OBINUTUZUMAB

N/A

Manufactured by Genentech, Inc.

28,651 FDA adverse event reports analyzed

Last updated: 2026-04-14

About OBINUTUZUMAB

OBINUTUZUMAB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Genentech, Inc.. The most commonly reported adverse reactions for OBINUTUZUMAB include OFF LABEL USE, NEUTROPENIA, COVID-19, FEBRILE NEUTROPENIA, PYREXIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for OBINUTUZUMAB.

Top Adverse Reactions

OFF LABEL USE1,713 reports
NEUTROPENIA1,287 reports
COVID 191,059 reports
FEBRILE NEUTROPENIA1,023 reports
PYREXIA933 reports
THROMBOCYTOPENIA880 reports
DISEASE PROGRESSION879 reports
INFUSION RELATED REACTION819 reports
PNEUMONIA752 reports
ANAEMIA681 reports
ATRIAL FIBRILLATION582 reports
INFECTION574 reports
DEATH502 reports
NAUSEA496 reports
NO ADVERSE EVENT490 reports
DYSPNOEA478 reports
MYELOSUPPRESSION478 reports
DIARRHOEA469 reports
CYTOPENIA463 reports
CHILLS462 reports
DRUG INEFFECTIVE446 reports
CYTOKINE RELEASE SYNDROME424 reports
PLATELET COUNT DECREASED404 reports
HAEMORRHAGE381 reports
FATIGUE370 reports
ASPERGILLUS INFECTION367 reports
HYPOTENSION344 reports
WHITE BLOOD CELL COUNT DECREASED313 reports
TUMOUR LYSIS SYNDROME306 reports
NEUTROPHIL COUNT DECREASED300 reports
COVID 19 PNEUMONIA298 reports
RASH298 reports
VOMITING298 reports
SEPSIS280 reports
ASTHENIA243 reports
PANCYTOPENIA224 reports
LYMPHADENOPATHY223 reports
COUGH220 reports
HYPOGAMMAGLOBULINAEMIA211 reports
LYMPHOCYTE COUNT DECREASED196 reports
URINARY TRACT INFECTION194 reports
CHEST DISCOMFORT193 reports
HEADACHE187 reports
INTENTIONAL PRODUCT USE ISSUE185 reports
HYPERTENSION181 reports
ACUTE KIDNEY INJURY171 reports
DIZZINESS164 reports
HYPERSENSITIVITY164 reports
CYTOMEGALOVIRUS INFECTION160 reports
FOLLICULAR LYMPHOMA156 reports
BACK PAIN155 reports
PRURITUS154 reports
PAIN153 reports
WEIGHT DECREASED150 reports
MALAISE149 reports
PRODUCT USE IN UNAPPROVED INDICATION142 reports
BLOOD LACTATE DEHYDROGENASE INCREASED141 reports
RESPIRATORY FAILURE136 reports
SYNCOPE136 reports
ABDOMINAL PAIN133 reports
ASPARTATE AMINOTRANSFERASE INCREASED133 reports
OXYGEN SATURATION DECREASED133 reports
LEUKOPENIA130 reports
HERPES ZOSTER128 reports
FLUSHING124 reports
CARDIAC DISORDER123 reports
CONSTIPATION120 reports
PNEUMONITIS120 reports
ALANINE AMINOTRANSFERASE INCREASED119 reports
DIFFUSE LARGE B CELL LYMPHOMA119 reports
INTERSTITIAL LUNG DISEASE119 reports
SEPTIC SHOCK118 reports
ARTHRALGIA115 reports
DECREASED APPETITE115 reports
PULMONARY EMBOLISM114 reports
BLOOD PRESSURE DECREASED113 reports
CHEST PAIN110 reports
CHRONIC LYMPHOCYTIC LEUKAEMIA110 reports
LYMPHOMA110 reports
HYPERHIDROSIS109 reports
PLEURAL EFFUSION109 reports
TREMOR108 reports
END STAGE RENAL DISEASE103 reports
ERYTHEMA103 reports
HAEMOGLOBIN DECREASED103 reports
AGRANULOCYTOSIS102 reports
HYPOXIA102 reports
DRUG INTOLERANCE99 reports
BRONCHOPULMONARY ASPERGILLOSIS98 reports
NEUROPATHY PERIPHERAL95 reports
TACHYCARDIA94 reports
MALIGNANT NEOPLASM PROGRESSION93 reports
COLITIS90 reports
BASAL CELL CARCINOMA88 reports
INFLUENZA87 reports
DRUG HYPERSENSITIVITY86 reports
FALL86 reports
CARDIAC FAILURE85 reports
RENAL FAILURE85 reports
ANAPHYLACTIC REACTION83 reports

Report Outcomes

Out of 15,392 classified reports for OBINUTUZUMAB:

Serious 83.7%Non-Serious 16.3%

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

Male7,481 (58.9%)
Female5,159 (40.6%)
Unknown59 (0.5%)

Reports by Age

Age 70403 reports
Age 67373 reports
Age 60363 reports
Age 73358 reports
Age 65342 reports
Age 72336 reports
Age 68323 reports
Age 71311 reports
Age 66300 reports
Age 69299 reports
Age 74299 reports
Age 62295 reports
Age 64292 reports
Age 59291 reports
Age 75286 reports
Age 63282 reports
Age 77261 reports
Age 76256 reports
Age 58242 reports
Age 78228 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 OBINUTUZUMAB?

This profile reflects 28,651 FDA FAERS reports that mention OBINUTUZUMAB. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for OBINUTUZUMAB?

Frequently reported terms in FAERS include OFF LABEL USE, NEUTROPENIA, COVID-19, FEBRILE NEUTROPENIA, PYREXIA, THROMBOCYTOPENIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures OBINUTUZUMAB?

Labeling and FAERS entries often list Genentech, Inc. in connection with OBINUTUZUMAB. 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.