Regulatory record

Regulatory recordSupporting passage inspected

The DEA reports that the FDA has never approved clenbuterol for human use in the United States under the Federal Food, Drug and Cosmetic Act. The only current FDA-approved clenbuterol product is a veterinary syrup for airway obstruction in horses; outside the United States, some countries permit clenbuterol prescriptions for human bronchial asthma.[7]

Jurisdiction
United States
Product
Clenbuterol (all human-use products)
Indication
No FDA-approved human indication; approved only as a veterinary bronchodilator (Ventipulmin Syrup) for airway obstruction in horses (1998)
Record date
2026-09-08
  • A US enforcement-agency fact sheet describing regulatory/control status; it does not itself establish clinical safety or efficacy for any population.
  • Other countries' prescribing practices are described narratively and in general terms in this source, not verified jurisdiction-by-jurisdiction.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· Added from a freshly inspected DEA fact sheet to state clenbuterol's US regulatory status precisely, addressing a named batch research priority (clenbuterol is not an approved human drug in the US). Independent editorial review pending; no qualified clinical review.

Safety findings

Case reportAbstract inspected

A confirmed clenbuterol-poisoning case described prolonged tachycardia with low potassium, phosphate and magnesium. Symptoms persisted after the measured drug level became undetectable.[1]

  • A poisoning case demonstrates a possible clinical presentation, not its frequency or a safe exposure threshold.
  • Abstract-checked; no qualified clinical review.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· Independent source inspection; applicability narrowed and inherited assertions excluded where unsupported. No qualified clinical review.

· Independently reopened the PubMed abstract via NCBI E-utilities. Confirmed exactly: 28-year-old woman, oral ingestion, sustained sinus tachycardia 140/min, hypokalemia 2.4 mEq/L, hypophosphatemia 0.9 mg/dL, hypomagnesemia 1.52 mg/dL; symptomatic more than 20 hours; serum clenbuterol 2.93 microg/L at 3 hours, undetectable at 20 hours while still symptomatic. Europe PMC confirms this record is not open access; full text remains unobtained. No correction needed to the claim text; no qualified clinical review.

Interaction evidence

Regulatory recordSupporting passage inspected

CYTOMEL labeling states that sympathomimetics may increase the effects of thyroid hormone or sympathomimetics; coronary insufficiency is a particular concern in coronary artery disease.[2]

  • A drug-class label warning for oral liothyronine; not a clinical trial of each selected pair.
  • Caffeine, phenylpiracetam and all products tagged “stimulant” cannot automatically be treated as equivalent.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· Supporting passages inspected, scope corrected and legacy assertions reassessed; no clinician review performed.

· Independently reopened every cited source afresh on 2026-09-09 (interaction batch, fresh deep-research pass); disposition and wording reconfirmed against the live sources, not carried over from the prior pass. No qualified clinical review.

Mechanistic inferenceSupporting passage inspected

FDA warns that people who “stack” steroid-like bodybuilding products with other products, including stimulants, may be at greater risk for serious and life-threatening reactions. This broad warning does not establish the effect or severity of an individual compound pair.[3]

  • This evidence does not establish the magnitude or frequency of harm from the selected combination.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· Supporting passages inspected, scope corrected and legacy assertions reassessed; no clinician review performed.

· Independently reopened every cited source afresh on 2026-09-09 (interaction batch, fresh deep-research pass); disposition and wording reconfirmed against the live sources, not carried over from the prior pass. No qualified clinical review.

Mechanistic inferenceAbstract inspected

FARESTON labeling warns about QT prolongation and low potassium, and lists specific drug classes known to prolong QT; clenbuterol and other beta2-agonists are not among the named classes. A clenbuterol overdose report documented marked hypokalemia and arrhythmias in a patient not using AAS. A combined risk is plausible, but no toremifene-clenbuterol interaction was directly measured.[4][5]

  • This evidence does not establish the magnitude or frequency of harm from the selected combination.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· Supporting passages inspected, scope corrected and legacy assertions reassessed; no clinician review performed.

