Drug · FAERS side-effect profile with label screen
Heparin side effects: what 13,673 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Heparin Sodium (Heparin Sodium)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
13,673 reports · 79% serious · 2,609 with death outcome · 46% female
openFDA FAERS counts, all years, deduplication not applied
Used for
HEPARIN SODIUM IN SODIUM CHLORIDE INJECTION is indicated for: • Prophylaxis and treatment of venous thrombosis and pulmonary embolism; • Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation; • Treatment of acute.
FDA label, Indications and Usage
What it is
Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans possessing anticoagulant properties. It is composed of polymers of alternating derivat.
FDA label, Description section
Boxed warning
None in the current 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 2Labeled (related wording) 3Reporting / coding artifact 7Lab value / disease marker 8Not in label — unassessed 20
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.
- 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. 1,050 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 |
|---|---|---|---|---|---|---|
| Appendicolith | 227 | 2,319.7 1,887.1–2,851.5ROR 2,358.8 · χ² 206,730 / p <1e-300 | 849.9 EB05 761.1 · IC025 +8.0 3/3 methods agree | Not in label — unassessed | serious n=227 · ♀ 2% (drug 46%) · 97% clinician | not reported in cached trials |
| Anti factor v antibody | 13 | 2,184.6 934.0–5,109.8ROR 2,186.7 · χ² 10,731 / p <1e-300 | 385.6 EB05 239.8 · IC025 +3.8 3/3 methods agree | Lab value / disease marker | serious n=13 | not reported in cached trials |
| Autoimmune heparin-induced thrombocytopenia | 30 | 1,972.7 1,146.2–3,395.2ROR 1,977.0 · χ² 24,807 / p <1e-300 | 552.8 EB05 405.9 · IC025 +5.2 3/3 methods agree | Labeled (related wording) related wording | serious n=30 · ♀ 17% (drug 46%) | not reported in cached trials |
| Sleep disorder therapy | 84 | 1,270.4 951.0–1,697.1ROR 1,278.3 · χ² 57,218 / p <1e-300 | 596.4 EB05 496.9 · IC025 +6.7 3/3 methods agree | Reporting / coding artifact | serious n=84 · ♀ 7% (drug 46%) · 98% clinician | not reported in cached trials |
| Antacid therapy | 54 | 1,256.5 876.2–1,801.8ROR 1,261.4 · χ² 36,318 / p <1e-300 | 551.7 EB05 438.9 · IC025 +6.1 3/3 methods agree | Reporting / coding artifact | serious n=54 · ♀ 10% (drug 46%) · 100% clinician | not reported in cached trials |
| Heparin resistance | 44 | 937.3 643.7–1,364.6ROR 940.3 · χ² 24,832 / p <1e-300 | 462.2 EB05 358.5 · IC025 +5.8 3/3 methods agree | Reporting / coding artifact | serious n=39 · 100% clinician | not reported in cached trials |
| White clot syndrome | 13 | 655.4 341.9–1,256.1ROR 656.0 · χ² 5,478 / p <1e-300 | 273.6 EB05 170.2 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Analgesic therapy | 84 | 580.1 451.3–745.6ROR 583.7 · χ² 34,681 / p <1e-300 | 382.9 EB05 318.9 · IC025 +6.6 3/3 methods agree | Reporting / coding artifact | serious n=84 · ♀ 7% (drug 46%) · 98% clinician | not reported in cached trials |
| Heparin-induced thrombocytopenia | 1,273 | 533.2 501.3–567.1ROR 587.8 · χ² 499,663 / p <1e-300 | 392.1 EB05 374.4 · IC025 +8.3 3/3 methods agree | Labeled adverse reaction exact term | serious n=1,204 · 96% clinician | NCT00986154: 1/4,122 (0.0%) on Heparin (serious AE) |
| Drug therapy | 82 | 530.0 412.4–681.2ROR 533.2 · χ² 31,670 / p <1e-300 | 359.7 EB05 299.0 · IC025 +6.5 3/3 methods agree | Reporting / coding artifact | serious n=82 · ♀ 7% (drug 46%) · 98% clinician | NCT00986154: 1/4,122 (0.0%) on Heparin (serious AE) |
