Uses
REMERON/REMERONSolTab are indicated for the treatment of major depressive disorder (MDD) in adults. REMERON/REMERONSolTab is indicated for the treatment of major depressive disorder (MDD) in adults.
Source: US FDA prescribing information
- Presentations
- 12
- Brands
- 2
- Manufacturers
- 1
- Available from stock
- 0
Mirtazapine is a prescription medicine indicated for the treatment of major depressive disorder (MDD) in adults. It is available as tablets and orally disintegrating tablets. MedsAcross supplies Mirtazapine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Key facts
- ATC classification
- N06AX11 Mirtazapine · Antidepressant, subgroup N06AX
- US FDA first approval
- 14 June 1996
- EU status
- Not recorded
- Orphan designation
- Not recorded
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Routes
- Oral
- Dosage forms
- Tablet, Orally disintegrating tablet
- Identifiers
- UNII A051Q2099QRxCUI 15996CAS 85650-52-8DrugBank DB00370Q421930
Clinical information
From the regulator-approved product information. Each section names its source.
How it works
The mechanism of action of mirtazapine for the treatment of major depressive disorder, is unclear. However, its efficacy could be mediated through its activity as an antagonist at central presynaptic α 2 -adrenergic inhibitory autoreceptors and heteroreceptors and enhancing central noradrenergic and serotonergic activity.
Source: US FDA prescribing information
Dosing overview
Starting dose: 15-mg once daily, may increase up to maximum recommended dose of 45 mg once daily. Administer orally once daily, preferably in the evening prior to sleep. Administer REMERONSolTab immediately after removal from blister pack. Reduce dose gradually when discontinuing REMERON/REMERONSolTab.
Source: US FDA prescribing information
Contraindications
REMERON/REMERONSolTab is 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. With a known hypersensitivity to mirtazapine or to any of the excipients in REMERON/REMERONSolTab. 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 REMERON/REMERONSolTab. Concomitant use of monoamine oxidase inhibitors (MAOIs) or use within 14 days of stopping MAOIs.
Source: US FDA prescribing information
Warnings and precautions
Boxed 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. REMERON/REMERONSolTab is not approved for use in pediatric patients. Agranulocytosis: If sore throat, fever, stomatitis or signs of infection occur, along with a low white blood cell count, treatment with REMERON/REMERONSolTab should be discontinued and the patient should be closely monitored. 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 REMERON/REMERONSolTab and initiate supportive treatment.
Source: US FDA prescribing information
Side effects
The following adverse reactions are described in more detail in other sections of the prescribing information: Hypersensitivity Suicidal Thoughts and Behaviors Agranulocytosis Serotonin Syndrome Angle-Closure Glaucoma QT Prolongation and Torsades de Pointes Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Increased Appetite and Weight Gain Somnolence Activation of Mania or Hypomania Seizures Elevated Cholesterol and Triglycerides Hyponatremia Transaminase Elevations Discontinuation Syndrome Use in Patients with Concomitant Illness Most common adverse reactions (≥5% or greater and twice placebo) were somnolence, increased appetite, weight gain, and dizziness.
Source: US FDA prescribing information
Interactions
Table 5 includes clinically important drug interactions with REMERON/REMERONSolTab. Table 5: Clinically Important Drug Interactions with REMERON/REMERONSolTab Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact The concomitant use of serotonergic drugs, including REMERON/REMERONSolTab, and MAOIs increases the risk of serotonin syndrome. Intervention REMERON/REMERONSolTab is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue. Examples selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Other Serotonergic Drugs Clinical Impact The concomitant use of serotonergic drugs with REMERON/REMERONSolTab increases the risk of serotonin syndrome. Intervention Monitor patients for signs and symptoms of serotonin syndrome, particularly during treatment initiation and dosage increases.
Source: US FDA prescribing information
Storage
Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Box of 5 × 6-unit dose blister packs/30 count 78206-158-01 45 mg White, round tablet " T 4 Z " debossed on one side Box of 5 × 6-unit dose blister packs/30 count 78206-159-01 Storage Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light and moisture.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
All presentations
12 presentations of Mirtazapine, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Mirtazapine 15 mg tabletOralGeneric name | — | US FDA | Available on request |
| Mirtazapine 30 mg tabletOralGeneric name | — | US FDA | Available on request |
| Mirtazapine 45 mg tabletOralGeneric name | — | US FDA | Available on request |
| Mirtazapine 7.5 mg tabletOralGeneric name | — | US FDA | Available on request |
| Mirtazapine 30 mg orally disintegrating tabletOralGeneric name | — | US FDA | Available on request |
| Mirtazapine 15 mg orally disintegrating tabletOralGeneric name | — | US FDA | Available on request |
| Mirtazapine 45 mg orally disintegrating tabletOralGeneric name | — | US FDA | Available on request |
| Remeron 15 mg tabletOral | Organon | US FDA | Available on request |
| Remeron 30 mg tabletOral | Organon | US FDA | Available on request |
| Remeronsoltab 15 mg orally disintegrating tabletOral | Organon | US FDA | Available on request |
| Remeronsoltab 30 mg orally disintegrating tabletOral | Organon | US FDA | Available on request |
| Remeronsoltab 45 mg orally disintegrating tabletOral | Organon | US FDA | Available on request |
Brands by market
2 brand names across 1 markets.
United States
Manufacturers
Regulatory status
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 14 June 1996 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions
Conditions linked to Mirtazapine in public data. This is not a list of approved uses, see the clinical information.
Questions and answers
Is Mirtazapine available for export from India?
Yes, on request. MedsAcross lists 12 presentations of Mirtazapine and sources them for licensed hospitals, importers and physicians against valid import documents.
What brand names does Mirtazapine have?
The catalogue lists 2 brand names for Mirtazapine, including Remeron, Remeronsoltab.
Is Mirtazapine approved by the US FDA?
Yes. The US FDA first approved Mirtazapine on 14 June 1996, according to Drugs@FDA.
Does Mirtazapine need cold chain shipping?
No listed presentation of Mirtazapine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Which ATC class is Mirtazapine in?
Mirtazapine is classified under ATC code N06AX11 (Mirtazapine).
References
- REMERONSOLTAB prescribing information (Organon). U.S. National Library of Medicine, DailyMed. Retrieved 6 August 2025
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