Drug
Tenofovir Alafenamide
Important: Reactions below are the flagged terms from this drug’s
FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate
disproportionality in spontaneous reporting, not causation.
Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
| Reaction | Co-reports (a) | PRR | ROR | Signal | |
|---|---|---|---|---|---|
| 1 | Intentional Dose Omission | 69 | 13.1 | 13.3 | signal |
| 2 | Hepatic Cancer | 49 | 10.4 | 10.6 | signal |
| 3 | Drug Resistance | 46 | 9.3 | 9.4 | signal |
| 4 | Hepatic Cirrhosis | 28 | 7.7 | 7.8 | signal |
| 5 | Dialysis | 18 | 6.5 | 6.6 | signal |
| 6 | Osteoporosis | 52 | 6.5 | 6.6 | signal |
| 7 | Product Dispensing Error | 24 | 5.7 | 5.7 | signal |
| 8 | Glomerular Filtration Rate Decreased | 13 | 5.5 | 5.6 | signal |
| 9 | Product Dose Omission | 71 | 5.5 | 5.6 | signal |
| 10 | Hepatic Encephalopathy | 10 | 5.5 | 5.5 | signal |
| 11 | Neoplasm Malignant | 68 | 5.3 | 5.3 | signal |
| 12 | Transaminases Increased | 22 | 5.1 | 5.1 | signal |
| 13 | Osteopenia | 15 | 5.1 | 5.1 | signal |
| 14 | Cytopenia | 11 | 4.8 | 4.8 | signal |
| 15 | Economic Problem | 14 | 4.7 | 4.7 | signal |
| 16 | Pneumocystis Jirovecii Pneumonia | 9 | 4.7 | 4.7 | signal |
| 17 | Anhedonia | 23 | 4.5 | 4.5 | signal |
| 18 | Ventricular Extrasystoles | 9 | 4.5 | 4.5 | signal |
| 19 | Hepatic Failure | 26 | 4.4 | 4.5 | signal |
| 20 | Liver Disorder | 38 | 4.4 | 4.5 | signal |
| 21 | Product Dose Omission In Error | 23 | 4.4 | 4.4 | signal |
| 22 | Alanine Aminotransferase Increased | 52 | 4.4 | 4.4 | signal |
| 23 | Nephropathy Toxic | 9 | 4.2 | 4.2 | signal |
| 24 | Liver Function Test Increased | 17 | 4.1 | 4.1 | signal |
| 25 | Treatment Noncompliance | 43 | 4.1 | 4.1 | signal |
| 26 | Renal Impairment | 65 | 4.0 | 4.1 | signal |
| 27 | Renal Disorder | 36 | 4.0 | 4.0 | signal |
| 28 | End Stage Renal Disease | 14 | 3.9 | 3.9 | signal |
| 29 | Hepatic Function Abnormal | 28 | 3.9 | 3.9 | signal |
| 30 | Adrenal Insufficiency | 9 | 3.9 | 3.9 | signal |
| 31 | Leukaemia | 7 | 3.8 | 3.8 | signal |
| 32 | Proteinuria | 13 | 3.6 | 3.6 | signal |
| 33 | Quality Of Life Decreased | 9 | 3.5 | 3.5 | signal |
| 34 | Foetal Exposure During Pregnancy | 54 | 3.4 | 3.5 | signal |
| 35 | Cerebral Infarction | 16 | 3.4 | 3.4 | signal |
| 36 | Maternal Exposure During Pregnancy | 56 | 3.3 | 3.3 | signal |
| 37 | Fracture | 12 | 3.3 | 3.3 | signal |
| 38 | Product Dose Omission Issue | 178 | 3.2 | 3.3 | signal |
| 39 | Tuberculosis | 8 | 3.2 | 3.2 | signal |
| 40 | Liver Injury | 15 | 3.2 | 3.2 | signal |
| 41 | Chronic Kidney Disease | 47 | 3.2 | 3.2 | signal |
| 42 | Splenomegaly | 7 | 3.1 | 3.1 | signal |
| 43 | Jaundice | 16 | 3.1 | 3.1 | signal |
| 44 | Subarachnoid Haemorrhage | 6 | 3.0 | 3.0 | signal |
| 45 | Hyperbilirubinaemia | 6 | 3.0 | 3.0 | signal |
| 46 | Lymphoma | 9 | 3.0 | 3.0 | signal |
| 47 | Dementia | 16 | 3.0 | 3.0 | signal |
| 48 | Drug Eruption | 10 | 2.9 | 2.9 | signal |
| 49 | Decreased Activity | 6 | 2.9 | 2.9 | signal |
| 50 | Drug Interaction | 88 | 2.9 | 2.9 | signal |
| 51 | Cardiovascular Disorder | 14 | 2.8 | 2.8 | signal |
| 52 | Agranulocytosis | 10 | 2.8 | 2.8 | signal |
