Drug · FAERS side-effect profile with label screen

Dalteparin side effects: what 10,517 FDA adverse event reports show

Dalteparin Sodium · 1,104 reaction terms · 51,134 drug–reaction co-reports · data 2026-09-14

Drug class

Low molecular weight heparin (lmwh)

FDA label, Indications wording of the closest related product

Label matched

Dalteparin Sodium (Fragmin)

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

Who reports

10,517 reports · 92% serious · 2,287 with death outcome · 52% female

openFDA FAERS counts, all years, deduplication not applied

Used for

FRAGMIN is a low molecular weight heparin (LMWH) indicated for • Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction ( 1.1 ) • Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement sur.

FDA label, Indications and Usage

What it is

FRAGMIN Injection (dalteparin sodium injection) is a sterile, low molecular weight heparin. It is available in single-dose, prefilled syringes preassembled with a needle guard device, and multiple-dose vials. With reference to the W.H.O.

FDA label, Description section

Boxed warning

SPINAL/EPIDURAL HEMATOMAS Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures.

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 (related wording) 2Reporting / coding artifact 6Lab value / disease marker 3Not in label — unassessed 29

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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,064 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
Appendicolith	270	5,056.8 4,039.5–6,330.3ROR 5,190.1 · χ² 380,737 / p <1e-300	1,286.2 EB05 1,162.5 · IC025 +8.4 3/3 methods agree	Not in label — unassessed	serious n=270 · ♀ 7% (drug 52%) · 96% clinician	no trial arm names this drug
Antacid therapy	78	3,741.2 2,564.6–5,457.6ROR 3,769.2 · χ² 99,203 / p <1e-300	977.6 EB05 808.7 · IC025 +6.8 3/3 methods agree	Reporting / coding artifact	serious n=78 · ♀ 23% (drug 52%) · 100% clinician	no trial arm names this drug
Sleep disorder therapy	102	2,446.2 1,830.3–3,269.4ROR 2,470.1 · χ² 110,018 / p <1e-300	904.1 EB05 766.2 · IC025 +7.1 3/3 methods agree	Reporting / coding artifact	serious n=102 · ♀ 7% (drug 52%) · 98% clinician	no trial arm names this drug
Analgesic therapy	112	1,153.2 914.0–1,455.0ROR 1,165.6 · χ² 80,549 / p <1e-300	646.4 EB05 552.0 · IC025 +7.1 3/3 methods agree	Reporting / coding artifact	serious n=112 · ♀ 16% (drug 52%) · 96% clinician	no trial arm names this drug
Drug therapy	108	1,021.1 809.9–1,287.3ROR 1,031.7 · χ² 71,777 / p <1e-300	600.5 EB05 511.3 · IC025 +7.0 3/3 methods agree	Reporting / coding artifact	serious n=108 · ♀ 16% (drug 52%) · 96% clinician	no trial arm names this drug
Anticoagulant therapy	80	810.9 625.5–1,051.5ROR 817.2 · χ² 45,249 / p <1e-300	504.8 EB05 418.6 · IC025 +6.6 3/3 methods agree	Reporting / coding artifact	serious n=80 · ♀ 25% (drug 52%) · 94% clinician	no trial arm names this drug
Venous pressure jugular decreased	10	702.3 341.3–1,445.5ROR 703.0 · χ² 4,656 / p <1e-300	260.4 EB05 151.2 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=10	no trial arm names this drug
Malignant melanoma stage 0	44	640.9 456.3–900.2ROR 643.6 · χ² 20,723 / p <1e-300	399.4 EB05 309.8 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious n=44 · ♀ 0% (drug 52%) · 100% clinician	no trial arm names this drug
