Partial
Partially Aligned
Patient Risk:
Moderate
Summary
Several statements are generally consistent with the label (indication for OCD, use by mouth, need for clinician-directed management, gradual titration rationale, and stopping without guidance). However, multiple assertions are either not supported by the provided label text (specific side effects, heart/blood pressure changes, cardiac conduction impact, dose timing/titration to reduce side effects, and seizure/serotonin/QT interaction specifics) or are only partially aligned/indirect relative to the provided labeling excerpts.
Category Scores
Accurate Statements
Tablet formulations of clomipramine are used for obsessive-compulsive disorder (OCD), including when symptoms are severe or persistent.
INDICATIONS AND USAGE: indicated for treatment of obsessions/compulsions in patients with OCD, with requirement that obsessions/compulsions cause marked distress, are time-consuming, or significantly interfere (severity/persistence concept supported).
Clomipramine is a tricyclic antidepressant (TCA).
Clomipramine tablets can reduce the intensity of obsessions and compulsions in OCD.
INDICATIONS AND USAGE: studies demonstrate mean reduction on YBOCS and decrement on NIMH-OC vs placebo.
Changes from clomipramine in OCD are typically noticed over time rather than immediately.
Clomipramine treatment for OCD is usually continued and adjusted based on response and tolerability.
INDICATIONS AND USAGE: for extended periods, physician should periodically reevaluate long-term usefulness; DOSAGE AND ADMINISTRATION concept of titration/adjustments supported (see steady-state and waiting 2–3 weeks after dosage change).
Clomipramine tablets are taken by mouth as directed by a clinician.
DOSAGE AND ADMINISTRATION provided as oral divided doses with meals; also patient instruction concept in Information for Patients (appropriate use counseling).
Whether clomipramine is actually prescribed for depression or anxiety conditions depends on the patient, local prescribing practices, and specific regulatory approvals in a given country.
Whether clomipramine is actually prescribed for depression or anxiety conditions depends on the patient, local prescribing practices, and specific regulatory approvals in a given country.
Patients should follow the prescribed schedule for clomipramine.
Information for Patients: counsel patients in appropriate use and instruct to alert prescriber if issues occur; also Medication Guide counseling.
Patients should not stop clomipramine abruptly without medical guidance.
Unsupported Statements
Clomipramine is a tricyclic antidepressant (TCA).
The provided labeling excerpts do not explicitly state it is a TCA.
Changes from clomipramine in OCD are typically noticed over time rather than immediately.
No timing-of-onset claim is supported by the provided label text excerpts.
Clomipramine may be discussed in relation to depression or anxiety conditions.
Provided label excerpts do not indicate depression/anxiety use indications.
Whether clomipramine is actually prescribed for depression or anxiety conditions depends on the patient, local prescribing practices, and specific regulatory approvals in a given country.
The provided label excerpts do not address or support this conditional discussion.
Dose timing and gradual titration of clomipramine can be used to reduce side effects.
The label supports divided doses with meals to reduce GI side effects and an initial titration goal to minimize side effects, but the provided statement is broader than the label (does not specify GI side effects).
Patients should not stop clomipramine abruptly without medical guidance.
No discontinuation/abrupt stopping instruction is present in the provided excerpts.
Common side effects of clomipramine can include dry mouth.
Adverse reactions section is empty in the provided label excerpts; dry mouth is not supported.
Common side effects of clomipramine can include constipation.
Adverse reactions section is empty in the provided label excerpts; constipation is not supported.
Common side effects of clomipramine can include blurred vision.
Adverse reactions section is empty in the provided label excerpts; blurred vision is not supported.
Common side effects of clomipramine can include drowsiness.
Adverse reactions section is empty in the provided label excerpts; drowsiness is not supported.
Common side effects of clomipramine can include dizziness.
Adverse reactions section is empty in the provided label excerpts; dizziness is not supported.
Common side effects of clomipramine can include weight changes.
Adverse reactions section is empty in the provided label excerpts; weight changes are not supported.
Clomipramine can cause changes in heart rate.
No cardiovascular adverse reaction details are present in the provided excerpts.
Clomipramine can cause changes in blood pressure.
No blood pressure adverse reaction details are present in the provided excerpts.
Clomipramine can impact cardiac conduction.
No cardiac conduction warning details are present in the provided excerpts.
Prescribers typically take careful history and may monitor for safety when using clomipramine due to effects on cardiac conduction.
No such monitoring/ cardiac conduction guidance is present in the provided excerpts.
Clomipramine interacts with other medicines.
The provided label excerpts do discuss interactions, but the statement is too generic to be a direct label-supported claim as provided; not enough specificity to score as accurate.
Clomipramine can increase risk in certain situations when combined with drugs that also affect serotonin.
The label excerpt supports serotonin syndrome risk with MAOIs and linezolid/IV methylene blue; the statement is broader than these specific contraindications.
Clomipramine can increase risk in certain situations when combined with drugs that affect heart rhythm.
No QT/heart-rhythm interaction content is present in the provided excerpts.
Clomipramine should not be started or changed without a clinician.
Generic clinician involvement is supported, but the specific 'should not be started or changed' instruction is not explicitly present in the provided excerpts.
Clomipramine should not be started or changed without a clinician especially if the patient takes other antidepressants.
No label excerpt addresses other antidepressants specifically.
Clomipramine should not be started or changed without a clinician especially if the patient takes migraine medicines (like triptans).
No label excerpt addresses triptans.
Clomipramine should not be started or changed without a clinician especially if the patient takes linezolid.
The label contraindicates starting Anafranil in patients treated with linezolid (provided), so this is partially supported; however the statement focuses on 'without clinician' rather than contraindication. Still counted as unsupported because the phrasing misaligns with label's explicit contraindication wording. (Also see interaction/contraindication scoring.)
Clomipramine should not be started or changed without a clinician especially if the patient takes lithium.
No label excerpt addresses lithium.
Clomipramine should not be started or changed without a clinician especially if the patient takes medications known to affect QT prolongation.
No label excerpt addresses QT-prolonging medications.
Contradictions
Low
AI Statement
Clomipramine is a tricyclic antidepressant (TCA).
Label Reference
No direct contradiction; however not supported by provided excerpts.
Low
AI Statement
Clomipramine interacts with other medicines.
Label Reference
The provided excerpts do not contradict; no direct label conflict.
Important Omissions
Contraindications: history of hypersensitivity to clomipramine/other TCAs; contraindication with MAOIs and within 14 days of stopping an MAOI; contraindication with linezolid or IV methylene blue; contraindication during acute recovery period after myocardial infarction.
Importance:
Moderate
Specific dosage constraints: divided doses with meals during initial titration; steady-state plasma levels may not be achieved until 2–3 weeks after dosage change; appropriateness of waiting 2–3 weeks between further dosage adjustments; maximum adult dose 250 mg/day and pediatric dosing limit 3 mg/kg (up to 200 mg).
Importance:
Moderate
Monitoring/safety warnings present in provided excerpts: seizure risk discussion and caution in patients with seizure history; antidepressant suicidality monitoring statement (though it appears in the excerpt as part of class warning).
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Moderate
Several interaction and adverse effect claims are unsupported by the provided labeling excerpts (e.g., QT/heart rhythm, serotonin risk broadly, specific 'common side effects', and cardiac conduction). While the label does contain specific contraindications (MAOIs, linezolid/IV methylene blue), the AI response includes additional, unsupported medication interaction claims and omits explicit contraindication details.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
Yes |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Medium |
Recommendation
Partially Aligned
Primary Issue
Multiple claims are not supported by the provided label excerpts, particularly regarding specific adverse reactions, cardiac effects/QT, and broader serotonin/interaction statements beyond the explicit contraindications listed.
Suggested Improvement
Restrict statements to the provided label text (OCD indication, divided dosing with meals, timing/steady-state after dosage changes, explicit contraindications: MAOIs/linezolid/IV methylene blue/acute MI recovery; and include seizure-related caution). Remove or rephrase unsupported 'common side effects' and unsupported QT/heart-rhythm/cardiac conduction claims unless corresponding label text is provided.