Drug · FAERS side-effect profile with label screen
Methylcellulose side effects: what 2,142 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Fiber Therapy
openFDA label
Who reports
2,142 reports · 56% serious · 122 with death outcome · 68% female
openFDA FAERS counts, all years, deduplication not applied
Used for
• relieves constipation (irregularity) • helps to restore and maintain regularity • for treating bowel disorders when recommended by a doctor • generally provide effect in 12-72 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
Reporting / coding artifact 7No label text to screen 33
What the badges mean
- 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.
- 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. 79 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 |
|---|---|---|---|---|---|---|
| Hyperlipidaemia | 19 | 14.5 9.3–22.7ROR 14.6 · χ² 225 / p 4e-51 | 13.8 EB05 8.8 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.8 | no trial data cached |
| Appendicitis | 13 | 12.8 7.4–22.0ROR 12.8 · χ² 129 / p 3e-30 | 11.4 EB05 6.3 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.2 | no trial data cached |
| Ventricular fibrillation | 13 | 10.7 6.2–18.3ROR 10.7 · χ² 104 / p 9e-25 | 9.1 EB05 5.2 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.7 | no trial data cached |
| Blood test abnormal | 16 | 10.4 6.4–17.0ROR 10.5 · χ² 127 / p 1e-29 | 9.1 EB05 5.6 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 14.2 | no trial data cached |
| Cardiogenic shock | 16 | 10.2 6.3–16.7ROR 10.3 · χ² 124 / p 4e-29 | 8.9 EB05 5.5 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.2 | no trial data cached |
| Iron deficiency anaemia | 10 | 9.9 5.4–18.5ROR 10.0 · χ² 72 / p 1e-17 | 7.9 EB05 4.2 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.6 | no trial data cached |
| Incorrect product administration duration | 21 | 9.5 6.2–14.5ROR 9.5 · χ² 150 / p 7e-35 | 8.4 EB05 5.6 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious n=15 · 95% consumer | no trial data cached |
| End stage renal disease | 19 | 9.4 6.0–14.7ROR 9.5 · χ² 135 / p 2e-31 | 8.3 EB05 5.4 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.3 | no trial data cached |
| Hiatus hernia | 12 | 8.4 4.8–14.9ROR 8.5 · χ² 71 / p 1e-17 | 6.8 EB05 4.0 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.7 | no trial data cached |
| Gout | 16 | 8.1 5.0–13.3ROR 8.2 · χ² 93 / p 3e-22 | 6.9 EB05 4.4 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.1 | no trial data cached |
| Micturition urgency | 10 | 8.1 4.3–15.0ROR 8.1 · χ² 55 / p 6e-14 | 6.3 EB05 3.5 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.7 | no trial data cached |
| Choking | 17 | 8.0 5.0–12.8ROR 8.0 · χ² 97 / p 3e-23 | 6.9 EB05 4.4 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.7 | no trial data cached |
| Neuralgia | 21 | 7.9 5.2–12.1ROR 8.0 · χ² 120 / p 3e-28 | 7.0 EB05 4.7 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.5 | no trial data cached |
| Bacterial infection | 16 | 7.9 4.8–12.8ROR 7.9 · χ² 89 / p 2e-21 | 6.7 EB05 4.3 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.7 | no trial data cached |
| Product taste abnormal | 11 | 7.5 4.1–13.5ROR 7.5 · χ² 55 / p 5e-14 | 6.0 EB05 3.5 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious n=3 | no trial data cached |
| Incorrect route of product administration | 13 | 7.1 4.1–12.1ROR 7.1 · χ² 62 / p 2e-15 | 5.8 EB05 3.6 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 15.5 | no trial data cached |
| Rectal haemorrhage | 31 | 6.6 4.6–9.3ROR 6.6 · χ² 141 / p 8e-33 | 6.0 EB05 4.4 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.5 · 75% consumer | no trial data cached |
