Diltiazem Extended-Release side effects: what 11,307 FDA adverse event reports show
Drug class
Nondihydropyridine calcium channel blocker
Label matched
Diltiazem Hydrochloride Extended-Release Tablets (Diltiazem Hydrochloride)
Who reports
11,307 reports · 84% serious · 2,693 with death outcome · 63% female
Used for
Diltiazem Hydrochloride Extended-Release Tablets is a nondihydropyridine calcium channel blocker indicated for: • treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It can be used alone or in combination with other antihypertensives.
What it is
Diltiazem hydrochloride is a nondihydropyridine calcium channel blocker (slow channel blocker or calcium antagonist).
Boxed warning
None in the current label
Causality screen of the 40 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.
- 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.
- 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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,090 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 |
|---|---|---|---|---|---|---|
| Heart sounds | 49 | 1,906.1 1,278.0–2,842.8ROR 1,914.4 · calibrated p 2e-19 ✓ | 682.9 EB05 537.0 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=49 · ♀ 100% (drug 63%) | no trial data cached |
| Anti-cyclic citrullinated peptide antibody | 136 | 475.4 394.0–573.6ROR 481.2 · calibrated p 1e-13 ✓ | 358.4 EB05 310.7 · IC025 +7.0 3/3 methods agree | Lab value / disease marker | serious n=136 · ♀ 100% (drug 63%) · 99% clinician | no trial data cached |
| Prolonged expiration | 49 | 422.6 309.9–576.2ROR 424.4 · calibrated p 1e-12 ✓ | 302.8 EB05 238.1 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=49 · ♀ 100% (drug 63%) | no trial data cached |
| Lupus vulgaris | 207 | 391.0 336.9–453.8ROR 398.2 · calibrated p 8e-13 ✓ | 312.9 EB05 278.8 · IC025 +7.3 3/3 methods agree | Not in label — unassessed | serious n=207 · ♀ 100% (drug 63%) · 96% clinician | no trial data cached |
| Sedation complication | 433 | 389.0 351.3–430.8ROR 404.5 · calibrated p 6e-13 ✓ | 316.4 EB05 292.2 · IC025 +7.7 3/3 methods agree | Reporting / coding artifact | serious n=432 · ♀ 100% (drug 63%) | no trial data cached |
| Amaurosis fugax | 181 | 378.2 322.6–443.4ROR 384.3 · calibrated p 1e-12 ✓ | 303.5 EB05 268.1 · IC025 +7.2 3/3 methods agree | Not in label — unassessed | serious n=181 · 92% clinician | no trial data cached |
| Spirometry abnormal | 68 | 242.8 188.7–312.5ROR 244.3 · calibrated p 1e-10 ✓ | 202.3 EB05 165.1 · IC025 +6.0 3/3 methods agree | Lab value / disease marker | serious n=68 · ♀ 0% (drug 63%) | no trial data cached |
| Creatinine renal clearance decreased | 450 | 233.3 211.8–256.9ROR 242.9 · calibrated p 7e-11 ✓ | 205.2 EB05 189.8 · IC025 +7.2 3/3 methods agree | Lab value / disease marker | serious n=450 · ♀ 100% (drug 63%) | no trial data cached |
| Deep vein thrombosis postoperative | 218 | 232.0 201.7–266.8ROR 236.5 · calibrated p 1e-10 ✓ | 202.3 EB05 180.8 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious n=218 · ♀ 100% (drug 63%) · 97% clinician | no trial data cached |
| Mite allergy | 68 | 221.2 172.1–284.3ROR 222.5 · calibrated p 3e-10 ✓ | 187.1 EB05 152.7 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=68 · ♀ 0% (drug 63%) | no trial data cached |
| Adjustment disorder with depressed mood | 210 | 215.7 187.2–248.6ROR 219.8 · calibrated p 2e-10 ✓ | 189.7 EB05 169.1 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious n=210 · ♀ 100% (drug 63%) · 95% clinician | no trial data cached |
