ETOPOSIDE 50 mg Capsule, 20-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Topoisomerase Inhibitor class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Etoposide is a chemotherapy drug approved for two main cancers: small cell lung cancer and refractory testicular tumors — meaning testicular cancer that hasn't responded to other t...
- What exactly is etoposide being used to treat in my case?
- The most common things people experience are low blood counts — which means a higher risk of infection and bleeding — nausea, hair loss, fatigue, and appetite changes. Nausea is us...
- What side effects should I actually expect?
Patient education
Supplement & herbal interactions
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII XF417D3PSL
Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
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UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
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UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
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UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
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UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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UNII B697894SGQ
Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
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UNII 506T60A25R
Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
11 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Etoposide 50 mg 00378-3266-94 | Mylan | 20 capsules | — | AB | FDA listed | — |
| Etoposide 50 mgthis 83270-0451-05 | Onesource | 20 capsules | — | AB | FDA listed | — |
| VePesid 50 mg 69238-2811-02 | Amneal | 20 capsules | — | AB | FDA listed | — |
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⏳ Availability & generic status
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
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📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 83270-0451-05 You're viewing this | 20 CAPSULE in 1 CARTON (83270-451-05) | 2026-05-29 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
Warnings Etoposide should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Severe myelosuppression with resulting infection or bleeding may occur.
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Etoposide is indicated in the management of: Small Cell Lung Cancer —Etoposide capsules in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION For recommended dosing adjustments in patients with renal impairment see PRECAUTIONS section. Chemotherapy courses are repeated at 3 to 4-week intervals after adequate recovery from any toxicity. Etoposide Capsules In small cell lung cancer, the recommended dose of Etoposide Capsules is two times the IV dose rounded to the nearest 50 mg (i.e., two times 35 mg/m 2 /day for 4 days to 50 mg/m 2 /day for 5 days).
The dosage should be modified to take into account the myelosuppressive effects of other drugs in the combination or the effects of prior x-ray therapy or chemotherapy which may have compromised bone marrow reserve. Administration Precautions To minimize the risk of dermal exposure, always wear impervious gloves when handling blister packs of individually labeled blisters containing Etoposide capsules. This includes all handling activities in clinical settings, pharmacies, storerooms, and home healthcare settings, including during unpacking and inspection, transport within a facility, and dose preparation and administration.
Stability Etoposide capsules must be stored under refrigeration 2°C to 8°C (36°F to 46°F). The capsules are stable for 24 months under such refrigeration conditions. Procedures for proper handling and disposal of anticancer drugs should be considered.
Several guidelines on this subject have been published. 1-8 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.
⛔ Contraindications ▾
CONTRAINDICATIONS Etoposide is contraindicated in patients who have demonstrated a previous hypersensitivity to etoposide or any component of the formulation.
⚠️ Warnings ▾
WARNINGS Patients being treated with Etoposide must be frequently observed for myelosuppression both during and after therapy. Myelosuppression resulting in death has been reported. Dose-limiting bone marrow suppression is the most significant toxicity associated with Etoposide therapy.
Therefore, the following studies should be obtained at the start of therapy and prior to each subsequent cycle of Etoposide: platelet count, hemoglobin, white blood cell count, and differential. The occurrence of a platelet count below 50,000/mm 3 or an absolute neutrophil count below 500/mm 3 is an indication to withhold further therapy until the blood counts have sufficiently recovered. Pregnancy Etoposide can cause fetal harm when administered to a pregnant woman.
Etoposide has been shown to be teratogenic in mice and rats. In rats, an intravenous etoposide dose of 0.4 mg/kg/day (about 1/20th of the human dose on a mg/m 2 basis) during organogenesis caused maternal toxicity, embryotoxicity, and teratogenicity (skeletal abnormalities, exencephaly, encephalocele, and anophthalmia); higher doses of 1.2 and 3.6 mg/kg/day (about 1/7th and 1/2 of human dose on a mg/m 2 basis) resulted in 90 and 100% embryonic resorptions. In mice, a single 1.0 mg/kg (1/16th of human dose on a mg/m 2 basis) dose of etoposide administered intraperitoneally on days 6, 7, or 8 of gestation caused embryotoxicity, cranial abnormalities, and major skeletal malformations.
