Drug · FAERS side-effect profile with label screen
Botulinum Toxin Type A side effects: what 12,337 FDA adverse event reports show
Drug class
Acetylcholine Release Inhibitor, Neuromuscular Blocker
FDA label (Established Pharmacologic Class) · compare the class
Brand names
Dysport
openFDA label
Who reports
12,337 reports · 55% serious · 1,874 with death outcome · 84% female
openFDA FAERS counts, all years, deduplication not applied
Used for
DYSPORT is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for: the treatment of cervical dystonia in adults ( 1.1 ) the temporary improvement in the appearance of moderate to severe glabellar lines associated with proceru.
FDA label, Indications and Usage
What it is
Botulinum toxin type A, the active ingredient in DYSPORT, is a purified neurotoxin type A complex produced by fermentation of the bacterium Clostridium botulinum type A, Hall Strain. It is purified from the culture supernatant by a series of precipitation, dialysis, and chromatography steps.
FDA label, Description section
Boxed warning
DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of DYSPORT and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects.
FDA 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) 2Likely indication confounding 1Lab value / disease marker 5Not in label — unassessed 31
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.
- 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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 968 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 |
|---|---|---|---|---|---|---|
| Hepatic enzyme | 67 | 1,581.1 1,132.9–2,206.6ROR 1,589.7 · calibrated p 7e-19 ✓ | 659.6 EB05 537.3 · IC025 +6.5 3/3 methods agree vs other Acetylcholine Release Inhibitors: only this drug | Not in label — unassessed | serious n=67 · 100% clinician | not reported in cached trials |
| Neuromuscular toxicity | 166 | 1,580.3 1,279.3–1,952.1ROR 1,601.8 · calibrated p 2e-19 ✓ | 743.5 EB05 653.3 · IC025 +7.6 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 30.6 (21.2–44.3) | Likely indication confounding shares a disease stem with the indications wording | serious n=154 | not reported in cached trials |
| Botulism | 168 | 535.1 450.2–636.1ROR 542.5 · calibrated p 4e-14 ✓ | 387.9 EB05 341.1 · IC025 +7.3 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 2.7 (2.3–3.3) | Not in label — unassessed | serious n=167 | not reported in cached trials |
| Neovascularisation | 59 | 509.6 380.9–681.6ROR 512.0 · calibrated p 1e-13 ✓ | 346.9 EB05 278.8 · IC025 +6.1 3/3 methods agree vs other Acetylcholine Release Inhibitors: only this drug | Not in label — unassessed | serious n=59 · 92% clinician | not reported in cached trials |
| Facet joint syndrome | 685 | 472.9 435.2–513.8ROR 500.6 · calibrated p 6e-14 ✓ | 365.2 EB05 342.9 · IC025 +8.1 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 116.2 (83.5–161.7) | Not in label — unassessed | serious n=685 · 95% clinician | not reported in cached trials |
| Vascular malformation | 43 | 431.4 308.7–602.9ROR 432.9 · calibrated p 1e-12 ✓ | 297.8 EB05 230.3 · IC025 +5.6 3/3 methods agree vs other Acetylcholine Release Inhibitors: only this drug | Not in label — unassessed | serious n=43 | not reported in cached trials |
| Hypocholesterolaemia | 58 | 395.0 296.9–525.6ROR 396.9 · calibrated p 2e-12 ✓ | 289.3 EB05 232.1 · IC025 +6.0 3/3 methods agree vs other Acetylcholine Release Inhibitors: only this drug | Not in label — unassessed | serious n=58 · 97% clinician | not reported in cached trials |
