Drug · FAERS side-effect profile with label screen
Psyllium Husk side effects: what 9,815 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Dr. Fibra
openFDA label
Who reports
9,815 reports · 61% serious · 770 with death outcome · 58% female
openFDA FAERS counts, all years, deduplication not applied
Used for
For relief of occasional constipation (irregularity). 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
Reporting / coding artifact 7Lab value / disease marker 4No label text to screen 29
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.
- 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. 1,053 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 |
|---|---|---|---|---|---|---|
| Salpingo-oophorectomy unilateral | 28 | 727.9 473.9–1,118.1ROR 730.0 · χ² 14,569 / p <1e-300 | 394.8 EB05 286.6 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=28 · ♀ 100% (drug 58%) | not reported in cached trials |
| Appendicolith | 40 | 251.4 181.3–348.8ROR 252.5 · χ² 8,691 / p <1e-300 | 203.0 EB05 155.5 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=40 · ♀ 0% (drug 58%) · 100% clinician | not reported in cached trials |
| Antacid therapy | 11 | 214.5 115.4–398.7ROR 214.7 · χ² 1,932 / p <1e-300 | 146.0 EB05 87.0 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious n=11 | not reported in cached trials |
| Sleep disorder therapy | 16 | 200.5 120.1–334.8ROR 200.9 · χ² 2,721 / p <1e-300 | 150.6 EB05 98.3 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious n=16 | not reported in cached trials |
| Analgesic therapy | 18 | 133.0 82.6–214.1ROR 133.2 · χ² 2,096 / p <1e-300 | 110.8 EB05 74.1 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious n=18 | not reported in cached trials |
| Drug therapy | 17 | 119.7 73.5–195.1ROR 119.9 · χ² 1,783 / p <1e-300 | 100.8 EB05 66.7 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious n=17 | not reported in cached trials |
| Temperature regulation disorder | 113 | 116.4 96.4–140.5ROR 117.8 · χ² 12,145 / p <1e-300 | 108.4 EB05 92.6 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=113 · ♀ 100% (drug 58%) · 92% clinician | not reported in cached trials |
| Venous pressure jugular increased | 17 | 103.5 63.6–168.3ROR 103.6 · χ² 1,548 / p <1e-300 | 89.1 EB05 58.9 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=17 | not reported in cached trials |
| Anticoagulant therapy | 11 | 88.1 48.2–160.9ROR 88.2 · χ² 827 / p 3e-182 | 74.1 EB05 44.2 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious n=11 | not reported in cached trials |
| Sinusitis fungal | 29 | 81.5 56.3–118.1ROR 81.8 · χ² 2,144 / p <1e-300 | 74.8 EB05 54.6 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=29 · ♀ 100% (drug 58%) | not reported in cached trials |
| Food allergy | 189 | 54.8 47.5–63.2ROR 55.8 · χ² 9,675 / p <1e-300 | 53.1 EB05 47.1 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=189 · ♀ 100% (drug 58%) · 93% clinician | not reported in cached trials |
| Multiple drug therapy | 15 | 46.9 28.1–78.1ROR 46.9 · χ² 615 / p 6e-136 | 43.5 EB05 28.0 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious n=15 | not reported in cached trials |
| Foetal death | 111 | 46.7 38.7–56.3ROR 47.2 · χ² 4,812 / p <1e-300 | 45.4 EB05 38.7 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=111 · ♀ 100% (drug 58%) · 93% clinician | not reported in cached trials |
| Female genital tract fistula | 35 | 44.3 31.7–61.9ROR 44.4 · χ² 1,409 / p <1e-300 | 42.5 EB05 31.9 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=35 · ♀ 100% (drug 58%) | not reported in cached trials |
| Hyperphosphataemia | 36 | 36.9 26.5–51.2ROR 37.0 · χ² 1,200 / p 3e-263 | 35.6 EB05 26.9 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=36 · ♀ 0% (drug 58%) · 100% clinician | not reported in cached trials |
| Rectal prolapse | 20 | 36.0 23.1–55.9ROR 36.0 · χ² 635 / p 3e-140 | 34.3 EB05 23.5 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=20 · ♀ 100% (drug 58%) | not reported in cached trials |
| Sputum increased | 34 | 34.9 24.9–48.9ROR 35.0 · χ² 1,067 / p 3e-234 | 33.7 EB05 25.2 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=34 · ♀ 100% (drug 58%) | not reported in cached trials |
| Blood phosphorus increased | 40 | 31.8 23.3–43.4ROR 31.9 · χ² 1,145 / p 3e-251 | 30.9 EB05 23.7 · IC025 +4.0 3/3 methods agree | Lab value / disease marker | serious n=40 · ♀ 0% (drug 58%) · 100% clinician | not reported in cached trials |
