Ocrevus

N/A

Manufactured by Genentech, Inc.

124,640 FDA adverse event reports analyzed

Last updated: 2026-05-19

About Ocrevus

Ocrevus is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Genentech, Inc.. The most commonly reported adverse reactions for Ocrevus include COVID-19, FATIGUE, URINARY TRACT INFECTION, HEADACHE, MULTIPLE SCLEROSIS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for Ocrevus.

Top Adverse Reactions

COVID 1911,553 reports
FATIGUE6,150 reports
URINARY TRACT INFECTION3,760 reports
HEADACHE3,229 reports
MULTIPLE SCLEROSIS2,963 reports
ASTHENIA2,685 reports
GAIT DISTURBANCE2,681 reports
MULTIPLE SCLEROSIS RELAPSE2,661 reports
NASOPHARYNGITIS2,549 reports
PAIN2,500 reports
FALL2,497 reports
PNEUMONIA2,418 reports
OFF LABEL USE2,405 reports
DRUG INEFFECTIVE2,396 reports
INFUSION RELATED REACTION2,177 reports
INFLUENZA2,006 reports
COUGH1,810 reports
PYREXIA1,762 reports
NAUSEA1,752 reports
DIZZINESS1,715 reports
MUSCULAR WEAKNESS1,663 reports
PRURITUS1,660 reports
PAIN IN EXTREMITY1,608 reports
HYPOAESTHESIA1,601 reports
MALAISE1,565 reports
HERPES ZOSTER1,455 reports
SARS COV 2 TEST POSITIVE1,427 reports
NO ADVERSE EVENT1,416 reports
DYSPNOEA1,413 reports
THROAT IRRITATION1,370 reports
BALANCE DISORDER1,238 reports
RASH1,218 reports
PARAESTHESIA1,143 reports
ALOPECIA1,130 reports
DIARRHOEA1,127 reports
MEMORY IMPAIRMENT1,125 reports
INFECTION1,117 reports
BACK PAIN1,090 reports
ARTHRALGIA1,063 reports
MUSCLE SPASMS1,057 reports
INSOMNIA1,051 reports
DEPRESSION1,031 reports
OROPHARYNGEAL PAIN1,015 reports
FEELING ABNORMAL974 reports
ORAL HERPES926 reports
SINUSITIS884 reports
WEIGHT INCREASED860 reports
VOMITING858 reports
ANXIETY846 reports
WEIGHT DECREASED824 reports
HYPERSENSITIVITY779 reports
TREMOR731 reports
ERYTHEMA727 reports
SEPSIS719 reports
HYPERTENSION711 reports
MIGRAINE708 reports
URTICARIA708 reports
MOBILITY DECREASED707 reports
ILLNESS689 reports
COVID 19 PNEUMONIA678 reports
MUSCLE SPASTICITY678 reports
CYSTITIS641 reports
VISUAL IMPAIRMENT633 reports
BRONCHITIS632 reports
SOMNOLENCE630 reports
FLUSHING613 reports
UPPER RESPIRATORY TRACT INFECTION612 reports
MUSCULOSKELETAL STIFFNESS573 reports
HEART RATE INCREASED552 reports
CONDITION AGGRAVATED548 reports
JC POLYOMAVIRUS TEST POSITIVE547 reports
CHILLS546 reports
INFLUENZA LIKE ILLNESS538 reports
VISION BLURRED527 reports
DEATH513 reports
DRUG HYPERSENSITIVITY509 reports
INTENTIONAL PRODUCT USE ISSUE495 reports
B LYMPHOCYTE COUNT DECREASED489 reports
COGNITIVE DISORDER489 reports
PERIPHERAL SWELLING486 reports
RHINORRHOEA482 reports
MATERNAL EXPOSURE BEFORE PREGNANCY470 reports
URINARY INCONTINENCE470 reports
NEURALGIA469 reports
STRESS467 reports
CHEST PAIN465 reports
CONSTIPATION457 reports
ABDOMINAL PAIN UPPER450 reports
FEELING HOT448 reports
BREAST CANCER444 reports
MYALGIA442 reports
SEIZURE436 reports
FUNGAL INFECTION428 reports
IMMUNODEFICIENCY428 reports
CELLULITIS421 reports
BLOOD PRESSURE INCREASED418 reports
DYSPHAGIA413 reports
HYPOTENSION406 reports
PALPITATIONS398 reports
LIMB DISCOMFORT396 reports

Report Outcomes

Out of 60,577 classified reports for Ocrevus:

  • Serious: 30,291 reports (50.0%) — includes hospitalization, disability, life-threatening events, or death
  • Non-Serious: 30,286 reports (50.0%)
Serious 50.0%Non-Serious 50.0%

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

Female38,411 (72.2%)
Male14,414 (27.1%)
Unknown363 (0.7%)

Reports by Age

Age 51909 reports
Age 50899 reports
Age 52893 reports
Age 53884 reports
Age 49856 reports
Age 55856 reports
Age 43850 reports
Age 44845 reports
Age 42840 reports
Age 40835 reports
Age 48829 reports
Age 56822 reports
Age 46808 reports
Age 54805 reports
Age 41799 reports
Age 45783 reports
Age 57771 reports
Age 39755 reports
Age 47754 reports
Age 58752 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 Ocrevus?

This profile reflects 124,640 FDA FAERS reports that mention Ocrevus. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for Ocrevus?

Frequently reported terms in FAERS include COVID-19, FATIGUE, URINARY TRACT INFECTION, HEADACHE, MULTIPLE SCLEROSIS, ASTHENIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures Ocrevus?

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