Drug · FAERS side-effect profile with label screen
Nortriptyline side effects: what 5,759 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Nortriptyline Hydrochloride (Nortriptyline 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
5,759 reports · 71% serious · 708 with death outcome · 75% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Nortriptyline hydrochloride, USP is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.
FDA label, Indications and Usage
What it is
DESCRIPTION Nortriptyline hydrochloride, USP is 1-propanamine, 3-(10,11-dihydro-5 H -dibenzo [ a,d ]cyclohepten-5-ylidene)- N -methyl-, hydrochloride.
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 40 strongest signals
Labeled adverse reaction 5Reporting / coding artifact 5Lab value / disease marker 2Outcome field, not a reaction 1Not in label — unassessed 27
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.
- 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. 514 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Immunodeficiency | 383 | 97.1 88.1–107.2ROR 104.0 · χ² 35,417 / p <1e-300 | 94.2 EB05 86.5 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious PRR 82.8 · ♀ 99% (drug 75%) | no trial data cached |
| Coeliac disease | 244 | 92.8 81.9–105.1ROR 96.8 · χ² 21,511 / p <1e-300 | 89.8 EB05 80.8 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious PRR 90.4 · ♀ 100% (drug 75%) | no trial data cached |
| Bursitis | 259 | 79.8 70.8–90.0ROR 83.5 · χ² 19,655 / p <1e-300 | 77.7 EB05 70.1 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 73.5 · ♀ 98% (drug 75%) | no trial data cached |
| Prescribed overdose | 328 | 62.7 56.4–69.8ROR 66.5 · χ² 19,541 / p <1e-300 | 61.5 EB05 56.1 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 84.3 · ♀ 100% (drug 75%) · 91% clinician | no trial data cached |
| Contraindicated product administered | 283 | 34.5 30.7–38.6ROR 36.2 · χ² 9,087 / p <1e-300 | 34.1 EB05 30.9 · IC025 +4.8 3/3 methods agree | Reporting / coding artifact | serious PRR 34.1 · ♀ 97% (drug 75%) | no trial data cached |
| Pneumonia aspiration | 205 | 30.2 26.4–34.5ROR 31.3 · χ² 5,713 / p <1e-300 | 29.9 EB05 26.6 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 24.2 · ♀ 96% (drug 75%) | no trial data cached |
| Upper respiratory tract infection (cold/sinus infection) | 373 | 29.6 26.9–32.7ROR 31.6 · χ² 10,234 / p <1e-300 | 29.4 EB05 27.0 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 39.5 · ♀ 98% (drug 75%) | no trial data cached |
| Rash erythematous | 326 | 25.5 22.9–28.3ROR 27.0 · χ² 7,611 / p <1e-300 | 25.3 EB05 23.1 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 40.7 · ♀ 100% (drug 75%) | no trial data cached |
| Osteopenia | 96 | 23.0 18.9–28.1ROR 23.4 · χ² 1,990 / p <1e-300 | 22.8 EB05 19.2 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 21.8 · ♀ 97% (drug 75%) | no trial data cached |
| Sedation | 164 | 23.0 19.8–26.8ROR 23.7 · χ² 3,417 / p <1e-300 | 22.8 EB05 20.1 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 25.0 · ♀ 4% (drug 75%) | no trial data cached |
| Decreased immune responsiveness | 60 | 22.5 17.5–28.9ROR 22.7 · χ² 1,203 / p 7e-264 | 22.2 EB05 17.9 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 22.4 · ♀ 100% (drug 75%) | no trial data cached |
| Hepatic enzyme increased | 409 | 22.0 20.1–24.2ROR 23.6 · χ² 8,166 / p <1e-300 | 21.9 EB05 20.2 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious PRR 25.3 · ♀ 98% (drug 75%) | no trial data cached |
| Fluid retention | 293 | 21.1 18.9–23.6ROR 22.2 · χ² 5,568 / p <1e-300 | 20.9 EB05 19.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 23.3 · ♀ 100% (drug 75%) | no trial data cached |
| Exposure during pregnancy | 343 | 20.2 18.2–22.4ROR 21.4 · χ² 6,217 / p <1e-300 | 20.1 EB05 18.3 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 24.2 · ♀ 100% (drug 75%) · 94% clinician | no trial data cached |
| Infusion related reaction (reaction during infusion) | 328 | 18.2 16.3–20.2ROR 19.2 · χ² 5,290 / p <1e-300 | 18.1 EB05 16.5 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 18.3 · ♀ 99% (drug 75%) | no trial data cached |
