EVEROLIMUS TABLETS

N/A

Manufactured by Amneal Pharmaceuticals NY LLC

31,530 FDA adverse event reports analyzed

Last updated: 2026-04-14

About EVEROLIMUS TABLETS

EVEROLIMUS TABLETS is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals NY LLC. The most commonly reported adverse reactions for EVEROLIMUS TABLETS include MALIGNANT NEOPLASM PROGRESSION, OFF LABEL USE, DIARRHOEA, DRUG INEFFECTIVE, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for EVEROLIMUS TABLETS.

Top Adverse Reactions

MALIGNANT NEOPLASM PROGRESSION1,470 reports
OFF LABEL USE1,201 reports
DIARRHOEA1,148 reports
DRUG INEFFECTIVE940 reports
FATIGUE782 reports
DISEASE PROGRESSION723 reports
PRODUCT USE IN UNAPPROVED INDICATION720 reports
DEATH708 reports
NAUSEA707 reports
DYSPNOEA631 reports
PYREXIA590 reports
PNEUMONIA571 reports
VOMITING571 reports
ANAEMIA533 reports
DRUG INTERACTION527 reports
METASTASES TO LIVER486 reports
ACUTE KIDNEY INJURY455 reports
STOMATITIS442 reports
DECREASED APPETITE433 reports
METASTASES TO BONE429 reports
ASTHENIA426 reports
RENAL IMPAIRMENT425 reports
PNEUMONITIS403 reports
THROMBOCYTOPENIA394 reports
NEUTROPENIA392 reports
WEIGHT DECREASED379 reports
COUGH363 reports
TOXICITY TO VARIOUS AGENTS362 reports
PLEURAL EFFUSION355 reports
RASH333 reports
HYPERTENSION320 reports
DEHYDRATION317 reports
TRANSPLANT REJECTION302 reports
ABDOMINAL PAIN294 reports
BK VIRUS INFECTION288 reports
METASTASES TO LUNG288 reports
CYTOMEGALOVIRUS INFECTION285 reports
POLYOMAVIRUS ASSOCIATED NEPHROPATHY280 reports
URINARY TRACT INFECTION275 reports
SEPSIS271 reports
MUCOSAL INFLAMMATION270 reports
PAIN267 reports
COVID 19265 reports
BREAST CANCER METASTATIC264 reports
GENERAL PHYSICAL HEALTH DETERIORATION263 reports
RENAL FAILURE255 reports
BLOOD CREATININE INCREASED254 reports
INTERSTITIAL LUNG DISEASE244 reports
POST TRANSPLANT LYMPHOPROLIFERATIVE DISORDER243 reports
LEUKOPENIA239 reports
HEADACHE236 reports
OEDEMA PERIPHERAL224 reports
RESPIRATORY FAILURE223 reports
THROMBOTIC MICROANGIOPATHY215 reports
INFECTION211 reports
NEOPLASM PROGRESSION210 reports
CONDITION AGGRAVATED206 reports
BREAST CANCER203 reports
MALAISE198 reports
SEPTIC SHOCK197 reports
ARTHRALGIA193 reports
BLOOD PRESSURE INCREASED186 reports
PROTEINURIA186 reports
METASTASES TO LYMPH NODES185 reports
PANCYTOPENIA183 reports
BACK PAIN180 reports
ABDOMINAL PAIN UPPER175 reports
PRURITUS173 reports
POLYOMAVIRUS VIRAEMIA171 reports
ASCITES167 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME166 reports
DRUG INTOLERANCE164 reports
HYPERGLYCAEMIA164 reports
OSTEONECROSIS OF JAW163 reports
THERAPY INTERRUPTED163 reports
HYPOTENSION161 reports
CONSTIPATION160 reports
CARDIAC FAILURE158 reports
SEIZURE157 reports
CHEST PAIN148 reports
HAEMOGLOBIN DECREASED148 reports
PULMONARY EMBOLISM148 reports
PRODUCT USE ISSUE145 reports
DRUG RESISTANCE143 reports
DIZZINESS142 reports
PALMAR PLANTAR ERYTHRODYSAESTHESIA SYNDROME142 reports
EPSTEIN BARR VIRUS INFECTION136 reports
DRUG LEVEL INCREASED133 reports
DIABETES MELLITUS132 reports
TREATMENT FAILURE132 reports
KIDNEY TRANSPLANT REJECTION131 reports
VIRAEMIA129 reports
MOUTH ULCERATION127 reports
FEBRILE NEUTROPENIA126 reports
PLATELET COUNT DECREASED126 reports
HOSPITALISATION122 reports
NEPHROPATHY TOXIC118 reports
PAIN IN EXTREMITY115 reports
EPISTAXIS113 reports
FALL113 reports

Report Outcomes

Out of 15,879 classified reports for EVEROLIMUS TABLETS:

Serious 89.4%Non-Serious 10.6%

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

Male7,075 (50.6%)
Female6,791 (48.6%)
Unknown114 (0.8%)

Reports by Age

Age 65384 reports
Age 62362 reports
Age 64357 reports
Age 61329 reports
Age 60325 reports
Age 58318 reports
Age 63316 reports
Age 56306 reports
Age 57296 reports
Age 59287 reports
Age 68287 reports
Age 51285 reports
Age 66278 reports
Age 55263 reports
Age 67259 reports
Age 72259 reports
Age 70237 reports
Age 54222 reports
Age 52217 reports
Age 69207 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 EVEROLIMUS TABLETS?

This profile reflects 31,530 FDA FAERS reports that mention EVEROLIMUS TABLETS. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for EVEROLIMUS TABLETS?

Frequently reported terms in FAERS include MALIGNANT NEOPLASM PROGRESSION, OFF LABEL USE, DIARRHOEA, DRUG INEFFECTIVE, FATIGUE, DISEASE PROGRESSION. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures EVEROLIMUS TABLETS?

Labeling and FAERS entries often list Amneal Pharmaceuticals NY LLC in connection with EVEROLIMUS TABLETS. 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.