Drug
Nelfinavir Mesylate
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 | Drug Exposure During Pregnancy | 413 | 121.6 | 151.4 | signal |
| 2 | Anhedonia | 210 | 80.2 | 89.1 | signal |
| 3 | Caesarean Section | 88 | 75.7 | 78.9 | signal |
| 4 | Osteopenia | 91 | 60.2 | 62.9 | signal |
| 5 | Economic Problem | 89 | 58.3 | 60.8 | signal |
| 6 | Pregnancy | 96 | 47.9 | 50.1 | signal |
| 7 | Eyelid Ptosis | 46 | 45.6 | 46.6 | signal |
| 8 | Premature Baby | 115 | 38.4 | 40.6 | signal |
| 9 | Bone Density Decreased | 115 | 36.6 | 38.6 | signal |
| 10 | Osteoporosis | 137 | 33.5 | 35.8 | signal |
| 11 | Blood Lactate Dehydrogenase Increased | 40 | 25.2 | 25.7 | signal |
| 12 | Foetal Exposure During Pregnancy | 203 | 25.1 | 27.7 | signal |
| 13 | Multiple Fractures | 41 | 24.9 | 25.4 | signal |
| 14 | Splenomegaly | 27 | 23.2 | 23.5 | signal |
| 15 | Platelet Count Increased | 29 | 22.3 | 22.6 | signal |
| 16 | Bone Loss | 33 | 21.9 | 22.2 | signal |
| 17 | Decreased Activity | 23 | 21.6 | 21.8 | signal |
| 18 | Osteonecrosis | 67 | 20.3 | 21.0 | signal |
| 19 | Emotional Distress | 236 | 19.5 | 21.9 | signal |
| 20 | Abortion Induced | 18 | 19.2 | 19.4 | signal |
| 21 | Chronic Kidney Disease | 140 | 18.4 | 19.6 | signal |
| 22 | Nephropathy | 17 | 18.2 | 18.4 | signal |
| 23 | Hyperlipidaemia | 21 | 17.6 | 17.8 | signal |
| 24 | Hepatomegaly | 17 | 17.3 | 17.4 | signal |
| 25 | Diplopia | 41 | 15.9 | 16.2 | signal |
| 26 | End Stage Renal Disease | 28 | 15.3 | 15.5 | signal |
| 27 | Quality Of Life Decreased | 20 | 15.0 | 15.1 | signal |
| 28 | Abortion Spontaneous | 58 | 14.5 | 14.9 | signal |
| 29 | Hypotonia | 14 | 14.0 | 14.1 | signal |
| 30 | Tooth Loss | 28 | 13.5 | 13.6 | signal |
| 31 | Vitamin D Deficiency | 13 | 13.4 | 13.5 | signal |
| 32 | Drug Resistance | 33 | 12.9 | 13.1 | signal |
| 33 | Skeletal Injury | 13 | 12.5 | 12.6 | signal |
| 34 | Blood Triglycerides Increased | 22 | 12.5 | 12.6 | signal |
| 35 | Hepatic Encephalopathy | 10 | 10.8 | 10.8 | signal |
| 36 | Hyperbilirubinaemia | 11 | 10.7 | 10.8 | signal |
| 37 | Proteinuria | 20 | 10.7 | 10.8 | signal |
| 38 | Ventricular Extrasystoles | 11 | 10.6 | 10.7 | signal |
| 39 | Foot Fracture | 20 | 10.6 | 10.7 | signal |
| 40 | Gamma-glutamyltransferase Increased | 23 | 10.4 | 10.5 | signal |
| 41 | Lactic Acidosis | 33 | 10.3 | 10.5 | signal |
| 42 | Drug Toxicity | 14 | 10.2 | 10.2 | signal |
| 43 | Cholestasis | 19 | 10.0 | 10.1 | signal |
| 44 | Ankle Fracture | 15 | 9.7 | 9.8 | signal |
| 45 | Blood Creatine Phosphokinase Increased | 28 | 9.6 | 9.7 | signal |
| 46 | Blood Creatinine Increased | 62 | 9.5 | 9.8 | signal |
| 47 | Aspartate Aminotransferase Increased | 50 | 9.5 | 9.7 | signal |
| 48 | Hypercholesterolaemia | 9 | 9.4 | 9.5 | signal |
| 49 | Laboratory Test Abnormal | 27 | 9.2 | 9.3 | signal |
| 50 | Loss Of Personal Independence In Daily Activities | 43 | 9.1 | 9.3 | signal |
| 51 | Immunodeficiency | 13 | 8.9 | 8.9 | signal |
| 52 | Wrist Fracture | 10 | 8.4 | 8.4 | signal |
