Drug · FAERS side-effect profile with label screen
Pentoxifylline side effects: what 4,295 FDA adverse event reports show
Drug class
Blood Viscosity Reducer
FDA label (Established Pharmacologic Class)
Who reports
4,295 reports · 82% serious · 746 with death outcome · 55% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Pentoxifylline Extended-Release Tablets are indicated for the treatment of patients with intermittent claudication on the basis of chronic occlusive arterial disease of the limbs. Pentoxifylline Extended-Release Tablets can improve function and symptoms but is not intended to replace more definitive therapy, such as surgical bypass, or removal of arterial obstructions when treating peripheral vascular disease.
FDA label, Indications and Usage
What it is
DESCRIPTION Pentoxifylline Extended-Release Tablets USP for oral administration contain 400 mg of the active drug and the following inactive ingredients: hypromellose, povidone, talc, magnesiu.
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 1Labeled (related wording) 4Likely indication confounding 1Reporting / coding artifact 2Lab value / disease marker 3Not in label — unassessed 29
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. 248 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 |
|---|---|---|---|---|---|---|
| Ocular discomfort | 231 | 106.1 93.4–120.4ROR 112.0 · χ² 23,430 / p <1e-300 | 102.9 EB05 92.3 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=229 · 93% clinician | no trial data cached |
| Generalised oedema | 217 | 87.5 76.8–99.8ROR 92.1 · χ² 18,157 / p <1e-300 | 85.4 EB05 76.2 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 66.8 · 96% clinician | no trial data cached |
| Head discomfort | 231 | 64.8 57.1–73.6ROR 68.5 · χ² 14,275 / p <1e-300 | 63.7 EB05 57.1 · IC025 +5.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 79.6 · 93% clinician | no trial data cached |
| Altered state of consciousness | 237 | 54.3 47.9–61.4ROR 57.4 · χ² 12,211 / p <1e-300 | 53.4 EB05 48.0 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 37.9 · 94% clinician | no trial data cached |
| Haematemesis (vomiting blood) | 241 | 46.7 41.3–52.8ROR 49.4 · χ² 10,641 / p <1e-300 | 46.1 EB05 41.4 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 33.2 · 94% clinician | no trial data cached |
| Photophobia (light sensitivity) | 174 | 45.9 39.7–53.1ROR 47.8 · χ² 7,532 / p <1e-300 | 45.3 EB05 39.9 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 51.3 · 95% clinician | no trial data cached |
| Presyncope (near-fainting) | 205 | 41.7 36.5–47.7ROR 43.7 · χ² 8,040 / p <1e-300 | 41.2 EB05 36.7 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 37.0 · 96% clinician | no trial data cached |
| Ascites | 233 | 39.0 34.4–44.2ROR 41.1 · χ² 8,522 / p <1e-300 | 38.5 EB05 34.6 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 27.4 · 94% clinician | no trial data cached |
| Diplopia (double vision) | 205 | 38.8 33.9–44.4ROR 40.7 · χ² 7,463 / p <1e-300 | 38.4 EB05 34.2 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 36.9 · 96% clinician | no trial data cached |
| Haematuria (blood in urine) | 230 | 32.9 29.0–37.4ROR 34.7 · χ² 7,054 / p <1e-300 | 32.6 EB05 29.3 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 25.1 · ♀ 20% (drug 55%) · 95% clinician | no trial data cached |
| Blindness | 243 | 29.3 25.9–33.1ROR 31.0 · χ² 6,586 / p <1e-300 | 29.1 EB05 26.1 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 20.9 · 92% clinician | no trial data cached |
| Cardio-respiratory arrest | 249 | 29.0 25.7–32.8ROR 30.8 · χ² 6,686 / p <1e-300 | 28.8 EB05 25.9 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 20.2 · 93% clinician | no trial data cached |
| Hyperlipidaemia | 65 | 26.6 20.9–33.9ROR 27.0 · χ² 1,568 / p <1e-300 | 26.3 EB05 21.3 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 20.1 · ♀ 92% (drug 55%) | no trial data cached |
| Coma | 256 | 26.3 23.4–29.7ROR 27.9 · χ² 6,196 / p <1e-300 | 26.2 EB05 23.6 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 18.4 · 92% clinician | no trial data cached |
| Impaired quality of life | 67 | 22.8 18.0–29.0ROR 23.2 · χ² 1,371 / p 2e-300 | 22.6 EB05 18.4 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 23.6 · ♀ 100% (drug 55%) · 94% clinician | no trial data cached |
| Tinnitus (ringing in the ears) | 211 | 22.5 19.7–25.6ROR 23.6 · χ² 4,298 / p <1e-300 | 22.3 EB05 19.9 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 24.0 · 94% clinician | no trial data cached |
| Eye pain | 240 | 21.3 18.8–24.1ROR 22.5 · χ² 4,614 / p <1e-300 | 21.2 EB05 19.0 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 33.4 | no trial data cached |
| Poor quality sleep | 77 | 17.6 14.1–22.0ROR 17.9 · χ² 1,187 / p 2e-260 | 17.5 EB05 14.4 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 22.0 · ♀ 100% (drug 55%) · 92% clinician | no trial data cached |
| Tachycardia (fast heart rate) | 268 | 14.8 13.1–16.6ROR 15.7 · χ² 3,428 / p <1e-300 | 14.7 EB05 13.3 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.5 · 91% clinician | no trial data cached |
| Oral herpes | 56 | 14.1 10.9–18.3ROR 14.3 · χ² 667 / p 3e-147 | 13.9 EB05 11.0 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 23.1 · ♀ 100% (drug 55%) · 93% clinician | no trial data cached |
| Impaired work ability | 61 | 13.9 10.8–17.9ROR 14.1 · χ² 717 / p 3e-158 | 13.7 EB05 11.0 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 12.4 · ♀ 100% (drug 55%) · 100% clinician | no trial data cached |
| Sepsis (blood infection) | 282 | 12.4 11.0–13.8ROR 13.2 · χ² 2,941 / p <1e-300 | 12.3 EB05 11.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 · 92% clinician | no trial data cached |
| Skin ulcer | 64 | 12.1 9.5–15.5ROR 12.3 · χ² 641 / p 9e-142 | 11.9 EB05 9.5 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 | no trial data cached |
| Chills | 285 | 11.9 10.6–13.3ROR 12.6 · χ² 2,835 / p <1e-300 | 11.8 EB05 10.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 12.7 | no trial data cached |
| Syncope (fainting) | 228 | 11.1 9.8–12.6ROR 11.7 · χ² 2,099 / p <1e-300 | 11.0 EB05 9.9 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 · 92% clinician | no trial data cached |
| Akathisia (inner restlessness) | 30 | 10.7 7.5–15.4ROR 10.8 · χ² 255 / p 1e-57 | 10.1 EB05 7.2 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.7 · ♀ 0% (drug 55%) · 93% clinician | no trial data cached |
| End stage renal disease | 36 | 9.6 6.9–13.2ROR 9.6 · χ² 267 / p 3e-60 | 9.0 EB05 6.6 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Cellulitis (skin infection) | 98 | 9.5 7.8–11.6ROR 9.7 · χ² 737 / p 1e-162 | 9.3 EB05 7.8 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 · ♀ 83% (drug 55%) | no trial data cached |
| Bone density decreased | 61 | 9.4 7.3–12.1ROR 9.5 · χ² 450 / p 3e-100 | 9.1 EB05 7.2 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious PRR 8.2 · ♀ 95% (drug 55%) · 93% clinician | no trial data cached |
| International normalised ratio increased | 54 | 9.2 7.0–12.0ROR 9.3 · χ² 385 / p 6e-86 | 8.8 EB05 6.9 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious PRR 6.9 | no trial data cached |
| Skin disorder | 60 | 8.8 6.9–11.3ROR 8.9 · χ² 408 / p 6e-91 | 8.4 EB05 6.7 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.5 · ♀ 100% (drug 55%) | no trial data cached |
| Basal cell carcinoma | 26 | 8.1 5.5–11.9ROR 8.2 · χ² 156 / p 5e-36 | 7.3 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 · ♀ 0% (drug 55%) · 96% clinician | no trial data cached |
| Blood pressure increased | 247 | 7.9 7.0–8.9ROR 8.3 · χ² 1,485 / p <1e-300 | 7.8 EB05 7.0 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious PRR 7.8 | no trial data cached |
| Cataract | 95 | 7.8 6.4–9.6ROR 8.0 · χ² 560 / p 5e-124 | 7.6 EB05 6.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · ♀ 84% (drug 55%) | no trial data cached |
| Arteriosclerosis | 15 | 7.8 4.7–12.9ROR 7.8 · χ² 82 / p 7e-20 | 6.5 EB05 4.1 · IC025 +1.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 5.6 | no trial data cached |
| Mitral valve incompetence | 18 | 7.8 4.9–12.3ROR 7.8 · χ² 99 / p 1e-23 | 6.7 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Vision blurred (blurred vision) | 209 | 7.5 6.5–8.5ROR 7.8 · χ² 1,172 / p 4e-257 | 7.4 EB05 6.6 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.7 | no trial data cached |