| Paranasal cyst | 43 | 371.4 267.0–516.5ROR 372.7 · calibrated p 4e-12 ✓ | 268.0 EB05 207.2 · IC025 +5.6 3/3 methods agree vs other Acetylcholine Release Inhibitors: only this drug | Not in label — unassessed | serious n=43 | not reported in cached trials |
| Brow ptosis | 110 | 340.0 277.2–417.1ROR 343.1 · calibrated p 4e-12 ✓ | 269.6 EB05 229.9 · IC025 +6.6 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 1.5 (1.3–1.9) | Not in label — unassessed | serious n=24 | not reported in cached trials |
| Overlap syndrome | 103 | 298.6 242.3–367.9ROR 301.1 · calibrated p 1e-11 ✓ | 242.2 EB05 205.4 · IC025 +6.5 3/3 methods agree vs other Acetylcholine Release Inhibitors: only this drug | Not in label — unassessed | serious n=103 · 92% clinician | not reported in cached trials |
| Peripheral venous disease | 595 | 297.9 273.5–324.4ROR 312.9 · calibrated p 7e-12 ✓ | 251.0 EB05 234.5 · IC025 +7.6 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 116.7 (81.8–166.5) | Labeled (related wording) related wording | serious n=594 · 95% clinician | not reported in cached trials |
| Blepharospasm | 847 | 268.9 250.6–288.5ROR 288.6 · calibrated p 1e-11 ✓ | 230.6 EB05 217.9 · IC025 +7.6 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 28.1 (24.0–32.9) | Not in label — unassessed | serious n=817 · 92% clinician | not reported in cached trials |
| Onychomadesis | 502 | 233.7 213.2–256.1ROR 243.6 · calibrated p 7e-11 ✓ | 203.6 EB05 189.1 · IC025 +7.3 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 50.0 (38.5–65.0) | Not in label — unassessed | serious n=502 · 95% clinician | not reported in cached trials |
| Rheumatic fever | 512 | 225.7 206.2–247.1ROR 235.5 · calibrated p 1e-10 ✓ | 197.6 EB05 183.6 · IC025 +7.2 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 69.8 (51.7–94.4) | Not in label — unassessed | serious n=512 · 94% clinician | not reported in cached trials |
| Breast cancer stage iii | 742 | 221.6 205.7–238.8ROR 235.8 · calibrated p 9e-11 ✓ | 194.9 EB05 183.4 · IC025 +7.3 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 172.5 (117.5–253.1) | Not in label — unassessed | serious n=742 · 96% clinician | not reported in cached trials |
| Swollen joint count | 25 | 192.1 127.1–290.5ROR 192.5 · calibrated p 3e-9 ✓ | 152.6 EB05 108.7 · IC025 +4.6 3/3 methods agree vs other Acetylcholine Release Inhibitors: only this drug | Not in label — unassessed | serious n=25 · 100% clinician | not reported in cached trials |
| Duodenal ulcer perforation | 738 | 190.0 176.4–204.6ROR 202.0 · calibrated p 4e-10 ✓ | 170.0 EB05 160.0 · IC025 +7.1 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 140.3 (99.0–198.9) | Not in label — unassessed | serious PRR 178.7 · 95% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody positive | 689 | 182.5 169.0–197.0ROR 193.2 · calibrated p 6e-10 ✓ | 163.9 EB05 153.9 · IC025 +7.1 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 160.1 (109.0–235.2) | Lab value / disease marker | serious PRR 173.1 · 96% clinician | not reported in cached trials |
| Onychomycosis | 364 | 154.0 138.6–171.3ROR 158.7 · calibrated p 3e-9 ✓ | 140.1 EB05 128.5 · IC025 +6.7 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 51.9 (38.0–71.0) | Not in label — unassessed | serious n=363 · 93% clinician | not reported in cached trials |
| Infusion site reaction | 224 | 141.9 123.9–162.4ROR 144.5 · calibrated p 7e-9 ✓ | 129.5 EB05 115.9 · IC025 +6.4 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 78.1 (48.3–126.2) | Not in label — unassessed | serious n=224 · 100% clinician | not reported in cached trials |
