DEXAMETHASONE SODIUM PHOSPHATE

N/A

Manufactured by Amneal Pharmaceuticals LLC

19,106 FDA adverse event reports analyzed

Last updated: 2026-04-14

About DEXAMETHASONE SODIUM PHOSPHATE

DEXAMETHASONE SODIUM PHOSPHATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals LLC. The most commonly reported adverse reactions for DEXAMETHASONE SODIUM PHOSPHATE include OFF LABEL USE, NAUSEA, PYREXIA, ANAEMIA, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DEXAMETHASONE SODIUM PHOSPHATE.

Top Adverse Reactions

OFF LABEL USE857 reports
NAUSEA574 reports
PYREXIA570 reports
ANAEMIA467 reports
DIARRHOEA431 reports
PLATELET COUNT DECREASED423 reports
DRUG INEFFECTIVE419 reports
NEUTROPHIL COUNT DECREASED407 reports
WHITE BLOOD CELL COUNT DECREASED405 reports
MYELOSUPPRESSION385 reports
VOMITING378 reports
DYSPNOEA376 reports
FATIGUE372 reports
PNEUMONIA360 reports
FEBRILE NEUTROPENIA343 reports
DECREASED APPETITE340 reports
NEUTROPENIA330 reports
RASH298 reports
DEATH296 reports
PRODUCT USE IN UNAPPROVED INDICATION293 reports
THROMBOCYTOPENIA275 reports
PAIN245 reports
CONSTIPATION237 reports
NEUROPATHY PERIPHERAL234 reports
DISEASE PROGRESSION224 reports
MALAISE223 reports
CONDITION AGGRAVATED221 reports
HYPOKALAEMIA216 reports
ASTHENIA214 reports
ALOPECIA197 reports
HEADACHE196 reports
SEPSIS195 reports
INTERSTITIAL LUNG DISEASE194 reports
INFUSION RELATED REACTION185 reports
PRURITUS185 reports
ALANINE AMINOTRANSFERASE INCREASED182 reports
ABDOMINAL PAIN173 reports
DIZZINESS171 reports
PLASMA CELL MYELOMA168 reports
STOMATITIS166 reports
COUGH165 reports
INSOMNIA163 reports
ARTHRALGIA157 reports
ERYTHEMA154 reports
MALIGNANT NEOPLASM PROGRESSION154 reports
ASPARTATE AMINOTRANSFERASE INCREASED153 reports
HEPATIC FUNCTION ABNORMAL150 reports
HYPERTENSION144 reports
INFECTION141 reports
ACUTE KIDNEY INJURY138 reports
NEOPLASM PROGRESSION138 reports
LYMPHOCYTE COUNT DECREASED131 reports
GENERAL PHYSICAL HEALTH DETERIORATION128 reports
PRODUCT USE ISSUE128 reports
CHEST DISCOMFORT123 reports
RESPIRATORY FAILURE123 reports
HAEMOGLOBIN DECREASED122 reports
HYPOTENSION121 reports
HYPERSENSITIVITY120 reports
TREATMENT FAILURE120 reports
WEIGHT DECREASED120 reports
BACK PAIN119 reports
LEUKOPENIA118 reports
PANCYTOPENIA117 reports
CHILLS113 reports
HYPONATRAEMIA111 reports
HYPOAESTHESIA109 reports
BONE MARROW FAILURE108 reports
CARDIAC FAILURE107 reports
HYPOCALCAEMIA107 reports
SEPTIC SHOCK106 reports
COVID 19105 reports
PLEURAL EFFUSION104 reports
EYE PAIN102 reports
RENAL IMPAIRMENT102 reports
DEHYDRATION100 reports
HYPOALBUMINAEMIA100 reports
OEDEMA PERIPHERAL100 reports
PAIN IN EXTREMITY100 reports
PULMONARY EMBOLISM100 reports
BLOOD CREATININE INCREASED98 reports
C REACTIVE PROTEIN INCREASED95 reports
LOWER RESPIRATORY TRACT INFECTION94 reports
HYPERGLYCAEMIA93 reports
ANAPHYLACTIC SHOCK92 reports
ANXIETY92 reports
WEIGHT INCREASED90 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION89 reports
FALL89 reports
TACHYCARDIA89 reports
CONFUSIONAL STATE88 reports
ABDOMINAL DISCOMFORT87 reports
CYTOKINE RELEASE SYNDROME87 reports
CHEST PAIN84 reports
DRUG INTOLERANCE84 reports
URINARY TRACT INFECTION84 reports
RENAL FAILURE82 reports
ABDOMINAL PAIN UPPER81 reports
HEPATIC ENZYME INCREASED81 reports
INTENTIONAL PRODUCT USE ISSUE81 reports

Report Outcomes

Out of 9,371 classified reports for DEXAMETHASONE SODIUM PHOSPHATE:

Serious 92.6%Non-Serious 7.4%

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

Male4,316 (50.1%)
Female4,266 (49.5%)
Unknown36 (0.4%)

Reports by Age

Age 65222 reports
Age 62208 reports
Age 63207 reports
Age 66205 reports
Age 68203 reports
Age 67191 reports
Age 70189 reports
Age 61188 reports
Age 59187 reports
Age 69187 reports
Age 74186 reports
Age 71183 reports
Age 73178 reports
Age 64176 reports
Age 72173 reports
Age 58165 reports
Age 60159 reports
Age 75159 reports
Age 57154 reports
Age 55142 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 DEXAMETHASONE SODIUM PHOSPHATE?

This profile reflects 19,106 FDA FAERS reports that mention DEXAMETHASONE SODIUM PHOSPHATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for DEXAMETHASONE SODIUM PHOSPHATE?

Frequently reported terms in FAERS include OFF LABEL USE, NAUSEA, PYREXIA, ANAEMIA, DIARRHOEA, PLATELET COUNT DECREASED. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures DEXAMETHASONE SODIUM PHOSPHATE?

Labeling and FAERS entries often list Amneal Pharmaceuticals LLC in connection with DEXAMETHASONE SODIUM PHOSPHATE. 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.