| Ischaemic stroke | 27 | 7.4 5.1–10.8ROR 7.4 · χ² 143 / p 4e-33 | 6.7 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 · ♀ 80% (drug 55%) · 93% clinician | no trial data cached |
| Myalgia (muscle pain) | 247 | 7.1 6.3–8.0ROR 7.5 · χ² 1,297 / p 2e-284 | 7.0 EB05 6.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 · 91% clinician | no trial data cached |
| Drug interaction | 226 | 7.0 6.1–7.9ROR 7.3 · χ² 1,154 / p 2e-253 | 6.9 EB05 6.1 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 5.3 · 91% 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 |
|---|---|---|---|---|---|---|
| Fatigue (tiredness) | 457 | 2.9 2.6–3.1ROR 3.1 · χ² 577 / p 9e-128 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Diarrhoea (diarrhea) | 431 | 3.3 3.0–3.6ROR 3.5 · χ² 698 / p 3e-154 | 3.3 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 | no trial data cached |
| Dyspnoea (shortness of breath) | 405 | 3.5 3.2–3.8ROR 3.8 · χ² 739 / p 6e-163 | 3.5 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | no trial data cached |
| Fall | 376 | 5.5 5.0–6.1ROR 6.0 · χ² 1,409 / p <1e-300 | 5.5 EB05 5.0 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Dizziness | 371 | 3.6 3.3–4.0ROR 3.9 · χ² 724 / p 1e-159 | 3.6 EB05 3.3 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 | no trial data cached |
| Headache | 358 | 2.8 2.5–3.1ROR 3.0 · χ² 422 / p 4e-94 | 2.8 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 | no trial data cached |
| Asthenia (weakness) | 349 | 4.5 4.1–5.0ROR 4.8 · χ² 974 / p 4e-214 | 4.5 EB05 4.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Insomnia (trouble sleeping) | 341 | 6.2 5.6–6.9ROR 6.7 · χ² 1,514 / p <1e-300 | 6.2 EB05 5.7 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.8 · ♀ 84% (drug 55%) | no trial data cached |
| Arthralgia (joint pain) | 331 | 3.9 3.5–4.3ROR 4.1 · χ² 725 / p 6e-160 | 3.9 EB05 3.5 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Pruritus (itching) | 289 | 3.7 3.3–4.2ROR 3.9 · χ² 586 / p 1e-129 | 3.7 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.9 | no trial data cached |
| Vomiting | 288 | 3.0 2.7–3.4ROR 3.1 · χ² 390 / p 4e-87 | 3.0 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.0 | no trial data cached |
| Chills | 285 | 11.9 10.6–13.3ROR 12.6 · χ² 2,835 / p <1e-300 | 11.8 EB05 10.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 12.7 | no trial data cached |
| Sepsis (blood infection) | 282 | 12.4 11.0–13.8ROR 13.2 · χ² 2,941 / p <1e-300 | 12.3 EB05 11.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 · 92% clinician | no trial data cached |
| Cough | 280 | 4.9 4.4–5.5ROR 5.2 · χ² 873 / p 4e-192 | 4.8 EB05 4.4 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Decreased appetite (loss of appetite) | 280 | 5.9 5.3–6.6ROR 6.2 · χ² 1,147 / p 8e-252 | 5.8 EB05 5.3 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | 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.
- Ocular discomfort — n=231, PRR 106.1
- Generalised oedema — n=217, PRR 87.5
- Altered state of consciousness — n=237, PRR 54.3
- Haematemesis — n=241, PRR 46.7
- Photophobia — n=174, PRR 45.9
- Presyncope — n=205, PRR 41.7
- Ascites — n=233, PRR 39.0
- Diplopia — n=205, PRR 38.8
- Haematuria — n=230, PRR 32.9
- Blindness — n=243, PRR 29.3
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 Pentoxifylline?
In FDA FAERS, the most frequently co-reported reaction terms for Pentoxifylline are fatigue, diarrhoea, dyspnoea, fall, dizziness, headache. 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 Pentoxifylline have an FDA boxed warning?
No. The FDA label retrieved for Pentoxifylline has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Pentoxifylline 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 9ca79c97-e4e5-4297-85eb-7a9b3d8083b5, effective 20251107; matched on
openfda.generic_name.exact:"PENTOXIFYLLINE") - 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, 288 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.