| Dislocation of vertebra | 229 | 212.8 185.9–243.8ROR 217.2 · calibrated p 2e-10 ✓ | 187.8 EB05 168.2 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious n=229 · ♀ 100% (drug 63%) · 93% clinician | no trial data cached |
| Retinitis | 170 | 210.3 179.6–246.2ROR 213.5 · calibrated p 3e-10 ✓ | 184.8 EB05 162.6 · IC025 +6.7 3/3 methods agree | Not in label — unassessed | serious n=170 · ♀ 100% (drug 63%) · 96% clinician | no trial data cached |
| Seronegative arthritis | 103 | 187.4 153.1–229.3ROR 189.1 · calibrated p 9e-10 ✓ | 164.9 EB05 139.9 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=103 · ♀ 100% (drug 63%) · 96% clinician | no trial data cached |
| Pulmonary vasculitis | 48 | 185.1 137.7–249.0ROR 185.9 · calibrated p 2e-9 ✓ | 157.8 EB05 123.7 · IC025 +5.5 3/3 methods agree | Labeled (related wording) related wording | serious n=48 · ♀ 0% (drug 63%) | no trial data cached |
| Systemic lupus erythematosus rash | 71 | 180.0 141.2–229.6ROR 181.2 · calibrated p 2e-9 ✓ | 157.1 EB05 128.8 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=71 · ♀ 100% (drug 63%) · 96% clinician | no trial data cached |
| Multiple drug therapy | 61 | 177.6 136.6–230.8ROR 178.5 · calibrated p 2e-9 ✓ | 154.2 EB05 124.4 · IC025 +5.7 3/3 methods agree | Reporting / coding artifact | serious n=61 · ♀ 100% (drug 63%) · 92% clinician | no trial data cached |
| Mycotic allergy | 69 | 165.3 129.3–211.4ROR 166.3 · calibrated p 3e-9 ✓ | 145.7 EB05 119.0 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=69 · ♀ 0% (drug 63%) | no trial data cached |
| X-ray abnormal | 145 | 163.9 138.5–194.1ROR 166.1 · calibrated p 2e-9 ✓ | 147.6 EB05 128.5 · IC025 +6.4 3/3 methods agree | Lab value / disease marker | serious n=145 · ♀ 100% (drug 63%) · 94% clinician | no trial data cached |
| Alveolar osteitis | 31 | 145.3 100.9–209.4ROR 145.7 · calibrated p 2e-8 ✓ | 124.5 EB05 91.9 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=31 · ♀ 90% (drug 63%) | no trial data cached |
| Porphyria acute | 100 | 144.8 118.2–177.3ROR 146.0 · calibrated p 8e-9 ✓ | 130.9 EB05 110.7 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=100 · ♀ 100% (drug 63%) · 93% clinician | no trial data cached |
| Dust allergy | 69 | 142.9 111.9–182.4ROR 143.7 · calibrated p 1e-8 ✓ | 128.0 EB05 104.6 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=69 · ♀ 0% (drug 63%) | no trial data cached |
| Creatinine renal clearance increased | 53 | 140.6 106.4–185.9ROR 141.3 · calibrated p 1e-8 ✓ | 124.9 EB05 99.1 · IC025 +5.4 3/3 methods agree | Lab value / disease marker | serious n=53 · ♀ 100% (drug 63%) · 94% clinician | no trial data cached |
| Urinary tract discomfort | 31 | 136.2 94.6–196.1ROR 136.6 · calibrated p 3e-8 ✓ | 117.8 EB05 87.0 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=31 · ♀ 100% (drug 63%) | no trial data cached |
| Hypocholesterolaemia | 20 | 128.8 81.8–202.5ROR 129.0 · calibrated p 7e-8 ✓ | 108.2 EB05 73.9 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=20 | no trial data cached |
| Grip strength | 15 | 128.1 75.9–216.2ROR 128.3 · calibrated p 1e-7 ✓ | 104.3 EB05 67.1 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Total lung capacity abnormal | 23 | 119.1 78.2–181.6ROR 119.4 · calibrated p 1e-7 ✓ | 102.6 EB05 72.0 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 0% (drug 63%) | no trial data cached |