| Nightmare | 164 | 17.2 14.8–20.1ROR 17.7 · χ² 2,486 / p <1e-300 | 17.1 EB05 15.0 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 22.4 · ♀ 10% (drug 75%) | no trial data cached |
| Cyst | 58 | 17.1 13.2–22.1ROR 17.2 · χ² 857 / p 1e-188 | 16.9 EB05 13.5 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 18.0 · ♀ 98% (drug 75%) | no trial data cached |
| Deformity | 43 | 16.8 12.4–22.6ROR 16.9 · χ² 619 / p 6e-137 | 16.5 EB05 12.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 15.4 · ♀ 97% (drug 75%) | no trial data cached |
| Coma | 212 | 16.3 14.2–18.6ROR 16.8 · χ² 3,012 / p <1e-300 | 16.2 EB05 14.4 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.1 · ♀ 97% (drug 75%) | no trial data cached |
| Hyperhidrosis (excessive sweating) | 556 | 15.8 14.6–17.1ROR 17.3 · χ² 7,682 / p <1e-300 | 15.7 EB05 14.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 19.9 | no trial data cached |
| Poor venous access | 42 | 14.9 11.0–20.1ROR 15.0 · χ² 527 / p 5e-117 | 14.6 EB05 11.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=42 · ♀ 95% (drug 75%) | no trial data cached |
| Drug intolerance | 377 | 14.3 13.0–15.8ROR 15.2 · χ² 4,656 / p <1e-300 | 14.2 EB05 13.1 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 17.9 | no trial data cached |
| Blood potassium increased | 62 | 14.0 10.9–17.9ROR 14.1 · χ² 730 / p 4e-161 | 13.8 EB05 11.0 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious PRR 14.1 | no trial data cached |
| Rheumatoid arthritis | 410 | 13.2 12.1–14.5ROR 14.2 · χ² 4,635 / p <1e-300 | 13.2 EB05 12.1 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 12.9 · ♀ 100% (drug 75%) | no trial data cached |
| Intentional product misuse | 312 | 13.1 11.8–14.6ROR 13.8 · χ² 3,482 / p <1e-300 | 13.0 EB05 11.9 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 22.9 · ♀ 97% (drug 75%) | no trial data cached |
| Treatment failure | 294 | 13.1 11.7–14.6ROR 13.7 · χ² 3,268 / p <1e-300 | 13.0 EB05 11.8 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 19.9 · ♀ 98% (drug 75%) | no trial data cached |
| Nocturia (night-time urination) | 40 | 12.1 8.8–16.4ROR 12.1 · χ² 393 / p 7e-88 | 11.7 EB05 8.7 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.2 · ♀ 16% (drug 75%) | no trial data cached |
| Micturition urgency | 37 | 11.9 8.6–16.4ROR 12.0 · χ² 358 / p 4e-80 | 11.5 EB05 8.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 14.1 · ♀ 31% (drug 75%) | no trial data cached |
| Asthma | 364 | 11.9 10.7–13.1ROR 12.6 · χ² 3,614 / p <1e-300 | 11.8 EB05 10.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 13.0 · ♀ 99% (drug 75%) | no trial data cached |
| Nephrolithiasis (kidney stones) | 148 | 11.8 10.1–13.9ROR 12.1 · χ² 1,452 / p <1e-300 | 11.7 EB05 10.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 · ♀ 19% (drug 75%) | no trial data cached |
| Joint swelling | 389 | 11.8 10.7–13.0ROR 12.6 · χ² 3,839 / p <1e-300 | 11.7 EB05 10.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 16.2 · ♀ 98% (drug 75%) | no trial data cached |
| Gastrooesophageal reflux disease (acid reflux) | 258 | 11.7 10.4–13.2ROR 12.2 · χ² 2,526 / p <1e-300 | 11.7 EB05 10.5 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 14.6 | no trial data cached |
| Carpal tunnel syndrome | 44 | 11.4 8.5–15.4ROR 11.5 · χ² 408 / p 6e-91 | 11.0 EB05 8.4 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 10.8 | no trial data cached |
| Osteoarthritis | 122 | 10.5 8.8–12.5ROR 10.7 · χ² 1,036 / p 1e-227 | 10.3 EB05 8.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 | no trial data cached |
| Intervertebral disc degeneration | 26 | 10.2 6.9–15.0ROR 10.2 · χ² 206 / p 5e-47 | 9.4 EB05 6.5 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 | no trial data cached |
| Hypersensitivity (allergic reaction) | 490 | 9.6 8.9–10.5ROR 10.4 · χ² 3,811 / p <1e-300 | 9.6 EB05 8.9 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.5 · ♀ 97% (drug 75%) | no trial data cached |
| Retching | 56 | 9.6 7.4–12.5ROR 9.7 · χ² 422 / p 4e-94 | 9.2 EB05 7.3 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 14.4 | no trial data cached |
| Thrombocytopenia (low platelets) | 287 | 9.4 8.4–10.5ROR 9.8 · χ² 2,148 / p <1e-300 | 9.3 EB05 8.4 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.8 · ♀ 99% (drug 75%) | no trial data cached |