| Anticoagulant therapy | 55 | 379.8 282.8–510.2ROR 381.4 · χ² 16,308 / p <1e-300 | 274.8 EB05 219.1 · IC025 +5.9 3/3 methods agree | Reporting / coding artifact | serious n=55 · ♀ 12% (drug 46%) · 96% clinician | not reported in cached trials |
| Congenital hiatus hernia | 41 | 348.4 248.2–489.0ROR 349.4 · χ² 11,262 / p <1e-300 | 250.3 EB05 192.4 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=41 · ♀ 0% (drug 46%) · 100% clinician | not reported in cached trials |
| Anti factor x activity increased | 10 | 343.7 173.0–682.9ROR 344.0 · χ² 2,512 / p <1e-300 | 183.0 EB05 106.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Malignant melanoma stage 0 | 32 | 329.2 224.7–482.4ROR 330.0 · χ² 8,332 / p <1e-300 | 233.0 EB05 172.8 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=32 · ♀ 0% (drug 46%) · 100% clinician | not reported in cached trials |
| Heparin-induced thrombocytopenia test positive | 13 | 276.9 153.3–500.1ROR 277.2 · χ² 2,792 / p <1e-300 | 174.6 EB05 108.6 · IC025 +3.7 3/3 methods agree | Lab value / disease marker | serious n=13 | not reported in cached trials |
| Heparin-induced thrombocytopenia test | 11 | 244.7 129.4–462.5ROR 244.8 · χ² 2,092 / p <1e-300 | 154.7 EB05 92.2 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious n=10 | NCT00986154: 1/4,122 (0.0%) on Heparin (serious AE) |
| Coagulation time shortened | 36 | 183.3 129.8–259.0ROR 183.8 · χ² 5,661 / p <1e-300 | 150.7 EB05 113.7 · IC025 +5.1 3/3 methods agree | Lab value / disease marker | serious n=15 | not reported in cached trials |
| Bacteroides infection | 27 | 178.3 119.7–265.6ROR 178.7 · χ² 4,101 / p <1e-300 | 143.6 EB05 103.6 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=27 · ♀ 0% (drug 46%) · 100% clinician | not reported in cached trials |
| Vascular access site haemorrhage | 16 | 171.6 102.4–287.7ROR 171.8 · χ² 2,287 / p <1e-300 | 130.6 EB05 85.2 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | – | not reported in cached trials |
| Hypoaldosteronism | 21 | 125.5 80.5–195.9ROR 125.7 · χ² 2,282 / p <1e-300 | 105.1 EB05 72.6 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=21 | not reported in cached trials |
| Congenital multiplex arthrogryposis | 12 | 94.5 52.8–169.3ROR 94.6 · χ² 959 / p 8e-211 | 78.3 EB05 47.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Blood phosphorus increased | 155 | 92.5 78.7–108.7ROR 93.5 · χ² 13,133 / p <1e-300 | 86.3 EB05 75.5 · IC025 +5.8 3/3 methods agree | Lab value / disease marker | serious n=154 · ♀ 8% (drug 46%) · 96% clinician | not reported in cached trials |
| Gastroduodenal ulcer | 23 | 89.0 58.4–135.4ROR 89.1 · χ² 1,807 / p <1e-300 | 78.8 EB05 55.3 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 23% (drug 46%) · 100% clinician | not reported in cached trials |
| Hyperphosphataemia | 116 | 88.8 73.7–107.0ROR 89.5 · χ² 9,428 / p <1e-300 | 82.8 EB05 70.9 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=115 · ♀ 7% (drug 46%) · 97% clinician | not reported in cached trials |
| Coagulation time abnormal | 16 | 88.6 53.6–146.7ROR 88.7 · χ² 1,228 / p 2e-269 | 76.4 EB05 49.9 · IC025 +3.7 3/3 methods agree | Lab value / disease marker | serious n=13 | not reported in cached trials |
| Bullous haemorrhagic dermatosis | 11 | 86.6 47.2–159.1ROR 86.7 · χ² 802 / p 1e-176 | 72.2 EB05 43.0 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Subcapsular renal haematoma | 10 | 78.8 41.7–148.7ROR 78.8 · χ² 658 / p 2e-145 | 65.9 EB05 38.3 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Graft thrombosis | 12 | 72.9 40.8–130.1ROR 72.9 · χ² 745 / p 3e-164 | 63.0 EB05 38.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Adrenal haemorrhage | 25 | 71.1 47.6–106.1ROR 71.2 · χ² 1,583 / p <1e-300 | 64.7 EB05 46.1 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious n=25 · 100% clinician | not reported in cached trials |
