Mirtazapine
Mirtazapine is an antidepressant used to treat major depressive disorder (MDD), available as regular tablets and orally disintegrating tablets that melt on the tongue.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 102 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Mirtazapine is an antidepressant for major depressive disorder in adults. It blocks alpha-2 receptors (nerve-cell docking sites) to boost norepinephrine and serotonin, and it is a familiar alternative to the usual first-choice antidepressants, on the market since about 1996 and available generically, often chosen when depression comes with poor sleep and appetite. It also blocks histamine, so most people find it tolerable but notice heavy sleepiness, a bigger appetite and weight gain. Its boxed warning covers suicidal thoughts and behaviors in people 24 and younger, so watch for worsening mood or new suicidal thinking, especially early on. Take it in the evening, skip alcohol, and never stop it suddenly.
Clinical pearls
- Fever, sore throat or mouth sores need prompt attention, since mirtazapine rarely causes a dangerously low white blood cell count.
- Never combine it with an MAOI, including linezolid or IV methylene blue, or start it within 14 days of one.
- If you take warfarin, expect extra INR (clotting test) checks when mirtazapine starts, since it may raise your INR.
- Weight gain can come with higher cholesterol and triglycerides, so those blood fats are worth checking over time.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Antidepressants, including mirtazapine, can increase suicidal thoughts and behaviors in children, teens, and young adults (age 24 and younger). This was seen in short-term studies, with the highest risk in people treated for depression.
Anyone starting an antidepressant should be closely watched for worsening depression or new suicidal thoughts or behaviors, especially at the start or after dose changes. Contact the prescriber right away if these appear. Mirtazapine orally disintegrating tablets are not approved for pediatric patients.
Patient information guide A plain-language walkthrough of Mirtazapine, written from its FDA label.
What Mirtazapine is used for
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Mirtazapine is used for one main condition across its supported products.
- Major depressive disorder (MDD) in adults: approved for mirtazapine tablets, mirtazapine orally disintegrating tablets, Remeron, and RemeronSolTab.
- Studies showed benefit in six-week trials and maintained response for up to 40 weeks in one trial.
How Mirtazapine works
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The exact way mirtazapine treats depression is unclear. It blocks alpha-2 adrenergic receptors on nerve cells, which may boost norepinephrine and serotonin activity in the brain.
It also blocks histamine, serotonin 5-HT2 and 5-HT3, and other receptors, which may explain effects like sleepiness and dizziness on standing.
Mirtazapine dosage
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Mirtazapine is taken by mouth once a day, preferably in the evening before sleep. Food has minimal effect on absorption.
- Your prescriber may adjust the dose, but not more often than every 1 to 2 weeks.
- Orally disintegrating tablets go on the tongue, dissolve without chewing, and should be used right after removal from the package.
- Don't stop suddenly. The dose should be reduced gradually.
Follow your prescriber's directions and the label.