| Creatinine renal clearance increased | 11 | 31.7 17.5–57.5ROR 31.7 · χ² 293 / p 7e-66 | 29.7 EB05 17.6 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious n=11 | not reported in cached trials |
| Respiratory symptom | 40 | 30.9 22.6–42.2ROR 31.0 · χ² 1,112 / p 4e-244 | 30.1 EB05 23.0 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=40 · ♀ 83% (drug 58%) | not reported in cached trials |
| Sedation complication | 34 | 29.4 21.0–41.2ROR 29.5 · χ² 893 / p 2e-196 | 28.6 EB05 21.4 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious n=34 · ♀ 100% (drug 58%) | not reported in cached trials |
| Kyphosis | 24 | 29.3 19.6–43.8ROR 29.3 · χ² 619 / p 7e-137 | 28.3 EB05 20.0 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=24 · ♀ 100% (drug 58%) | not reported in cached trials |
| Immunodeficiency | 193 | 28.3 24.6–32.6ROR 28.9 · χ² 4,998 / p <1e-300 | 27.9 EB05 24.8 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 28.5 · ♀ 98% (drug 58%) · 90% clinician | not reported in cached trials |
| Diastolic dysfunction | 37 | 25.8 18.6–35.6ROR 25.9 · χ² 846 / p 3e-186 | 25.2 EB05 19.1 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=37 · ♀ 91% (drug 58%) | not reported in cached trials |
| Embolism venous | 34 | 24.2 17.2–33.9ROR 24.3 · χ² 724 / p 9e-160 | 23.6 EB05 17.7 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=34 · ♀ 100% (drug 58%) | not reported in cached trials |
| Bronchopulmonary aspergillosis allergic | 10 | 23.5 12.6–43.9ROR 23.6 · χ² 192 / p 7e-44 | 22.1 EB05 12.3 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | not reported in cached trials |
| Pleural fibrosis | 11 | 23.0 12.7–41.7ROR 23.1 · χ² 208 / p 2e-47 | 21.8 EB05 12.5 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | not reported in cached trials |
| Creatinine renal clearance decreased | 41 | 21.9 16.1–29.8ROR 22.0 · χ² 790 / p 3e-174 | 21.5 EB05 16.5 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious n=41 · ♀ 100% (drug 58%) | not reported in cached trials |
| Faeces hard | 37 | 20.5 14.9–28.4ROR 20.6 · χ² 662 / p 4e-146 | 20.1 EB05 15.2 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=15 · 78% consumer | not reported in cached trials |
| Prescribed overdose | 183 | 20.4 17.6–23.5ROR 20.7 · χ² 3,323 / p <1e-300 | 20.1 EB05 17.8 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 31.4 · ♀ 95% (drug 58%) | not reported in cached trials |
| Osteosclerosis | 14 | 19.1 11.3–32.3ROR 19.1 · χ² 220 / p 4e-50 | 18.2 EB05 11.1 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=14 | not reported in cached trials |
| Coeliac disease | 87 | 19.1 15.5–23.5ROR 19.2 · χ² 1,460 / p <1e-300 | 18.8 EB05 15.7 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.4 · ♀ 100% (drug 58%) · 91% clinician | not reported in cached trials |
| Iron deficiency | 38 | 18.4 13.4–25.3ROR 18.5 · χ² 603 / p 2e-133 | 18.1 EB05 13.7 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=37 · ♀ 0% (drug 58%) | not reported in cached trials |
| Chronic sinusitis | 31 | 17.8 12.5–25.3ROR 17.9 · χ² 471 / p 1e-104 | 17.4 EB05 12.8 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=30 · ♀ 100% (drug 58%) | not reported in cached trials |
| Bursitis | 98 | 17.5 14.3–21.3ROR 17.6 · χ² 1,494 / p <1e-300 | 17.3 EB05 14.6 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.2 · ♀ 93% (drug 58%) | not reported in cached trials |
| Left atrial dilatation | 10 | 16.7 9.0–31.2ROR 16.8 · χ² 132 / p 9e-31 | 15.1 EB05 7.6 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | not reported in cached trials |
| Diverticulum | 56 | 16.7 12.9–21.7ROR 16.8 · χ² 806 / p 2e-177 | 16.5 EB05 13.1 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=49 · ♀ 89% (drug 58%) | not reported in cached trials |
| Nasal polyps | 36 | 16.0 11.6–22.3ROR 16.1 · χ² 489 / p 1e-108 | 15.7 EB05 11.7 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=36 · ♀ 100% (drug 58%) | not reported in cached trials |
| Obstructive sleep apnoea syndrome | 10 | 15.4 8.3–28.7ROR 15.4 · χ² 120 / p 4e-28 | 13.6 EB05 6.8 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=9 | not reported in cached trials |
| Blood uric acid increased | 41 | 15.3 11.2–20.8ROR 15.3 · χ² 529 / p 2e-117 | 15.0 EB05 11.4 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious n=37 · ♀ 0% (drug 58%) · 90% clinician | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Psyllium Husk as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).
