Prescription medication · Noradrenergic and Specific Serotonergic Antidepressant (NaSSA)
mirtazapine
Also sold as Remeron. Mirtazapine is used to treat major depressive disorder (MDD) in adults.
Data updated 2026-05-15
- 87,759
- FDA reportsOften reported
- 29
- InteractionsSeveral interactions
- 95% less
- Generic vs brandHuge savings
- $5.89
- Brand price (NADAC)
What the data shows
mirtazapine (Remeron) is a prescription Noradrenergic and Specific Serotonergic Antidepressant (NaSSA), more reported than most tracked drugs (87,759 FDA reports), whose generic costs a fraction of the brand (about 95% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
mirtazapine (Remeron) is a prescription Noradrenergic and Specific Serotonergic Antidepressant (NaSSA). Mirtazapine is used to treat major depressive disorder (MDD) in adults.
Mirtazapine is a medicine used to treat depression in adults. It can help improve your mood and energy levels.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$5.89/unit
Generic Price
$0.30/unit
Generic Savings
95%
Generic Available
Yes (7 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Mirtazapine is used to treat major depressive disorder (MDD) in adults.
Common side effects
Feeling sleepy, Increased appetite, Weight gain
Key warnings
Antidepressants may increase the risk of suicidal thoughts and behaviors in young adults.
The sections below are summarized in plain English from mirtazapine's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Mirtazapine works by affecting certain chemicals in the brain called neurotransmitters. It helps to increase the levels of norepinephrine and serotonin. These chemicals can help improve mood and reduce symptoms of depression.
Side Effects (from patient reports)
Based on 87,759 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for mirtazapine, by number of reports
- Nausea
Nausea
4,838 reports
- Fatigue
Fatigue
4,715 reports
- Fall
Fall
4,027 reports
- Diarrhoea
Diarrhoea
3,961 reports
- Toxicity To Various Agents
Toxicity To Various Agents
3,703 reports
- Anxiety
Anxiety
3,472 reports
- Dizziness
Dizziness
3,429 reports
- Dyspnoea
Dyspnoea
3,394 reports
- Death
Death
3,322 reports
- Drug Interaction
Drug Interaction
3,249 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for mirtazapine each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where mirtazapine sits
mirtazapine has more FDA adverse-event reports than 83% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is mirtazapine; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 87,759 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2003–2025.
Total Reports
87,759
Reports Mentioning Death
13,537
15.4% of reports — not proof of cause
Hospitalization Reports
36,013
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | NAUSEA | 4,838 |
| 2 | FATIGUE | 4,715 |
| 4 | FALL | 4,027 |
| 5 | DIARRHOEA | 3,961 |
| 7 | TOXICITY TO VARIOUS AGENTS | 3,703 |
| 8 | ANXIETY | 3,472 |
| 9 | DIZZINESS | 3,429 |
| 10 | DYSPNOEA | 3,394 |
| 11 | DEATH | 3,322 |
| 12 | DRUG INTERACTION | 3,249 |
| 13 | DEPRESSION | 3,210 |
| 14 | VOMITING | 3,192 |
| 15 | HEADACHE | 3,058 |
| 16 | SOMNOLENCE | 2,993 |
| 17 | ASTHENIA | 2,911 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Antidepressants may increase the risk of suicidal thoughts and behaviors in young adults. Your doctor should closely watch you for worsening depression or suicidal thoughts. Mirtazapine is not approved for use in children.
Known Drug Interactions
Intervention Mirtazapine is 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 increases the risk of serotonin syndrome.
Mechanism: Linezolid blocks the breakdown of a brain chemical called serotonin, and adding mirtazapine can cause levels to become dangerously high.
Examples diazepam, alprazolam, alcohol Drugs that Prolong QTc Interval Clinical Impact The concomitant use of other drugs which prolong the QTc interval with mirtazapine, increase the risk of QTc prolongation and/or ventricular arrhythmias (e.g., Torsades de Pointes).
Mechanism: Taking these two drugs together can change the electrical timing of your heartbeat. This increases the risk of developing a dangerous irregular heart rhythm.
Examples diazepam, alprazolam, alcohol Drugs that Prolong QTc Interval Clinical Impact The concomitant use of other drugs which prolong the QTc interval with mirtazapine, increase the risk of QTc prolongation and/or ventricular arrhythmias (e.g., Torsades de Pointes).
Mechanism: Both medications can interfere with the heart's electrical system when used at the same time. This can lead to serious heart rhythm issues that may be life-threatening.
Examples selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Other Serotonergic Drugs Clinical Impact The concomitant use of serotonergic drugs with mirtazapine increases the risk of serotonin syndrome.
Mechanism: Both of these medicines increase the level of a brain chemical called serotonin. Taking them together can cause serotonin to reach dangerous levels in the body.
Examples selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Other Serotonergic Drugs Clinical Impact The concomitant use of serotonergic drugs with mirtazapine increases the risk of serotonin syndrome.
Mechanism: These drugs both work by raising serotonin levels in your system. Using them at the same time increases the risk of a serious condition called serotonin syndrome.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
Can I stop taking mirtazapine suddenly?
Can mirtazapine cause weight gain?
Can I drink alcohol while taking mirtazapine?
How long does it take for mirtazapine to start working?
What should I do if I experience side effects?
Can mirtazapine interact with other medications?
What if I have kidney problems?
What if I have liver problems?
Can mirtazapine cause glaucoma?
Can mirtazapine cause sleepiness?
What are the common side effects of mirtazapine?
Does mirtazapine interact with other medications?
What drug class is mirtazapine?
Is there a generic version of mirtazapine?
What pregnancy or breastfeeding source fields are listed for mirtazapine?
Related Medications in Noradrenergic and Specific Serotonergic Antidepressant (NaSSA)
Other drugs grouped near mirtazapine - same-class peers and common alternatives.
acamprosate
Campral
Acamprosate is a medicine that can help you stay away from alcohol if you are alcohol-dependent and have already stopped drinking.
Compare with mirtazapine →
alprazolam
Xanax
Alprazolam (Xanax) is a medication that can help you with anxiety and panic disorders.
Compare with mirtazapine →
amitriptyline
Elavil
Amitriptyline is a medicine used to treat depression.
Compare with mirtazapine →
amphetamine/dextroamphetamine
Adderall, Adderall XR
Adderall XR is a stimulant medicine.
Compare with mirtazapine →
aripiprazole
Abilify
Aripiprazole (Abilify) is a medicine used to treat certain mental disorders and mood problems.
Compare with mirtazapine →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for mirtazapine: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 87,759.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 15.43%.
- thiamine Δ 0.06 pts · 11,724 reports · Vitamin B1 Supplement 15.49%death share
- senna Δ 0.09 pts · 20,197 reports · Stimulant Laxative 15.34%death share
- palonosetron Δ 0.16 pts · 3,330 reports · 5-HT3 Receptor Antagonist (Antiemetic) 15.59%death share
- entacapone Δ 0.18 pts · 3,955 reports · COMT Inhibitor 15.25%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
Save on mirtazapine
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What the FDA Data Shows for mirtazapine
The FDA label for mirtazapine (sold under brand names such as Remeron) classifies it as a prescription-only medication in the Noradrenergic and Specific Serotonergic Antidepressant (NaSSA) class. Mirtazapine is used to treat major depressive disorder (MDD) in adults. Official labeling lists 4 commonly reported side effects, including Feeling sleepy, Increased appetite, Weight gain.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 87,759 voluntary reports. The database also lists 29 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $0.30 versus $5.89 for the brand - a 95% generic savings.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: August 1, 2022
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages