Nisoldipine side effects: what 1,197 FDA adverse event reports show
Drug class
Dihydropyridine Calcium Channel Blocker
Who reports
1,197 reports · 65% serious · 123 with death outcome · 62% female
Used for
Nisoldipine extended-release tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
What it is
DESCRIPTION Nisoldipine Extended-Release Tablets are an extended release tablet dosage form of the dihydropyridine calcium channel blocker nisoldipine. Nisoldipine is 3,5-pyridinedicarboxylic .
Boxed warning
None in the current label
Causality screen of the 28 strongest signals
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.
- 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. 6 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 |
|---|---|---|---|---|---|---|
| End stage renal disease | 24 | 22.9 15.4–34.0ROR 23.3 · χ² 480 / p 1e-106 | 22.5 EB05 15.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 20.1 | no trial data cached |
| Economic problem | 17 | 19.4 12.1–31.0ROR 19.6 · χ² 278 / p 1e-62 | 18.8 EB05 12.2 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 18.7 | no trial data cached |
| Atelectasis | 9 | 16.3 8.5–31.2ROR 16.4 · χ² 114 / p 6e-27 | 14.5 EB05 6.8 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 14.5 | no trial data cached |
| Nephropathy | 8 | 15.0 7.5–29.8ROR 15.1 · χ² 91 / p 9e-22 | 12.6 EB05 5.6 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 14.1 | no trial data cached |
| Coronary artery disease | 25 | 14.4 9.8–21.2ROR 14.7 · χ² 298 / p 4e-67 | 13.9 EB05 9.6 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.9 | no trial data cached |
| Anhedonia | 21 | 13.9 9.1–21.3ROR 14.1 · χ² 239 / p 3e-54 | 13.3 EB05 8.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 13.6 | no trial data cached |
| Cardiomegaly | 9 | 12.7 6.6–24.4ROR 12.8 · χ² 86 / p 1e-20 | 10.5 EB05 5.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 11.5 | no trial data cached |
| Mitral valve incompetence | 8 | 12.4 6.2–24.7ROR 12.5 · χ² 73 / p 7e-18 | 9.8 EB05 4.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 | no trial data cached |
| Arteriosclerosis | 6 | 11.2 5.0–24.8ROR 11.2 · χ² 46 / p 7e-12 | 7.7 EB05 3.3 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 | no trial data cached |
| Chronic kidney disease | 46 | 10.5 7.9–14.0ROR 10.9 · χ² 388 / p 1e-86 | 10.1 EB05 7.8 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 | no trial data cached |
| Renal injury | 16 | 9.3 5.7–15.2ROR 9.5 · χ² 111 / p 3e-26 | 8.0 EB05 5.0 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 | no trial data cached |
| Myocardial ischaemia | 6 | 9.2 4.1–20.4ROR 9.2 · χ² 36 / p 1e-9 | 6.2 EB05 2.9 · IC025 +1.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.1 | no trial data cached |
| Transient ischaemic attack (mini-stroke) | 17 | 8.8 5.5–14.1ROR 8.9 · χ² 110 / p 5e-26 | 7.6 EB05 4.8 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Cardiac failure congestive | 40 | 8.7 6.4–11.7ROR 8.9 · χ² 264 / p 1e-59 | 8.1 EB05 6.1 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.7 | no trial data cached |
| Fluid overload | 7 | 8.3 4.0–17.4ROR 8.4 · χ² 38 / p 3e-10 | 5.9 EB05 3.0 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 | no trial data cached |
| Feeling jittery | 9 | 8.3 4.3–15.8ROR 8.3 · χ² 50 / p 6e-13 | 6.3 EB05 3.4 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| Local swelling | 8 | 7.9 4.0–15.8ROR 8.0 · χ² 42 / p 5e-11 | 5.9 EB05 3.1 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Injury | 31 | 7.7 5.4–10.9ROR 7.9 · χ² 174 / p 4e-40 | 7.1 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | no trial data cached |
| Bone disorder | 7 | 6.7 3.2–14.0ROR 6.7 · χ² 28 / p 5e-8 | 4.9 EB05 2.5 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Stevens-johnson syndrome (severe blistering skin reaction) | 8 | 6.3 3.2–12.6ROR 6.3 · χ² 31 / p 2e-8 | 4.8 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Myocardial infarction (heart attack) | 54 | 5.4 4.1–7.0ROR 5.6 · χ² 190 / p 2e-43 | 5.2 EB05 4.1 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 | no trial data cached |
| Drug administration error | 9 | 5.1 2.6–9.7ROR 5.1 · χ² 26 / p 2e-7 | 4.1 EB05 2.4 · IC025 +0.9 3/3 methods agree | Reporting / coding artifact | serious PRR 7.3 | no trial data cached |
