Mirtazapine — $0 on Listed Strengths

Related medications

Other medications associated with the same conditions in this catalog.

Also listed for Major Depressive Disorder

• Citalopram
• Bupropion
• Duloxetine
• Escitalopram
• Fluoxetine
• Paroxetine
• Sertraline
• Trazodone

Other medications in Mental Health

• Molindone
• Naltrexone
• Nefazodone
• Nortriptyline
• Olanzapine
• Paliperidone
• Perphenazine
• Phenelzine

What Mirtazapine is approved for (FDA label)

Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)] . Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults. (1)

Source: Read the full FDA label on DailyMed. Label effective date: September 16, 2026.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Boxed warning for Mirtazapine (FDA label)

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1)] . Mirtazapine tablets are not approved for use in pediatric patients [see Use in Specific Populations (8.4)]. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Increased risk of suicidal thoughts and behavior in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. Mirtazapine tablets are not approved for use in pediatric patients. (5.1, 8.4)

Source: FDA prescribing information (DailyMed). Set ID: 63f140c2-2a18-4dea-96fe-2658dda28a0c. SPL document ID: 65d56a7a-38e7-4132-96d0-d568757472e4. Label effective date: September 16, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Mirtazapine (FDA label)

Mirtazapine Tablets, USP are supplied as: 7.5 mg tablets: Yellow colored, round, biconvex film-coated tablets debossed with “886” on one side and “N” on the other side, free from physical defects 15 mg tablets: Yellow colored, oblong, biconvex film-coated tablets, functionally scored on one side and debossed with “N 887” on the other side, free from physical defects 30 mg tablets: Brown colored, oblong, biconvex film-coated tablets, functionally scored on one side and debossed with “N 888” on the other side, free from physical defects 45 mg tablets: White to off white colored, oblong, biconvex film-coated tablets debossed with “N 889” on one side and plain on the other side, free from physical defects Tablets : 7.5 mg unscored, 15 mg functionally scored, 30 mg functionally scored and 45 mg unscored. (3)

Source: FDA prescribing information (DailyMed). Set ID: 63f140c2-2a18-4dea-96fe-2658dda28a0c. SPL document ID: 65d56a7a-38e7-4132-96d0-d568757472e4. Label effective date: September 16, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Mirtazapine (FDA label)

The following adverse reactions are described in more detail in other sections of the prescribing information: Hypersensitivity [see Contraindications (4)] Suicidal Thoughts and Behaviors [see Warnings and Precautions (5.1)] Agranulocytosis [see Warnings and Precautions (5.2)] Serotonin Syndrome [see Contraindications (4), Warnings and Precautions (5.3), Drug Interactions (7)] Angle-Closure Glaucoma [see Warnings and Precautions (5.4)] QT Prolongation and Torsades de Pointes [see Warnings and Precautions (5.5)] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions (5.6)] Increased Appetite and Weight Gain [see Warnings and Precautions (5.7)] Somnolence [see Warnings and Precautions (5.8)] Activation of Mania or Hypomania [see Warnings and Precautions (5.9)] Seizures [see Warnings and Precautions (5.10)] Elevated Cholesterol and Triglycerides [see Warnings and Precautions (5.11)] Hyponatremia [see Warnings and Precautions (5.12)] Transaminase Elevations [see Warnings and Precautions (5.13)] Discontinuation Syndrome [see Warnings and Precautions (5.14)] Use in Patients with Concomitant Illness [see Warnings and Precautions (5.15)] Most common adverse reactions (≥5% or greater and twice placebo) were somnolence, increased appetite, weight gain, and dizziness. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Source: FDA prescribing information (DailyMed). Set ID: 63f140c2-2a18-4dea-96fe-2658dda28a0c. SPL document ID: 65d56a7a-38e7-4132-96d0-d568757472e4. Label effective date: September 16, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Mirtazapine (FDA label)

Mirtazapine tablets are contraindicated in patients: Taking, or within 14 days of stopping, MAOIs (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.3), Drug Interactions (7)] . With a known hypersensitivity to mirtazapine or to any of the excipients in mirtazapine tablets . Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome, bullous dermatitis, erythema multiforme and toxic epidermal necrolysis have been reported following the use of mirtazapine tablets [see Warnings and Precautions (5.6), Adverse Reactions (6.2)]. Concomitant use of monoamine oxidase inhibitors (MAOIs) or use within 14 days of stopping MAOIs. (2.4, 4, 7) Known hypersensitivity to mirtazapine or any of the excipients in mirtazapine tablets. (4)

Source: FDA prescribing information (DailyMed). Set ID: 63f140c2-2a18-4dea-96fe-2658dda28a0c. SPL document ID: 65d56a7a-38e7-4132-96d0-d568757472e4. Label effective date: September 16, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Mirtazapine (FDA label)

Agranulocytosis : If sore throat, fever, stomatitis or signs of infection occur, along with a low white blood cell count, treatment with mirtazapine tablets should be discontinued and the patient should be closely monitored. (5.2) Serotonin Syndrome : Increased risk when co-administered with other serotonergic drugs (e.g., SSRI, SNRI, triptans), but also when taken alone. If it occurs, discontinue mirtazapine tablets and initiate supportive treatment. (2.4, 4, 5.3, 7) Angle-Closure Glaucoma : Angle closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants. (5.4) QT Prolongation : Use mirtazapine tablets with caution in patients with risk factors for QT prolongation. (5.5, 7) Drug Reaction with Eosinophilia and System Symptoms (DRESS) : Discontinue mirtazapine tablets if DRESS is suspected. (5.6) Increased Appetite/Weight Gain : Mirtazapine tablets have been associated with increased appetite and weight gain. (5.7) Somnolence : May impair judgment, thinking and/or motor skills.

Source: FDA prescribing information (DailyMed). Set ID: 63f140c2-2a18-4dea-96fe-2658dda28a0c. SPL document ID: 65d56a7a-38e7-4132-96d0-d568757472e4. Label effective date: September 16, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Mirtazapine (FDA label)

Table 5 includes clinically important drug interactions with mirtazapine tablets [see Clinical Pharmacology (12.3)]. Table 5: Clinically Important Drug Interactions with Mirtazapine Tablets Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact The concomitant use of serotonergic drugs, including mirtazapine tablets, and MAOIs increases the risk of serotonin syndrome. Intervention Mirtazapine tablets are contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Dosage and Administration (2.4), Contraindications (4), Warnings and Precautions (5.3)]. Examples selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Other Serotonergic Drugs Clinical Impact The concomitant use of serotonergic drugs with mirtazapine tablets increases the risk of serotonin syndrome. Intervention Monitor patients for signs and symptoms of serotonin syndrome, particularly during treatment initiation and dosage increases. If serotonin syndrome occurs, consider discontinuation of mirtazapine tablets and/or concomitant serotonergic drugs [see Warnings and Precautions (5.3)]. Examples SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, amphetamines, St.

Source: FDA prescribing information (DailyMed). Set ID: 63f140c2-2a18-4dea-96fe-2658dda28a0c. SPL document ID: 65d56a7a-38e7-4132-96d0-d568757472e4. Label effective date: September 16, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.