MYCOPHENILIC ACID

N/A

Manufactured by Accord Healthcare Inc.

32,957 FDA adverse event reports analyzed

Last updated: 2026-04-14

About MYCOPHENILIC ACID

MYCOPHENILIC ACID is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Accord Healthcare Inc.. The most commonly reported adverse reactions for MYCOPHENILIC ACID include OFF LABEL USE, DRUG INEFFECTIVE, DIARRHOEA, ACUTE KIDNEY INJURY, COVID-19. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for MYCOPHENILIC ACID.

Top Adverse Reactions

OFF LABEL USE2,056 reports
DRUG INEFFECTIVE1,400 reports
DIARRHOEA991 reports
ACUTE KIDNEY INJURY828 reports
COVID 19784 reports
PRODUCT USE IN UNAPPROVED INDICATION733 reports
PYREXIA727 reports
DRUG INTERACTION708 reports
NAUSEA682 reports
DEATH657 reports
FATIGUE597 reports
CYTOMEGALOVIRUS INFECTION586 reports
PNEUMONIA552 reports
HEADACHE548 reports
DYSPNOEA537 reports
VOMITING529 reports
SEPSIS508 reports
CONDITION AGGRAVATED485 reports
RENAL IMPAIRMENT442 reports
TRANSPLANT REJECTION440 reports
TOXICITY TO VARIOUS AGENTS403 reports
ABDOMINAL PAIN402 reports
COUGH387 reports
ASTHENIA384 reports
POST TRANSPLANT LYMPHOPROLIFERATIVE DISORDER360 reports
NEUTROPENIA358 reports
RESPIRATORY FAILURE348 reports
URINARY TRACT INFECTION344 reports
KIDNEY TRANSPLANT REJECTION341 reports
ARTHRALGIA332 reports
ANAEMIA326 reports
LEUKOPENIA324 reports
MALAISE321 reports
DIZZINESS318 reports
BLOOD CREATININE INCREASED312 reports
SEPTIC SHOCK310 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME290 reports
INFECTION288 reports
ABDOMINAL PAIN UPPER286 reports
DECREASED APPETITE279 reports
RENAL FAILURE275 reports
WEIGHT DECREASED268 reports
FALL266 reports
CHILLS259 reports
PRURITUS254 reports
BLOOD PRESSURE INCREASED253 reports
SOMNOLENCE249 reports
PANCYTOPENIA242 reports
TACHYCARDIA241 reports
HAEMATURIA240 reports
MYALGIA236 reports
PAIN231 reports
CYTOMEGALOVIRUS VIRAEMIA228 reports
GASTROINTESTINAL DISORDER226 reports
POLYOMAVIRUS ASSOCIATED NEPHROPATHY218 reports
COMA217 reports
INSOMNIA217 reports
HYPERTENSION213 reports
THROMBOTIC MICROANGIOPATHY208 reports
THROMBOCYTOPENIA206 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION205 reports
DRUG INTOLERANCE203 reports
RASH200 reports
HYPOTENSION194 reports
VISION BLURRED190 reports
TREATMENT FAILURE189 reports
BRONCHOPULMONARY ASPERGILLOSIS187 reports
ASCITES184 reports
ASPERGILLUS INFECTION182 reports
DISEASE RECURRENCE182 reports
DISEASE PROGRESSION180 reports
DRUG LEVEL INCREASED180 reports
HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS177 reports
CHRONIC KIDNEY DISEASE176 reports
HOSPITALISATION175 reports
PRODUCT DOSE OMISSION ISSUE173 reports
BK VIRUS INFECTION172 reports
EPSTEIN BARR VIRUS INFECTION172 reports
COMPLICATIONS OF TRANSPLANTED KIDNEY170 reports
SYNCOPE168 reports
EYE PAIN167 reports
GENERALISED OEDEMA163 reports
BLINDNESS161 reports
ACUTE RESPIRATORY DISTRESS SYNDROME158 reports
PROTEINURIA157 reports
HYPERKALAEMIA156 reports
CARDIO RESPIRATORY ARREST154 reports
PNEUMOCYSTIS JIROVECII PNEUMONIA153 reports
ABDOMINAL DISCOMFORT151 reports
IMMUNOSUPPRESSANT DRUG LEVEL INCREASED151 reports
TREMOR151 reports
POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME150 reports
PRODUCT USE ISSUE150 reports
ALTERED STATE OF CONSCIOUSNESS149 reports
HAEMATEMESIS147 reports
HAEMORRHAGIC STROKE147 reports
HEAD DISCOMFORT146 reports
MATERNAL EXPOSURE DURING PREGNANCY146 reports
WEIGHT INCREASED146 reports
DEHYDRATION145 reports

Report Outcomes

Out of 19,221 classified reports for MYCOPHENILIC ACID:

Serious 91.2%Non-Serious 8.8%

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

Male8,964 (52.7%)
Female7,994 (47.0%)
Unknown39 (0.2%)

Reports by Age

Age 65397 reports
Age 63378 reports
Age 64378 reports
Age 58361 reports
Age 67360 reports
Age 59337 reports
Age 60331 reports
Age 55322 reports
Age 56320 reports
Age 61314 reports
Age 69311 reports
Age 68303 reports
Age 66301 reports
Age 57296 reports
Age 52295 reports
Age 62294 reports
Age 54290 reports
Age 70286 reports
Age 53267 reports
Age 50262 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 MYCOPHENILIC ACID?

This profile reflects 32,957 FDA FAERS reports that mention MYCOPHENILIC ACID. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for MYCOPHENILIC ACID?

Frequently reported terms in FAERS include OFF LABEL USE, DRUG INEFFECTIVE, DIARRHOEA, ACUTE KIDNEY INJURY, COVID-19, PRODUCT USE IN UNAPPROVED INDICATION. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures MYCOPHENILIC ACID?

Labeling and FAERS entries often list Accord Healthcare Inc. in connection with MYCOPHENILIC ACID. 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.