TENOFOVIR DISOPROXIL FUMARATE TABLETS

N/A

Manufactured by Chartwell RX, LLC.

14,129 FDA adverse event reports analyzed

Last updated: 2026-04-14

About TENOFOVIR DISOPROXIL FUMARATE TABLETS

TENOFOVIR DISOPROXIL FUMARATE TABLETS is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Chartwell RX, LLC.. The most commonly reported adverse reactions for TENOFOVIR DISOPROXIL FUMARATE TABLETS include PATHOGEN RESISTANCE, VIROLOGIC FAILURE, VIRAL MUTATION IDENTIFIED, FOETAL EXPOSURE DURING PREGNANCY, DRUG RESISTANCE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TENOFOVIR DISOPROXIL FUMARATE TABLETS.

Top Adverse Reactions

PATHOGEN RESISTANCE746 reports
VIROLOGIC FAILURE743 reports
VIRAL MUTATION IDENTIFIED704 reports
FOETAL EXPOSURE DURING PREGNANCY703 reports
DRUG RESISTANCE493 reports
DRUG INEFFECTIVE435 reports
MATERNAL EXPOSURE DURING PREGNANCY378 reports
DRUG INTERACTION336 reports
TREATMENT FAILURE299 reports
ABORTION SPONTANEOUS259 reports
DEATH251 reports
OSTEOPOROSIS237 reports
EXPOSURE DURING PREGNANCY228 reports
RENAL IMPAIRMENT225 reports
IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME214 reports
HEADACHE209 reports
TREATMENT NONCOMPLIANCE207 reports
NEPHROPATHY TOXIC205 reports
HEPATITIS B193 reports
OFF LABEL USE189 reports
ANAEMIA182 reports
NAUSEA176 reports
ACUTE KIDNEY INJURY172 reports
DIARRHOEA168 reports
PYREXIA167 reports
BLOOD CREATININE INCREASED160 reports
CONDITION AGGRAVATED157 reports
PREMATURE BABY153 reports
VOMITING150 reports
ALANINE AMINOTRANSFERASE INCREASED142 reports
FANCONI SYNDROME ACQUIRED139 reports
FATIGUE137 reports
TREMOR125 reports
RENAL FAILURE124 reports
CHRONIC KIDNEY DISEASE122 reports
BLOOD HIV RNA INCREASED119 reports
DRUG INTOLERANCE117 reports
ASTHENIA115 reports
DRUG INDUCED LIVER INJURY105 reports
LIPODYSTROPHY ACQUIRED105 reports
RHEUMATOID ARTHRITIS103 reports
ASPARTATE AMINOTRANSFERASE INCREASED100 reports
DECREASED APPETITE91 reports
FANCONI SYNDROME91 reports
STILLBIRTH91 reports
HEPATIC FAILURE89 reports
RASH89 reports
VIRAL LOAD INCREASED89 reports
MALAISE88 reports
RENAL FAILURE ACUTE88 reports
WEIGHT DECREASED88 reports
HEPATITIS B REACTIVATION87 reports
PREMATURE DELIVERY86 reports
HEPATIC CIRRHOSIS85 reports
HYPOPHOSPHATAEMIA84 reports
PROTEINURIA84 reports
RENAL TUBULAR DISORDER84 reports
DYSPNOEA81 reports
GENOTYPE DRUG RESISTANCE TEST POSITIVE78 reports
ABDOMINAL PAIN76 reports
RENAL TUBULAR DYSFUNCTION71 reports
CAESAREAN SECTION70 reports
DIABETES MELLITUS70 reports
DEPRESSION68 reports
HEPATOCELLULAR CARCINOMA67 reports
CONTRAINDICATED PRODUCT ADMINISTERED64 reports
LIVE BIRTH63 reports
CONGENITAL ANOMALY61 reports
COUGH61 reports
HIV VIRAEMIA61 reports
ANXIETY60 reports
DIPLOPIA60 reports
PAIN60 reports
OSTEONECROSIS59 reports
EYELID PTOSIS58 reports
LACTIC ACIDOSIS58 reports
TOXICITY TO VARIOUS AGENTS58 reports
ARTHRALGIA57 reports
LOW BIRTH WEIGHT BABY57 reports
HEPATIC CANCER56 reports
PNEUMONIA56 reports
FOETAL GROWTH RESTRICTION55 reports
IMMUNE RECONSTITUTION SYNDROME55 reports
MYALGIA55 reports
CONFUSIONAL STATE54 reports
MITOCHONDRIAL TOXICITY54 reports
SEPSIS54 reports
THROMBOCYTOPENIA54 reports
PRODUCT USE IN UNAPPROVED INDICATION53 reports
DIZZINESS52 reports
HEPATITIS B DNA INCREASED52 reports
RENAL TUBULAR NECROSIS52 reports
INSOMNIA51 reports
LIVER DISORDER51 reports
PANCYTOPENIA51 reports
DRUG HYPERSENSITIVITY50 reports
HEPATIC FUNCTION ABNORMAL50 reports
METABOLIC ACIDOSIS50 reports
PROGRESSIVE EXTERNAL OPHTHALMOPLEGIA50 reports
PRURITUS50 reports

Report Outcomes

Out of 8,479 classified reports for TENOFOVIR DISOPROXIL FUMARATE TABLETS:

Serious 96.5%Non-Serious 3.5%

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

Male3,648 (60.1%)
Female2,371 (39.0%)
Unknown53 (0.9%)

Reports by Age

Age 50171 reports
Age 54132 reports
Age 52131 reports
Age 40124 reports
Age 43120 reports
Age 34114 reports
Age 39111 reports
Age 59111 reports
Age 47109 reports
Age 31106 reports
Age 38105 reports
Age 48103 reports
Age 42102 reports
Age 32101 reports
Age 45101 reports
Age 4496 reports
Age 5596 reports
Age 4194 reports
Age 3592 reports
Age 4691 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 TENOFOVIR DISOPROXIL FUMARATE TABLETS?

This profile reflects 14,129 FDA FAERS reports that mention TENOFOVIR DISOPROXIL FUMARATE TABLETS. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for TENOFOVIR DISOPROXIL FUMARATE TABLETS?

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

Who manufactures TENOFOVIR DISOPROXIL FUMARATE TABLETS?

Labeling and FAERS entries often list Chartwell RX, LLC. in connection with TENOFOVIR DISOPROXIL FUMARATE TABLETS. 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.