Congenital hiatus hernia	52	612.3 448.8–835.4ROR 615.4 · χ² 23,738 / p <1e-300	398.5 EB05 315.6 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious n=52 · ♀ 0% (drug 52%) · 100% clinician	no trial arm names this drug
Truncus arteriosus persistent	43	542.1 387.0–759.3ROR 544.3 · χ² 17,783 / p <1e-300	357.4 EB05 276.4 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious n=43 · 92% clinician	no trial arm names this drug
Bacteroides infection	34	301.2 210.0–431.9ROR 302.2 · χ² 8,563 / p <1e-300	227.9 EB05 170.6 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious n=34 · ♀ 0% (drug 52%) · 100% clinician	no trial arm names this drug
Arteriovenous fistula occlusion	21	269.9 171.1–425.7ROR 270.5 · χ² 4,714 / p <1e-300	195.5 EB05 134.9 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=21 · ♀ 100% (drug 52%)	no trial arm names this drug
Lymph node calcification	16	177.8 106.6–296.4ROR 178.0 · χ² 2,420 / p <1e-300	136.8 EB05 89.3 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=16	no trial arm names this drug
Vessel puncture site bruise	15	163.9 96.8–277.4ROR 164.1 · χ² 2,094 / p <1e-300	127.2 EB05 81.8 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=15	no trial arm names this drug
Hyperphosphataemia	148	149.7 126.8–176.8ROR 151.8 · χ² 20,180 / p <1e-300	136.8 EB05 119.3 · IC025 +6.3 3/3 methods agree	Not in label — unassessed	serious n=148 · ♀ 13% (drug 52%) · 97% clinician	no trial arm names this drug
Blood phosphorus increased	180	141.0 121.4–163.9ROR 143.5 · χ² 23,224 / p <1e-300	129.9 EB05 114.7 · IC025 +6.3 3/3 methods agree	Lab value / disease marker	serious n=180 · ♀ 12% (drug 52%) · 96% clinician	no trial arm names this drug
Foetal chromosome abnormality	10	125.3 66.1–237.3ROR 125.4 · χ² 1,045 / p 2e-229	96.7 EB05 56.1 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=10	no trial arm names this drug
Genital erosion	17	123.4 75.6–201.3ROR 123.6 · χ² 1,828 / p <1e-300	103.0 EB05 68.1 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=17	no trial arm names this drug
Blue toe syndrome	22	119.5 77.7–183.7ROR 119.8 · χ² 2,327 / p <1e-300	102.9 EB05 71.6 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=22 · ♀ 100% (drug 52%)	no trial arm names this drug
Bronchopulmonary aspergillosis allergic	48	110.1 82.4–147.2ROR 110.6 · χ² 4,813 / p <1e-300	100.3 EB05 78.7 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious n=48 · ♀ 0% (drug 52%) · 100% clinician	no trial arm names this drug
Staphylococcal scalded skin syndrome	11	102.0 55.7–187.0ROR 102.1 · χ² 952 / p 2e-209	83.5 EB05 49.7 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=11	no trial arm names this drug
Cardiac septal defect	35	101.2 72.1–142.1ROR 101.6 · χ² 3,208 / p <1e-300	91.6 EB05 68.9 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious n=35 · 100% clinician	no trial arm names this drug
Abdominal wall haemorrhage	12	97.1 54.4–173.3ROR 97.2 · χ² 998 / p 2e-219	81.1 EB05 49.4 · IC025 +3.3 3/3 methods agree	Labeled (related wording) related wording	serious n=12	no trial arm names this drug