| Body tinea | 33 | 115.1 81.0–163.6ROR 115.5 · calibrated p 9e-8 ✓ | 102.1 EB05 76.1 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=33 · ♀ 100% (drug 63%) · 100% clinician | no trial data cached |
| Rheumatic fever | 246 | 110.6 97.4–125.6ROR 113.1 · calibrated p 5e-8 ✓ | 103.5 EB05 93.1 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=246 · ♀ 100% (drug 63%) · 94% clinician | no trial data cached |
| Swollen joint count increased | 173 | 108.8 93.5–126.7ROR 110.5 · calibrated p 6e-8 ✓ | 101.7 EB05 89.6 · IC025 +6.1 3/3 methods agree | Lab value / disease marker | serious n=173 · ♀ 100% (drug 63%) · 96% clinician | no trial data cached |
| Duodenal ulcer perforation | 401 | 107.1 97.0–118.3ROR 111.0 · calibrated p 5e-8 ✓ | 100.8 EB05 92.7 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious PRR 69.0 · ♀ 100% (drug 63%) · 96% clinician | no trial data cached |
| Muscle injury | 438 | 104.5 95.1–114.9ROR 108.7 · calibrated p 6e-8 ✓ | 98.5 EB05 91.0 · IC025 +6.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 73.1 · ♀ 100% (drug 63%) · 97% clinician | no trial data cached |
| Bone erosion | 188 | 103.9 89.8–120.2ROR 105.6 · calibrated p 9e-8 ✓ | 97.4 EB05 86.3 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=188 · ♀ 100% (drug 63%) · 91% clinician | no trial data cached |
| Swollen joint count | 13 | 103.3 59.1–180.6ROR 103.5 · calibrated p 6e-7 ✓ | 85.9 EB05 53.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Adulterated product | 10 | 101.6 53.7–192.0ROR 101.7 · calibrated p 1e-6 ✓ | 81.8 EB05 47.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Anti-cyclic citrullinated peptide antibody positive | 367 | 100.9 91.0–111.9ROR 104.3 · calibrated p 9e-8 ✓ | 95.2 EB05 87.3 · IC025 +6.2 3/3 methods agree | Lab value / disease marker | serious PRR 65.5 · ♀ 100% (drug 63%) · 96% clinician | no trial data cached |
| Bunion operation | 28 | 97.3 66.6–142.3ROR 97.6 · calibrated p 3e-7 ✓ | 87.1 EB05 63.3 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious n=28 · ♀ 100% (drug 63%) | no trial data cached |
| Facet joint syndrome | 152 | 93.9 79.8–110.4ROR 95.1 · calibrated p 2e-7 ✓ | 88.4 EB05 77.2 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=152 · ♀ 100% (drug 63%) · 92% clinician | no trial data cached |
| Sleep disorder due to general medical condition, insomnia type | 306 | 92.5 82.6–103.6ROR 95.0 · calibrated p 2e-7 ✓ | 87.6 EB05 79.7 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=306 · ♀ 100% (drug 63%) · 99% clinician | no trial data cached |
| Conjunctivitis allergic | 69 | 91.7 72.1–116.8ROR 92.3 · calibrated p 3e-7 ✓ | 85.4 EB05 69.8 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=69 · ♀ 0% (drug 63%) | 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 |
|---|---|---|---|---|---|---|
| Dyspnoea (shortness of breath) | 1,297 | 4.3 4.0–4.5ROR 4.7 · calibrated p 0.272 | 4.2 EB05 4.1 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 | no trial data cached |
| Pain | 1,171 | 3.5 3.3–3.7ROR 3.8 · calibrated p 0.412 | 3.5 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 · ♀ 94% (drug 63%) | no trial data cached |
| Fatigue (tiredness) | 1,114 | 2.7 2.5–2.8ROR 2.8 · calibrated p 0.680 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.0 | no trial data cached |
| Fall | 1,049 | 5.9 5.5–6.2ROR 6.4 · calibrated p 0.129 | 5.8 EB05 5.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · ♀ 88% (drug 63%) | no trial data cached |