· Independently reopened every cited source afresh on 2026-09-09 (interaction batch, fresh deep-research pass); disposition and wording reconfirmed against the live sources, not carried over from the prior pass. No qualified clinical review.

Case reportAbstract inspected

DNP and clenbuterol were analytically detected in a fatal case. The authors considered DNP-related hyperthermia the likely cause; the case cannot isolate an additional drug-pair effect.[6]

  • One forensic case; this is documented coexposure, not a demonstrated causal interaction.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· Supporting passages inspected, scope corrected and legacy assertions reassessed; no clinician review performed.

· Independently reopened every cited source afresh on 2026-09-09 (interaction batch, fresh deep-research pass); disposition and wording reconfirmed against the live sources, not carried over from the prior pass. No qualified clinical review.

What remains unresolved

Editorial assessment

These notes describe the scope of this review. Linked PMIDs are audit identifiers; an identifier alone does not verify a claim.

Narrowly supported passages published with study/product limits; remaining inherited assertions withheld from established-fact displays.

  • Not a comprehensive systematic review. Original monograph topics beyond the individual published claims—including monitoring schedules, contraindication lists, recovery assurances and detailed mechanisms—remain unverified.
  • No qualified clinician has reviewed these claims. Long-term outcomes and all marketed formulations have not been fully assessed.

This reference does not supply a dosing plan, monitoring timetable or recovery regimen. Discuss personal symptoms, medicines and laboratory results with a qualified clinician.

Explore the interaction evidence for this compound →

References

  1. Clenbuterol ingestion causing prolonged tachycardia, hypokalemia, and hypophosphatemia with confirmation by quantitative levels.

    2001. PMID:11527226 Abstract only.

    Inspected location: PubMed abstract: Case report: confirmed exposure, electrolyte abnormalities, tachycardia and persistence after undetectable serum level

    Study context and inspection record
  2. CYTOMEL (liothyronine sodium) prescribing information

    2025-04. Product label.

    Inspected location: Boxed warning; sections 5.5, 7.2 and 7.7

    Study context and inspection record
  3. FDA: Caution - Bodybuilding Products Can Be Risky

    undated. Regulatory document.

    Inspected location: Opening paragraphs; adverse-reaction lists; "stacking" paragraph naming stimulants; "What to Do"; footer "Content current as of: 09/20/2024"

    Study context and inspection record
  4. FARESTON (toremifene) prescribing information

    2024-10. Product label.

    Inspected location: Boxed warning; sections 4.2, 5.1 and 7.2

    Study context and inspection record
  5. Acute clenbuterol overdose resulting in supraventricular tachycardia and atrial fibrillation

    2007-06. PMID:18072161 Abstract only.

    Inspected location: PubMed abstract; publication types and CommentsCorrections in NLM EFetch XML

    Study context and inspection record
  6. Death of an apprentice bodybuilder following 2,4-dinitrophenol and clenbuterol intake

    2020-05. PMID:32125503 Abstract only.

    Inspected location: PubMed abstract; publication types and CommentsCorrections in NLM EFetch XML

    Study context and inspection record
  7. DEA Diversion Control Division: Clenbuterol drug and chemical evaluation

    2026-01. Regulatory document.

    Inspected location: Introduction; Licit Uses; Control Status

    Study context and inspection record

Source inspection and clinical review are separate. An abstract check is not a full-text review. The records above identify what was actually inspected and do not certify the complete literature.

Recorded verification attempts
  • Fresh PubMed EUtils retrieval for inherited lead PMID 11527226; identity, abstract and linked corrections checked where an abstract existed.
  • https://pubmed.ncbi.nlm.nih.gov/11527226/ — abstract; PubMed abstract: Case report: confirmed exposure, electrolyte abnormalities, tachycardia and persistence after undetectable serum level

View this compound in the research library →

Related records in this class

Grouped under Other compounds for navigation only. Shared class membership does not make findings, formulations or evidence interchangeable between records.

StackItSmart

Age confirmation

This reference discusses steroids, SARMs and other compounds. It is educational, not medical advice, and does not recommend using or combining them.

Your confirmation is saved in this browser when storage is available.