COBICISTAT

N/A

Manufactured by Gilead Sciences, Inc.

1,443 FDA adverse event reports analyzed

Last updated: 2026-04-15

About COBICISTAT

COBICISTAT is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Gilead Sciences, Inc.. The most commonly reported adverse reactions for COBICISTAT include DRUG INTERACTION, CUSHING^S SYNDROME, FOETAL EXPOSURE DURING PREGNANCY, IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME, SEROTONIN SYNDROME. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for COBICISTAT.

Top Adverse Reactions

DRUG INTERACTION176 reports
CUSHING^S SYNDROME59 reports
FOETAL EXPOSURE DURING PREGNANCY48 reports
IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME36 reports
SEROTONIN SYNDROME36 reports
ADRENAL INSUFFICIENCY32 reports
OFF LABEL USE28 reports
ANXIETY26 reports
DRUG INEFFECTIVE25 reports
PAIN25 reports
VIROLOGIC FAILURE24 reports
EMOTIONAL DISTRESS22 reports
ANHEDONIA20 reports
DEPRESSION20 reports
PRODUCT USE IN UNAPPROVED INDICATION19 reports
LIPODYSTROPHY ACQUIRED18 reports
BRAIN INJURY17 reports
SOMNOLENCE17 reports
TREATMENT NONCOMPLIANCE17 reports
ACUTE KIDNEY INJURY16 reports
DEATH16 reports
GASTROSCHISIS16 reports
NAUSEA16 reports
CHRONIC KIDNEY DISEASE15 reports
FOETAL GROWTH ABNORMALITY15 reports
FOETAL GROWTH RESTRICTION15 reports
METABOLIC ACIDOSIS15 reports
OSTEOPOROSIS15 reports
PNEUMONIA ASPIRATION15 reports
ABORTION SPONTANEOUS14 reports
HYDROCEPHALUS14 reports
RENAL IMPAIRMENT14 reports
RHABDOMYOLYSIS14 reports
DIARRHOEA13 reports
EXPOSURE DURING PREGNANCY13 reports
NEUROPATHY PERIPHERAL13 reports
SPINA BIFIDA13 reports
CONGENITAL INTESTINAL MALFORMATION12 reports
DRUG INTOLERANCE12 reports
FOETAL DEATH12 reports
PRODUCT PRESCRIBING ERROR12 reports
DIABETES MELLITUS11 reports
DRUG LEVEL INCREASED11 reports
ELECTROCARDIOGRAM QT PROLONGED11 reports
PYREXIA11 reports
RENAL DYSPLASIA11 reports
SINGLE FUNCTIONAL KIDNEY11 reports
VOMITING11 reports
DRUG RESISTANCE10 reports
MEMORY IMPAIRMENT10 reports
OSTEOPENIA10 reports
BLOOD CREATININE INCREASED9 reports
EYELID PTOSIS9 reports
MATERNAL EXPOSURE DURING PREGNANCY9 reports
PATHOGEN RESISTANCE9 reports
PREMATURE LABOUR9 reports
PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY9 reports
RENAL FAILURE9 reports
CONDITION AGGRAVATED8 reports
ECONOMIC PROBLEM8 reports
GAIT DISTURBANCE8 reports
HEPATIC ENZYME INCREASED8 reports
LIP DISCOLOURATION8 reports
LOW BIRTH WEIGHT BABY8 reports
LOW DENSITY LIPOPROTEIN INCREASED8 reports
MYOCARDIAL INFARCTION8 reports
NAIL DISCOLOURATION8 reports
NERVE INJURY8 reports
ORTHOSTATIC HYPOTENSION8 reports
OSTEONECROSIS8 reports
RENAL APLASIA8 reports
SKIN DISCOLOURATION8 reports
VIRAL MUTATION IDENTIFIED8 reports
ADVERSE EVENT7 reports
ANAEMIA7 reports
BONE DENSITY DECREASED7 reports
CHOLESTASIS OF PREGNANCY7 reports
CUSHINGOID7 reports
HAEMORRHAGE7 reports
HEADACHE7 reports
HELLP SYNDROME7 reports
INTENTIONAL PRODUCT MISUSE7 reports
LIPOEDEMA7 reports
MYALGIA7 reports
POSTPARTUM HAEMORRHAGE7 reports
PRE ECLAMPSIA7 reports
PREMATURE BABY7 reports
RASH7 reports
TOXICITY TO VARIOUS AGENTS7 reports
ASTHENIA6 reports
BACK PAIN6 reports
BLOOD HIV RNA INCREASED6 reports
CONTUSION6 reports
DISABILITY6 reports
DIZZINESS6 reports
DYSPHAGIA6 reports
FATIGUE6 reports
FOETAL EXPOSURE DURING DELIVERY6 reports
GENE MUTATION6 reports
HYPERTENSION6 reports

Report Outcomes

Out of 603 classified reports for COBICISTAT:

Serious 93.7%Non-Serious 6.3%

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

Male320 (69.4%)
Female140 (30.4%)
Unknown1 (0.2%)

Reports by Age

Age 6032 reports
Age 3418 reports
Age 5318 reports
Age 5418 reports
Age 4916 reports
Age 5515 reports
Age 3613 reports
Age 4611 reports
Age 5911 reports
Age 6311 reports
Age 6911 reports
Age 7211 reports
Age 610 reports
Age 4110 reports
Age 5210 reports
Age 49 reports
Age 509 reports
Age 618 reports
Age 648 reports
Age 297 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 COBICISTAT?

This profile reflects 1,443 FDA FAERS reports that mention COBICISTAT. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for COBICISTAT?

Frequently reported terms in FAERS include DRUG INTERACTION, CUSHING^S SYNDROME, FOETAL EXPOSURE DURING PREGNANCY, IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME, SEROTONIN SYNDROME, ADRENAL INSUFFICIENCY. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures COBICISTAT?

Labeling and FAERS entries often list Gilead Sciences, Inc. in connection with COBICISTAT. 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.