Vorinostat
Vorinostat is a cancer medicine (an HDAC inhibitor) taken by mouth to treat skin symptoms of cutaneous T-cell lymphoma after other treatments have not worked.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Vorinostat (Zolinza) is a specialist cancer medicine, on the U.S. market since about 2006, that blocks HDAC enzymes cancer cells use to control their genes. It treats the skin symptoms of cutaneous T-cell lymphoma after two systemic (whole-body) treatments have not worked. Many people find it demanding, mostly through diarrhea, tiredness, nausea, poor appetite with weight loss, and an odd change in taste. Watch above all for a blood clot, and get help right away for sudden breathlessness, chest pain, or a swollen, painful leg. Expect frequent blood tests for platelets, blood sugar and electrolytes, and drink plenty of fluids so diarrhea does not turn into dehydration.
Clinical pearls
- Take the capsules once a day with a meal, swallowed whole, never opened or crushed.
- On warfarin, vorinostat can push your INR (a clotting test) up, so INR checks need to be more frequent.
- Valproic acid with vorinostat has caused severe low platelets with gut bleeding, so make sure every prescriber knows you take it.
- Women need effective birth control for at least 6 months after the last dose, and men for at least 3 months.
Patient information guide A plain-language walkthrough of Vorinostat, written from its FDA label.
What Vorinostat is used for
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Vorinostat is used for one cancer-related condition:
- Zolinza (vorinostat capsules) treats skin symptoms of cutaneous T-cell lymphoma (CTCL) in people whose disease is progressing, persisting or has returned on or after two systemic therapies.
How Vorinostat works
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Vorinostat is a histone deacetylase (HDAC) inhibitor. It blocks the activity of HDAC enzymes, including HDAC1, HDAC2, HDAC3 and HDAC6. Blocking these enzymes is how it works against CTCL.
Vorinostat dosage
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Zolinza is a capsule taken by mouth once a day with food. Swallow it whole and do not open or crush it. Treatment can continue as long as the disease is not getting worse and side effects are acceptable.
- Your prescriber may lower the dose if you can't tolerate it.
- A lower starting dose is used for mild to moderate liver problems.
- Follow your label and prescriber for exact directions.
Dosing details from the FDA-approved label
From the Vorinostat prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Recommended dose (cutaneous T-cell lymphoma, per ZOLINZA label)
- 400 mg orally once daily with food
- Treatment may be continued as long as there is no evidence of progressive disease or unacceptable toxicity
- Capsules should not be opened or crushed
- Patients intolerant to therapy (dose modification for toxicity)
- Reduce to 300 mg orally once daily with food
- May be further reduced to 300 mg once daily with food for 5 consecutive days each week, as necessary
- Take with food
- Mild to moderate hepatic impairment (bilirubin 1 to 3 × ULN or AST greater than ULN)
- Reduce the starting dose to 300 mg orally once daily with food
- Insufficient evidence to recommend a starting dose for severe hepatic impairment (bilirubin greater than 3 × ULN)
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION 400 mg orally once daily with food. ( 2.1 ) If patient is intolerant to therapy, reduce the dose to 300 mg orally once daily with food. If necessary, reduce the dose further to 300 mg once daily with food for 5 consecutive days each week. ( 2.2 , 5 ) Reduce dose in patients with mild or moderate hepatic impairment. ( 2.2 ) 2.1 Dosing Information The recommended dose is 400 mg orally once daily with food. Treatment may be continued as long as there is no evidence of progressive disease or unacceptable toxicity. ZOLINZA capsules should not be opened or crushed [see How Supplied/Storage and Handling (16) ] . 2.2 Dose Modifications For Toxicity If a patient is intolerant to therapy, the dose may be reduced to 300 mg orally once daily with food. The dose may be further reduced to 300 mg once daily with food for 5 consecutive days each week, as necessary. Hepatic Impairment Reduce the starting dose to 300 mg orally once daily with food in patients with mild to moderate hepatic impairment (bilirubin 1 to 3 × ULN or AST greater than ULN). There is insufficient evidence to recommend a starting dose for patients with severe hepatic impairment (bilirubin greater than 3 × ULN) [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ] .
Read the full Dosage and Administration section on DailyMed →
Vorinostat side effects
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The most common side effects seen in studies were:
Common side effects
- Diarrhea
- Tiredness (fatigue)
- Nausea
- Low platelet counts (thrombocytopenia)
- Loss of appetite
- Changes in taste (dysgeusia)
- Weight loss
- Muscle spasms
- Weight loss, muscle spasms, hair loss, dry mouth
When to get medical help
- Call your doctor right away if you have signs of a blood clot in the lung (pulmonary embolism) or leg (deep vein thrombosis).
- Tell your doctor about unusual bleeding or bruising. Vorinostat can lower platelets and red blood cells (anemia).
- Get help if nausea, vomiting or diarrhea is severe or you can't keep fluids down. Dehydration can be serious.
- Report very high blood sugar symptoms. Vorinostat can raise blood glucose.
- Tell your doctor if you are pregnant or think you might be.
Serious problems include blood clots in the lung or legs, severe anemia or low platelets, severe high blood sugar, and dehydration. Call your doctor promptly if you notice these.
Vorinostat warnings and precautions
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- Blood clots: Pulmonary embolism and deep vein thrombosis can occur, especially if you've had clots before.
- Low blood counts: Platelets and red blood cells can drop. Counts are checked every 2 weeks for the first 2 months, then monthly.
- Stomach and bowel upset: Nausea, vomiting and diarrhea may need medicines and fluids to prevent dehydration.
- High blood sugar: Glucose is monitored on the same schedule.
