EMTRICITABINE

N/A

Manufactured by Gilead Sciences, Inc.

13,674 FDA adverse event reports analyzed

Last updated: 2026-04-15

About EMTRICITABINE

EMTRICITABINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Gilead Sciences, Inc.. The most commonly reported adverse reactions for EMTRICITABINE include DRUG INTERACTION, FOETAL EXPOSURE DURING PREGNANCY, ANXIETY, DRUG RESISTANCE, VIROLOGIC FAILURE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for EMTRICITABINE.

Top Adverse Reactions

DRUG INTERACTION656 reports
FOETAL EXPOSURE DURING PREGNANCY621 reports
ANXIETY432 reports
DRUG RESISTANCE431 reports
VIROLOGIC FAILURE402 reports
DRUG INEFFECTIVE317 reports
IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME298 reports
OFF LABEL USE265 reports
PAIN264 reports
EMOTIONAL DISTRESS239 reports
DEPRESSION231 reports
EXPOSURE DURING PREGNANCY218 reports
PATHOGEN RESISTANCE218 reports
ACUTE KIDNEY INJURY208 reports
RENAL FAILURE205 reports
ANHEDONIA204 reports
PYREXIA192 reports
DEATH191 reports
SUICIDAL IDEATION191 reports
ANAEMIA183 reports
PSYCHIATRIC DECOMPENSATION183 reports
MATERNAL EXPOSURE DURING PREGNANCY179 reports
CHRONIC KIDNEY DISEASE176 reports
DIARRHOEA175 reports
VIRAL MUTATION IDENTIFIED175 reports
RENAL IMPAIRMENT173 reports
FATIGUE172 reports
TREATMENT FAILURE169 reports
TREATMENT NONCOMPLIANCE167 reports
PSYCHOTIC DISORDER166 reports
PARANOIA161 reports
PRODUCT USE IN UNAPPROVED INDICATION157 reports
DEPRESSION SUICIDAL155 reports
TEARFULNESS154 reports
NAUSEA151 reports
BLOOD HIV RNA INCREASED150 reports
DEPRESSIVE SYMPTOM144 reports
VOMITING143 reports
OSTEOPOROSIS141 reports
BLOOD CREATININE INCREASED139 reports
PSYCHOMOTOR SKILLS IMPAIRED139 reports
PREMATURE BABY134 reports
DYSPNOEA119 reports
ABORTION SPONTANEOUS114 reports
CONDITION AGGRAVATED110 reports
ECONOMIC PROBLEM110 reports
ASTHENIA102 reports
HEADACHE101 reports
NEPHROPATHY TOXIC100 reports
CUSHING^S SYNDROME97 reports
STILLBIRTH97 reports
TOXICITY TO VARIOUS AGENTS97 reports
ALANINE AMINOTRANSFERASE INCREASED94 reports
BONE DENSITY DECREASED87 reports
PANCYTOPENIA87 reports
PREMATURE DELIVERY87 reports
PNEUMONIA86 reports
ASPARTATE AMINOTRANSFERASE INCREASED85 reports
NEUTROPENIA84 reports
RASH83 reports
END STAGE RENAL DISEASE79 reports
OSTEOPENIA78 reports
INSOMNIA76 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES76 reports
RENAL FAILURE ACUTE73 reports
HYPOTENSION72 reports
SPINA BIFIDA72 reports
INTENTIONAL PRODUCT USE ISSUE70 reports
LACTIC ACIDOSIS69 reports
WEIGHT DECREASED68 reports
ABDOMINAL PAIN66 reports
DYSPHAGIA66 reports
CONFUSIONAL STATE65 reports
VENTRICULAR SEPTAL DEFECT64 reports
THROMBOCYTOPENIA63 reports
ATRIAL SEPTAL DEFECT61 reports
CONGENITAL ANOMALY61 reports
HYPERTENSION61 reports
PRURITUS61 reports
ARTHRALGIA60 reports
MYOCARDIAL INFARCTION60 reports
SEPSIS60 reports
DIZZINESS59 reports
VIRAL LOAD INCREASED59 reports
HYPERBILIRUBINAEMIA57 reports
METABOLIC ACIDOSIS57 reports
RENAL TUBULAR NECROSIS57 reports
GAIT DISTURBANCE56 reports
MYALGIA56 reports
CSF HIV ESCAPE SYNDROME55 reports
FANCONI SYNDROME ACQUIRED55 reports
PSYCHOMOTOR RETARDATION55 reports
ABORTION INDUCED54 reports
DRUG EXPOSURE DURING PREGNANCY53 reports
GENOTYPE DRUG RESISTANCE TEST POSITIVE53 reports
MALAISE53 reports
DECREASED APPETITE52 reports
COUGH51 reports
LYMPHADENOPATHY51 reports
PROTEINURIA51 reports

Report Outcomes

Out of 7,086 classified reports for EMTRICITABINE:

Serious 95.5%Non-Serious 4.5%

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

Male3,411 (66.0%)
Female1,743 (33.7%)
Unknown14 (0.3%)

Reports by Age

Age 44197 reports
Age 50184 reports
Age 54166 reports
Age 43162 reports
Age 40135 reports
Age 39133 reports
Age 35131 reports
Age 53130 reports
Age 42122 reports
Age 41116 reports
Age 49116 reports
Age 45103 reports
Age 48103 reports
Age 47102 reports
Age 5599 reports
Age 3496 reports
Age 5794 reports
Age 3693 reports
Age 5192 reports
Age 3091 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 EMTRICITABINE?

This profile reflects 13,674 FDA FAERS reports that mention EMTRICITABINE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for EMTRICITABINE?

Frequently reported terms in FAERS include DRUG INTERACTION, FOETAL EXPOSURE DURING PREGNANCY, ANXIETY, DRUG RESISTANCE, VIROLOGIC FAILURE, DRUG INEFFECTIVE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures EMTRICITABINE?

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