| Basal cell carcinoma | 11 | 6.4 3.6–11.6ROR 6.5 · χ² 45 / p 9e-12 | 5.2 EB05 3.1 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.6 | no trial data cached |
| Irritable bowel syndrome | 15 | 6.4 3.9–10.6ROR 6.4 · χ² 63 / p 9e-16 | 5.5 EB05 3.5 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.2 | no trial data cached |
| Ulcer | 11 | 6.3 3.5–11.4ROR 6.3 · χ² 44 / p 2e-11 | 5.1 EB05 3.0 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.7 | no trial data cached |
| Constipation | 142 | 6.0 5.1–7.0ROR 6.3 · χ² 591 / p 7e-131 | 5.9 EB05 5.1 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.1 | no trial data cached |
| Product complaint | 16 | 5.9 3.6–9.5ROR 5.9 · χ² 60 / p 6e-15 | 5.1 EB05 3.3 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious n=13 | no trial data cached |
| Sleep apnoea syndrome | 12 | 5.7 3.3–10.1ROR 5.8 · χ² 42 / p 4e-11 | 4.8 EB05 2.9 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.2 | no trial data cached |
| Urinary incontinence | 18 | 5.5 3.5–8.8ROR 5.6 · χ² 63 / p 1e-15 | 4.9 EB05 3.3 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.9 | no trial data cached |
| Osteoarthritis | 25 | 5.4 3.6–7.9ROR 5.4 · χ² 85 / p 2e-20 | 4.9 EB05 3.5 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.0 | no trial data cached |
| Diverticulitis | 16 | 5.3 3.2–8.6ROR 5.3 · χ² 51 / p 4e-13 | 4.6 EB05 3.0 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.8 | no trial data cached |
| Restless legs syndrome | 10 | 5.0 2.7–9.3ROR 5.0 · χ² 28 / p 5e-8 | 4.2 EB05 2.4 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.2 | no trial data cached |
| Pulmonary fibrosis | 10 | 4.8 2.6–8.9ROR 4.8 · χ² 26 / p 2e-7 | 4.0 EB05 2.4 · IC025 +0.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.3 | no trial data cached |
| Frequent bowel movements | 14 | 4.7 2.8–8.0ROR 4.8 · χ² 38 / p 4e-10 | 4.2 EB05 2.7 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.3 | no trial data cached |
| Joint injury | 11 | 4.7 2.6–8.5ROR 4.7 · χ² 28 / p 5e-8 | 4.0 EB05 2.4 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.7 | no trial data cached |
| Drug administration error | 16 | 4.7 2.9–7.6ROR 4.7 · χ² 43 / p 3e-11 | 4.2 EB05 2.7 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 10.4 | no trial data cached |
| Cystitis | 16 | 4.6 2.8–7.4ROR 4.6 · χ² 41 / p 7e-11 | 4.1 EB05 2.7 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.1 | no trial data cached |
| Hip fracture | 15 | 4.3 2.6–7.1ROR 4.3 · χ² 34 / p 2e-9 | 3.8 EB05 2.5 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.8 | no trial data cached |
| Flatulence (gas) | 26 | 4.2 2.9–6.1ROR 4.2 · χ² 60 / p 4e-15 | 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 3.7 · 84% consumer | no trial data cached |
| Ageusia (loss of taste) | 11 | 4.0 2.2–7.2ROR 4.0 · χ² 22 / p 1e-6 | 3.5 EB05 2.1 · IC025 +0.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.4 | no trial data cached |
| Dementia | 12 | 3.9 2.2–6.9ROR 3.9 · χ² 23 / p 7e-7 | 3.5 EB05 2.2 · IC025 +0.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.7 | no trial data cached |
| Chronic obstructive pulmonary disease | 22 | 3.9 2.5–5.8ROR 3.9 · χ² 44 / p 2e-11 | 3.6 EB05 2.5 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.9 | no trial data cached |
| Incorrect drug administration duration | 12 | 3.8 2.2–6.8ROR 3.9 · χ² 22 / p 1e-6 | 3.4 EB05 2.1 · IC025 +0.8 3/3 methods agree | Reporting / coding artifact | serious PRR 4.0 | no trial data cached |
| Transient ischaemic attack (mini-stroke) | 14 | 3.8 2.2–6.4ROR 3.8 · χ² 26 / p 2e-7 | 3.4 EB05 2.2 · IC025 +0.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.2 | no trial data cached |
| Coronary artery disease | 12 | 3.6 2.0–6.3ROR 3.6 · χ² 20 / p 4e-6 | 3.2 EB05 2.0 · IC025 +0.7 | No label text to screen label has no adverse-reaction text | serious PRR 3.7 | 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 | 142 | 6.0 5.1–7.0ROR 6.3 · χ² 591 / p 7e-131 | 5.9 EB05 5.1 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.1 | no trial data cached |
| Rectal haemorrhage | 31 | 6.6 4.6–9.3ROR 6.6 · χ² 141 / p 8e-33 | 6.0 EB05 4.4 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.5 · 75% consumer | no trial data cached |
| Intentional product misuse | 27 | 2.8 1.9–4.1ROR 2.9 · χ² 30 / p 2e-8 | 2.7 EB05 2.0 · IC025 +0.8 | Reporting / coding artifact | serious PRR 4.5 | no trial data cached |
| Flatulence (gas) | 26 | 4.2 2.9–6.1ROR 4.2 · χ² 60 / p 4e-15 | 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 3.7 · 84% consumer | no trial data cached |
| Drug dose omission | 25 | 1.4 0.9–2.0ROR 1.4 · χ² 2 / p 0.076 | 1.4 EB05 1.0 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 3.3 | no trial data cached |
| Hot flush (hot flashes) | 25 | 3.0 2.0–4.5ROR 3.0 · χ² 32 / p 8e-9 | 2.9 EB05 2.1 · IC025 +0.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 1.7 · 75% consumer | no trial data cached |
| Osteoarthritis | 25 | 5.4 3.6–7.9ROR 5.4 · χ² 85 / p 2e-20 | 4.9 EB05 3.5 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.0 | no trial data cached |
| Dysgeusia (altered taste) | 24 | 2.9 2.0–4.4ROR 3.0 · χ² 29 / p 4e-8 | 2.8 EB05 2.0 · IC025 +0.8 | No label text to screen label has no adverse-reaction text | serious PRR 3.8 | no trial data cached |
| Chronic obstructive pulmonary disease | 22 | 3.9 2.5–5.8ROR 3.9 · χ² 44 / p 2e-11 | 3.6 EB05 2.5 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.9 | no trial data cached |
| Neuralgia | 21 | 7.9 5.2–12.1ROR 8.0 · χ² 120 / p 3e-28 | 7.0 EB05 4.7 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.5 | no trial data cached |
| Incorrect product administration duration | 21 | 9.5 6.2–14.5ROR 9.5 · χ² 150 / p 7e-35 | 8.4 EB05 5.6 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious n=15 · 95% consumer | no trial data cached |
| Nervousness | 20 | 3.5 2.2–5.4ROR 3.5 · χ² 33 / p 5e-9 | 3.3 EB05 2.2 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.1 | no trial data cached |
| End stage renal disease | 19 | 9.4 6.0–14.7ROR 9.5 · χ² 135 / p 2e-31 | 8.3 EB05 5.4 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.3 | no trial data cached |
| Hyperlipidaemia | 19 | 14.5 9.3–22.7ROR 14.6 · χ² 225 / p 4e-51 | 13.8 EB05 8.8 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.8 | no trial data cached |
| Urinary incontinence | 18 | 5.5 3.5–8.8ROR 5.6 · χ² 63 / p 1e-15 | 4.9 EB05 3.3 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | 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.
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 Methylcellulose?
In FDA FAERS, the most frequently co-reported reaction terms for Methylcellulose are constipation, rectal haemorrhage, flatulence, hot flush, osteoarthritis, dysgeusia. 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 Methylcellulose have an FDA boxed warning?
No. The FDA label retrieved for Methylcellulose has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Methylcellulose 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 31033385-7932-448e-8980-11f2e8197eae, effective 20260416; matched on
openfda.generic_name.exact:"METHYLCELLULOSE") - 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, 119 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.