| Pelvic pain | 5 | 4.8 2.0–11.6ROR 4.8 · χ² 12 / p 3e-4 | 3.5 EB05 1.7 · IC025 +0.3 | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Pharmaceutical product complaint | 7 | 4.7 2.2–9.8ROR 4.7 · χ² 17 / p 2e-5 | 3.7 EB05 2.0 · IC025 +0.6 | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Emotional distress | 26 | 3.8 2.6–5.5ROR 3.8 · χ² 50 / p 7e-13 | 3.5 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Completed suicide (death by suicide) | 17 | 3.5 2.2–5.7ROR 3.6 · χ² 29 / p 4e-8 | 3.3 EB05 2.2 · IC025 +0.9 3/3 methods agree | Outcome field, not a reaction | serious PRR 3.1 | no trial data cached |
| Extrapyramidal disorder | 5 | 3.5 1.5–8.4ROR 3.5 · χ² 7 / p 0.005 | 2.8 EB05 1.4 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Skin burning sensation | 10 | 2.5 1.3–4.6ROR 2.5 · χ² 7 / p 0.003 | 2.3 EB05 1.4 · IC025 +0.1 | Not in label — unassessed | – | 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 |
|---|---|---|---|---|---|---|
| Myocardial infarction (heart attack) | 54 | 5.4 4.1–7.0ROR 5.6 · χ² 190 / p 2e-43 | 5.2 EB05 4.1 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 | no trial data cached |
| Chronic kidney disease | 46 | 10.5 7.9–14.0ROR 10.9 · χ² 388 / p 1e-86 | 10.1 EB05 7.8 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 | no trial data cached |
| Cardiac failure congestive | 40 | 8.7 6.4–11.7ROR 8.9 · χ² 264 / p 1e-59 | 8.1 EB05 6.1 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.7 | no trial data cached |
| Injury | 31 | 7.7 5.4–10.9ROR 7.9 · χ² 174 / p 4e-40 | 7.1 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | no trial data cached |
| Emotional distress | 26 | 3.8 2.6–5.5ROR 3.8 · χ² 50 / p 7e-13 | 3.5 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Coronary artery disease | 25 | 14.4 9.8–21.2ROR 14.7 · χ² 298 / p 4e-67 | 13.9 EB05 9.6 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.9 | no trial data cached |
| End stage renal disease | 24 | 22.9 15.4–34.0ROR 23.3 · χ² 480 / p 1e-106 | 22.5 EB05 15.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 20.1 | no trial data cached |
| Anhedonia | 21 | 13.9 9.1–21.3ROR 14.1 · χ² 239 / p 3e-54 | 13.3 EB05 8.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 13.6 | no trial data cached |
| Completed suicide (death by suicide) | 17 | 3.5 2.2–5.7ROR 3.6 · χ² 29 / p 4e-8 | 3.3 EB05 2.2 · IC025 +0.9 3/3 methods agree | Outcome field, not a reaction | serious PRR 3.1 | no trial data cached |
| Transient ischaemic attack (mini-stroke) | 17 | 8.8 5.5–14.1ROR 8.9 · χ² 110 / p 5e-26 | 7.6 EB05 4.8 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Economic problem | 17 | 19.4 12.1–31.0ROR 19.6 · χ² 278 / p 1e-62 | 18.8 EB05 12.2 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 18.7 | no trial data cached |
| Renal injury | 16 | 9.3 5.7–15.2ROR 9.5 · χ² 111 / p 3e-26 | 8.0 EB05 5.0 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 | no trial data cached |
| Skin burning sensation | 10 | 2.5 1.3–4.6ROR 2.5 · χ² 7 / p 0.003 | 2.3 EB05 1.4 · IC025 +0.1 | Not in label — unassessed | – | no trial data cached |
| Drug administration error | 9 | 5.1 2.6–9.7ROR 5.1 · χ² 26 / p 2e-7 | 4.1 EB05 2.4 · IC025 +0.9 3/3 methods agree | Reporting / coding artifact | serious PRR 7.3 | no trial data cached |
| Feeling jittery | 9 | 8.3 4.3–15.8ROR 8.3 · χ² 50 / p 6e-13 | 6.3 EB05 3.4 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=3 | 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.
- End stage renal disease — n=24, PRR 22.9
- Anhedonia — n=21, PRR 13.9
- Chronic kidney disease — n=46, PRR 10.5
- Injury — n=31, PRR 7.7
- Emotional distress — n=26, PRR 3.8
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 Nisoldipine?
In FDA FAERS, the most frequently co-reported reaction terms for Nisoldipine are myocardial infarction, chronic kidney disease, cardiac failure congestive, injury, emotional distress, coronary artery 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 Nisoldipine have an FDA boxed warning?
No. The FDA label retrieved for Nisoldipine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Nisoldipine 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 a52b773a-44f9-442f-a4be-39f79a558bd2, effective 20260608; matched on
openfda.generic_name.exact:"NISOLDIPINE") - 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, 34 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.