Dosing details from the FDA-approved label
From the Mirtazapine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Major depressive disorder (initial treatment)
- Starting dose 15 mg once daily, administered orally, preferably in the evening prior to sleep
- If no adequate response to the initial 15 mg dose, increase the dose
- Dose changes should not be made in intervals of less than 1 to 2 weeks
- Maximum: 45 mg per day
- Mirtazapine orally disintegrating tablets: place the whole tablet on the tongue immediately after removal from the blister pack, do not split
- Elderly patients and patients with renal or hepatic impairment
- No specific regimen stated
- Clearance of mirtazapine is reduced in elderly patients and in patients with moderate to severe renal or hepatic impairment, so plasma levels may be increased
- Prescriber should be aware plasma mirtazapine levels may be increased compared to younger adults without impairment
- Maintenance/extended treatment
- Efficacy maintained for periods of up to 40 weeks following 8 to 12 weeks of initial treatment at a dose of 15 to 45 mg/day
- It is unknown whether the maintenance dose is identical to the dose needed for initial response
- Periodically reassess need for maintenance treatment and appropriate dose
- Discontinuation of treatment
- A gradual reduction in the dose over several weeks, rather than abrupt cessation, is recommended whenever possible
- Monitor for symptoms upon discontinuation or dose reduction
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION • Starting dose: 15 mg once daily; may increase up to maximum recommended dose of 45 mg once daily. ( 2.1 ) • Administer orally once daily, preferably in the evening prior to sleep. ( 2.1 ) • Administer mirtazapine orally disintegrating tablets immediately after removal from blister pack or container pack. ( 2.2 ) • Reduce dose gradually when discontinuing mirtazapine orally disintegrating tablets. ( 2.6 , 5.14 ) 2.1 Recommended Dosage The recommended starting dose of mirtazapine orally disintegrating tablets is 15 mg once daily, administered orally, preferably in the evening prior to sleep. If patients do not have an adequate response to the initial 15 mg dose, increase the dose up to a maximum of 45 mg per day. Dose changes should not be made in intervals of less than 1 to 2 weeks to allow sufficient time for evaluation of response to a given dose [see Clinical Pharmacology (12.3) ]. 2.2 Administration of Mirtazapine Orally Disintegrating Tablets • The tablet should remain in the blister pack or container pack until the patient is ready to take it. • The patient or caregiver should use dry hands to open the blister or container. • As soon as the blister or container is opened, the tablet should be removed and placed on the patient’s tongue. • Use mirtazapine orally disintegrating tablets immediately after removal from its blister or container; once removed, it cannot be stored. • The whole tablet should be placed on the tongue and allowed to disintegrate without chewing or crushing. Do not attempt to split the tablet. • The tablet will disintegrate in saliva so that it can be swallowed. 2.3 Screen for Bipolar Disorder Prior to Starting Mirtazapine Orally Disintegrating Tablets Prior to initiating treatment with mirtazapine orally disintegrating tablets or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions (5.9) ]. 2.4 Switching Patients to or from a Monoamine Oxidase Inhibitor Antidepressant At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of mirtazapine orally disintegrating tablets.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Mirtazapine side effects
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The most common side effects in studies were:
Common side effects
- Sleepiness (very common)
- Increased appetite
- Weight gain
- Dizziness
- Dry mouth
- Constipation
- Weakness or tiredness (asthenia)
- Abnormal dreams
When to get medical help
- Call right away for new or worsening depression, suicidal thoughts, unusual behavior changes, agitation, or anxiety.
- Get help for sore throat, fever, mouth sores or signs of infection, which can signal a dangerously low white blood cell count (agranulocytosis).
- Seek help for signs of serotonin syndrome (a dangerous buildup of serotonin), especially if you take other serotonin-affecting medicines.
- Stop the medicine and get help for a severe skin rash or reaction, including DRESS, Stevens-Johnson syndrome, or peeling skin.
- Report fast or irregular heartbeat or fainting, which could reflect QT prolongation (a heart rhythm problem).
- Tell your doctor about eye pain or vision changes, which can signal angle-closure glaucoma.
- Report seizures, or signs of mania such as unusual elevated mood or very little need for sleep.
- Report symptoms of low sodium (hyponatremia), and of liver problems, since liver enzyme elevations have occurred.
Mirtazapine warnings and precautions
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- Suicidal thoughts and behaviors (boxed warning) in people 24 and younger.
- Agranulocytosis: low white blood cells, with sore throat, fever, or infection.
- Serotonin syndrome, even when taken alone.
- Angle-closure glaucoma in people with narrow angles.
- QT prolongation and Torsades de Pointes.
- Severe skin reactions, including DRESS.
- Weight gain, higher cholesterol and triglycerides.
- Sleepiness affecting driving and alertness.
- Mania or hypomania; seizures; low sodium; raised liver enzymes.
- Discontinuation symptoms if stopped abruptly.
Mirtazapine interactions
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Several medicines and substances can interact with mirtazapine.
- MAOIs (including linezolid and IV methylene blue): contraindicated because of serotonin syndrome risk.
- Other serotonergic drugs (SSRIs, SNRIs, triptans, tramadol, St. John's Wort): raise serotonin syndrome risk.
