Drugs › Low molecular weight heparin
Brand name · Enoxaparin sodium
Lovenox: adverse event reports filed with FDA
15,183 reports list it as a suspect or interacting product, 2004–2026. Class: Low molecular weight heparin. Also reported as Lovenox /00889602/, Lovenox Inj.
- 15,183
- reports as suspect product
- 0.1% of all reports · about 675 a year
- 774
- reports, 12 months to June 2026
- 803 in the 12 months before
- 80.4%
- marked serious by the reporter
- 81.3% across the class
- 14.1%
- record death among outcomes, as reported
- 2,136 reports · not verified by FDA
15,183 adverse event reports received by FDA list the brand name Lovenox (enoxaparin sodium) as a suspect or interacting product, from January 2004 to June 2026. A further 20,911 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 774 reports listed it, close to the 803 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 675 reports a year and 0.1% of the 20,646,523 reports in the database, and 60.1% of the reports for the low molecular weight heparin class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded off label use (5.5%), thrombocytopenia (4.2%) and anaemia (3.9%). A report can list several reactions, so shares add to more than 100%; 1,422 different terms appear across these reports. Off label use is recorded in 5.5% of these reports, about the same share as in the median low molecular weight heparin drug (4.9%).
80.4% of the reports are marked serious by the reporter (81.3% across the class); 14.1% record death among the outcomes and 46.9% record hospitalisation, as reported. 28.6% of the reports came from physicians, and the largest patient age group is 45 to 64 (22.2%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Lovenox reports recording the termmedian drug in low molecular weight heparin
- Off label useused for a purpose or in a way not on the label5.5%832
- Thrombocytopenialow platelets4.2%642
- Anaemialow red blood cells3.9%596
- Haematomaa collection of blood under the skin or in tissue3.5%537
- Haemorrhagebleeding3%463
- Pulmonary embolisma blood clot in the lung2.9%439
- Gastrointestinal haemorrhagebleeding in the stomach or bowel2.7%412
- Deep vein thrombosisa blood clot in a deep vein2.5%373
- Heparin-induced thrombocytopenia2.4%359
- Deaththe patient died; cause not stated by this term2.4%358
- Cholestasis2.3%354
- Rash maculo-papulara rash of flat and raised spots2.3%353
- Shock haemorrhagic2.2%338
- Thrombosis2.2%333
- Hepatocellular injury2.1%320
- Neutropenialow neutrophils, a type of white blood cell2.1%318
- Acute kidney injurysudden loss of kidney function2.1%314
- Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement2%303
- Eosinophilia2%301
- Contusiona bruise1.9%295
- Injection site painpain where the injection was given1.9%295
- Haemoglobin decreasedlow haemoglobin1.9%286
- Hypotensionlow blood pressure1.9%285
- Injection site bruisingbruising where the injection was given1.9%283
- Drug ineffectivethe medicine did not work as expected1.8%268
- Hepatic cytolysis1.8%268
- Drug interactionan interaction between medicines1.8%267
- Dyspnoeashortness of breath1.7%252
- International normalised ratio increasedblood clotting slower than intended (raised INR)1.6%241
Top 30 of 1,422 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 2 drugs in the low molecular weight heparin class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 25,243 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 47.1% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Thrombosis prophylaxis | 2,743 | 18.1% |
| Prophylaxis | 860 | 5.7% |
| Deep vein thrombosis | 766 | 5% |
| Pulmonary embolism | 702 | 4.6% |
| Anticoagulant therapy | 500 | 3.3% |
| Thrombosis | 470 | 3.1% |
The indication field is filled in by the reporter and is often blank; shares are of all 15,183 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Lovenox reports |
|---|---|---|
| Kardegic | 1,038 | 6.8% |
| Coumadin | 989 | 6.5% |
| Xarelto | 963 | 6.3% |
| Aspirin | 930 | 6.1% |
| Pantoprazole | 870 | 5.7% |
| Furosemide | 826 | 5.4% |
| Acetaminophen | 701 | 4.6% |
| Paracetamol | 669 | 4.4% |
| Plavix | 487 | 3.2% |
| Lansoprazole | 450 | 3% |
Other products listed in reports where Lovenox is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Lovenox | Low molecular weight heparin | All reports |
|---|---|---|---|
| Reports as suspect product | 15,183 | 25,243 | 20,646,523 |
| Share of that pool | — | 60.1% | 0.1% |
| Reports, latest 12 months | 774 | — | 1,332,454 |
| Marked serious | 80.4% | 81.3% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 141 | 157 | 91 |
| Hospitalisation recorded, per 1,000 reports | 469 | 443 | 213 |
| Consumer-filed share | 28.2% | 24.2% | 45.8% |
| Top term, share of reports | Off label use 5.5% | median 4.9% | 4.1% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the low molecular weight heparin class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Enoxaparin sodium | generic | 10,060 | 761 | 82.7% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Lovenox reports
How many adverse event reports has FDA received for Lovenox?
15,183 reports list Lovenox as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 774 of them arrived in the latest 12 months. Another 20,911 list it only as a concomitant medication.
What reactions are recorded in Lovenox reports?
off label use (5.5%), thrombocytopenia (4.2%), anaemia (3.9%), haematoma (3.5%) and haemorrhage (3%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Lovenox was responsible.
How serious are the reports?
80.4% are marked serious by the reporter. Among the outcomes recorded, 14.1% of reports include death and 46.9% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
physician (28.6%), consumer or non-health professional (28.2%) and other health professional (23.2%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Lovenox rising?
774 reports in the 12 months to June 2026, close to the 803 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Lovenox was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Lovenox?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Lovenox as a suspect or interacting product; reports listing it only as a concomitant medication (20,911) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.