Imipramine side effects: what 560 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Imipramine Hydrochloride (Imipramine Hydrochloride)
Who reports
560 reports · 71% serious · 30 with death outcome · 69% female
Used for
Depression - For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident. Childhood Enuresis .
What it is
DESCRIPTION Imipramine hydrochloride tablets USP are supplied in tablet form for oral administration. Imipramine hydrochloride USP, the original tricyclic antidepressant, are a member of the dibenzazepine group of compounds.
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.
Causality screen of the 12 strongest signals
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- 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. 2 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Hallucination, auditory | 28 | 66.0 46.0–94.7ROR 69.4 · χ² 1,726 / p <1e-300 | 63.2 EB05 45.9 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 61.5 · ♀ 96% (drug 69%) | no trial data cached |
| Decreased activity | 16 | 56.0 34.5–90.8ROR 57.6 · χ² 809 / p 3e-178 | 52.6 EB05 34.3 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 68.0 | no trial data cached |
| Paranoia | 25 | 54.1 36.9–79.4ROR 56.6 · χ² 1,250 / p 4e-274 | 52.0 EB05 37.1 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 54.9 · ♀ 100% (drug 69%) | no trial data cached |
| Psychotic disorder | 28 | 35.5 24.8–51.0ROR 37.3 · χ² 906 / p 3e-199 | 34.7 EB05 25.2 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 31.2 · ♀ 96% (drug 69%) | no trial data cached |
| Sleep apnoea syndrome | 13 | 25.5 14.9–43.6ROR 26.0 · χ² 282 / p 2e-63 | 24.6 EB05 15.1 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 20.7 | no trial data cached |
| Neuroleptic malignant syndrome | 8 | 25.2 12.7–50.2ROR 25.6 · χ² 163 / p 2e-37 | 23.4 EB05 11.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 15.3 | no trial data cached |
| Frequent bowel movements | 16 | 22.3 13.7–36.1ROR 22.9 · χ² 304 / p 2e-68 | 21.7 EB05 14.0 · IC025 +2.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 27.8 | no trial data cached |
| Colitis | 19 | 18.9 12.1–29.4ROR 19.5 · χ² 305 / p 1e-68 | 18.4 EB05 12.3 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 16.4 | no trial data cached |
| Carpal tunnel syndrome | 6 | 16.0 7.2–35.5ROR 16.2 · χ² 70 / p 3e-17 | 12.5 EB05 4.7 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 16.0 | no trial data cached |
| Colitis ulcerative | 19 | 16.0 10.3–24.8ROR 16.5 · χ² 252 / p 5e-57 | 15.4 EB05 10.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 13.9 | no trial data cached |
| Respiratory depression | 5 | 15.3 6.4–36.6ROR 15.4 · χ² 53 / p 2e-13 | 10.8 EB05 3.7 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 12.7 | no trial data cached |
| Tendon rupture (torn tendon) | 5 | 15.1 6.3–36.2ROR 15.3 · χ² 53 / p 2e-13 | 10.7 EB05 3.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 13.4 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Psychotic disorder | 28 | 35.5 24.8–51.0ROR 37.3 · χ² 906 / p 3e-199 | 34.7 EB05 25.2 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 31.2 · ♀ 96% (drug 69%) | no trial data cached |
| Hallucination, auditory | 28 | 66.0 46.0–94.7ROR 69.4 · χ² 1,726 / p <1e-300 | 63.2 EB05 45.9 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 61.5 · ♀ 96% (drug 69%) | no trial data cached |
| Paranoia | 25 | 54.1 36.9–79.4ROR 56.6 · χ² 1,250 / p 4e-274 | 52.0 EB05 37.1 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 54.9 · ♀ 100% (drug 69%) | no trial data cached |
| Colitis ulcerative | 19 | 16.0 10.3–24.8ROR 16.5 · χ² 252 / p 5e-57 | 15.4 EB05 10.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 13.9 | no trial data cached |
| Colitis | 19 | 18.9 12.1–29.4ROR 19.5 · χ² 305 / p 1e-68 | 18.4 EB05 12.3 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 16.4 | no trial data cached |
| Frequent bowel movements | 16 | 22.3 13.7–36.1ROR 22.9 · χ² 304 / p 2e-68 | 21.7 EB05 14.0 · IC025 +2.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 27.8 | no trial data cached |
| Decreased activity | 16 | 56.0 34.5–90.8ROR 57.6 · χ² 809 / p 3e-178 | 52.6 EB05 34.3 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 68.0 | no trial data cached |
| Sleep apnoea syndrome | 13 | 25.5 14.9–43.6ROR 26.0 · χ² 282 / p 2e-63 | 24.6 EB05 15.1 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 20.7 | no trial data cached |
| Neuroleptic malignant syndrome | 8 | 25.2 12.7–50.2ROR 25.6 · χ² 163 / p 2e-37 | 23.4 EB05 11.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 15.3 | no trial data cached |
| Carpal tunnel syndrome | 6 | 16.0 7.2–35.5ROR 16.2 · χ² 70 / p 3e-17 | 12.5 EB05 4.7 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 16.0 | no trial data cached |
| Tendon rupture (torn tendon) | 5 | 15.1 6.3–36.2ROR 15.3 · χ² 53 / p 2e-13 | 10.7 EB05 3.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 13.4 | no trial data cached |
| Respiratory depression | 5 | 15.3 6.4–36.6ROR 15.4 · χ² 53 / p 2e-13 | 10.8 EB05 3.7 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 12.7 | no trial data cached |
| Parkinsonism | 4 | 15.4 5.8–40.8ROR 15.5 · χ² 40 / p 1e-10 | 9.6 EB05 3.0 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.8 | no trial data cached |
| Libido decreased (lower sex drive) | 3 | 9.1 2.9–28.0ROR 9.1 · χ² 14 / p 8e-5 | 4.7 EB05 1.7 · IC025 +0.0 | Labeled (related wording) related wording | serious PRR 8.7 | 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.
- Hallucination, auditory — n=28, PRR 66.0
- Paranoia — n=25, PRR 54.1
- Psychotic disorder — n=28, PRR 35.5
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 Imipramine?
In FDA FAERS, the most frequently co-reported reaction terms for Imipramine are psychotic disorder, hallucination, auditory, paranoia, colitis ulcerative, colitis, frequent bowel movements. 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 Imipramine 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 Imipramine 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 48e8b819-a9a0-aa5a-e063-6394a90ad9c2, effective 20260121; matched on
openfda.generic_name.exact:"IMIPRAMINE HYDROCHLORIDE") - 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, fieldpatient.drug.openfda.generic_name.exact, 14 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.