| Muscle injury | 611 | 136.7 126.1–148.1ROR 143.7 · calibrated p 7e-9 ✓ | 126.0 EB05 117.8 · IC025 +6.7 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 98.3 (71.1–135.9) | Labeled (related wording) related wording | serious PRR 143.3 · 96% clinician | not reported in cached trials |
| Lupus vulgaris | 86 | 132.3 106.3–164.7ROR 133.2 · calibrated p 2e-8 ✓ | 119.5 EB05 99.8 · IC025 +5.8 3/3 methods agree vs other Acetylcholine Release Inhibitors: only this drug | Not in label — unassessed | serious n=86 · 94% clinician | not reported in cached trials |
| Folliculitis | 745 | 132.1 122.9–142.0ROR 140.5 · calibrated p 8e-9 ✓ | 122.1 EB05 114.9 · IC025 +6.7 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 133.6 (95.2–187.4) | Not in label — unassessed | serious PRR 150.9 · 96% clinician | not reported in cached trials |
| Post-traumatic headache | 11 | 130.7 70.8–241.4ROR 130.8 · calibrated p 2e-7 ✓ | 100.7 EB05 60.0 · IC025 +3.3 3/3 methods agree vs other Acetylcholine Release Inhibitors: only this drug | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Helicobacter infection | 720 | 129.1 120.0–139.0ROR 137.1 · calibrated p 1e-8 ✓ | 119.6 EB05 112.4 · IC025 +6.7 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 188.3 (125.4–282.7) | Not in label — unassessed | serious PRR 132.8 · 96% clinician | not reported in cached trials |
| Nail disorder | 604 | 126.9 117.1–137.6ROR 133.4 · calibrated p 1e-8 ✓ | 117.6 EB05 110.0 · IC025 +6.6 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 164.8 (108.7–249.9) | Not in label — unassessed | serious n=604 · 96% clinician | not reported in cached trials |
| Facial asymmetry | 66 | 126.7 98.7–162.6ROR 127.3 · calibrated p 3e-8 ✓ | 114.0 EB05 92.7 · IC025 +5.6 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 1.7 (1.3–2.2) | Labeled adverse reaction exact term | serious n=24 | not reported in cached trials |
| Finger deformity | 330 | 124.1 111.1–138.6ROR 127.5 · calibrated p 2e-8 ✓ | 114.8 EB05 104.8 · IC025 +6.4 3/3 methods agree vs other Acetylcholine Release Inhibitors: only this drug | Not in label — unassessed | serious n=330 · 92% clinician | not reported in cached trials |
| Lip dry | 591 | 120.0 110.6–130.2ROR 126.0 · calibrated p 2e-8 ✓ | 111.6 EB05 104.3 · IC025 +6.5 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 106.0 (75.4–149.0) | Not in label — unassessed | serious n=588 · 96% clinician | not reported in cached trials |
| Drug specific antibody | 86 | 114.3 91.9–142.1ROR 115.1 · calibrated p 5e-8 ✓ | 104.6 EB05 87.3 · IC025 +5.7 3/3 methods agree vs other Acetylcholine Release Inhibitors: only this drug | Lab value / disease marker | serious n=86 | not reported in cached trials |
| Hypercholesterolaemia | 602 | 114.1 105.2–123.7ROR 119.9 · calibrated p 3e-8 ✓ | 106.5 EB05 99.6 · IC025 +6.5 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 145.3 (98.1–215.1) | Not in label — unassessed | serious PRR 119.0 · 95% clinician | not reported in cached trials |
| Live birth | 519 | 112.9 103.5–123.2ROR 117.9 · calibrated p 3e-8 ✓ | 105.5 EB05 98.1 · IC025 +6.4 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 34.6 (27.8–43.1) | Not in label — unassessed | serious PRR 135.1 · 95% clinician | not reported in cached trials |
| Bursitis | 749 | 112.5 104.7–120.8ROR 119.7 · calibrated p 3e-8 ✓ | 105.2 EB05 99.0 · IC025 +6.5 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 95.9 (71.9–128.0) | Not in label — unassessed | serious PRR 130.1 · 95% clinician | not reported in cached trials |
| Pemphigus | 767 | 111.7 104.1–119.9ROR 119.1 · calibrated p 3e-8 ✓ | 104.5 EB05 98.5 · IC025 +6.5 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 83.0 (63.6–108.3) | Not in label — unassessed | serious PRR 110.1 · 96% clinician | not reported in cached trials |