An I.P. dose of 1.5 mg/kg (about 1/10th of human dose on a mg/m 2 basis) on day 7 of gestation caused an increase in the incidence of intrauterine death and fetal malformations and a significant decrease in the average fetal body weight. Women of childbearing potential should be advised to avoid becoming pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be warned of the potential hazard to the fetus.
Etoposide should be considered a potential carcinogen in humans. The occurrence of acute leukemia with or without a preleukemic phase has been reported in rare instances in patients treated with etoposide alone or in association with other neoplastic agents. The risk of development of a preleukemic or leukemic syndrome is unclear.
Carcinogenicity tests with etoposide have not been conducted in laboratory animals.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The following data on adverse reactions are based on both oral and intravenous administration of Etoposide as a single agent, using several different dose schedules for treatment of a wide variety of malignancies. Hematologic Toxicity Myelosuppression is dose related and dose limiting, with granulocyte nadirs occurring 7 to 14 days after drug administration and platelet nadirs occurring 9 to 16 days after drug administration. Bone marrow recovery is usually complete by day 20, and no cumulative toxicity has been reported.
Fever and infection have also been reported in patients with neutropenia. Death associated with myelosuppression has been reported. The occurrence of acute leukemia with or without a preleukemic phase has been reported rarely in patients treated with Etoposide in association with other antineoplastic agents.
( See WARNINGS .) Gastrointestinal Toxicity Nausea and vomiting are the major gastrointestinal toxicities. The severity of such nausea and vomiting is generally mild to moderate with treatment discontinuation required in 1% of patients. Nausea and vomiting can usually be controlled with standard antiemetic therapy.
Mild to severe mucositis/esophagitis may occur. Gastrointestinal toxicities are slightly more frequent after oral administration than after intravenous infusion. Allergic Reaction Anaphylactic-like reactions characterized by chills, fever, tachycardia, bronchospasm, dyspnea, and/or hypotension have been reported to occur in 0.7% to 2% of patients receiving intravenous Etoposide and in less than 1% of the patients treated with the oral capsules.
These reactions have usually responded promptly to the cessation of the infusion and administration of pressor agents, corticosteroids, antihistamines, or volume expanders as appropriate; however, the reactions can be fatal. Hypertension and/or flushing have also been reported. Blood pressure usually normalizes within a few hours after cessation of the infusion.
Anaphylactic-like reactions have occurred during the initial infusion of Etoposide. Facial/tongue swelling, coughing, diaphoresis, cyanosis, tightness in throat, laryngospasm, back pain, and/or loss of consciousness have sometimes occurred in association with the above reactions. In addition, an apparent hypersensitivity-associated apnea has been reported rarely.
Rash, urticaria, and/or pruritus have infrequently been reported at recommended doses. At investigational doses, a generalized pruritic erythematous maculopapular rash, consistent with perivasculitis, has been reported. Alopecia Reversible alopecia, sometimes progressing to total baldness, was observed in up to 66% of patients.
Other Toxicities The following adverse reactions have been infrequently reported: abdominal pain, aftertaste, constipation, dysphagia, asthenia, fatigue, malaise, somnolence, transient cortical blindness, optic neuritis, interstitial pneumonitis/pulmonary fibrosis, fever, seizure (occasionally associated with allergic reactions), Stevens-Johnson syndrome, and toxic epidermal necrolysis, pigmentation, and a single report of radiation recall dermatitis. Hepatic toxicity, generally in patients receiving higher doses of the drug than those recommended, has been reported with Etoposide.
Metabolic acidosis has also been reported in patients receiving higher doses. The incidences of adverse reactions in the table that follows are derived from multiple data bases from studies in 2,081 patients when Etoposide was used either orally or by injection as a single agent. ADVERSE DRUG EFFECT PERCENT RANGE OF REPORTED INCIDENCE Hematologic toxicity Leukopenia (less than 1,000 WBC/mm 3 ) 3 to 17 Leukopenia (less than 4,000 WBC/mm 3 ) 60 to 91 Thrombocytopenia (less than 50,000 platelets/mm 3 ) 1 to 20 Thrombocytopenia (less than 100,000 platelets/mm 3 ) 22 to 41 Anemia 0 to 33 Gastrointestinal toxicity Nausea and vomiting 31 to 43 Abdominal pain 0 to 2 Anorexia 10 to 13 Diarrhea 1 to 13 Stomatitis 1 to 6 Hepatic…
🆘 Overdosage ▾
OVERDOSAGE No proven antidotes have been established for Etoposide overdosage.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Etoposide has been shown to cause metaphase arrest in chick fibroblasts. Its main effect, however, appears to be at the G 2 portion of the cell cycle in mammalian cells. Two different dose-dependent responses are seen.