| Spinal epidural haematoma | 23 | 65.1 42.9–98.9ROR 65.2 · χ² 1,332 / p 7e-292 | 59.6 EB05 41.8 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=23 | not reported in cached trials |
| Activated partial thromboplastin time prolonged | 202 | 63.5 55.2–73.0ROR 64.4 · χ² 11,864 / p <1e-300 | 60.6 EB05 53.9 · IC025 +5.5 3/3 methods agree | Lab value / disease marker | serious n=184 · 92% clinician | not reported in cached trials |
| Bronchopulmonary aspergillosis allergic | 35 | 60.8 43.4–85.3ROR 61.0 · χ² 1,923 / p <1e-300 | 56.8 EB05 42.7 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=35 · ♀ 0% (drug 46%) · 100% clinician | not reported in cached trials |
| Operative haemorrhage | 17 | 59.9 36.9–97.3ROR 60.0 · χ² 892 / p 3e-196 | 54.4 EB05 35.9 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | – | NCT00986154: 2/4,118 (0.0%) on Heparin (serious AE) |
| Conductive deafness | 12 | 59.1 33.2–105.2ROR 59.2 · χ² 605 / p 7e-134 | 52.5 EB05 32.0 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Haemorrhagic infarction | 20 | 57.7 36.9–90.2ROR 57.8 · χ² 1,020 / p 4e-224 | 53.0 EB05 36.2 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious n=19 | NCT00986154: 1/4,118 (0.0%) on Heparin (serious AE) |
| Restrictive cardiomyopathy | 11 | 57.2 31.3–104.4ROR 57.2 · χ² 532 / p 5e-118 | 50.6 EB05 30.1 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Infective aneurysm | 17 | 55.3 34.1–89.7ROR 55.4 · χ² 823 / p 3e-181 | 50.5 EB05 33.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=17 | not reported in cached trials |
| Venoocclusive disease | 85 | 53.8 43.4–66.8ROR 54.1 · χ² 4,204 / p <1e-300 | 51.4 EB05 42.9 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=85 · 100% clinician | not reported in cached trials |
| Activated partial thromboplastin time shortened | 14 | 52.7 30.9–89.7ROR 52.7 · χ² 637 / p 9e-141 | 47.8 EB05 30.3 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious n=9 | not reported in cached trials |
| Enterococcus test positive | 21 | 51.0 33.0–78.7ROR 51.1 · χ² 948 / p 2e-208 | 47.4 EB05 32.7 · IC025 +3.8 3/3 methods agree | Lab value / disease marker | serious n=21 | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Heparin as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (5 of 40 signal terms matched).
- NCT02984384 — PREVENTion of Clot in Orthopaedic Trauma (N=12424, PHASE3; 7 AE terms posted; arms: Low Molecular Weight Heparin (LMWH)-Enox; Acetylsalicylic Acid (ASA)-Aspirin)
- NCT00986154 — Comparative Investigation of Low Molecular Weight (LMW) Heparin/Edoxaban Tosylate (DU176b) Versus (LMW) Hepari (N=8292, PHASE3; 808 AE terms posted; arms: Heparin/Edoxaban Tosylate; Heparin/Warfarin)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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 |
|---|---|---|---|---|---|---|
| Heparin-induced thrombocytopenia | 1,273 | 533.2 501.3–567.1ROR 587.8 · χ² 499,663 / p <1e-300 | 392.1 EB05 374.4 · IC025 +8.3 3/3 methods agree | Labeled adverse reaction exact term | serious n=1,204 · 96% clinician | NCT00986154: 1/4,122 (0.0%) on Heparin (serious AE) |
| Drug ineffective (drug did not work) | 1,000 | 1.2 1.1–1.2ROR 1.2 · χ² 25 / p 3e-7 | 1.2 EB05 1.1 · IC025 +0.1 | Reporting / coding artifact | serious PRR 1.4 · 93% clinician | not reported in cached trials |
| Off label use (used outside approved label) | 757 | 1.3 1.2–1.4ROR 1.4 · χ² 67 / p 1e-16 | 1.3 EB05 1.3 · IC025 +0.3 | Reporting / coding artifact | serious PRR 1.7 | not reported in cached trials |
| Nausea | 745 | 1.4 1.4–1.6ROR 1.5 · χ² 107 / p 2e-25 | 1.4 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.6 | NCT00986154: 1/4,122 (0.0%) on Heparin (serious AE) |