| Diaphragmatic rupture | 11 | 110.4 60.0–203.1ROR 110.5 · calibrated p 6e-7 ✓ | 88.2 EB05 52.6 · IC025 +3.2 3/3 methods agree vs other Acetylcholine Release Inhibitors: only this drug | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Wound infection | 649 | 107.9 99.9–116.6ROR 113.8 · calibrated p 4e-8 ✓ | 101.1 EB05 94.8 · IC025 +6.4 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 83.1 (62.2–111.1) | Not in label — unassessed | serious PRR 114.0 · 95% clinician | not reported in cached trials |
| C-reactive protein abnormal | 378 | 106.5 96.1–118.0ROR 109.8 · calibrated p 6e-8 ✓ | 99.7 EB05 91.6 · IC025 +6.3 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 118.6 (75.7–185.9) | Lab value / disease marker | serious n=378 · 94% clinician | not reported in cached trials |
| C-reactive protein | 52 | 103.2 78.1–136.5ROR 103.7 · calibrated p 1e-7 ✓ | 94.0 EB05 74.5 · IC025 +5.2 3/3 methods agree vs other Acetylcholine Release Inhibitors: only this drug | Lab value / disease marker | serious n=52 · 98% clinician | not reported in cached trials |
| X-ray abnormal | 102 | 103.0 84.4–125.6ROR 103.8 · calibrated p 1e-7 ✓ | 95.4 EB05 80.8 · IC025 +5.7 3/3 methods agree vs other Acetylcholine Release Inhibitors: only this drug | Lab value / disease marker | serious n=102 · 98% clinician | not reported in cached trials |
| Hand deformity | 722 | 99.2 92.2–106.7ROR 105.3 · calibrated p 8e-8 ✓ | 93.5 EB05 87.9 · IC025 +6.3 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 206.0 (134.8–314.7) | Not in label — unassessed | serious PRR 106.8 · 95% 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 Botulinum Toxin Type A 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).
- NCT03004248 — Safety of Single and Repeat Treatments of DaxibotulinumtoxinA for Injection for Treatment of Moderate to Sever (N=2691, PHASE3; 30 AE terms posted; arms: Overall)
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 |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 4,777 | 9.4 9.2–9.6ROR 14.7 · calibrated p 0.008 ✓ | 9.3 EB05 9.1 · IC025 +3.2 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 2.1 (2.1–2.2) | Reporting / coding artifact | serious PRR 10.5 | not reported in cached trials |
| Drug ineffective (drug did not work) | 3,661 | 4.7 4.6–4.9ROR 6.3 · calibrated p 0.131 | 4.7 EB05 4.6 · IC025 +2.2 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 0.8 (0.7–0.8) | Reporting / coding artifact | serious PRR 6.6 | not reported in cached trials |
| Headache | 1,595 | 4.3 4.1–4.5ROR 4.8 · calibrated p 0.254 | 4.3 EB05 4.1 · IC025 +2.0 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 2.5 (2.3–2.6) | Labeled adverse reaction exact term | serious PRR 7.6 | NCT03004248: 158/2,691 (5.9%) on Botulinum Toxin Type A |
| Drug intolerance | 1,333 | 23.8 22.7–25.1ROR 26.6 · calibrated p 5e-4 ✓ | 23.5 EB05 22.5 · IC025 +4.5 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 48.1 (41.1–56.3) | Reporting / coding artifact | serious PRR 39.1 | not reported in cached trials |
| Product use in unapproved indication | 1,310 | 9.2 8.7–9.6ROR 10.1 · calibrated p 0.031 ✓ | 9.1 EB05 8.7 · IC025 +3.1 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 8.4 (7.8–9.2) | Reporting / coding artifact | serious PRR 20.7 | not reported in cached trials |
| Nausea | 1,266 | 2.7 2.6–2.9ROR 2.9 · calibrated p 0.651 | 2.7 EB05 2.6 · IC025 +1.4 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 3.6 (3.4–3.9) | Labeled adverse reaction exact term | serious PRR 4.9 | not reported in cached trials |
