PREDNISOLONE SODIUM PHOSPHATE

N/A

Manufactured by Advanz Pharma (US) Corp.

5,859 FDA adverse event reports analyzed

Last updated: 2026-04-15

About PREDNISOLONE SODIUM PHOSPHATE

PREDNISOLONE SODIUM PHOSPHATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Advanz Pharma (US) Corp.. The most commonly reported adverse reactions for PREDNISOLONE SODIUM PHOSPHATE include DRUG INEFFECTIVE, OFF LABEL USE, PYREXIA, TREATMENT FAILURE, CONDITION AGGRAVATED. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PREDNISOLONE SODIUM PHOSPHATE.

Top Adverse Reactions

DRUG INEFFECTIVE179 reports
OFF LABEL USE157 reports
PYREXIA152 reports
TREATMENT FAILURE149 reports
CONDITION AGGRAVATED145 reports
VOMITING128 reports
HYPERSENSITIVITY108 reports
RHEUMATOID ARTHRITIS108 reports
FATIGUE106 reports
HEADACHE106 reports
PNEUMONIA106 reports
ASTHMA99 reports
PAIN98 reports
HEPATITIS B REACTIVATION93 reports
PRODUCT USE ISSUE88 reports
RASH86 reports
DYSPNOEA83 reports
ACUTE HEPATIC FAILURE75 reports
DRUG HYPERSENSITIVITY74 reports
MALAISE71 reports
COUGH70 reports
EYE PAIN70 reports
CONTRAINDICATED PRODUCT ADMINISTERED69 reports
INTRAOCULAR PRESSURE INCREASED69 reports
VISUAL ACUITY REDUCED69 reports
NAUSEA66 reports
HYPERTENSION64 reports
DIARRHOEA62 reports
THROMBOCYTOPENIA62 reports
UPPER RESPIRATORY TRACT INFECTION62 reports
ARTHRALGIA61 reports
ENDOPHTHALMITIS61 reports
JOINT SWELLING60 reports
UVEITIS60 reports
WHEEZING60 reports
GENERAL PHYSICAL HEALTH DETERIORATION59 reports
NASOPHARYNGITIS59 reports
SEPSIS59 reports
CHOROIDITIS56 reports
HYPERHIDROSIS55 reports
PSORIASIS55 reports
HEPATIC ENZYME INCREASED54 reports
INFUSION RELATED REACTION54 reports
DRUG INTOLERANCE52 reports
MOBILITY DECREASED52 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES51 reports
LOWER LIMB FRACTURE51 reports
CONSTIPATION50 reports
BACK PAIN48 reports
BURSITIS48 reports
LOWER RESPIRATORY TRACT INFECTION47 reports
OSTEOPOROSIS47 reports
PRESCRIBED OVERDOSE47 reports
NEUTROPENIA46 reports
CHEST DISCOMFORT45 reports
EXPOSURE DURING PREGNANCY45 reports
INFECTION45 reports
INFLUENZA45 reports
ERYTHEMA44 reports
FALL44 reports
ANXIETY43 reports
DIZZINESS43 reports
IMMUNODEFICIENCY43 reports
FLUID RETENTION42 reports
CARDIAC DISORDER41 reports
OEDEMA41 reports
ANGINA PECTORIS40 reports
FOETAL DEATH40 reports
RHINORRHOEA40 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE40 reports
CHEST PAIN39 reports
COELIAC DISEASE39 reports
FOOD ALLERGY39 reports
WEIGHT INCREASED39 reports
ASTHENIA38 reports
CONFUSIONAL STATE38 reports
RASH ERYTHEMATOUS38 reports
TEMPERATURE REGULATION DISORDER38 reports
INTENTIONAL PRODUCT MISUSE37 reports
OVERDOSE37 reports
ARTHRITIS35 reports
MUSCULAR WEAKNESS35 reports
ABDOMINAL PAIN34 reports
SEPTIC SHOCK34 reports
BEDRIDDEN33 reports
DEATH33 reports
FOOT FRACTURE33 reports
GASTROINTESTINAL DISORDER32 reports
OEDEMA PERIPHERAL32 reports
LEUKOPENIA31 reports
MUSCLE SPASMS31 reports
OSTEONECROSIS31 reports
PRODUCT USE IN UNAPPROVED INDICATION31 reports
SINUSITIS31 reports
INTENTIONAL PRODUCT USE ISSUE30 reports
CYTOMEGALOVIRUS INFECTION29 reports
DYSPHAGIA29 reports
INSOMNIA29 reports
WEIGHT DECREASED29 reports
CATARACT28 reports

Report Outcomes

Out of 2,318 classified reports for PREDNISOLONE SODIUM PHOSPHATE:

Serious 87.2%Non-Serious 12.8%

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

Female1,089 (55.1%)
Male882 (44.6%)
Unknown7 (0.4%)

Reports by Age

Age 3876 reports
Age 5261 reports
Age 6559 reports
Age 3650 reports
Age 6145 reports
Age 6443 reports
Age 238 reports
Age 533 reports
Age 430 reports
Age 728 reports
Age 6728 reports
Age 5027 reports
Age 5627 reports
Age 5827 reports
Age 826 reports
Age 7626 reports
Age 7225 reports
Age 7425 reports
Age 5723 reports
Age 6623 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 PREDNISOLONE SODIUM PHOSPHATE?

This profile reflects 5,859 FDA FAERS reports that mention PREDNISOLONE SODIUM PHOSPHATE. Reporting is voluntary and does not prove that the drug caused any listed event.

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

Frequently reported terms in FAERS include DRUG INEFFECTIVE, OFF LABEL USE, PYREXIA, TREATMENT FAILURE, CONDITION AGGRAVATED, VOMITING. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures PREDNISOLONE SODIUM PHOSPHATE?

Labeling and FAERS entries often list Advanz Pharma (US) Corp. in connection with PREDNISOLONE 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.