Heparin Sodium
According to the FDA label: 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 and chronic consumption coagulopathies (disseminated intravascular coagulation); • Prevention of clotting in arterial and cardiac surgery; • Prophylaxis and treatment of peripheral arterial embolism; • Anticoagulant use in blood transfusions,…
13,199 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Heparin Sodium in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
Tap any term below for a plain-language definition.
- Heparin-induced Thrombocytopenia 1,232 reports
Drug Ineffective 947 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Off Label Use 719 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Nausea 717 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Drug Hypersensitivity 613 reports
An allergic-type reaction to a medication.
Full definition in the glossary →Vomiting 583 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Hypotension 549 reports
Dyspnoea 530 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Pyrexia 480 reports
The medical term for fever, meaning a raised body temperature.
Full definition in the glossary → See all drugs reporting this event →Pulmonary Embolism 471 reports
A blockage in one of the arteries of the lungs, usually caused by a blood clot. This is a serious condition that needs urgent medical care.
Full definition in the glossary →Sepsis 462 reports
A serious, body-wide response to an infection that can become life threatening and needs urgent care.
Full definition in the glossary →Thrombocytopenia 462 reports
A low level of platelets, the blood cells that help with clotting.
Full definition in the glossary →Anaemia 453 reports
A condition where there are too few healthy red blood cells to carry enough oxygen, often causing tiredness and paleness. Also spelled anemia in American English.
Full definition in the glossary → See all drugs reporting this event →Abdominal Pain 452 reports
Pain in the belly or stomach area.
Full definition in the glossary → See all drugs reporting this event →Thrombosis 417 reports
The formation of a blood clot inside a blood vessel.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Male | 5,907 |
| Female | 4,983 |
| Unknown | 148 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 709 |
| 18-34 | 696 |
| 35-49 | 1,214 |
| 50-64 | 2,488 |
| 65-74 | 2,316 |
| 75+ | 2,091 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Heparin Sodium. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 6,721 |
| Hospitalization | 5,266 |
| Non-Serious | 2,719 |
| Death | 2,552 |
| Life-Threatening | 2,026 |
| Disability | 555 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Heparin Sodium. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2004 | 464 |
| 2005 | 225 |
| 2006 | 189 |
| 2007 | 127 |
| 2008 | 1,028 |
| 2009 | 247 |
| 2010 | 471 |
| 2011 | 404 |
| 2012 | 356 |
| 2013 | 329 |
| 2014 | 276 |
| 2015 | 367 |
| 2016 | 402 |
| 2017 | 527 |
| 2018 | 640 |
| 2019 | 796 |
| 2020 | 701 |
| 2021 | 969 |
| 2022 | 1,139 |
| 2023 | 1,250 |
| 2024 | 1,013 |
| 2025 | 991 |
| 2026 (partial) | 288 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Heparin Sodium
In FDA adverse event reports that mention Heparin Sodium, these medications appeared most often in the same report.
- Furosemide (1,846 reports)
- Acetaminophen (1,707 reports)
- Aspirin (1,477 reports)
- Pantoprazole (1,028 reports)
- Ondansetron (1,026 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026