| 53 | Anxiety | 236 | 8.3 | 9.2 | signal |
| 54 | Ascites | 24 | 8.2 | 8.3 | signal |
| 55 | Premature Delivery | 13 | 8.2 | 8.2 | signal |
| 56 | Hepatic Function Abnormal | 30 | 8.1 | 8.2 | signal |
| 57 | Toxic Skin Eruption | 8 | 8.0 | 8.0 | signal |
| 58 | Renal Impairment | 65 | 7.8 | 8.0 | signal |
| 59 | Anorexia | 10 | 7.7 | 7.7 | signal |
| 60 | Hepatic Cirrhosis | 14 | 7.5 | 7.6 | signal |
| 61 | Alanine Aminotransferase Increased | 46 | 7.5 | 7.7 | signal |
| 62 | Renal Failure | 100 | 7.5 | 7.8 | signal |
| 63 | Jaundice | 20 | 7.4 | 7.5 | signal |
| 64 | Hepatitis C | 9 | 7.4 | 7.4 | signal |
| 65 | Rib Fracture | 15 | 7.3 | 7.4 | signal |
| 66 | Cardiomegaly | 9 | 7.3 | 7.3 | signal |
| 67 | Pharyngitis | 9 | 7.3 | 7.3 | signal |
| 68 | Dysstasia | 21 | 7.2 | 7.3 | signal |
| 69 | Renal Tubular Necrosis | 7 | 7.1 | 7.2 | signal |
| 70 | Mitral Valve Incompetence | 8 | 7.1 | 7.1 | signal |
| 71 | Acute Myeloid Leukaemia | 11 | 7.1 | 7.1 | signal |
| 72 | Hepatitis | 18 | 7.1 | 7.1 | signal |
| 73 | Renal Injury | 21 | 7.0 | 7.1 | signal |
| 74 | Acute Hepatic Failure | 9 | 6.6 | 6.7 | signal |
| 75 | Pancytopenia | 36 | 6.5 | 6.6 | signal |
| 76 | Intervertebral Disc Degeneration | 6 | 6.5 | 6.5 | signal |
| 77 | Anaemia | 120 | 6.3 | 6.6 | signal |
| 78 | Maternal Exposure During Pregnancy | 54 | 6.1 | 6.3 | signal |
| 79 | Spinal Fracture | 12 | 6.0 | 6.1 | signal |
| 80 | Upper Limb Fracture | 12 | 6.0 | 6.1 | signal |
| 81 | Pancreatitis Acute | 13 | 5.9 | 5.9 | signal |
| 82 | Fracture | 11 | 5.8 | 5.9 | signal |
| 83 | Pulmonary Hypertension | 12 | 5.8 | 5.8 | signal |
| 84 | Lymphopenia | 8 | 5.7 | 5.7 | signal |
| 85 | Lymphadenopathy | 20 | 5.7 | 5.7 | signal |
| 86 | Impaired Work Ability | 12 | 5.6 | 5.6 | signal |
| 87 | Skin Lesion | 15 | 5.5 | 5.6 | signal |
| 88 | Hypocalcaemia | 10 | 5.3 | 5.3 | signal |
| 89 | Renal Disorder | 24 | 5.2 | 5.2 | signal |
| 90 | Parkinsonism | 5 | 5.1 | 5.2 | signal |
| 91 | Folliculitis | 5 | 4.9 | 4.9 | signal |
| 92 | Depression | 110 | 4.8 | 5.0 | signal |
| 93 | Liver Function Test Abnormal | 14 | 4.8 | 4.8 | signal |
| 94 | Renal Pain | 5 | 4.8 | 4.8 | signal |
| 95 | Neutropenia | 64 | 4.7 | 4.9 | signal |
| 96 | Glaucoma | 9 | 4.7 | 4.7 | signal |
| 97 | Hip Arthroplasty | 7 | 4.6 | 4.6 | signal |
| 98 | Tooth Fracture | 5 | 4.6 | 4.6 | signal |
| 99 | Myocarditis | 5 | 4.4 | 4.4 | signal |
| 100 | Haematotoxicity | 4 | 4.3 | 4.3 | signal |
| 101 | Exposure During Pregnancy | 25 | 4.0 | 4.1 | signal |
| 102 | Convulsion | 22 | 3.8 | 3.8 | signal |
| 103 | Neoplasm Progression | 12 | 3.4 | 3.4 | signal |
| 104 | Tuberculosis | 4 | 3.1 | 3.1 | no signal |
| 105 | Decreased Immune Responsiveness | 3 | 3.1 | 3.1 | no signal |
| 106 | Pneumocystis Jirovecii Pneumonia | 3 | 3.0 | 3.0 | no signal |
| 107 | Coronary Artery Occlusion | 4 | 2.9 | 2.9 | no signal |
| 108 | Gynaecomastia | 7 | 2.2 | 2.2 | no signal |
| 109 | Pharmaceutical Product Complaint | 3 | 1.1 | 1.1 | no signal |