Two medicines, side by side
Amitriptyline vs mirtazapine
Amitriptyline and mirtazapine are both labeled for depression. Drugs@FDA records approvals of amitriptyline since 1961 and of mirtazapine since 1996. Pharmacies paid $0.03 per amitriptyline HCl 10 mg tablet and $0.063 per mirtazapine 15 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like.
Check it at the source: the amitriptyline FDA label on DailyMed (effective September 8, 2026); the mirtazapine FDA label on DailyMed (effective August 6, 2025).
Highlights of the amitriptyline record
Amitriptyline (Elavil) · label of September 8, 2026
Suicidality and Antidepressant Drugs: Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of amitriptyline hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need.
Used for
From the label: indicationsFor the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.
On the market
- Earliest approval on file
- April 7, 1961
- Generic labelers
- 34 labelers
- Pharmacy cost
- $0.03 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 2
Highlights of the mirtazapine record
Mirtazapine (Remeron) · label of August 6, 2025
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) ].
Used for
From the label: indicationsREMERON/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.
On the market
- Earliest approval on file
- June 14, 1996
- Generic labelers
- 36 labelers
- Pharmacy cost
- $0.063 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 5
Source: FDA drug labels via openFDA (Amitriptyline label of September 8, 2026, Mirtazapine label of August 6, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do amitriptyline and mirtazapine differ on the record?
How each works, in its label's words: Amitriptyline, “It is not a monoamine oxidase inhibitor and it does not act primarily by stimulation of the central nervous system.”; Mirtazapine, “The mechanism of action of mirtazapine for the treatment of major depressive disorder, is unclear.”
Both labels carry a boxed warning; the records quote them.
Generics: amitriptyline since 1976; mirtazapine since 2003 (Drugs@FDA).
| Amitriptyline | Mirtazapine | |
|---|---|---|
| Labeled for | Depression | Depression |
| Pharmacologic class | Tricyclic Antidepressant | n/a |
| How it works (label) | in man is not known. It is not a monoamine oxidase inhibitor and it does not act primarily by stimulation of the central nervous system. | The mechanism of action of mirtazapine for the treatment of major depressive disorder, is unclear. |
| Half-life (label) | n/a | Elimination Mirtazapine has a half-life of about 20 to 40 hours following oral administration of REMERON or REMERONSolTab. |
| Earliest approval on file (Drugs@FDA) | April 7, 1961 | June 14, 1996 |
| First generic approved | November 16, 1976 | January 24, 2003 |
| Generic labelers (NDC) | 34 labelers | 36 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.03 per tablet (Amitriptyline HCl 10 mg tablet) | $0.063 per tablet (Mirtazapine 15 mg tablet) |
| 12-month price change | -19% | -12% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 2 | 5 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 17,441 | 91,057 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
What do the labels say about using others of their kind?
Amitriptyline label, warningsIf concomitant use of amitriptyline hydrochloride with other serotonergic drugs, including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan, and St. John’s Wort is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases.
Mirtazapine label, warnings and precautionsIncreased risk when co-administered with other serotonergic drugs (e.g., SSRI, SNRI, triptans), but also when taken alone.
Source: FDA drug labels via openFDA
What next?
- Alternatives to amitriptyline
- every medicine labeled for the same conditions