| Arthralgia (joint pain) | 897 | 4.0 3.8–4.3ROR 4.3 · calibrated p 0.330 | 4.0 EB05 3.8 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · ♀ 87% (drug 63%) | no trial data cached |
| Headache | 873 | 2.6 2.4–2.8ROR 2.7 · calibrated p 0.725 | 2.6 EB05 2.4 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.2 · ♀ 88% (drug 63%) | no trial data cached |
| Diarrhoea (diarrhea) | 870 | 2.5 2.4–2.7ROR 2.6 · calibrated p 0.758 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.7 | no trial data cached |
| Dizziness | 860 | 3.2 3.0–3.4ROR 3.4 · calibrated p 0.513 | 3.2 EB05 3.0 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 | no trial data cached |
| Pruritus (itching) | 841 | 4.1 3.9–4.4ROR 4.4 · calibrated p 0.314 | 4.1 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 · ♀ 87% (drug 63%) | no trial data cached |
| Hypotension (low blood pressure) | 834 | 7.7 7.3–8.3ROR 8.3 · calibrated p 0.060 | 7.7 EB05 7.3 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.0 | no trial data cached |
| Nausea | 827 | 1.9 1.8–2.1ROR 2.0 · calibrated p 0.954 | 1.9 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 2.3 | no trial data cached |
| Pyrexia (fever) | 819 | 4.4 4.1–4.7ROR 4.7 · calibrated p 0.275 | 4.4 EB05 4.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 · ♀ 85% (drug 63%) | no trial data cached |
| Drug ineffective (drug did not work) | 810 | 1.1 1.1–1.2ROR 1.2 · calibrated p 0.408 | 1.1 EB05 1.1 · IC025 +0.1 | Reporting / coding artifact | serious PRR 1.8 | no trial data cached |
| Off label use (used outside approved label) | 763 | 1.6 1.5–1.7ROR 1.7 · calibrated p 0.754 | 1.6 EB05 1.5 · IC025 +0.6 | Reporting / coding artifact | serious PRR 1.9 · ♀ 85% (drug 63%) | no trial data cached |
| Mobility decreased | 710 | 18.6 17.3–19.9ROR 19.7 · calibrated p 0.002 ✓ | 18.4 EB05 17.3 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 18.2 · ♀ 97% (drug 63%) | 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.
- Heart sounds — n=49, PRR 1,906.1
- Prolonged expiration — n=49, PRR 422.6
- Lupus vulgaris — n=207, PRR 391.0
- Amaurosis fugax — n=181, PRR 378.2
- Deep vein thrombosis postoperative — n=218, PRR 232.0
- Mite allergy — n=68, PRR 221.2
- Adjustment disorder with depressed mood — n=210, PRR 215.7
- Dislocation of vertebra — n=229, PRR 212.8
- Retinitis — n=170, PRR 210.3
- Seronegative arthritis — n=103, PRR 187.4
✓ A hand-written Bradford Hill causality assessment exists for this drug: Diltiazem (non-dihydropyridine CCBs) ↔ Bradycardia / AV block.
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 Diltiazem Extended-Release?
In FDA FAERS, the most frequently co-reported reaction terms for Diltiazem Extended-Release are dyspnoea, pain, fatigue, fall, arthralgia, headache. 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 Diltiazem Extended-Release have an FDA boxed warning?
No. The FDA label retrieved for Diltiazem Extended-Release has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Diltiazem Extended-Release 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 73b3607a-99d0-44d8-92ef-0074684c9d7d, effective 20250401; matched on
openfda.generic_name.exact:"DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS") - 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, 1,130 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 2026-10-14. 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.