- Alcohol and benzodiazepines: add to mental and motor impairment.
- CYP3A inducers (carbamazepine, phenytoin, rifampin): lower mirtazapine levels.
- CYP3A inhibitors and cimetidine: raise mirtazapine levels.
- QT-prolonging drugs: raise heart rhythm risk.
- Warfarin: may increase INR.
Interactions listed in the FDA-approved label
From the Mirtazapine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Monoamine oxidase inhibitors (MAOIs), including linezolid and intravenous methylene blue (e.g., selegiline, tranylcypromine, isocarboxazid, phenelzine): Concomitant use of serotonergic drugs, including mirtazapine, and MAOIs increases the risk of serotonin syndrome. Contraindicated in patients taking MAOIs; at least 14 days should elapse between stopping an MAOI and starting mirtazapine, and at least 14 days after stopping mirtazapine before starting an MAOI.
- Other serotonergic drugs (SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, amphetamines, St. John's Wort, tramadol, tryptophan, buspirone): Concomitant use increases the risk of serotonin syndrome. Monitor for signs and symptoms of serotonin syndrome, particularly during treatment initiation and dosage increases; if it occurs, consider discontinuing mirtazapine and/or the concomitant serotonergic drugs.
- Strong CYP3A inducers (phenytoin, carbamazepine, rifampin): Decrease the plasma concentration of mirtazapine. Increase the mirtazapine dose if needed; a decrease in dosage may be needed if the CYP3A inducer is discontinued.
- Strong CYP3A inhibitors (itraconazole, ritonavir, nefazodone): May increase the plasma concentration of mirtazapine. Decrease the mirtazapine dose if needed; an increase in dosage may be needed if the CYP3A inhibitor is discontinued.
- Cimetidine: Cimetidine, a CYP1A2, CYP2D6, and CYP3A inhibitor, may increase the plasma concentration of mirtazapine. Decrease the mirtazapine dose if needed; an increase in dosage may be needed if cimetidine is discontinued.
- Benzodiazepines and alcohol (diazepam, alprazolam, alcohol): Increase the impairment of cognitive and motor skills produced by mirtazapine alone. Avoid concomitant use.
- Drugs that prolong the QTc interval: Increase the risk of QT prolongation and/or ventricular arrhythmias (e.g., Torsades de Pointes). Use caution when using mirtazapine concomitantly with drugs that prolong the QTc interval.
- Warfarin: Concomitant use may result in an increase in INR. Monitor INR during concomitant use.
Read the label’s full interactions text
7 DRUG INTERACTIONS Table 5 includes clinically important drug interactions with mirtazapine orally disintegrating tablets [see Clinical Pharmacology (12.3) ]. Table 5: Clinically Important Drug Interactions with Mirtazapine Orally Disintegrating Tablets Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact The concomitant use of serotonergic drugs, including mirtazapine orally disintegrating tablets, and MAOIs increases the risk of serotonin syndrome. Intervention Mirtazapine orally disintegrating 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 orally disintegrating tablets increase 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 orally disintegrating tablets and/or concomitant serotonergic drugs [see Warnings and Precautions (5.3) ]. 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 mirtazapine orally disintegrating tablets decrease the plasma concentration of mirtazapine [see Clinical Pharmacology (12.3) ] . Intervention Increase the dose of mirtazapine orally disintegrating tablets if needed with concomitant CYP3A inducer use. Conversely, a decrease in dosage of mirtazapine orally disintegrating tablets may be needed if the CYP3A inducer is discontinued [see Dosage and Administration (2.5) ].
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Mirtazapine
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- Don't use with an MAOI or within 14 days of stopping one.
- Don't use if allergic to mirtazapine or its ingredients.
- Screen for bipolar disorder history first.
- Use caution with seizures, glaucoma risk, heart rhythm risks, or liver disease.
- Kidney or liver impairment may require a lower dose.
- Not established for children; safety and effectiveness were not shown in pediatric trials.
- Older adults need caution and a conservative dose.
- Pregnancy: no reliable risk of birth defects has been identified, but discuss with your doctor; a pregnancy registry exists.