Congenital cardiovascular anomaly	35	85.6 61.1–120.0ROR 85.9 · χ² 2,724 / p <1e-300	78.7 EB05 59.1 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=35 · 100% clinician	no trial arm names this drug
Operative haemorrhage	18	82.7 51.6–132.5ROR 82.8 · χ² 1,317 / p 1e-288	73.5 EB05 49.2 · IC025 +3.9 3/3 methods agree	Labeled (related wording) related wording	serious n=18	no trial arm names this drug
Haemangioma congenital	15	64.5 38.6–107.9ROR 64.6 · χ² 848 / p 9e-187	58.1 EB05 37.4 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=15	no trial arm names this drug
Appendicitis	275	60.8 54.0–68.4ROR 62.4 · χ² 15,631 / p <1e-300	58.8 EB05 53.1 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious PRR 37.5 · ♀ 7% (drug 52%) · 96% clinician	no trial arm names this drug
Activated partial thromboplastin time prolonged	144	58.1 49.3–68.5ROR 58.9 · χ² 7,800 / p <1e-300	56.1 EB05 48.8 · IC025 +5.3 3/3 methods agree	Lab value / disease marker	serious n=142 · 96% clinician	no trial arm names this drug
Selective eating disorder	25	56.3 37.8–83.7ROR 56.4 · χ² 1,266 / p 1e-277	52.6 EB05 37.5 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=25	no trial arm names this drug
Total lung capacity decreased	43	55.0 40.6–74.4ROR 55.2 · χ² 2,165 / p <1e-300	52.3 EB05 40.5 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=43 · ♀ 16% (drug 52%) · 95% clinician	no trial arm names this drug
Device operational issue	113	54.8 45.5–66.0ROR 55.4 · χ² 5,753 / p <1e-300	52.9 EB05 45.2 · IC025 +5.1 3/3 methods agree	Reporting / coding artifact	–	no trial arm names this drug
Blood uric acid increased	148	52.5 44.6–61.7ROR 53.2 · χ² 7,233 / p <1e-300	50.8 EB05 44.3 · IC025 +5.2 3/3 methods agree	Lab value / disease marker	serious n=148 · ♀ 17% (drug 52%) · 98% clinician	no trial arm names this drug
Foetal heart rate deceleration abnormality	18	52.4 32.8–83.6ROR 52.5 · χ² 834 / p 1e-183	48.6 EB05 32.5 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=18	no trial arm names this drug
Iron deficiency	106	48.7 40.2–59.0ROR 49.2 · χ² 4,784 / p <1e-300	47.1 EB05 40.1 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious n=106 · ♀ 12% (drug 52%) · 95% clinician	no trial arm names this drug
Engraftment syndrome	14	48.6 28.6–82.6ROR 48.7 · χ² 592 / p 5e-131	44.8 EB05 28.4 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=14	no trial arm names this drug
Gastric antral vascular ectasia	12	47.1 26.6–83.5ROR 47.2 · χ² 485 / p 1e-107	43.1 EB05 26.3 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=12	no trial arm names this drug
Congestive hepatopathy	10	45.8 24.5–85.8ROR 45.9 · χ² 386 / p 3e-86	41.5 EB05 24.1 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=10	no trial arm names this drug
Aortic stenosis	76	44.5 35.4–55.8ROR 44.8 · χ² 3,115 / p <1e-300	43.1 EB05 35.5 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=76 · ♀ 26% (drug 52%) · 96% clinician	no trial arm names this drug
Mucosal erosion	19	42.7 27.1–67.2ROR 42.7 · χ² 716 / p 4e-158	40.2 EB05 27.2 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=19	no trial arm names this drug
Cardiogenic shock	295	42.1 37.6–47.1ROR 43.3 · χ² 11,549 / p <1e-300	41.1 EB05 37.3 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious PRR 25.8 · ♀ 11% (drug 52%) · 96% clinician	no trial arm names this drug

