Drug · FAERS side-effect profile with label screen

Desipramine side effects: what 1,735 FDA adverse event reports show

Desipramine · 55 reaction terms · 806 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Desipramine Hydrochloride (Desipramine Hydrochloride)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

1,735 reports · 72% serious · 331 with death outcome · 70% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Desipramine hydrochloride tablets is indicated for the treatment of depression.

FDA label, Indications and Usage

What it is

DESCRIPTION Desipramine hydrochloride, USP is an antidepressant drug of the tricyclic type, and is chemically: 5H-Dibenz [bƒ] azepine-5-propanamine,10,11-dihydro-N-methyl-, monohydrochloride. .

FDA label, Description section

Boxed warning

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.

FDA label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 21 strongest signals

Labeled adverse reaction 6Labeled (related wording) 1Reporting / coding artifact 3Lab value / disease marker 1Outcome field, not a reaction 1Not in label — unassessed 9

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 34 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Angina pectoris	41	23.0 17.0–31.0ROR 23.7 · χ² 839 / p 9e-185	22.7 EB05 17.4 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Ileus	17	22.3 13.9–35.8ROR 22.6 · χ² 325 / p 6e-73	21.7 EB05 14.2 · IC025 +3.0 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Completed suicide (death by suicide)	116	22.3 18.7–26.5ROR 24.3 · χ² 2,341 / p <1e-300	22.2 EB05 19.0 · IC025 +4.0 3/3 methods agree	Outcome field, not a reaction	–	no trial data cached
Dyspnoea exertional	47	20.2 15.3–26.8ROR 20.9 · χ² 840 / p 5e-185	20.0 EB05 15.7 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Therapy non-responder	42	15.2 11.3–20.5ROR 15.7 · χ² 544 / p 1e-120	15.0 EB05 11.5 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Myoclonus	11	14.9 8.3–26.8ROR 15.0 · χ² 129 / p 3e-30	13.4 EB05 7.0 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Osteoarthritis	37	14.1 10.2–19.3ROR 14.4 · χ² 436 / p 3e-97	13.8 EB05 10.3 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Mydriasis	10	12.6 6.8–23.4ROR 12.7 · χ² 95 / p 8e-23	10.6 EB05 5.3 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Sinus tachycardia	11	12.5 7.0–22.6ROR 12.6 · χ² 105 / p 5e-25	10.7 EB05 5.6 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Serotonin syndrome	14	11.8 7.0–19.9ROR 11.9 · χ² 128 / p 6e-30	10.4 EB05 6.0 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Urinary retention	24	11.6 7.8–17.3ROR 11.8 · χ² 223 / p 1e-50	10.9 EB05 7.4 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Therapeutic product effect decreased	30	10.9 7.7–15.5ROR 11.1 · χ² 261 / p 6e-59	10.3 EB05 7.3 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Aspartate aminotransferase increased	34	10.3 7.4–14.4ROR 10.6 · χ² 278 / p 1e-62	9.8 EB05 7.1 · IC025 +2.6 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Intestinal obstruction	23	9.9 6.6–14.9ROR 10.1 · χ² 176 / p 2e-40	9.0 EB05 6.1 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Interstitial lung disease	28	9.4 6.5–13.5ROR 9.5 · χ² 201 / p 7e-46	8.6 EB05 6.1 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Dyskinesia (involuntary movements)	15	6.0 3.6–9.9ROR 6.0 · χ² 57 / p 2e-14	5.1 EB05 3.3 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Respiratory arrest	10	5.8 3.1–10.8ROR 5.8 · χ² 35 / p 2e-9	4.7 EB05 2.7 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Toxicity to various agents	60	5.8 4.5–7.4ROR 6.0 · χ² 234 / p 5e-53	5.5 EB05 4.5 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Panic attack	13	5.7 3.3–9.9ROR 5.8 · χ² 46 / p 5e-12	4.9 EB05 3.0 · IC025 +1.4 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Drug effect decreased	15	4.4 2.7–7.3ROR 4.5 · χ² 37 / p 7e-10	3.9 EB05 2.6 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Drug withdrawal syndrome	12	2.2 1.2–3.8ROR 2.2 · χ² 7 / p 0.005	2.1 EB05 1.3 · IC025 +0.1	Labeled (related wording) related wording	–	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Completed suicide (death by suicide)	116	22.3 18.7–26.5ROR 24.3 · χ² 2,341 / p <1e-300	22.2 EB05 19.0 · IC025 +4.0 3/3 methods agree	Outcome field, not a reaction	–	no trial data cached
Toxicity to various agents	60	5.8 4.5–7.4ROR 6.0 · χ² 234 / p 5e-53	5.5 EB05 4.5 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Dyspnoea exertional	47	20.2 15.3–26.8ROR 20.9 · χ² 840 / p 5e-185	20.0 EB05 15.7 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Therapy non-responder	42	15.2 11.3–20.5ROR 15.7 · χ² 544 / p 1e-120	15.0 EB05 11.5 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Angina pectoris	41	23.0 17.0–31.0ROR 23.7 · χ² 839 / p 9e-185	22.7 EB05 17.4 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Osteoarthritis	37	14.1 10.2–19.3ROR 14.4 · χ² 436 / p 3e-97	13.8 EB05 10.3 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Aspartate aminotransferase increased	34	10.3 7.4–14.4ROR 10.6 · χ² 278 / p 1e-62	9.8 EB05 7.1 · IC025 +2.6 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Therapeutic product effect decreased	30	10.9 7.7–15.5ROR 11.1 · χ² 261 / p 6e-59	10.3 EB05 7.3 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Interstitial lung disease	28	9.4 6.5–13.5ROR 9.5 · χ² 201 / p 7e-46	8.6 EB05 6.1 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Urinary retention	24	11.6 7.8–17.3ROR 11.8 · χ² 223 / p 1e-50	10.9 EB05 7.4 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Intestinal obstruction	23	9.9 6.6–14.9ROR 10.1 · χ² 176 / p 2e-40	9.0 EB05 6.1 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Ileus	17	22.3 13.9–35.8ROR 22.6 · χ² 325 / p 6e-73	21.7 EB05 14.2 · IC025 +3.0 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Drug effect decreased	15	4.4 2.7–7.3ROR 4.5 · χ² 37 / p 7e-10	3.9 EB05 2.6 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Dyskinesia (involuntary movements)	15	6.0 3.6–9.9ROR 6.0 · χ² 57 / p 2e-14	5.1 EB05 3.3 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Serotonin syndrome	14	11.8 7.0–19.9ROR 11.9 · χ² 128 / p 6e-30	10.4 EB05 6.0 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Angina pectoris — n=41, PRR 23.0
Dyspnoea exertional — n=47, PRR 20.2
Osteoarthritis — n=37, PRR 14.1
Intestinal obstruction — n=23, PRR 9.9
Interstitial lung disease — n=28, PRR 9.4
Toxicity to various agents — n=60, PRR 5.8

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Desipramine?

In FDA FAERS, the most frequently co-reported reaction terms for Desipramine are toxicity to various agents, dyspnoea exertional, angina pectoris, osteoarthritis, aspartate aminotransferase increased, interstitial lung disease. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Desipramine have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: 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.

Do FAERS signals prove that Desipramine causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 6ab5e113-82ef-493d-a4e3-a2756608fa60, effective 20251209; matched on openfda.generic_name:"DESIPRAMINE")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 55 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.