| 53 | Pancytopenia | 30 | 2.8 | 2.8 | signal |
| 54 | Appendicitis | 5 | 2.8 | 2.8 | signal |
| 55 | Nephropathy | 5 | 2.8 | 2.8 | no signal |
| 56 | Autoimmune Disorder | 5 | 2.7 | 2.7 | no signal |
| 57 | Dysphagia | 49 | 2.7 | 2.7 | signal |
| 58 | Type 2 Diabetes Mellitus | 17 | 2.6 | 2.6 | signal |
| 59 | Product Storage Error | 43 | 2.6 | 2.6 | signal |
| 60 | Hepatitis C | 6 | 2.5 | 2.5 | signal |
| 61 | Drug Level Decreased | 5 | 2.5 | 2.5 | no signal |
| 62 | Chromaturia | 11 | 2.5 | 2.5 | signal |
| 63 | Febrile Neutropenia | 32 | 2.5 | 2.5 | signal |
| 64 | Multiple Fractures | 8 | 2.5 | 2.5 | signal |
| 65 | Mouth Ulceration | 10 | 2.5 | 2.5 | signal |
| 66 | Acute Myocardial Infarction | 14 | 2.4 | 2.4 | signal |
| 67 | Therapy Cessation | 24 | 2.4 | 2.4 | signal |
| 68 | Renal Injury | 14 | 2.4 | 2.4 | signal |
| 69 | Spinal Fracture | 9 | 2.3 | 2.3 | signal |
| 70 | Surgery | 26 | 2.3 | 2.3 | signal |
| 71 | Product Use Issue | 83 | 2.3 | 2.3 | signal |
| 72 | Lactic Acidosis | 14 | 2.3 | 2.3 | signal |
| 73 | Metastases To Lung | 5 | 2.2 | 2.2 | no signal |
| 74 | Abortion Induced | 4 | 2.2 | 2.2 | no signal |
| 75 | Therapy Change | 4 | 2.1 | 2.1 | no signal |
| 76 | Blood Triglycerides Increased | 7 | 2.0 | 2.0 | no signal |
| 77 | Rhabdomyolysis | 16 | 2.0 | 2.0 | no signal |
| 78 | Cytokine Release Syndrome | 7 | 1.9 | 1.9 | no signal |
| 79 | Therapy Interrupted | 24 | 1.8 | 1.8 | no signal |
| 80 | Bone Density Decreased | 11 | 1.8 | 1.8 | no signal |
| 81 | Neurotoxicity | 6 | 1.8 | 1.8 | no signal |
| 82 | Metastases To Liver | 6 | 1.8 | 1.8 | no signal |
| 83 | Caesarean Section | 4 | 1.8 | 1.8 | no signal |
| 84 | Colon Cancer | 5 | 1.7 | 1.7 | no signal |
| 85 | Haemorrhage Intracranial | 5 | 1.7 | 1.7 | no signal |
| 86 | Brain Neoplasm | 3 | 1.7 | 1.7 | no signal |
| 87 | Inability To Afford Medication | 3 | 1.6 | 1.6 | no signal |
| 88 | Cytomegalovirus Infection | 5 | 1.6 | 1.6 | no signal |
| 89 | Premature Baby | 9 | 1.5 | 1.5 | no signal |
| 90 | Death | 251 | 1.5 | 1.5 | no signal |
| 91 | Glycosylated Haemoglobin Increased | 7 | 1.4 | 1.4 | no signal |
| 92 | Circumstance Or Information Capable Of Leading To Medication Error | 9 | 1.4 | 1.4 | no signal |
| 93 | Acute Myeloid Leukaemia | 4 | 1.3 | 1.3 | no signal |
| 94 | Product Physical Issue | 5 | 1.3 | 1.3 | no signal |
| 95 | Tooth Loss | 5 | 1.2 | 1.2 | no signal |
| 96 | Emotional Distress | 29 | 1.2 | 1.2 | no signal |
| 97 | Myelosuppression | 8 | 1.2 | 1.2 | no signal |
| 98 | Gastric Cancer | 6 | 1.2 | 1.2 | no signal |
| 99 | Oesophageal Carcinoma | 7 | 1.2 | 1.2 | no signal |
| 100 | Pancreatic Carcinoma | 6 | 1.1 | 1.1 | no signal |
| 101 | Bone Loss | 3 | 1.0 | 1.0 | no signal |
| 102 | Lung Neoplasm Malignant | 8 | 1.0 | 1.0 | no signal |
| 103 | Premature Delivery | 3 | 1.0 | 1.0 | no signal |
| 104 | Plasma Cell Myeloma | 7 | 0.9 | 0.9 | no signal |
| 105 | Extra Dose Administered | 7 | 0.9 | 0.9 | no signal |
| 106 | Abortion Spontaneous | 6 | 0.8 | 0.8 | no signal |
| 107 | Breast Cancer | 13 | 0.7 | 0.7 | no signal |
| 108 | Product Complaint | 3 | 0.6 | 0.6 | no signal |
| 109 | Prostate Cancer | 6 | 0.4 | 0.4 | no signal |