- Breastfeeding: low levels pass into milk, with no adverse effects reported in most cases.
- Orally disintegrating tablets contain phenylalanine.
Mirtazapine overdose
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Overdose has caused disorientation, drowsiness, impaired memory, and fast heartbeat. Serious outcomes, including deaths, have been reported, especially with mixed overdoses, along with QT prolongation. There is no specific antidote, so contact Poison Control at 1-800-222-1222.
What Mirtazapine does in the body
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Mirtazapine blocks alpha-2 adrenergic receptors and serotonin 5-HT2 and 5-HT3 receptors. It also blocks histamine H1, peripheral alpha-1, and muscarinic receptors. The H1 effect likely explains the prominent sleepiness, and alpha-1 blockade likely explains dizziness on standing. At a dose above the maximum recommended, it did not prolong the QTc interval meaningfully in healthy people.
How your body processes Mirtazapine
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About half of an oral dose reaches the bloodstream, with peak levels in about 2 hours. Steady levels build within about 5 days, and the half-life is roughly 20 to 40 hours. It is heavily processed by the liver and cleared mostly in urine (75%) and feces (15%). Clearance is lower in older adults, women's half-lives are longer, and kidney impairment slows clearance.
How to store Mirtazapine
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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.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Mirtazapine
212 supplements and herbal products have documented interactions with Mirtazapine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 4
- Moderate · 162
- Minor · 46
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Nutrient depletion considerations
Mirtazapine has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
Mirtazapine: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Mirtazapine — the kind of thing our pharmacy team would talk through with you at the counter.
What is mirtazapine used for?
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When should I take it, and does food matter?
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What side effects should I expect?
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Can I drink alcohol or take other medicines with it?
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Is it safe for teens or young adults?
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Can I stop it when I feel better?
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Is Mirtazapine available over the counter?
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When was Mirtazapine first available?
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Who makes Mirtazapine?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Mirtazapine on HelloPharmacist
Mirtazapine forms and strengths (how it comes)
Mirtazapine is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Mirtazapine tablets are used to treat major depressive disorder in adults.
- Remeron is used to treat major depressive disorder in adults.
- Mirtazapine tablets are taken by mouth once daily, preferably in the evening before sleep.
- Remeron is taken by mouth once daily, preferably in the evening before sleep.
- Mirtazapine tablets: the dose should be lowered gradually when stopping.
Orally disintegrating tablet
How this form is used
- Mirtazapine orally disintegrating tablets are used to treat major depressive disorder in adults.
- RemeronSolTab is used to treat major depressive disorder in adults.
- Mirtazapine orally disintegrating tablets: keep in the blister or container pack until ready to use, and open with dry hands.
- RemeronSolTab: take the tablet out right before use, as it cannot be stored once removed.
- Mirtazapine orally disintegrating tablets: place the whole tablet on the tongue and let it dissolve; do not chew, crush, or split it.
- Mirtazapine orally disintegrating tablets contain phenylalanine, which matters for people with phenylketonuria.
Mirtazapine on the U.S. market: products, makers and brands
How Mirtazapine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
37 companies list 144 Mirtazapine product records with the FDA, mostly as tablet, orally disintegrating tablet; the earliest marketing or approval year on record is 1996. Brand names on the directory include Remeron, Remeron SolTab, Mirataz and 1 more; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (14) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Mirtazapine is used (Medicaid data)
A general measure of how commonly Mirtazapine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Mirtazapine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Mirtazapine prescribed? Of the 1,601 medications we measure, Mirtazapine ranks #86 by Medicaid prescriptions — more than 95% of them.
Utilization by Mirtazapine product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
mirtazapine 15 MG Oral Tablet Most dispensed
Summed across the 19 of 148 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 311725
mirtazapine 30 MG Oral Tablet
Summed across the 15 of 135 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 314111
mirtazapine 7.5 MG Oral Tablet
Summed across the 10 of 45 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 476809
mirtazapine 45 MG Oral Tablet
Summed across the 11 of 63 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 311726
mirtazapine 15 MG Disintegrating Oral Tablet
Summed across the 3 of 14 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 283406
mirtazapine 30 MG Disintegrating Oral Tablet
Summed across the 3 of 15 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 283407
mirtazapine 45 MG Disintegrating Oral Tablet
Summed across the 3 of 16 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 283485
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Mirtazapine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 64 of 436 listed Mirtazapine NDCs with Medicaid activity.
