ORPHA:464458
Paracetamol poisoning
Also known as: Acetaminophen poisoning
Publications
2,014
85.6th percentile
Trials
3
Interventional, condition-specific
Researchers
986
Distinct authors in sample
Gene link
—
Readiness
2/6
Stages with a signal
Clinical definition (Orphanet)
A rare intoxication due to a medical product occurring as a result of accidental or intentional overdosing of paracetamol (acetaminophen). Patients may develop gastroenteritis within hours and hepatotoxicity within 24 to 72 hours after ingestion, potentially leading to acute liver injury and liver failure. Possible non-hepatic sequelae include renal failure, thrombocytopenia, pancreatitis, and subendocardial myocyte necrosis. Chronic paracetamol poisoning may be asymptomatic or include all signs and symptoms potentially occurring in acute poisoning.
How rare: 1-5 / 10 000 — about one to five people per ten thousand (still uncommon, but less ultra-rare).
Cross-references
Joined from Mondo / Orphanet. MeSH labels may enter searches; UMLS / OMIM / NCIT are stored for reference.
Additional Mondo synonyms (1)
acetaminophen poisoning
Research stages
Trial readiness signals
Where this condition sits on an open-data research pipeline — not how close a treatment is, and not medical advice. Empty stages often mean “not in these databases under this Mondo ID,” not “impossible.”
2/6 stages with a signal
An interventional trial matched this condition name on ClinicalTrials.gov — see trials below.
- Gene identifiedNot found
No GenCC disease–gene assertion in this build
- LiteraturePresent
2,014 matched papers (679 in last 10 years) Source
- Phenotype characterisedNot found
No HPO disease–phenotype associations via Monarch for these Mondo IDs
- Animal modelNot found
No Alliance genotype “model of” associations via Monarch for these Mondo IDs
- Orphan designationNot found
No FDA or EMA orphan-drug designation matched this disease via UMLS or preferred name Source
- Interventional trialPresent
3 matched on ClinicalTrials.gov
Biology
Genes and phenotypes
Gene–disease validity from GenCC, plus phenotypes and animal models joined from Monarch Initiative via Mondo ID — not a clinical diagnosis aid.
Do we know what causes it?
Not yet — the cause hasn't been pinned down in GenCC.
No strong gene–disease assertion joined for this Orphanet entity.
Phenotypes (Monarch / HPO)
None returned for this Mondo ID. That often means “not linked under this ID,” not “no clinical features.”
Animal models (Monarch / Alliance)
None returned for this Mondo ID. Empty here is not proof that no model organism work exists under another name or gene.
Monarch fetch 2026-07-29
Therapies
Designations, candidates, and chemicals
FDA OOPD and EMA orphan designations, Open Targets clinical candidates, and CTD chemical associations via MyDisease.info. These never change the interventional-trial headline.
Orphan designation (FDA · EMA)
No designation matched this disease via UMLS or preferred name on the FDA OOPD mirror or EMA orphan register. Absence here is not proof that none exists under another wording.
Open Targets candidates
No drugs or clinical candidates returned for this Mondo ID on Open Targets.
CTD chemicals (MyDisease.info)
No CTD chemical associations returned for this Mondo ID.
Literature
Is anyone studying this?
2,014
2,014 papers have been published on this condition. That is a real research literature — still far smaller than common diseases (breast cancer: over 700,000 papers). Median papers in the last 10 years for a rare disease in this dataset (publications denominator n=3967) is 59.
2,014 papers since the earliest indexed year in this search — median last-10-year count for a rare disease in this dataset is 59 (publications denominator n=3967).
679 in the last 10 years · high confidence · 85.6th percentile (publications denominator)
Phrase hits: 2,014 · MeSH hits: 0
Who's working on it?
986
Distinct author names in 200 sampled papers — named people below.
Who's working on it?
People publishing on this condition (sampled Europe PMC records). Affiliation is the most recent found in that sample.
- 01Buckley NA7 papers · 2026
NSW Poisons Information Centre, Children's Hospital at Westmead, Sydney, NSW.
Papers in Europe PMC - 02Mullins ME7 papers · 2026
Section of Medical Toxicology, Department of Emergency Medicine, Washington University School of Medicine, St. Louis, Missouri, USA.
Papers in Europe PMC - 03Chiew AL6 papers · 2026
Prince of Wales Hospital and Community Health Services, Sydney, NSW.
Papers in Europe PMC - 04Dear JW6 papers · 2026
Centre for Cardiovascular Science, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.
Papers in Europe PMC - 05Mehrpour O5 papers · 2026
Medical Toxicology and Drug Abuse Research Center (MTDRC), Birjand University of Medical Sciences (BUMS), Birjand, Iran. omid.mehrpour@yahoo.com.au.
