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Compound reference

Toremifene

Fareston

Ancillary compounds3 cited findingsClinical review: not reviewed

Safety findings

Human randomized studyAbstract inspected

A trial in men receiving androgen-deprivation therapy reported more venous thromboembolic events with toremifene than placebo (17 of 646, 2.6%, vs 7 of 638, 1.1%). This was a prostate-cancer population and does not provide a risk estimate for people using it for other purposes.[1]

  • Disease, age and background treatment differ from nonmedical use; this trial does not assess every product-label warning.
  • The same trial's primary endpoint (vertebral-fracture reduction) had a confidence interval crossing zero despite a reported P=0.05, a borderline result relevant to judging the trial's overall precision.
  • Abstract-checked; full paper not confirmed open access as of 2026-09-09. 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.

· Citation-coverage follow-up removed an incidental QT-warning assertion from the trial limitation. QT findings remain in the separately cited FARESTON-label claim; the trial result is unchanged.

· Reopened the abstract on 2026-09-09; verified the exact VTE numerators/denominators and added them to the claim text; flagged the trial's borderline primary-endpoint confidence interval as context for overall trial precision.

Regulatory recordSupporting passage inspected

FARESTON has a boxed warning for dose- and concentration-related QT prolongation, which can lead to serious arrhythmia (Torsade de pointes). The label identifies low potassium or magnesium, existing QT prolongation and interacting medicines as relevant concerns.[2]

  • Product-label warning; a documented class mechanism does not imply a clinically studied pair for every directory compound.
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.

· Reopened the current FDA label PDF on 2026-09-09 (Reference ID 5494543, supplement s018) and confirmed via Drugs@FDA that no newer supplement exists; added the Torsade de pointes detail from the boxed warning.

Interaction evidence

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.[3][4]

  • 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.

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. Toremifene to reduce fracture risk in men receiving androgen deprivation therapy for prostate cancer.

    2013-01. PMID:23234631 · DOI:10.1016/j.juro.2012.11.016 Abstract only.

    Inspected location: PubMed abstract: full Results (venous thromboembolic events: 7 of 638 placebo [1.1%] vs 17 of 646 toremifene [2.6%]; primary endpoint new vertebral fractures 4.9% placebo vs 2.5% toremifene, relative risk reduction 50%, 95% CI -1.5 to 75.0, P=0.05; BMD, bone-turnover-marker and lipid secondary endpoints) and Methods (646 toremifene/638 placebo, 2-year phase III)

    Study context and inspection record
  2. FARESTON toremifene: US prescribing information

    2024-12. NDA020497 Product label.

    Inspected location: Boxed warning: QT Prolongation (full text); Section 1 Indications and Usage (metastatic breast cancer, ER-positive or unknown, postmenopausal women); Section 5.1 Prolongation of the QT Interval (full text); Section 4.2 Contraindications

    Study context and inspection record
  3. 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
  4. 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

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 23234631; identity, abstract and linked corrections checked where an abstract existed.
  • https://pubmed.ncbi.nlm.nih.gov/23234631/ — abstract; PubMed abstract: Results: venous thromboembolic events; Methods: men receiving androgen deprivation for prostate cancer
  • https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020497s018lbl.pdf — label; Boxed warning; section 5.1

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Related records in this class

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

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