| Drug hypersensitivity | 628 | 5.0 4.6–5.4ROR 5.2 · χ² 2,001 / p <1e-300 | 4.9 EB05 4.6 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.7 | NCT00986154: 1/4,122 (0.0%) on Heparin (serious AE) |
| Vomiting | 610 | 2.0 1.8–2.2ROR 2.0 · χ² 309 / p 2e-69 | 2.0 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 1.8 | NCT00986154: 1/4,122 (0.0%) on Heparin (serious AE) |
| Hypotension (low blood pressure) | 562 | 4.3 4.0–4.7ROR 4.5 · χ² 1,436 / p <1e-300 | 4.3 EB05 4.0 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 | NCT00986154: 2/4,122 (0.0%) on Heparin (serious AE) |
| Dyspnoea (shortness of breath) | 548 | 1.5 1.4–1.6ROR 1.5 · χ² 89 / p 2e-21 | 1.5 EB05 1.4 · IC025 +0.4 | Not in label — unassessed | serious PRR 1.2 | NCT00986154: 6/4,122 (0.1%) on Heparin (serious AE) |
| Pulmonary embolism (lung blood clot) | 500 | 8.1 7.4–8.8ROR 8.3 · χ² 3,087 / p <1e-300 | 8.0 EB05 7.4 · IC025 +2.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 5.8 · 94% clinician | NCT02984384: 90/6,110 (1.5%) on Heparin (serious AE) |
| Sepsis (blood infection) | 490 | 6.8 6.2–7.4ROR 7.0 · χ² 2,401 / p <1e-300 | 6.7 EB05 6.2 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · 91% clinician | NCT00986154: 10/4,122 (0.2%) on Heparin (serious AE) |
| Pyrexia (fever) | 485 | 2.2 2.0–2.3ROR 2.2 · χ² 302 / p 7e-68 | 2.1 EB05 2.0 · IC025 +1.0 | Labeled (related wording) related wording | serious PRR 1.9 | NCT00986154: 6/4,122 (0.1%) on Heparin (serious AE) |
| Anaemia (low red blood cells) | 479 | 3.9 3.5–4.2ROR 4.0 · χ² 1,017 / p 2e-223 | 3.8 EB05 3.6 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 · 93% clinician | NCT00986154: 13/4,122 (0.3%) on Heparin (serious AE) |
| Abdominal pain | 478 | 3.2 2.9–3.4ROR 3.2 · χ² 709 / p 2e-156 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 · ♀ 25% (drug 46%) | NCT00986154: 5/4,118 (0.1%) on Heparin (serious AE) |
| Thrombocytopenia (low platelets) | 471 | 6.5 5.9–7.1ROR 6.7 · χ² 2,189 / p <1e-300 | 6.4 EB05 6.0 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 · 90% clinician | NCT00986154: 1/4,118 (0.0%) on Heparin (serious AE) |
| Thrombosis | 437 | 8.3 7.6–9.2ROR 8.6 · χ² 2,814 / p <1e-300 | 8.3 EB05 7.6 · IC025 +2.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 6.0 | NCT02984384: 103/6,110 (1.7%) on Heparin (serious AE) |
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=227, PRR 2,319.7
- Congenital hiatus hernia — n=41, PRR 348.4
- Malignant melanoma stage 0 — n=32, PRR 329.2
- Bacteroides infection — n=27, PRR 178.3
- Hypoaldosteronism — n=21, PRR 125.5
- Gastroduodenal ulcer — n=23, PRR 89.0
- Hyperphosphataemia — n=116, PRR 88.8
- Spinal epidural haematoma — n=23, PRR 65.1
- Bronchopulmonary aspergillosis allergic — n=35, PRR 60.8
- Venoocclusive disease — n=85, PRR 53.8
✓ A hand-written Bradford Hill causality assessment exists for this drug: Heparin ↔ Heparin-induced thrombocytopenia (HIT).
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 Heparin?
In FDA FAERS, the most frequently co-reported reaction terms for Heparin are heparin-induced thrombocytopenia, nausea, drug hypersensitivity, vomiting, hypotension, dyspnoea. 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 Heparin have an FDA boxed warning?
No. The FDA label retrieved for Heparin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Heparin 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 0413f511-6b34-4c15-e48b-3fad08baacbe, effective 20260512; matched on
openfda.generic_name.exact:"HEPARIN 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, fieldpatient.drug.openfda.generic_name.exact, 1,090 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
HEPARIN, 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.