Prescription medicine
Mirtazapine Brand names: Remeronsoltab, Remeron
Mirtazapine (Remeron) is a prescription medicine with an FDA approval on record since 1996. FDA's NDC Directory lists it from 36 generic labelers, and pharmacies paid $0.063 per mirtazapine 15 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the mirtazapine FDA label on DailyMed (effective August 6, 2025, Organon LLC); the NDA 20415 record on Drugs@FDA; every mirtazapine label on DailyMed.
Highlights of the record
FDA label of August 6, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
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) ]. REMERON/REMERONSolTab is 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. REMERON/REMERONSolTab is not approved for use in pediatric patients.
Used for
From the label: indications and usageREMERON/REMERONSolTab are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14) ].
Forms and strengths
- 7.5 mg
- 15 mg
- 30 mg
- 45 mg
Film-coated tablet; orally disintegrating tablet; tablet.
On the market
- Earliest approval on file
- June 14, 1996 Remeron, Organon; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 24 first January 24, 2003; 12 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 37 of which 36 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.063 per tablet Mirtazapine 15 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 5 since 2013 2 Class I among all firms' recalls; latest March 18, 2020; 2 more by firms not listed as its makers
- FAERS reports
- 91,057 through July 30, 2026
What is mirtazapine used for?
From the label: indications and usageREMERON/REMERONSolTab are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14) ]. REMERON/REMERONSolTab is indicated for the treatment of major depressive disorder (MDD) in adults.
Conditions named in the indications of mirtazapine's FDA labels, with every medicine labeled for each:
Source: FDA drug label (REMERON), Organon LLC, effective August 6, 2025 (SPL set 98ad1917-a094-44f5-a28f-a64a8cfcd887), via openFDA; the full label on DailyMed
What does the patient leaflet for mirtazapine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about REMERON and REMERONSolTab?REMERON and REMERONSolTab may cause serious side effects, including: Increased risk of suicidal thoughts or actions in some children and young adults. REMERON, REMERONSolTab, and other antidepressant medicines may increase suicidal thoughts or actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. REMERON and REMERONSolTab are not for use in children. Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. How can I watch for and try to prevent suicidal thoughts and actions? Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the dose is changed. Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms. Call your healthcare provider or get emergency medical help right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you: attempts to commit suicide acting aggressive, being angry or violent new or worse depression panic attacks new or worse irritability an extreme increase in activity or talking (mania) acting on dangerous impulses thoughts about suicide or dying new or worse anxiety feeling very agitated or restless trouble sleeping other unusual changes in behavior or mood
From the patient leaflet: What should I avoid while taking REMERON and REMERONSolTab?Do not drive, operate heavy machinery, or do other dangerous activities until you know how REMERON and REMERONSolTab affects you. REMERON and REMERONSolTab can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. Avoid drinking alcohol during treatment with REMERON and REMERONSolTab. Avoid taking medicines used to treat anxiety, insomnia, and seizures, called benzodiazepines, during treatment with REMERON and REMERONSolTab. Ask your healthcare provider if you are not sure if you take one of these medicines.
From the patient leaflet: How should I store REMERON and REMERONSolTab?Store REMERON and REMERONSolTab at room temperature between 68°F to 77°F (20°C to 25°C). Keep REMERON and REMERONSolTab away from light and moisture. Keep REMERON, REMERONSolTab, and all medicines out of the reach of children.
Source: FDA drug label (REMERON), Organon LLC, effective August 6, 2025 (SPL set 98ad1917-a094-44f5-a28f-a64a8cfcd887), via openFDA; the full label on DailyMed
Is there a generic for mirtazapine (Remeron)?
The FDA approved the first generic mirtazapine on January 24, 2003. 24 generic applications are approved; 12 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists mirtazapine from 36 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1996 earliest approval on file
- 2003 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for mirtazapine (Remeron)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.063 per Mirtazapine 15 mg tablet, down 12% from $0.0712 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Mirtazapine 15 mg tablet (generic)
- Remeron 15 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Mirtazapine 15 mg ODT | Generic | $0.314 per unit | n/a | -14% |
| Mirtazapine 15 mg tablet | Generic | $0.063 per tablet | $1.89 | -12% |
| Mirtazapine 30 mg ODT | Generic | $0.423 per unit | n/a | +3% |
| Mirtazapine 30 mg tablet | Generic | $0.0885 per tablet | $2.66 | -1% |
| Mirtazapine 45 mg ODT | Generic | $0.408 per unit | n/a | -18% |
| Mirtazapine 45 mg tablet | Generic | $0.111 per tablet | $3.33 | -4% |
| Mirtazapine 7.5 mg tablet | Generic | $0.349 per tablet | $10.46 | -7% |
| Remeron 15 mg tablet | Brand | $6.36 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $190.89 | +3% |
| Remeron 30 mg tablet | Brand | $6.67 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $200.19 | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has mirtazapine been recalled?
The FDA's Enforcement Report lists 7 recalls naming mirtazapine since 2013: 2 Class I (the most serious), 5 Class II, 0 Class III; 0 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of mirtazapine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 18, 2020 | Class II | Aurobindo Pharma USA Inc. | CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed |
| November 20, 2019 | Class I | AuroMedics Pharma LLC | Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets … |
| January 27, 2017 | Class II | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) | Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled |
| January 19, 2017 | Class II | Mylan Pharmaceuticals Inc. | Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling:Label Mixup; MIRTAZAPINE Tablet, 7.5 mg may be potentially mislabeled as BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg, NDC 00574010603, Pedigree … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling:Label Mixup; MIRTAZAPINE Tablet, 7.5 mg may be potentially mislabeled as ISONIAZID, Tablet, 300 mg, NDC 00555007102, Pedigree: W003691, EXP: 6/26/2014. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the mirtazapine label say about other medicines?
The mirtazapine label names 21 other medicines in its interaction, contraindication or warning sections. The labels of 33 other medicines name mirtazapine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Alprazolam | drug interactions | Examples; diazepam, alprazolam, alcohol |
| Buspirone | drug interactions | Examples SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, amphetamines, St. John's Wort, tramadol, tryptophan, buspirone Strong CYP3A Inducers Clinical Impact The concomitant use of strong CYP3A inducers with REMERON/REMERONSolTab decreases the plasma concentration of mirtazapine [see Clinical … |
| Carbamazepine | drug interactions | Examples; phenytoin, carbamazepine, rifampin |
| Cimetidine | drug interactions | Clinical Impact; The concomitant use of cimetidine, a CYP1A2, CYP2D6, and CYP3A inhibitor, with REMERON/REMERONSolTab may increase the plasma concentration of mirtazapine [see ]. |
| Diazepam | drug interactions | Examples; diazepam, alprazolam, alcohol |
| Fentanyl | drug interactions | Examples SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, amphetamines, St. John's Wort, tramadol, tryptophan, buspirone Strong CYP3A Inducers Clinical Impact The concomitant use of strong CYP3A inducers with REMERON/REMERONSolTab decreases the plasma concentration of mirtazapine [see Clinical … |
| Isocarboxazid | drug interactions | Examples; selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue |
| Itraconazole | drug interactions | Examples; itraconazole, ritonavir, nefazodone |
| Linezolid | contraindications | 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 [see Warnings and Precautions (5.3), Drug Interactions (7) ]. |
| Lithium | drug interactions | Examples SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, amphetamines, St. John's Wort, tramadol, tryptophan, buspirone Strong CYP3A Inducers Clinical Impact The concomitant use of strong CYP3A inducers with REMERON/REMERONSolTab decreases the plasma concentration of mirtazapine [see Clinical … |
| Methylene blue | contraindications | 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 [see Warnings and Precautions (5.3), Drug Interactions (7) ]. |
| Moxifloxacin | warnings and precautions | Prolongation and Torsades de Pointes The effect of REMERON (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. |
| Nefazodone | drug interactions | Examples; itraconazole, ritonavir, nefazodone |
| Phenelzine | drug interactions | Examples; selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue |
Every other medicine the mirtazapine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Phenytoin | drug interactions | Examples; phenytoin, carbamazepine, rifampin |
| Rifampin | drug interactions | Examples; phenytoin, carbamazepine, rifampin |
| Ritonavir | drug interactions | Examples; itraconazole, ritonavir, nefazodone |
| Selegiline | drug interactions | Examples; selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue |
| Tramadol | drug interactions | Examples SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, amphetamines, St. John's Wort, tramadol, tryptophan, buspirone Strong CYP3A Inducers Clinical Impact The concomitant use … |
| Tranylcypromine | drug interactions | Examples; selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue |
| Warfarin | drug interactions | Clinical Impact; The concomitant use of warfarin with REMERON/REMERONSolTab may result in an increase in INR [see ]. |
Other labels that name mirtazapine
Source: FDA drug label (REMERON), Organon LLC, effective August 6, 2025 (SPL set 98ad1917-a094-44f5-a28f-a64a8cfcd887), via openFDA; the full label on DailyMed
What do FAERS reports show for mirtazapine?
The FDA Adverse Event Reporting System holds 91,057 reports that list mirtazapine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 13,998 are coded as a death and 37,233 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as mirtazapine?
30 other medicines are given the same way (oral) and in the same FDA class as mirtazapine or labeled mainly for the same use (depression), the same class first. Depression lists all 37 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Bupropion | Depression | 73 labelers | $0.0785 per tablet 150 mg tablet | No current entry |
| Venlafaxine | Depression | 62 labelers | $0.0799 per capsule 75 mg capsule | No current entry |
| Aripiprazole | Depression | 47 labelers | $0.110 per tablet 5 mg tablet | No current entry |
| Fluoxetine | Depression | 59 labelers | $0.0519 per capsule 40 mg capsule | No current entry |
| Sertraline | Depression | 48 labelers | $0.0507 per tablet 100 mg tablet | No current entry |
| Amitriptyline | Depression | 36 labelers | $0.03 per tablet 10 mg tablet | No current entry |
| Duloxetine | Depression | 45 labelers | $0.102 per capsule 30 mg capsule | No current entry |
| Doxepin | Depression | 48 labelers | $0.0779 per capsule 10 mg capsule | No current entry |
Every medicine labeled for the same conditions as mirtazapine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does mirtazapine compare with medicines for the same use?
14 side-by-side pages set mirtazapine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to mirtazapine
- 30 medicines for the same use
- Mirtazapine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other