DALTEPARIN SODIUM

N/A

Manufactured by Pfizer Laboratories Div Pfizer Inc

23,703 FDA adverse event reports analyzed

Last updated: 2026-04-14

About DALTEPARIN SODIUM

DALTEPARIN SODIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Pfizer Laboratories Div Pfizer Inc. The most commonly reported adverse reactions for DALTEPARIN SODIUM include NAUSEA, OFF LABEL USE, PULMONARY EMBOLISM, DYSPNOEA, VOMITING. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DALTEPARIN SODIUM.

Top Adverse Reactions

NAUSEA674 reports
OFF LABEL USE659 reports
PULMONARY EMBOLISM569 reports
DYSPNOEA563 reports
VOMITING545 reports
ABDOMINAL PAIN490 reports
PYREXIA472 reports
SEPSIS463 reports
DIARRHOEA459 reports
FATIGUE432 reports
GENERAL PHYSICAL HEALTH DETERIORATION421 reports
CONSTIPATION416 reports
DEATH406 reports
ANAEMIA402 reports
PNEUMONIA374 reports
CONDITION AGGRAVATED365 reports
PAIN354 reports
DRUG INTERACTION320 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME319 reports
ABDOMINAL DISTENSION317 reports
THROMBOSIS305 reports
ASCITES304 reports
DEEP VEIN THROMBOSIS304 reports
HYPONATRAEMIA302 reports
DRUG INEFFECTIVE295 reports
HAEMOGLOBIN DECREASED283 reports
FEBRILE NEUTROPENIA280 reports
THROMBOCYTOPENIA274 reports
SOMNOLENCE271 reports
CARDIOGENIC SHOCK265 reports
ACUTE KIDNEY INJURY264 reports
STRESS262 reports
HEADACHE255 reports
FALL246 reports
APPENDICITIS245 reports
APPENDICOLITH241 reports
ASTHENIA240 reports
NEEDLE ISSUE232 reports
DEHYDRATION213 reports
HYPERTENSION210 reports
HYPOTENSION210 reports
OEDEMA PERIPHERAL208 reports
WEIGHT DECREASED206 reports
VENTRICULAR FIBRILLATION205 reports
DRUG HYPERSENSITIVITY202 reports
GASTROINTESTINAL HAEMORRHAGE202 reports
SWELLING201 reports
RASH200 reports
CONFUSIONAL STATE198 reports
BLOOD CREATININE INCREASED195 reports
MALAISE195 reports
NEUTROPENIA194 reports
COUGH193 reports
ERYTHEMA193 reports
PLEURAL EFFUSION190 reports
TOXIC EPIDERMAL NECROLYSIS188 reports
DIZZINESS178 reports
PLATELET COUNT DECREASED178 reports
PAIN IN EXTREMITY177 reports
HAEMORRHAGE173 reports
DRY MOUTH170 reports
PRODUCT USE IN UNAPPROVED INDICATION169 reports
DECREASED APPETITE167 reports
FOETAL EXPOSURE DURING PREGNANCY167 reports
CHEST PAIN156 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE156 reports
URINARY TRACT INFECTION152 reports
BLOOD PHOSPHORUS INCREASED151 reports
RENAL FAILURE151 reports
BACK PAIN149 reports
DIABETES MELLITUS148 reports
LOWER RESPIRATORY TRACT INFECTION146 reports
MALIGNANT NEOPLASM PROGRESSION145 reports
BACTERIAL INFECTION142 reports
EPISTAXIS141 reports
PRURITUS141 reports
ALANINE AMINOTRANSFERASE INCREASED139 reports
PANCYTOPENIA139 reports
BLOOD CHOLESTEROL INCREASED138 reports
DRUG INTOLERANCE135 reports
SLEEP DISORDER135 reports
ASPARTATE AMINOTRANSFERASE INCREASED134 reports
ARTHRALGIA131 reports
CEREBRAL HAEMORRHAGE131 reports
MATERNAL EXPOSURE DURING PREGNANCY129 reports
INTENTIONAL PRODUCT MISUSE128 reports
MYASTHENIA GRAVIS128 reports
NEURALGIA128 reports
RENAL FAILURE ACUTE126 reports
WEIGHT INCREASED126 reports
BLOOD PRESSURE INCREASED125 reports
INCORRECT ROUTE OF PRODUCT ADMINISTRATION124 reports
BLOOD URIC ACID INCREASED123 reports
INFECTION123 reports
PREMATURE BABY120 reports
HYPOPHOSPHATAEMIA119 reports
NASOPHARYNGITIS119 reports
PERIPHERAL SWELLING119 reports
HYPERPHOSPHATAEMIA118 reports
TACHYCARDIA118 reports

Report Outcomes

Out of 10,246 classified reports for DALTEPARIN SODIUM:

Serious 92.5%Non-Serious 7.5%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female4,694 (51.3%)
Male4,421 (48.3%)
Unknown37 (0.4%)

Reports by Age

Age 80373 reports
Age 67225 reports
Age 72215 reports
Age 75203 reports
Age 70200 reports
Age 73197 reports
Age 54194 reports
Age 68187 reports
Age 76184 reports
Age 65181 reports
Age 66174 reports
Age 69172 reports
Age 60170 reports
Age 74163 reports
Age 71160 reports
Age 62153 reports
Age 78152 reports
Age 63150 reports
Age 77146 reports
Age 58145 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with DALTEPARIN SODIUM?

This profile reflects 23,703 FDA FAERS reports that mention DALTEPARIN SODIUM. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for DALTEPARIN SODIUM?

Frequently reported terms in FAERS include NAUSEA, OFF LABEL USE, PULMONARY EMBOLISM, DYSPNOEA, VOMITING, ABDOMINAL PAIN. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures DALTEPARIN SODIUM?

Labeling and FAERS entries often list Pfizer Laboratories Div Pfizer Inc in connection with DALTEPARIN SODIUM. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.