- Electrolytes and kidney tests: Low potassium and magnesium should be corrected before starting.
- Pregnancy: It can harm an unborn baby.
Vorinostat interactions
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Two interactions are highlighted on the label:
- Warfarin-type (coumarin) blood thinners: clotting tests (PT/INR) can rise, so INR is monitored more often.
- Other HDAC inhibitors such as valproic acid: severe low platelets and stomach or bowel bleeding have been reported, so platelets are checked more often.
Interactions listed in the FDA-approved label
From the Vorinostat prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Coumarin-derivative anticoagulants: Prolongation of prothrombin time (PT) and International Normalized Ratio (INR) were observed in patients receiving ZOLINZA concomitantly with coumarin-derivative anticoagulants. Monitor PT and INR more frequently in patients concurrently administered ZOLINZA and coumarin derivatives.
- Other HDAC inhibitors (e.g., valproic acid): Severe thrombocytopenia and gastrointestinal bleeding have been reported with concomitant use of ZOLINZA and other HDAC inhibitors. Monitor platelet count every 2 weeks for the first 2 months.
Read the label’s full interactions text
7 DRUG INTERACTIONS Coumarin-derivative anticoagulants: Prolongation of prothrombin time and International Normalized Ratio (INR) have been observed with concomitant use. Monitor INR frequently. ( 7.1 ) 7.1 Coumarin-Derivative Anticoagulants Prolongation of prothrombin time (PT) and International Normalized Ratio (INR) were observed in patients receiving ZOLINZA concomitantly with coumarin-derivative anticoagulants. Physicians should monitor PT and INR more frequently in patients concurrently administered ZOLINZA and coumarin derivatives. 7.2 Other HDAC Inhibitors Severe thrombocytopenia and gastrointestinal bleeding have been reported with concomitant use of ZOLINZA and other HDAC inhibitors (e.g., valproic acid). Monitor platelet count every 2 weeks for the first 2 months [see Warnings and Precautions (5.6) ].
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Vorinostat
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- No absolute contraindications are listed.
- Tell your doctor if you are pregnant or may become pregnant. Use effective contraception during treatment and for at least 6 months afterward (women) or 3 months afterward (men with partners who can become pregnant).
- Do not breastfeed.
- Mention liver problems, since a lower starting dose is used.
- Mention a history of blood clots, high blood sugar, or electrolyte problems.
- Kidney impairment was not studied, but the kidneys do not play a role in clearing vorinostat.
Vorinostat overdose
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No specific treatment for Zolinza overdose is known. Usual supportive care is reasonable, such as removing unabsorbed drug from the stomach and bowel, monitoring, and supportive treatment as needed. It is not known whether dialysis removes vorinostat. Seek emergency help or call poison control if you take too much.
What Vorinostat does in the body
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Vorinostat blocks HDAC enzymes. In a study of a single high dose in people with advanced cancer, it did not appear to lengthen the QTc interval (a heart rhythm measure), though that study had no positive control. In CTCL trials, a few people had QTc prolongation, which is why electrolytes such as potassium and magnesium are checked.
How your body processes Vorinostat
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After a dose by mouth, vorinostat peaks in the blood in a few hours. Taking it with a high-fat meal slightly increases how much is absorbed, and trials were done with food. The body clears it mostly by metabolism, not through the CYP liver enzyme pathways. Its half-life is about 2 hours, and little unchanged drug leaves in urine.
How to store Vorinostat
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Store at 20-25°C (68-77°F), excursions permitted between 15-30°C (59-86°F) .
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Vorinostat: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Vorinostat — the kind of thing our pharmacy team would talk through with you at the counter.
What is vorinostat for?
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How should I take it?
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What side effects should I expect?
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When should I call my doctor right away?
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Why do I need so many blood tests?
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Can I take it if I'm pregnant or breastfeeding?
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Is Vorinostat available over the counter?
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When was Vorinostat first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Vorinostat on HelloPharmacist
Vorinostat forms and strengths (how it comes)
Vorinostat is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Capsule
How this form is used
- Zolinza is used for skin symptoms of cutaneous T-cell lymphoma in people whose disease is progressive, persistent or recurrent on or after two systemic therapies.
- Zolinza is taken by mouth once daily with food.
- Zolinza capsules should not be opened or crushed.
- Zolinza may be given at a reduced dose if side effects occur or if you have mild to moderate liver impairment.
Vorinostat on the U.S. market: products, makers and brands
How Vorinostat appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 1 Vorinostat product record with the FDA, mostly as capsule; the earliest marketing or approval year on record is 2006. Brand names on the directory include Zolinza; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (2) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Compare Vorinostat products
A representative set of FDA-listed product records for Vorinostat — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 100 mg | Oral | Merck Sharp & Dohme LLC | NDA | View NDC → |
Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Vorinostat NDCs →
Vorinostat side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Vorinostat — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Vorinostat in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Vorinostat FDA approval history
How Vorinostat went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Vorinostat recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Vorinostat recalls since July 2021.
✅No Vorinostat recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 194337 1 dose form · 1 strength
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Dose form (SCDF) Oral Capsule RxCUI 668578In current FDA listingsClinical drug / strength (SCD) 100 MGRxCUI 668579
Look up RxCUI 194337 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Vorinostat supply and shortage status
Whether Vorinostat is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Vorinostat brand names
Vorinostat is sold under one brand name in the FDA directory — Zolinza. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Vorinostat: manufacturers and labelers
One company lists Vorinostat products with the FDA. By number of product records, the largest are Merck Sharp & Dohme LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Vorinostat drug class (RxNorm)
Vorinostat belongs to the Histone Deacetylase Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Vorinostat page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Merck Sharp & Dohme LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →