METHYLPREDNISOLONE ACETATE

N/A

Manufactured by Pharmacia & Upjohn Company LLC

42,188 FDA adverse event reports analyzed

Last updated: 2026-04-14

About METHYLPREDNISOLONE ACETATE

METHYLPREDNISOLONE ACETATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Pharmacia & Upjohn Company LLC. The most commonly reported adverse reactions for METHYLPREDNISOLONE ACETATE include PAIN, DRUG INEFFECTIVE, OFF LABEL USE, RHEUMATOID ARTHRITIS, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for METHYLPREDNISOLONE ACETATE.

Top Adverse Reactions

PAIN1,516 reports
DRUG INEFFECTIVE1,238 reports
OFF LABEL USE1,218 reports
RHEUMATOID ARTHRITIS1,196 reports
FATIGUE1,125 reports
HEADACHE1,044 reports
JOINT SWELLING912 reports
NAUSEA758 reports
ARTHRALGIA748 reports
DRUG HYPERSENSITIVITY725 reports
RASH691 reports
PYREXIA650 reports
BACK PAIN637 reports
DRUG INTOLERANCE622 reports
HYPERSENSITIVITY611 reports
MALAISE611 reports
UPPER RESPIRATORY TRACT INFECTION597 reports
HEPATIC ENZYME INCREASED579 reports
HYPERTENSION553 reports
HYPERHIDROSIS545 reports
PAIN IN EXTREMITY542 reports
ERYTHEMA529 reports
TREATMENT FAILURE521 reports
PRODUCT USE ISSUE512 reports
BURSITIS510 reports
DIZZINESS499 reports
ASTHMA496 reports
DIARRHOEA485 reports
CONTRAINDICATED PRODUCT ADMINISTERED481 reports
MUSCULOSKELETAL STIFFNESS471 reports
IMMUNODEFICIENCY470 reports
INFUSION RELATED REACTION465 reports
RASH ERYTHEMATOUS454 reports
FOOD ALLERGY453 reports
PNEUMONIA448 reports
CONDITION AGGRAVATED435 reports
DYSPNOEA433 reports
MUSCULAR WEAKNESS433 reports
PSORIASIS424 reports
CONSTIPATION423 reports
PERIPHERAL SWELLING417 reports
FALL399 reports
ASTHENIA398 reports
FLUID RETENTION395 reports
COELIAC DISEASE391 reports
INFECTION380 reports
EXPOSURE DURING PREGNANCY379 reports
ARTHRITIS374 reports
TEMPERATURE REGULATION DISORDER373 reports
VOMITING372 reports
ANXIETY367 reports
OVERDOSE363 reports
FIBROMYALGIA352 reports
COUGH343 reports
THROMBOCYTOPENIA335 reports
PRESCRIBED OVERDOSE328 reports
BLOOD PRESSURE INCREASED313 reports
WEIGHT INCREASED303 reports
INTENTIONAL PRODUCT MISUSE302 reports
GASTROINTESTINAL DISORDER296 reports
MUSCULOSKELETAL PAIN288 reports
JOINT RANGE OF MOTION DECREASED279 reports
CONFUSIONAL STATE277 reports
SINUSITIS275 reports
OSTEOARTHRITIS265 reports
CATARACT262 reports
SYNOVITIS260 reports
C REACTIVE PROTEIN INCREASED259 reports
PRURITUS252 reports
NASOPHARYNGITIS246 reports
DRY MOUTH242 reports
FEELING ABNORMAL241 reports
DRY EYE240 reports
PALPITATIONS239 reports
DEPRESSION238 reports
SWELLING234 reports
HAND DEFORMITY227 reports
MYALGIA227 reports
DYSPHAGIA221 reports
ARTHROPATHY218 reports
INSOMNIA217 reports
HYPOAESTHESIA216 reports
CHEST DISCOMFORT215 reports
PARAESTHESIA214 reports
MUSCLE SPASMS208 reports
THERAPEUTIC PRODUCT EFFECT DECREASED207 reports
ABDOMINAL PAIN206 reports
WEIGHT DECREASED206 reports
PRODUCT USE IN UNAPPROVED INDICATION203 reports
FOETAL DEATH201 reports
ABDOMINAL DISCOMFORT198 reports
SYNOVIAL CYST196 reports
WHEEZING190 reports
SLEEP DISORDER188 reports
ANGINA PECTORIS184 reports
GENERAL PHYSICAL HEALTH DETERIORATION184 reports
PSORIATIC ARTHROPATHY183 reports
URTICARIA182 reports
CEREBROVASCULAR ACCIDENT180 reports
INFLUENZA180 reports

Report Outcomes

Out of 7,647 classified reports for METHYLPREDNISOLONE ACETATE:

Serious 85.0%Non-Serious 15.0%

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

Female4,728 (69.4%)
Male2,002 (29.4%)
Unknown86 (1.3%)

Reports by Age

Age 58371 reports
Age 40235 reports
Age 65218 reports
Age 36166 reports
Age 61158 reports
Age 44150 reports
Age 67128 reports
Age 68123 reports
Age 54113 reports
Age 59110 reports
Age 64106 reports
Age 5699 reports
Age 6097 reports
Age 5796 reports
Age 6696 reports
Age 6289 reports
Age 6388 reports
Age 4387 reports
Age 5386 reports
Age 4681 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 METHYLPREDNISOLONE ACETATE?

This profile reflects 42,188 FDA FAERS reports that mention METHYLPREDNISOLONE ACETATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for METHYLPREDNISOLONE ACETATE?

Frequently reported terms in FAERS include PAIN, DRUG INEFFECTIVE, OFF LABEL USE, RHEUMATOID ARTHRITIS, FATIGUE, HEADACHE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures METHYLPREDNISOLONE ACETATE?

Labeling and FAERS entries often list Pharmacia & Upjohn Company LLC in connection with METHYLPREDNISOLONE ACETATE. 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.