At high concentrations (10 mcg/mL or more), lysis of cells entering mitosis is observed. At low concentrations (0.3 to 10 mcg/mL), cells are inhibited from entering prophase. It does not interfere with microtubular assembly.
The predominant macromolecular effect of etoposide appears to be the induction of DNA strand breaks by an interaction with DNA topoisomerase II or the formation of free radicals.
📦 How Supplied / Storage and Handling ▾
How Supplied Etoposide Capsules, USP, 50 mg, are supplied as pink capsules with “V3545” printed in black and are available in blister packs of 20 individually labeled blisters, each containing one capsule (NDC 83270-451-05). Capsules are to be stored under refrigeration, between 2°C to 8°C (36°F to 46°F). DO NOT FREEZE.
References 1. ONS Clinical Practice Committee. Cancer Chemotherapy Guidelines and Recommendations for Practice.
Pittsburgh, PA: Oncology Nursing Society; 1999:32- 41. 2. Recommendations for the safe handling of parenteral antineoplastic drugs.
Washington, DC: Division of Safety, Clinical Center Pharmacy Department and Cancer Nursing Services, National Institutes of Health; 1992. US Dept of Health and Human Services, Public Health Service Publication NIH 92-2621. 3.
AMA Council on Scientific Affairs. Guidelines for handling parenteral antineoplastics. JAMA.
1985;253:1590-1592. 4. National Study Commission on Cytotoxic Exposure.
Recommendations for handling cytotoxic agents. 1987. Available from Louis P.
Jeffrey, ScD, Chairman, National Study Commission on Cytotoxic Exposure. Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, MA 02115. 5.
Clinical Oncological Society of Australia. Guidelines and recommendations for safe handling of antineoplastic agents. Med J Aust.
1983;1:426-428. 6. Jones RB, Frank R, Mass T.
Safe handling of chemotherapeutic agents: a report from The Mount Sinai Medical Center. CA Cancer J Clin. 1983;33:258-263.
7. American Society of Hospital Pharmacists. ASHP technical assistance bulletin on handling cytotoxic and hazardous drugs.
Am J Hosp Pharm. 1990;47:1033-1049. 8.
Controlling occupational exposure to hazardous drugs. (OSHA Work-Practice Guidelines.) Am J Health-Syst Pharm. 1996;53:1669-1685.
Manufactured by: Eirgen Pharma Ltd Westside Business Park, Waterford, X91 YV67, Ireland Rev. 07-2026-00
📋 Description ▾
DESCRIPTION Etoposide, USP (also commonly known as VP-16) is a semisynthetic derivative of podophyllotoxin used in the treatment of certain neoplastic diseases. It is 4’- demethylepipodophyllotoxin 9-[4,6-O-(R)-ethylidene-β-D-glucopyranoside]. It is very soluble in methanol and chloroform, slightly soluble in ethanol, and sparingly soluble in water and ether.
It is made more miscible with water by means of organic solvents. It has a molecular weight of 588.56 and a molecular formula of C 29 H 32 O 13 . Etoposide is administered orally.
Etoposide is available as 50 mg pink capsules. Each liquid- filled, soft gelatin capsule contains 50 mg of etoposide, USP in a vehicle consisting of citric acid anhydrous, polyethylene glycol 400, glycerol anhydrous, purified water, gelatin, glycerol anhydrous, sorbitol liquid partially dehydrated, titanium dioxide, red iron oxide, and Glycerol 85%. The capsules are printed with black edible ink, containing isopropyl alcohol, purified water, hypromellose, propylene glycol, FD&C red #40, FD& C blue #1.
The structural formula is: structure