Everolimus is a kinase inhibitor sold in the U.S. under 3 brand and generic names. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Everolimus (application ANDA216140). Other everolimus products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Patients receiving everolimus tablets may require dose adjustments based on everolimus blood concentrations achieved, tolerability, individual response, change in concomitant medications and the clinical situation. Optimally, dose adjustments of everolimus tablets should be based on trough concentrations obtained 4 or 5 days after a previous dosing change. Dose adjustment is required if the trough concentration is below 3 ng/mL. The total daily dose of everolimus tablets should be doubled using the available tablet strengths (0.25 mg, 0.5 mg, 0.75 mg, or 1 mg). Dose adjustment is also required if the trough concentration is greater than 8 ng/mL on 2 consecutive measures; the dose of everolimus tablets should be decreased by 0.25 mg twice daily [see Dosage and Administration (2.3), Clinical Pharmacology (12.3)] . • Kidney Transplantation: starting oral dose of 0.75 mg twice daily as soon as possible after transplantation ( 2.1 ) • Liver Transplantation: starting oral dose of 1 mg twice daily starting 30 days after transplantation ( 2.2 ) • Monitor Everolimus Concentrations: Adjust maintenance dose to achieve trough concentrations within the 3 to 8 ng/mL target range using LC/MS/MS assay method ( 2.1 , 2.2 , 2.3 ) • Administer consistently with or without food at the same time as cyclosporine or tacrolimus ( 2.6 , 12.3 ) • Mild Hepatic Impairment: Reduce initial daily dose by…
Most common adverse reactions were as follows: Kidney Transplantation (incidence greater than or equal to 20%): peripheral edema, constipation, hypertension, nausea, anemia, urinary tract infection (UTI), and hyperlipidemia ( 6.1 ) Liver Transplantation (incidence greater than 10%): diarrhea, headache, peripheral edema, hypertension, nausea, pyrexia, abdominal pain, leukopenia, and hypercholesterolemia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Biocon Pharma Inc., at 1-866-924-6266 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Serious and Otherwise Important Adverse Reactions The following adverse reactions are discussed in greater detail in other sections of the label. Hypersensitivity Reactions [ see Contraindications (4.1) ] Lymphomas and Other Malignancies [ see Boxed Warning, Warnings and Precautions (5.2) ] Serious Infections [ see Warnings and Precautions (5.3) ] Kidney Graft Thrombosis [ see Warnings an d Precautions ( 5.4 ) ] Hepatic Artery Thrombosis [ see Warnings and Precautions (5. 5 ) ] Everolimus and Calcineurin Inhibitor-Induced Nephrotoxicity [ see Warnings and Precautions ( 5. 6 ) ] Heart Transplantation [ see Warnings and Precautions (5.7) ] Angioedema [ see Warnings and Precautions (5. 8 ) ] Wound Healing and Fluid Accumulation [ see Warnings and Precautions ( 5. 9 ) ] Interstitial Lung Disease/Non-Infectious Pneumonitis [ see Warnings…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Tablet | Generic | $240 | View → | |
| 2 |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| EVR;2;5 | 2.5 mg | white | oval | — |
| EVR;5 | 5 mg | white | oval | — |
| EVR;7;5 | 7.5 mg | white | oval | — |
| EVR;NAT | 10 mg | white | oval | — |
| 5;NVR | 5 mg | white | oval | — |
| UHE;NVR | 10 mg | white |
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Everolimus tablets 7.5mg
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Endo USA, Inc. · Oct 10, 2025
Everolimus tablets 2.5 mg
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Endo USA, Inc. · Oct 10, 2025
Everolimus tablets 5mg
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Endo USA, Inc. · Oct 10, 2025
Everolimus tablets 10 mg
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Endo USA, Inc. · Oct 10, 2025
Everolimus tablets 5mg
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Endo USA, Inc. · Sep 5, 2025
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Hypersensitivity to everolimus, sirolimus, or to components of the drug product ( 4 ) 4.1 Hypersensitivity Reactions Everolimus tablets are contraindicated in patients with known hypersensitivity to everolimus, sirolimus, or to components of the drug product.
Strong-moderate CYP3A4 inhibitors (e.g., cyclosporine, ketoconazole, erythromycin, verapamil) and CYP3A4 inducers (e.g., rifampin) may affect everolimus concentrations ( 7.1 ). Consider everolimus tablets dose adjustment ( 5.14 ) Therapeutic drug monitoring and dose reduction for everolimus tablets should be considered when everolimus tablets are coadministered with cannabidiol (5.22, 7.13) 7.1 Interactions With Strong Inhibitors or Inducers of CYP3A4 and P-glycoprotein Everolimus is mainly metabolized by CYP3A4 in the liver and to some extent in the intestinal wall and is a substrate for the multidrug efflux pump, P-glycoprotein (P-gp). Therefore, absorption and subsequent elimination of systemically absorbed everolimus may be influenced by medicinal products that affect CYP3A4 and/or P-gp. Concurrent treatment with strong inhibitors (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir, boceprevir, telaprevir) and inducers (e.g., rifampin, rifabutin) of CYP3A4 is not recommended. Inhibitors of P-gp (e.g., digoxin, cyclosporine) may decrease the efflux of everolimus from intestinal cells and increase everolimus blood concentrations. In vitro , everolimus was a competitive inhibitor of CYP3A4 and of CYP2D6, potentially increasing the concentrations of medicinal products eliminated by these enzymes. Thus, caution should be exercised when…
| 68/100 |
| Prescription |
| Tablet |
| Generic |
| $240 |
| View → |
| 3 | 68/100 | Prescription | Tablet | Generic | $240 | View → |
| oval |
| — |
| LCL;NVR | 2.5 mg | white | oval | — |
|---|
| 7P5;NVR | 7.5 mg | white | oval | — |
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| D2;NVR | 2 mg | white | round | — |
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| D3;NVR | 3 mg | white | round | — |
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| D5;NVR | 5 mg | white | round | — |
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| B;5 | 5 mg | white | capsule | — |
|---|