Compare Mirtazapine products
A representative set of FDA-listed product records for Mirtazapine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 7.5 mg | Oral | A-S Medication Solutions | ANDA | View NDC → |
| 15 mg | Oral | A-S Medication Solutions × 2 listings | ANDA | View NDC → |
| 30 mg | Oral | A-S Medication Solutions × 2 listings | ANDA | View NDC → |
| 15 mg | Oral | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | View NDC → |
| 7.5 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 15 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 30 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 45 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 7.5 mg | Oral | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 15 mg | Oral | Aphena Pharma Solutions - Tennessee, LLC × 4 listings | ANDA | View NDC → |
| 30 mg | Oral | Aphena Pharma Solutions - Tennessee, LLC × 5 listings | ANDA | View NDC → |
| 15 mg | Oral | Apotex Corp. | ANDA | View NDC → |
| 30 mg | Oral | Apotex Corp. | ANDA | View NDC → |
| 45 mg | Oral | Apotex Corp. | ANDA | View NDC → |
| 7.5 mg | Oral | Atlantic Biologicals Corp. | ANDA | View NDC → |
| 7.5 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 15 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 30 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 45 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 7.5 mg | Oral | Aurolife Pharma LLC | ANDA | View NDC → |
| 15 mg | Oral | Aurolife Pharma LLC | ANDA | View NDC → |
| 30 mg | Oral | Aurolife Pharma LLC | ANDA | View NDC → |
| 45 mg | Oral | Aurolife Pharma LLC | ANDA | View NDC → |
| 7.5 mg | Oral | AvKARE | ANDA | View NDC → |
| 30 mg | Oral | AvKARE | ANDA | View NDC → |
| 7.5 mg | Oral | Bryant Ranch Prepack × 4 listings | ANDA | View NDC → |
| 15 mg | Oral | Bryant Ranch Prepack × 6 listings | ANDA | View NDC → |
| 30 mg | Oral | Bryant Ranch Prepack × 5 listings | ANDA | View NDC → |
| 45 mg | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 7.5 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 15 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 30 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 45 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 15 mg | Oral | Cardinal Health 107, LLC × 3 listings | ANDA | View NDC → |
| 7.5 mg | Oral | Coupler LLC | ANDA | View NDC → |
| 15 mg | Oral | Coupler LLC × 2 listings | ANDA | View NDC → |
| 30 mg | Oral | Coupler LLC × 2 listings | ANDA | View NDC → |
| 45 mg | Oral | Coupler LLC | ANDA | View NDC → |
| 15 mg | Oral | Direct_Rx | ANDA | View NDC → |
| 30 mg | Oral | Direct_Rx | ANDA | View NDC → |
| 15 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 30 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 45 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 15 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 15 mg | Oral | McKesson Corporation dba SKY Packaging | ANDA | View NDC → |
| 30 mg | Oral | McKesson Corporation dba SKY Packaging | ANDA | View NDC → |
| 15 mg | Oral | Mylan Institutional Inc. | ANDA | View NDC → |
| 30 mg | Oral | Mylan Institutional Inc. | ANDA | View NDC → |
| 45 mg | Oral | Mylan Institutional Inc. | ANDA | View NDC → |
| 15 mg | Oral | Mylan Pharmaceuticals Inc. | ANDA | View NDC → |
| 30 mg | Oral | Mylan Pharmaceuticals Inc. | ANDA | View NDC → |
| 45 mg | Oral | Mylan Pharmaceuticals Inc. | ANDA | View NDC → |
| 15 mg | Oral | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | View NDC → |
| 30 mg | Oral | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | View NDC → |
| 7.5 mg | Oral | NCS HealthCare of KY, LLC dba Vangard Labs × 2 listings | ANDA | View NDC → |
| 7.5 mg | Oral | NorthStar Rx LLC | ANDA | View NDC → |
| 15 mg | Oral | NuCare Pharmaceuticals,Inc. | ANDA | View NDC → |
| 30 mg | Oral | NuCare Pharmaceuticals,Inc. × 2 listings | ANDA | View NDC → |