Trial evidence (ClinicalTrials.gov)

ClinicalTrials.gov returned results-bearing trials mentioning Dalteparin only as a background or rescue medication (NCT02984384, NCT00089895); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.

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
Nausea	708	1.8 1.7–1.9ROR 1.8 · χ² 255 / p 8e-58	1.8 EB05 1.7 · IC025 +0.7	Not in label — unassessed	serious PRR 2.1	no trial arm names this drug
Off label use (used outside approved label)	694	1.6 1.5–1.7ROR 1.6 · χ² 160 / p 6e-37	1.6 EB05 1.5 · IC025 +0.5	Reporting / coding artifact	serious PRR 1.8	no trial arm names this drug
Pulmonary embolism (lung blood clot)	600	12.6 11.7–13.6ROR 13.3 · χ² 6,387 / p <1e-300	12.5 EB05 11.7 · IC025 +3.5 3/3 methods agree	Likely indication confounding term in indications	serious PRR 7.9	no trial arm names this drug
Dyspnoea (shortness of breath)	591	2.1 1.9–2.3ROR 2.1 · χ² 341 / p 2e-76	2.1 EB05 1.9 · IC025 +0.9	Not in label — unassessed	serious PRR 1.8	no trial arm names this drug
Vomiting	575	2.4 2.3–2.6ROR 2.5 · χ² 501 / p 3e-111	2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 2.3	no trial arm names this drug
Abdominal pain	526	4.5 4.2–4.9ROR 4.7 · χ² 1,451 / p <1e-300	4.5 EB05 4.2 · IC025 +2.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 3.8	no trial arm names this drug
Sepsis (blood infection)	495	8.9 8.1–9.7ROR 9.3 · χ² 3,456 / p <1e-300	8.8 EB05 8.2 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 5.6 · ♀ 21% (drug 52%) · 93% clinician	no trial arm names this drug
Pyrexia (fever)	490	2.8 2.6–3.1ROR 2.9 · χ² 584 / p 2e-129	2.8 EB05 2.6 · IC025 +1.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 2.2	no trial arm names this drug
Diarrhoea (diarrhea)	461	1.4 1.3–1.6ROR 1.4 · χ² 61 / p 3e-15	1.4 EB05 1.3 · IC025 +0.4	Not in label — unassessed	serious PRR 1.6	no trial arm names this drug
General physical health deterioration	460	8.0 7.3–8.8ROR 8.3 · χ² 2,820 / p <1e-300	7.9 EB05 7.3 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	serious PRR 5.9 · ♀ 27% (drug 52%) · 91% clinician	no trial arm names this drug
Fatigue (tiredness)	453	1.2 1.1–1.3ROR 1.2 · χ² 11 / p 6e-4	1.2 EB05 1.1 · IC025 +0.1	Not in label — unassessed	serious PRR 1.4	no trial arm names this drug
Constipation	447	4.1 3.8–4.5ROR 4.3 · χ² 1,064 / p 1e-233	4.1 EB05 3.8 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 4.6	no trial arm names this drug
Anaemia (low red blood cells)	438	4.6 4.2–5.0ROR 4.7 · χ² 1,232 / p 3e-270	4.6 EB05 4.2 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 3.2 · 90% clinician	no trial arm names this drug
Death	415	1.0 0.9–1.1ROR 1.0 · χ² 1 / p 0.209	1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC	Outcome field, not a reaction	serious PRR 0.6	no trial arm names this drug
Condition aggravated	400	2.6 2.4–2.9ROR 2.7 · χ² 412 / p 5e-92	2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 2.5 · 92% clinician	no trial arm names this drug

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.

Appendicolith — n=270, PRR 5,056.8
Malignant melanoma stage 0 — n=44, PRR 640.9
Congenital hiatus hernia — n=52, PRR 612.3
Truncus arteriosus persistent — n=43, PRR 542.1
Bacteroides infection — n=34, PRR 301.2
Arteriovenous fistula occlusion — n=21, PRR 269.9
Hyperphosphataemia — n=148, PRR 149.7
Blue toe syndrome — n=22, PRR 119.5
Bronchopulmonary aspergillosis allergic — n=48, PRR 110.1
Cardiac septal defect — n=35, PRR 101.2

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 Dalteparin?

In FDA FAERS, the most frequently co-reported reaction terms for Dalteparin are nausea, pulmonary embolism, dyspnoea, vomiting, abdominal pain, sepsis. 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 Dalteparin have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: SPINAL/EPIDURAL HEMATOMAS Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures.

Do FAERS signals prove that Dalteparin 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 23527b8b-9b28-4e6d-9751-33b143975ac7, effective 20250930; matched on openfda.generic_name.exact:"DALTEPARIN SODIUM")
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, 1,104 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
ClinicalTrials.gov API v2 (query DALTEPARIN, results-bearing studies sorted by enrollment)

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.