Papers in Europe PMC - 06Sturkenboom MGG5 papers · 2026
Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Papers in Europe PMC - 07Bateman DN4 papers · 2025
Clinical Toxicology, Pharmacology and Toxicology, Queen's Medical Research Institute, University of Edinburgh, UK.
Papers in Europe PMC - 08Cairns R4 papers · 2026
School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.
Papers in Europe PMC - 09Noghrehchi F4 papers · 2026
School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.
Papers in Europe PMC - 10Wong A4 papers · 2025
Victorian Poisons Information Centre, Austin Hospital, Melbourne, VIC.
Papers in Europe PMC
Clinical research
Is a treatment being tested?
3
interventional trials for this specific condition
3 interventional trials matched this specific condition name; none in our sample are currently recruiting. 119 trials are registered for poisoning, the broader category — shown separately because they may or may not enrol this specific subtype.
Data as of 11 September 2026
3 interventional trials — more than 77.2% of diseases in the trials denominator have none at all (5501 of 7126; this disease is at the 86.7th percentile).
high confidence · 86.7th percentile (trials denominator)
Recruiting interventional trials
From the matched ClinicalTrials.gov set
3 interventional trials matched after quoted-phrase search and title/condition post-filter.
No currently recruiting studies in the matched set. Open the same search on ClinicalTrials.gov.
Broader category: poisoning
119
Interventional trials for the parent category, exclusive of NCT IDs already counted above. Eligibility for this subtype is not guaranteed.
Worth raising with a clinician. How we count trials.
Recruiting under the broader category
- NCT06811675·RECRUITING·The Efficacy of Dexamethasone in Combination With N-acetylcysteine in Preventing Neurocognitive Sequelae Due to Carbon Monoxide Poisoning
Not reviewed·Conditions: Carbon Monoxide Poisoning · Delayed Neurocognitive Sequelae·Matched via name phrase
- NCT07103356·RECRUITING·Table-Top Water Pitcher to Reduce Arsenic Exposure Among Well Users in New Hampshire
Not reviewed·Conditions: Arsenic Poisoning · Environmental Exposure · Water-Related Diseases·Matched via name phrase
- NCT07234383·NOT YET RECRUITING·Accelerated HEmodiafiltration in Severe Acute Diquat (AHEAD) Poisoning
Not reviewed·Conditions: Diquat Poisoning·Matched via name phrase
- NCT07201311·RECRUITING·Combined Gastrointestinal Decontamination in Acute Severe Poisoning
Not reviewed·Conditions: Severe Poisoning With Cardiotropic or Psychotropic Drug · Admission to Intensive Care·Matched via name phrase
- NCT07459166·RECRUITING·A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade
Not reviewed·Conditions: Fentanyl Overdose · Fentanyl Poisoning·Matched via name phrase
- NCT04499885·RECRUITING·Potential Role of Gastric Lavage by Paraffin Oil in Acute Aluminum Phosphide Poisoning
Not reviewed·Conditions: Toxicity, Drug·Matched via name phrase
- NCT06574048·NOT YET RECRUITING·Carbon Monoxide Hyperbaric Oxygen With Steroid Therapy
Not reviewed·Conditions: Carbon Monoxide Poisoning · Carbon Monoxide Intoxication · Carbon Monoxide Encephalopathy · Carbon Monoxide-induced Parkinsonism·Matched via name phrase
- NCT05471479·RECRUITING·Activated CHARcoal in Poisoned Patient - Pilot Trial
Not reviewed·Conditions: Charcoal, Decontamination, Poisoning·Matched via name phrase
- NCT07632937·NOT YET RECRUITING·A Study to Assess the Efficacy of Public Health Campaigns in Reducing Lead Exposure
Not reviewed·Conditions: Lead Poisoning · Environmental Exposure·Matched via name phrase
- NCT06966765·NOT YET RECRUITING·Accelerated vs Standard Approach to Continuous Veno-venous Hemodiafiltration Post-hemoperfusion (ASAP) in Severe Acute Diquat Poisoning
Not reviewed·Conditions: Diquat Poisoning·Matched via name phrase
Observational and natural-history studies
1 observational study matches this condition. These do not test a treatment and are not counted in the interventional-trial headline, but they are genuine research: natural-history work often defines the endpoints needed for a future rare-disease trial, and families may be able to enroll.
None of the matched observational studies is currently listed as recruiting.
Other registries (secondary)
Broader net from EU CTIS, ISRCTN, and ICTRP when available — deduped against ClinicalTrials.gov IDs already counted above. Dual-model LLM relevance gates what we keep. These rows are not added to the interventional headline.
raw 26 · after dedupe 20 · already on CT.gov 0 · kept 0 · parent 0 · uncertain 20 · dropped 0 · fetched 2026-07-30
Source notes: ictrp: Error: ICTRP public search unavailable (WHO portal is SPA-only; SOAP needs partnership). Tried: https://apps.who.int/tri
No secondary-registry studies passed dual-model relevance for this condition name (after dedupe).
