The risks of adverse events with mirtazapine for adults with major depressive disorder: a systematic review with…
Worth asking your prescriber how you will monitor weight and daytime sleepiness on mirtazapine, and at what point you would adjust the dose or switch.
Top of the evidence hierarchy, independently funded. how we score evidence
Caveat on this rating: No external funding, but several authors (Moncrieff, Horowitz, Kirsch, Hengartner) are prominent critics of antidepressants and disclosed royalties/consulting tied to antidepressant-deprescribing work — a perspective readers should weigh.
Pooling 17 placebo-controlled randomised trials (2,131 adults), mirtazapine roughly quintupled the risk of weight gain (RR 4.75, 95% CI 2.05 to 10.99; about 1 extra person affected per 10 treated) and more than doubled somnolence (RR 2.61, 95% CI 1.26 to 5.37; about 1 per 4) and dizziness, while serious adverse events showed a possible but statistically unconfirmed increase (OR 1.82, 95% CI 0.95 to 3.48).
Worth asking
Worth asking your prescriber how you will monitor weight and daytime sleepiness on mirtazapine, and at what point you would adjust the dose or switch.
What it is FDA approved for
Read off the label. Trial duration and approval year are shown only where they were recorded — never inferred.
- Major depressive disorder (adults)
Source
The risks of adverse events with mirtazapine for adults with major depressive disorder: a systematic review with meta-analysis and trial sequential analysis — Kamp CB, Petersen JJ, Faltermeier P, et al. (2025)
Reputable peer-reviewed journal
Read the source: https://doi.org/10.1186/s12888-024-06396-6
DOI: 10.1186/s12888-024-06396-6
How this was scored
- Study design
- Meta-analysis of randomised trials
- Funding
- No external funding
- Published in
- Reputable peer-reviewed journal
- Sample size
- 2,131
- Preregistered
- Yes
- Conflicts disclosed
- Yes
- Independent of proponent
- Yes
- Retracted
- No
Read the full scoring rubric, including what it can't tell you.
Published August 19, 2026.
Questions
How strong is the evidence behind this?
Resolv rates this source "gold standard". Top of the evidence hierarchy, independently funded. It scores 95 out of 100 on our published rubric. One caveat travels with that badge: No external funding, but several authors (Moncrieff, Horowitz, Kirsch, Hengartner) are prominent critics of antidepressants and disclosed royalties/consulting tied to antidepressant-deprescribing work — a perspective readers should weigh. The score is calculated from recorded facts about the source — study design, funding, publication venue, sample size, preregistration — not typed in by an editor.
What is the source for this?
The risks of adverse events with mirtazapine for adults with major depressive disorder: a systematic review with meta-analysis and trial sequential analysis — Kamp CB, Petersen JJ, Faltermeier P, et al. (2025). Published in: Reputable peer-reviewed journal. DOI: 10.1186/s12888-024-06396-6. The full source is linked on this page so you can read it yourself.
Who paid for this research, and does that matter?
Study design: Meta-analysis of randomised trials. Funding: No external funding. The researchers were independent of whoever benefits from the result. Industry sponsorship is one of the most reliably measured biases in medicine, which is why funding carries real weight in the score rather than sitting in a footnote.
Is mirtazapine (Remeron), remeron FDA approved?
Yes — FDA approved for Major depressive disorder (adults). Approval is for a specific indication, not for everything the drug is prescribed for.
Is this medical advice?
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.