HIGH-VOLUME · HOSP-HEAVY

mirtazapine Side Effects

mirtazapine (also sold as Remeron) is HIGH-VOLUME in this FAERS book #87 of 524 by FAERS report count. Signature opener: HOSP-HEAVY - 41.0% mention hospitalization (36,013 reports).

Data updated 2026-05-15

87,759
FAERS reports

FAERS voluntary reports, 2003 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.

mirtazapine: 41.0% mention hospitalization (36,013 reports). Death stamp DEATH-HEAVY; volume band HIGH-VOLUME #87 of 524 by FAERS report count.

High-report extract for mirtazapine (Remeron): 87,759 FAERS rows (2003-2025). Top named reactions: NAUSEA, FATIGUE, FALL. Outcome stamps DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED. FAERS is voluntary signal detection, not incidence.

Counts from the openFDA FAERS extract (2003–2025). Stamps CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.

NAUSEA leads 4,838 of 87,759 reports

NAUSEA
4,838
FATIGUE
4,715
FALL
4,027
DIARRHOEA
3,961
TOXICITY TO VARIOUS AGENTS
3,703
ANXIETY
3,472
DIZZINESS
3,429
DYSPNOEA
3,394
DEATH
3,322
DRUG INTERACTION
3,249
DEPRESSION
3,210
VOMITING
3,192
HEADACHE
3,058
SOMNOLENCE
2,993
ASTHENIA
2,911
INSOMNIA
2,911
CONFUSIONAL STATE
2,881
PAIN
2,849

Who reports · age peak 45-64 (SEX-BALANCED)

Sex coding · SEX-BALANCED

Female 46,485 (57%)
Male 34,180 (42%)
Unknown 236

Age peak 45-64 (21,120 reports)

0-17 1,687 (3%)
18-44 15,320 (24%)
45-64 21,120 (33%)
65-74 11,897 (18%)
75+ 14,744 (23%)

FAERS filings rising toward 2025

2003 2025

Reactions in Death Reports

Death-mentioned subset is HEAVY here (13,537 reports, 15.4%). Top co-reported reactions in that subset - voluntary, not causal.

Reaction Reports
DEATH 3,312
COMPLETED SUICIDE 2,313
TOXICITY TO VARIOUS AGENTS 2,213
DRUG ABUSE 732
OVERDOSE 663
DRUG INTERACTION 632
CARDIO-RESPIRATORY ARREST 621
FATIGUE 598
CARDIAC ARREST 595
PNEUMONIA 572
FALL 570
DYSPNOEA 549
DIARRHOEA 540
NAUSEA 522
ASTHENIA 503
DECREASED APPETITE 470
SEPSIS 465
VOMITING 460
SOMNOLENCE 440

Reactions in Hospitalization Reports

Hospitalization is HEAVY (36,013, 41.0% of the book). Top reactions in those rows:

Reaction Reports
FALL 2,686
NAUSEA 2,100
DIARRHOEA 1,891
FATIGUE 1,827
DYSPNOEA 1,806
VOMITING 1,786
CONFUSIONAL STATE 1,760
PNEUMONIA 1,616
ASTHENIA 1,614
DEPRESSION 1,457
DRUG INTERACTION 1,437
TOXICITY TO VARIOUS AGENTS 1,428
INTENTIONAL OVERDOSE 1,425
HYPOTENSION 1,419
DIZZINESS 1,414
PYREXIA 1,335
SOMNOLENCE 1,327
PAIN 1,290
How to read mirtazapine FAERS figures (CASELOAD · DEATH-HEAVY · HOSP-HEAVY)

FAERS holds 87,759 voluntary reports linked to mirtazapine (Remeron), 2003-2025. Death is listed on 13,537 (15.4%). Hospitalization appears on 36,013 (41.0%). Top co-reported indication: Product Used For Unknown Indication.

CASELOAD books overweight common drugs and loud reporting cultures; HOSP-HEAVY is the page opener, not a per-patient risk.

Read with mirtazapine

Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-HEAVY stamps.