Uncertain / not reviewed (20)
- isrctn·ISRCTN49789010·Recruiting·Investigating topical steroid withdrawal: a newly recognised medical condition
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN10739567·No longer recruiting·A study in healthy volunteers to compare a new test medicine to an already marketed medicine when injected into the veins
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN11180128·Recruiting·Capsaicin 8% patch treatment in non-freezing cold injury (NFCI)
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN17516192·Recruiting·A trial of normal versus higher dose acetylcysteine in patients with paracetamol overdose
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN11484200·No longer recruiting·Developing a new test for liver injury after taking too much paracetamol
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN12637839·No longer recruiting·Cell therapy for acute liver injury trial
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN62968791·No longer recruiting·A programme to develop a skin patch containing two medicines (physostigmine and hyoscine), Study 8: Assessment of effects of consecutive 24-hour applications of patches for 21 days on the blood levels of the two medicines and any associated symptoms in healthy male and female participants
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN14813929·No longer recruiting·Pain control in older patients with rib fractures: A randomised feasibility trial of lidocaine patches
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN78730348·No longer recruiting·A study of the blood levels of physostigmine and hyoscine and associated symptoms following intravenous administration in healthy male and female participants.
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN10362655·No longer recruiting·A study of a skin patch containing two medicines (physostigmine and hyoscine) in healthy male participants to assess the blood levels of the two medicines and any associated symptoms.
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN16719542·No longer recruiting·The ASSERT (Acute Sacral inSufficiEncy fractuRe augmenTation) study
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN82948372·No longer recruiting·Study comparing a regional leg block vs. local anaesthetic infiltration for leg donor sites in burns patients - pain scores and analgesic requirements
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN42875603·No longer recruiting·Clinical trial to evaluate the safety and efficacy of a diclofenac epolamine (DHEP) plaster in minor soft tissue injuries
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN29470876·No longer recruiting·Phase III trial of diclofenac sodium medicated plaster in patients with fresh injuries of the limbs
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN73983810·No longer recruiting·Evaluation of primary hospital educational intervention
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN46653818·No longer recruiting·Femoral nerve blockade in hip fracture patients
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN94738550·No longer recruiting·Cost-effectiveness analysis of oral paracetamol and ibuprofen for treating pain after soft tissue limb injuries: double-blind, randomised controlled trial
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN20156397·No longer recruiting·N-AcetylCysteine as anti-oxidative treatment in severe malaria
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN40657638·No longer recruiting·A prospective study to evaluate the effect of the Molecular Adsorbent Recirculating System (MARS®) for patients with acute liver failure
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN91790322·No longer recruiting·Altitude Sickness in Climbers and Efficacy of Non-steroidal anti-inflammatory drugs (NSAIDs) Trial
skipped — LLM skipped (--skip-llm)
Where to find support
Condition-specific patient organisations, when Orphanet lists them, are on the disease’s Orphanet page. We also link umbrella groups that support undiagnosed and ultra-rare families.
Orphanet entry for Paracetamol poisoning — check Associations / patient organisations on that page.
India — NPRD
Last verified 2026-07-26This ORPHAcode is not on our curated NPRD list (direct or Mondo-parent match). That does not decide clinical eligibility; families in India should ask a notified Centre of Excellence about current coverage.
Hand-curated for this project. ORPHAcode mappings are best-effort and may be incomplete or imprecise for umbrella categories. Parent (Mondo) matches mean the policy lists a broader category — confirm eligibility with a Centre of Excellence. Financial entitlements summarised from public policy statements and may change. This is not official government guidance.
How we counted this
Europe PMC query (preferred label + any corrected label + Orphanet and Mondo exact synonyms, stoplisted; unioned with resolved MeSH labels when available). UMLS / OMIM / NCIT cross-references are stored on the overview but are not added to the query string.
"Paracetamol poisoning" OR "Acetaminophen poisoning"
ClinicalTrials.gov query (quoted phrases + MeSH via query.cond, plus recall-expansion terms when used):
"Paracetamol poisoning" OR "Acetaminophen poisoning"
Interventional trials matched via: phrase (mesh = registered under a MeSH descriptor no name phrase would catch; recall-expansion = gene / selected parent terms used only for trials).
Study-type breakdown: 3 interventional · 1 observational · 0 expanded access. Only interventional studies enter the trial headline.
Parent-category trials query:
"poisoning"
Query health: ok — strategies attempted: phrase; with hits: phrase
Run this search on ClinicalTrials.gov
Confidence reasoning
- Preferred label is multi-word and distinctive
- No synonyms dropped by stoplist
- No label/synonym collisions with other diseases in this corpus
Ingested 2026-07-27T16:56:32.603Z
