 18 | 6.5 4.1–10.4ROR 6.6 · χ² 79 / p 3e-19 | 5.7 EB05 3.8 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.1 | no trial data cached |
| Sleep apnoea syndrome | 15 | 5.6 3.4–9.2ROR 5.6 · χ² 52 / p 3e-13 | 4.8 EB05 3.1 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.7 | no trial data cached |
| Blood potassium increased | 11 | 4.8 2.7–8.7ROR 4.8 · χ² 30 / p 3e-8 | 4.1 EB05 2.5 · IC025 +1.0 3/3 methods agree | Lab value / disease marker | serious PRR 3.7 | no trial data cached |
| Irritable bowel syndrome | 14 | 4.7 2.8–7.9ROR 4.7 · χ² 37 / p 7e-10 | 4.1 EB05 2.6 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.0 | no trial data cached |
| Bone disorder | 12 | 4.6 2.6–8.2ROR 4.7 · χ² 31 / p 1e-8 | 4.0 EB05 2.5 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.3 | no trial data cached |
| Ankle fracture | 10 | 4.6 2.5–8.5ROR 4.6 · χ² 25 / p 4e-7 | 3.9 EB05 2.3 · IC025 +0.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.3 | no trial data cached |
| Basal cell carcinoma | 10 | 4.6 2.5–8.5ROR 4.6 · χ² 24 / p 4e-7 | 3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.3 | no trial data cached |
| Cellulitis (skin infection) | 32 | 4.5 3.2–6.4ROR 4.5 · χ² 84 / p 2e-20 | 4.3 EB05 3.2 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.2 | no trial data cached |
| Blood urine present | 12 | 4.5 2.5–7.9ROR 4.5 · χ² 29 / p 4e-8 | 3.9 EB05 2.4 · IC025 +1.0 3/3 methods agree | Lab value / disease marker | serious PRR 4.9 | no trial data cached |
| Gallbladder disorder | 11 | 4.4 2.4–7.9ROR 4.4 · χ² 25 / p 2e-7 | 3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.4 | no trial data cached |
| Fall | 201 | 4.3 3.8–4.9ROR 4.5 · χ² 513 / p 6e-114 | 4.3 EB05 3.8 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.4 | no trial data cached |
| Pollakiuria (frequent urination) | 25 | 4.3 2.9–6.3ROR 4.3 · χ² 59 / p 6e-15 | 4.0 EB05 2.8 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.0 | no trial data cached |
| Full blood count decreased | 12 | 4.2 2.4–7.4ROR 4.2 · χ² 26 / p 1e-7 | 3.7 EB05 2.3 · IC025 +0.9 3/3 methods agree | Lab value / disease marker | serious PRR 3.7 | no trial data cached |
| Rectal haemorrhage | 25 | 4.1 2.8–6.1ROR 4.1 · χ² 56 / p 3e-14 | 3.9 EB05 2.8 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.2 | no trial data cached |
| Oral pain | 13 | 4.1 2.4–7.1ROR 4.1 · χ² 28 / p 7e-8 | 3.6 EB05 2.3 · IC025 +0.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.8 | no trial data cached |
| Foot fracture | 11 | 4.1 2.3–7.4ROR 4.1 · χ² 23 / p 9e-7 | 3.6 EB05 2.2 · IC025 +0.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.1 | no trial data cached |
| Gastritis | 15 | 4.1 2.4–6.7ROR 4.1 · χ² 32 / p 1e-8 | 3.7 EB05 2.4 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.1 | no trial data cached |
| Sinusitis | 58 | 4.0 3.1–5.2ROR 4.1 · χ² 129 / p 4e-30 | 3.9 EB05 3.1 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.1 | no trial data cached |
| Joint injury | 12 | 4.0 2.3–7.0ROR 4.0 · χ² 24 / p 5e-7 | 3.5 EB05 2.2 · IC025 +0.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.0 | no trial data cached |
| Gout | 10 | 4.0 2.1–7.3ROR 4.0 · χ² 19 / p 6e-6 | 3.4 EB05 2.0 · IC025 +0.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.3 | no trial data cached |
| Hypotension (low blood pressure) | 111 | 3.9 3.3–4.7ROR 4.1 · χ² 243 / p 5e-55 | 3.9 EB05 3.3 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.0 · ♀ 86% (drug 64%) | no trial data cached |
| Osteomyelitis | 10 | 3.9 2.1–7.3ROR 3.9 · χ² 19 / p 7e-6 | 3.4 EB05 2.0 · IC025 +0.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.7 | no trial data cached |
| Gastroenteritis viral | 10 | 3.9 2.1–7.3ROR 3.9 · χ² 19 / p 7e-6 | 3.4 EB05 2.0 · IC025 +0.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.5 | no trial data cached |
| Nephrolithiasis (kidney stones) | 25 | 3.9 2.6–5.7ROR 3.9 · χ² 51 / p 5e-13 | 3.7 EB05 2.6 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.6 | no trial data cached |
| Urinary tract infection (bladder infection) | 92 | 3.8 3.1–4.7ROR 3.9 · χ² 192 / p 5e-44 | 3.8 EB05 3.2 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.3 | no trial data cached |
| Dementia | 15 | 3.8 2.3–6.3ROR 3.8 · χ² 29 / p 4e-8 | 3.5 EB05 2.3 · IC025 +0.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.8 | 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 |
|---|---|---|---|---|---|---|
| Constipation | 206 | 6.8 5.9–7.7ROR 7.2 · χ² 1,017 / p 2e-223 | 6.7 EB05 5.9 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.4 | no trial data cached |
| Fall | 201 | 4.3 3.8–4.9ROR 4.5 · χ² 513 / p 6e-114 | 4.3 EB05 3.8 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.4 | no trial data cached |
| Hypotension (low blood pressure) | 111 | 3.9 3.3–4.7ROR 4.1 · χ² 243 / p 5e-55 | 3.9 EB05 3.3 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.0 · ♀ 86% (drug 64%) | no trial data cached |
| Balance disorder | 103 | 8.5 7.0–10.2ROR 8.7 · χ² 672 / p 2e-148 | 8.2 EB05 7.0 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.1 · ♀ 88% (drug 64%) | no trial data cached |
| Urinary tract infection (bladder infection) | 92 | 3.8 3.1–4.7ROR 3.9 · χ² 192 / p 5e-44 | 3.8 EB05 3.2 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.3 | no trial data cached |
| Cognitive disorder | 87 | 13.3 10.8–16.4ROR 13.7 · χ² 979 / p 4e-215 | 13.2 EB05 11.0 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.9 · ♀ 95% (drug 64%) | no trial data cached |
| Mobility decreased | 81 | 8.0 6.5–10.0ROR 8.2 · χ² 494 / p 1e-109 | 7.8 EB05 6.4 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.6 · ♀ 95% (drug 64%) | no trial data cached |
| Sedation | 74 | 20.2 16.1–25.3ROR 20.7 · χ² 1,331 / p 1e-291 | 20.1 EB05 16.5 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.6 · ♀ 97% (drug 64%) | no trial data cached |
| Toxicity to various agents | 73 | 3.1 2.5–3.9ROR 3.1 · χ² 102 / p 3e-24 | 3.0 EB05 2.5 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.9 · ♀ 100% (drug 64%) · 90% clinician | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 70 | 28.6 22.7–36.1ROR 29.3 · χ² 1,832 / p <1e-300 | 28.3 EB05 23.2 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.8 · ♀ 100% (drug 64%) · 90% clinician | no trial data cached |
| Depressed level of consciousness | 69 | 12.4 9.9–15.7ROR 12.7 · χ² 715 / p 1e-157 | 12.2 EB05 9.9 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.7 · ♀ 100% (drug 64%) | no trial data cached |
| Blood calcium decreased | 69 | 43.7 34.6–55.2ROR 44.7 · χ² 2,821 / p <1e-300 | 43.0 EB05 35.1 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious PRR 50.0 · ♀ 98% (drug 64%) | no trial data cached |
| Sinusitis | 58 | 4.0 3.1–5.2ROR 4.1 · χ² 129 / p 4e-30 | 3.9 EB05 3.1 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.1 | no trial data cached |
| Injection site pain (pain where injected) | 42 | 1.0 0.7–1.3ROR 1.0 · χ² 0 / p 0.487 | 1.0 EB05 0.8 · IC025 -0.5 PRR-only: not supported by EBGM or IC | No label text to screen label has no adverse-reaction text | serious PRR 1.7 | no trial data cached |
| Hot flush (hot flashes) | 34 | 3.2 2.3–4.5ROR 3.2 · χ² 50 / p 1e-12 | 3.1 EB05 2.3 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.1 | 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.
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 Polycarbophil?
In FDA FAERS, the most frequently co-reported reaction terms for Polycarbophil are constipation, fall, hypotension, balance disorder, urinary tract infection, cognitive disorder. 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 Polycarbophil have an FDA boxed warning?
No. The FDA label retrieved for Polycarbophil has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Polycarbophil 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 06e46cb0-2928-479e-984d-2305fff995e0, effective 20241030; matched on
openfda.generic_name.exact:"CALCIUM POLYCARBOPHIL") - 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, 203 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.