| Migraine | 1,176 | 21.3 20.2–22.5ROR 23.5 · calibrated p 9e-4 ✓ | 21.1 EB05 20.1 · IC025 +4.3 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 3.1 (2.9–3.3) | Not in label — unassessed | serious PRR 40.3 | not reported in cached trials |
| Pain | 1,143 | 3.2 3.0–3.3ROR 3.4 · calibrated p 0.515 | 3.2 EB05 3.0 · IC025 +1.6 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 3.8 (3.5–4.1) | Labeled adverse reaction exact term | serious PRR 4.5 | NCT03004248: 1/2,691 (0.0%) on Botulinum Toxin Type A (serious AE) |
| Dizziness | 1,126 | 3.8 3.6–4.1ROR 4.1 · calibrated p 0.354 | 3.8 EB05 3.7 · IC025 +1.8 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 3.9 (3.7–4.2) | Labeled adverse reaction exact term | serious PRR 6.2 | not reported in cached trials |
| Hypoaesthesia (numbness) | 1,111 | 12.7 12.0–13.4ROR 13.8 · calibrated p 0.010 ✓ | 12.6 EB05 12.0 · IC025 +3.5 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 6.5 (6.0–7.0) | Not in label — unassessed | serious PRR 19.6 · 90% clinician | not reported in cached trials |
| Fatigue (tiredness) | 1,062 | 2.3 2.2–2.5ROR 2.4 · calibrated p 0.835 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 3.6 (3.4–3.9) | Labeled — boxed warning synonym match | serious PRR 4.1 | not reported in cached trials |
| Asthenia (weakness) | 1,034 | 4.7 4.4–5.0ROR 5.0 · calibrated p 0.233 | 4.7 EB05 4.4 · IC025 +2.1 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 5.1 (4.7–5.6) | Labeled — boxed warning exact term | serious PRR 6.4 | not reported in cached trials |
| Muscular weakness | 1,011 | 15.2 14.4–16.2ROR 16.5 · calibrated p 0.005 ✓ | 15.1 EB05 14.3 · IC025 +3.8 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 3.4 (3.1–3.6) | Labeled adverse reaction exact term | serious PRR 19.6 | not reported in cached trials |
| Paraesthesia (tingling/numbness) | 940 | 10.2 9.6–10.8ROR 10.9 · calibrated p 0.024 ✓ | 10.1 EB05 9.6 · IC025 +3.2 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 6.1 (5.5–6.6) | Labeled (related wording) related wording | serious PRR 17.4 | not reported in cached trials |
| Maternal exposure during pregnancy | 929 | 18.1 17.0–19.2ROR 19.5 · calibrated p 0.002 ✓ | 17.9 EB05 16.9 · IC025 +4.0 3/3 methods agree vs other Acetylcholine Release Inhibitors: PRR 23.9 (20.8–27.5) | Reporting / coding artifact | serious PRR 23.8 | not reported in cached trials |
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.
- Hepatic enzyme — n=67, PRR 1,581.1
- Botulism — n=168, PRR 535.1
- Neovascularisation — n=59, PRR 509.6
- Facet joint syndrome — n=685, PRR 472.9
- Vascular malformation — n=43, PRR 431.4
- Hypocholesterolaemia — n=58, PRR 395.0
- Paranasal cyst — n=43, PRR 371.4
- Brow ptosis — n=110, PRR 340.0
- Overlap syndrome — n=103, PRR 298.6
- Blepharospasm — n=847, PRR 268.9
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 Botulinum Toxin Type A?
In FDA FAERS, the most frequently co-reported reaction terms for Botulinum Toxin Type A are headache, nausea, migraine, pain, dizziness, hypoaesthesia. 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 Botulinum Toxin Type A have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of DYSPORT and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects.
Do FAERS signals prove that Botulinum Toxin Type A 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 71313a04-1349-4c26-b840-a39e4a3ddaed, effective 20241024; matched on
openfda.generic_name.exact:"BOTULINUM TOXIN TYPE A") - 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, 1,008 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
BOTULINUM TOXIN TYPE A, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. 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.