- NCT00727649 — Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence (N=80, PHASE2, PHASE3; 8 AE terms posted; arms: P1L2 (Psyllium First); 1st 4-weeks; L1P2 (Loperamide First): 1st 4-weeks; P1L2 (Loperamide Second); 2nd 4-weeks; L1P2 (Psyllium Second); 2nd 4-weeks)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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 |
|---|---|---|---|---|---|---|
| Fatigue (tiredness) | 1,069 | 2.9 2.8–3.1ROR 3.2 · χ² 1,418 / p <1e-300 | 2.9 EB05 2.8 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.4 | not reported in cached trials |
| Diarrhoea (diarrhea) | 1,023 | 3.4 3.2–3.6ROR 3.7 · χ² 1,782 / p <1e-300 | 3.4 EB05 3.2 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.1 | NCT00727649: 4/34 (11.8%) on Psyllium Husk |
| Constipation | 888 | 8.8 8.3–9.4ROR 9.6 · χ² 6,163 / p <1e-300 | 8.7 EB05 8.3 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.4 | NCT00727649: 3/34 (8.8%) on Psyllium Husk |
| Off label use (used outside approved label) | 819 | 2.0 1.9–2.2ROR 2.1 · χ² 436 / p 4e-97 | 2.0 EB05 1.9 · IC025 +0.9 | Reporting / coding artifact | serious PRR 2.5 | not reported in cached trials |
| Nausea | 724 | 2.0 1.8–2.1ROR 2.0 · χ² 352 / p 6e-79 | 2.0 EB05 1.8 · IC025 +0.8 | No label text to screen label has no adverse-reaction text | serious PRR 2.3 | not reported in cached trials |
| Headache | 701 | 2.4 2.2–2.6ROR 2.5 · χ² 583 / p 4e-129 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.4 | NCT00727649: 1/34 (2.9%) on Psyllium Husk |
| Drug ineffective (drug did not work) | 674 | 1.1 1.0–1.2ROR 1.1 · χ² 6 / p 0.009 | 1.1 EB05 1.0 · IC025 +0.0 | Reporting / coding artifact | serious PRR 1.5 | not reported in cached trials |
| Pain | 666 | 2.3 2.1–2.5ROR 2.4 · χ² 509 / p 5e-113 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.8 | NCT00727649: 2/34 (5.9%) on Psyllium Husk |
| Dyspnoea (shortness of breath) | 578 | 2.2 2.0–2.4ROR 2.3 · χ² 379 / p 9e-85 | 2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.3 | not reported in cached trials |
| Asthenia (weakness) | 506 | 2.9 2.6–3.1ROR 3.0 · χ² 627 / p 9e-139 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.9 | not reported in cached trials |
| Dizziness | 489 | 2.1 1.9–2.3ROR 2.2 · χ² 286 / p 1e-64 | 2.1 EB05 1.9 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | serious PRR 2.4 | not reported in cached trials |
| Rash | 458 | 2.3 2.1–2.5ROR 2.3 · χ² 326 / p 4e-73 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.3 | not reported in cached trials |
| Fall | 452 | 2.9 2.7–3.2ROR 3.0 · χ² 571 / p 2e-126 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.9 | not reported in cached trials |
| Arthralgia (joint pain) | 414 | 2.1 1.9–2.3ROR 2.2 · χ² 253 / p 3e-57 | 2.1 EB05 2.0 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | serious PRR 2.5 | not reported in cached trials |
| Weight decreased (weight loss) | 414 | 3.2 2.9–3.5ROR 3.3 · χ² 620 / p 3e-137 | 3.2 EB05 2.9 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.4 | not reported in cached trials |
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 Psyllium Husk?
In FDA FAERS, the most frequently co-reported reaction terms for Psyllium Husk are fatigue, diarrhoea, constipation, nausea, headache, pain. 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 Psyllium Husk have an FDA boxed warning?
No. The FDA label retrieved for Psyllium Husk has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Psyllium Husk 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 1a6151c9-e1c4-f0c1-e063-6394a90aad24, effective 20240722; matched on
openfda.generic_name.exact:"PSYLLIUM HUSK") - 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, 1,093 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 - ClinicalTrials.gov API v2 (query
PSYLLIUM HUSK, results-bearing studies sorted by enrollment)
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.