| 15 mg | Oral | Organon LLC | NDA | View NDC → |
| 30 mg | Oral | Organon LLC | NDA | View NDC → |
| 7.5 mg | Oral | Prasco Laboratories | ANDA | View NDC → |
| 15 mg | Oral | Prasco Laboratories | ANDA | View NDC → |
| 30 mg | Oral | Prasco Laboratories | ANDA | View NDC → |
| 45 mg | Oral | Prasco Laboratories | ANDA | View NDC → |
| 15 mg | Oral | Preferred Pharmaceuticals Inc. | ANDA | View NDC → |
| 30 mg | Oral | Preferred Pharmaceuticals Inc. | ANDA | View NDC → |
| 45 mg | Oral | Preferred Pharmaceuticals Inc. | ANDA | View NDC → |
| 15 mg | Oral | Proficient Rx LP × 2 listings | ANDA | View NDC → |
| 30 mg | Oral | Proficient Rx LP | ANDA | View NDC → |
| 45 mg | Oral | Proficient Rx LP | ANDA | View NDC → |
| 30 mg | Oral | Remedyrepack Inc. | ANDA | View NDC → |
| 7.5 mg | Oral | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 15 mg | Oral | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 30 mg | Oral | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 45 mg | Oral | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
Showing 104 of 144 products — FDA National Drug Code Directory. See every product, package size and price: browse all 144 Mirtazapine NDCs →
Mirtazapine side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Mirtazapine — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Mirtazapine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Mirtazapine FDA approval history
How Mirtazapine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Mirtazapine recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Mirtazapine recalls since July 2021.
✅No Mirtazapine recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 15996 3 dose forms · 8 strengths
-
Dose form (SCDF) Disintegrating Oral Tablet RxCUI 378442In current FDA listings -
Dose form (SCDF) Oral Tablet RxCUI 378384In current FDA listings -
Dose form (SCDF) Topical Ointment RxCUI 2049250No current FDA listingClinical drug / strength (SCD) 0.02 MG/MGRxCUI 2049251
Look up RxCUI 15996 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Mirtazapine supply and shortage status
Whether Mirtazapine is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Mirtazapine costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet, Film Coated · Oral | 15 mg | $0.063 per tablet | NDC details & price history |
| Tablet, Film Coated · Oral | 30 mg | $0.089 per tablet | NDC details & price history |
| Tablet, Film Coated · Oral | 45 mg | $0.111 per tablet | NDC details & price history |
| Tablet, Orally Disintegrating · Oral | 30 mg | $0.423 per tablet | NDC details & price history |
| Tablet, Orally Disintegrating · Oral | 45 mg | $0.408 per tablet | NDC details & price history |
| Tablet · Oral | 30 mg | $0.087–$0.089 per tablet | NDC details & price history |
| Tablet · Oral | 15 mg | $0.063 per tablet | NDC details & price history |
| Tablet · Oral | 45 mg | $0.111 per tablet | NDC details & price history |
| Tablet, Film Coated | 45 mg | $0.111 per tablet | NDC details & price history |
| Tablet, Orally Disintegrating | 15 mg | $0.314 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Mirtazapine brand names
Mirtazapine is sold under 4 brand names in the FDA directory — Remeron, Remeron SolTab, Mirataz, Remeronsoltab. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Mirtazapine: manufacturers and labelers
37 companies list Mirtazapine products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, Aphena Pharma Solutions - Tennessee, LLC, Remedyrepack Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
…and 13 more on the FDA NDC directory.
Mirtazapine drug class (RxNorm)
Mirtazapine belongs to the Other antidepressants class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Mirtazapine page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Organon LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →