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MIRTAZAPINE
DIR Classification
Classification:Most-DIQT concern
Severity Score:4.0
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- WARNINGS AND PRECAUTIONS
- QT Prolongation and Torsades de Pointes
- The effect of mirtazapine on QTc interval was assessed in a clinical randomized trial with placebo and positive (moxifloxacin) controls involving 54 healthy volunteers using exposure response analysis. This trial showed a positive relationship between mirtazapine concentrations and prolongation of the QTc interval. However, the degree of QT prolongation observed with both 45 mg and 75 mg (1.67 times the maximum recommended daily dose) doses of mirtazapine was not at a level generally considered to be clinically meaningful. During postmarketing use of mirtazapine, cases of QT prolongation, Torsades de Pointes, ventricular tachycardia, and sudden death, have been reported [see ADVERSE REACTIONS (6.1, 6.2)]. The majority of reports occurred in association with overdose or in patients with other risk factors for QT prolongation, including concomitant use of QTc-prolonging medicines [see DRUG INTERACTIONS (7) and OVERDOSAGE (10)]. Exercise caution when mirtazapine is prescribed in patients with known cardiovascular disease or family history of QT prolongation, and in concomitant use with other drugs thought to prolong the QTc interval.
- DRUG INTERACTIONS
- OVERDOSAGE
- Human Experience
- Based on postmarketing reports, serious outcomes (including fatalities) may occur at dosages higher than the recommended doses, especially with mixed overdoses. In these cases, QT prolongation and Torsades de Pointes have also been reported [see WARNINGS AND PRECAUTIONS (5.5), ADVERSE REACTIONS (6.2), and DRUG INTERACTIONS (7)].
- ADVERSE REACTIONS
- The following adverse reactions are described in more detail in other sections of the prescribing information:
- QT Prolongation and Torsades de Pointes [see WARNINGS AND PRECAUTIONS (5.5)]
- CLINICAL PHARMACOLOGY
- Pharmacodynamics
- Cardiac Electrophysiology
- The effect of mirtazapine on QTc interval was assessed in healthy subjects. At a dose of 75 mg (1.67 times the maximum recommended dosage), mirtazapine does not prolong the QTc interval to a clinically meaningful extent.
- [Pharmacokinetics]
- QTc-Prolonging Drugs
- The risk of QT prolongation and/or ventricular arrhythmias (e.g., Torsades de Pointes) may be increased with concomitant use of medicines which prolong the QTc interval (e.g., some antipsychotics and antibiotics) and in mirtazapine overdose [see WARNINGS AND PRECAUTIONS (5.5), ADVERSE REACTIONS (6.1, 6.2), Drug Interactions (7), and Overdosage (10)].
- PATIENT COUNSELING INFORMATION
- QTc Prolongation and Torsades de Pointes
- Inform patients to consult their physician immediately if they feel faint, lose consciousness, or have heart palpitations [see WARNINGS AND PRECAUTIONS (5.5), DRUG INTERACTIONS (7), OVERDOSAGE (10)]. Advise patients to inform physicians that they are taking mirtazapine before any new drug is taken.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
QT Prolongation
233
23859
Other ADRs
49142
38332445
Odds Ratio = 7.618
Drug Property Information
ATC Code(s):
- N06AX11 - mirtazapine
- N06AX - Other antidepressants
- N06A - ANTIDEPRESSANTS
- N06 - PSYCHOANALEPTICS
- N - NERVOUS SYSTEM
Active Ingredient:MIRTAZAPINE
Active Ingredient UNII:A051Q2099Q
Drugbank ID:DB00370
PubChem Compound:4205
CTD ID:D000078785
PharmGKB:PA450522
CAS Number:85650-52-8
Dosage Form(s):tablet, film coated
Route(s) Of Administrator:oral
Daily Dose:
- 30.0 mg/day N06AX11
Chemical Structure: 
SMILE Code:
CN1CCN2C(C1)C1=CC=CC=C1CC1=C2N=CC=C1
CN1CCN2C(C1)C1=CC=CC=C1CC1=C2N=CC=C1
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