EpistemisIntegrated Fit and Safety Summary
Quick reference tool for the specialist to verify the dose adjustment requirements in renal and hepatic failure and the safety category in pregnancy.
The former pregnancy categories A/B/C/D/X are no longer the FDA labeling system; narrative risk information replaced them under the PLLR. Assess pregnancy, breastfeeding and indication using current product information; a historical letter does not establish safety. Official source.
File
| Drug | Renal Adjustment (eGFR cutoff) | Liver Adjustment | Pregnancy (FDA / PLLR) | Major Critical Toxicity |
|---|---|---|---|---|
| Metformin | Contraindicated to eGFR < 30 mL/min | Avoid in severe insufficiency | Category B (Compatible, prefer insulin) | Lactic acidosis (BAD) |
| Empagliflozin | No efficacy at eGFR < 20 mL/min | No dosage adjustment required | Not recommended (Fetal tubular risk) | Euglycemic ketoacidosis, Fournier |
| Semaglutide | No dosage adjustment required | No dosage adjustment required | Contraindicated (Discontinue 2 months before) | Pancreatitis, Medullary Thyroid Ca (CMT) |
| Sitagliptin | Reduce by 50% in eGFR < 45; 25% in eGFR < 30 | No dosage adjustment required | Category B (Avoid) | Acute pancreatitis, severe arthralgia |
| Glimepiride | Avoid if eGFR < 30 mL/min | Contraindicated in severe failure | Contraindicated (neonatal hypoglycemia) | Refractory hypoglycemia |
| Pioglitazone | No dosage adjustment required | Do not use if transaminases > 2.5x ULN | Contraindicated (Embryonic death) | Fluid Retention, Heart Failure |
| L-Thyroxine | No dosage adjustment required | No dosage adjustment required | Category A (Increase dose 30-50%) | Induced thyrotoxicosis, AF, Angina |
| Methimazole | No dosage adjustment required | Use with caution | Of choice in T2 and T3 (Teratogen in T1) | Febrile agranulocytosis, Aplasia cutis |
| Hydrocortisone | No dosage adjustment required | Decrease dose in active cirrhosis | Compatible (Inactivated by 11β-HSD2) | Acute adrenal crisis due to sudden suppression |
| Desmopressin | Contraindicated if eGFR < 50 mL/min | No dosage adjustment required | Compatible (Central DI of choice) | Extreme dilutional hyponatremia, seizures |
| Ac. Zoledronic | Contraindicated if eGFR < 35 mL/min | No dosage adjustment required | Contraindicated (Fetal skeletal risk) | Acute phase, Jaw necrosis (ONJ) |
| Denosumab | No adjustment required (Monitor serum calcium) | No dosage adjustment required | Contraindicated (Fetal immune failure) | Hypocalcemia, Rebound of multiple fractures |
| Cinacalcet | No adjustment required (Designed for dialysis) | Monitor in moderate-severe insufficiency | Not recommended | Symptomatic hypocalcemia, Tetany, QTc |
| Atorvastatin | No dosage adjustment required | Contraindicated in active disease | Category X (Absolute contraindication) | Toxic myopathy, Rhabdomyolysis |
Epistemis is educational review material. It is not a medical device, does not diagnose or prescribe treatment, and does not replace formal medical training, current clinical guidelines, or professional clinical judgment.
- System
- Endocrine and Metabolism
- Group
- Comparative Table of Clinical Settings