| Completed suicide (death by suicide) | 215 | 9.3 8.2–10.6ROR 9.6 · χ² 1,591 / p <1e-300 | 9.2 EB05 8.2 · IC025 +3.0 3/3 methods agree | Outcome field, not a reaction | serious PRR 7.5 · 92% clinician | no trial data cached |
| Feeling cold | 70 | 9.2 7.2–11.6ROR 9.3 · χ² 500 / p 6e-111 | 8.8 EB05 7.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 11.3 · ♀ 28% (drug 75%) | 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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 853 | 2.4 2.2–2.5ROR 2.6 · χ² 710 / p 8e-157 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 4.3 | no trial data cached |
| Off label use (used outside approved label) | 793 | 3.3 3.1–3.5ROR 3.7 · χ² 1,343 / p 2e-294 | 3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 4.5 | no trial data cached |
| Pain | 730 | 4.3 4.0–4.6ROR 4.8 · χ² 1,914 / p <1e-300 | 4.3 EB05 4.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Headache | 716 | 4.2 3.9–4.5ROR 4.6 · χ² 1,770 / p <1e-300 | 4.2 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.9 | no trial data cached |
| Fatigue (tiredness) | 623 | 2.9 2.7–3.1ROR 3.2 · χ² 814 / p 2e-179 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 | no trial data cached |
| Nausea | 575 | 2.7 2.5–2.9ROR 2.8 · χ² 613 / p 1e-135 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | no trial data cached |
| Hyperhidrosis (excessive sweating) | 556 | 15.8 14.6–17.1ROR 17.3 · χ² 7,682 / p <1e-300 | 15.7 EB05 14.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 19.9 | no trial data cached |
| Hypersensitivity (allergic reaction) | 490 | 9.6 8.9–10.5ROR 10.4 · χ² 3,811 / p <1e-300 | 9.6 EB05 8.9 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.5 · ♀ 97% (drug 75%) | no trial data cached |
| Drug hypersensitivity | 445 | 8.4 7.6–9.1ROR 9.0 · χ² 2,894 / p <1e-300 | 8.3 EB05 7.7 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.8 | no trial data cached |
| Constipation | 433 | 7.3 6.7–8.0ROR 7.8 · χ² 2,365 / p <1e-300 | 7.2 EB05 6.7 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.7 | no trial data cached |
| Hypertension (high blood pressure) | 424 | 7.3 6.7–8.0ROR 7.8 · χ² 2,314 / p <1e-300 | 7.2 EB05 6.7 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.2 | no trial data cached |
| Rheumatoid arthritis | 410 | 13.2 12.1–14.5ROR 14.2 · χ² 4,635 / p <1e-300 | 13.2 EB05 12.1 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 12.9 · ♀ 100% (drug 75%) | no trial data cached |
| Hepatic enzyme increased | 409 | 22.0 20.1–24.2ROR 23.6 · χ² 8,166 / p <1e-300 | 21.9 EB05 20.2 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious PRR 25.3 · ♀ 98% (drug 75%) | no trial data cached |
| Overdose | 399 | 6.7 6.1–7.4ROR 7.1 · χ² 1,951 / p <1e-300 | 6.7 EB05 6.1 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 6.7 | no trial data cached |
| Joint swelling | 389 | 11.8 10.7–13.0ROR 12.6 · χ² 3,839 / p <1e-300 | 11.7 EB05 10.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 16.2 · ♀ 98% (drug 75%) | 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.
- Immunodeficiency — n=383, PRR 97.1
- Coeliac disease — n=244, PRR 92.8
- Bursitis — n=259, PRR 79.8
- Prescribed overdose — n=328, PRR 62.7
- Pneumonia aspiration — n=205, PRR 30.2
- Upper respiratory tract infection — n=373, PRR 29.6
- Rash erythematous — n=326, PRR 25.5
- Osteopenia — n=96, PRR 23.0
- Sedation — n=164, PRR 23.0
- Decreased immune responsiveness — n=60, PRR 22.5
✓ A hand-written Bradford Hill causality assessment exists for this drug: Nortriptyline ↔ QT prolongation.
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 Nortriptyline?
In FDA FAERS, the most frequently co-reported reaction terms for Nortriptyline are pain, headache, fatigue, nausea, hyperhidrosis, hypersensitivity. 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 Nortriptyline 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 Nortriptyline 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 1a904ddf-574a-8a24-e063-6394a90aba3b, effective 20240607; matched on
openfda.generic_name.exact:"NORTRIPTYLINE 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, 554 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.