Paclitaxel
Paclitaxel is a chemotherapy medicine used intravenously to treat certain breast, lung, ovarian, and pancreatic cancers, as well as AIDS-related Kaposi's sarcoma.
🧬 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 27 clinical label sets 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 →
Paclitaxel is a chemotherapy given into a vein for breast, ovarian, lung and pancreatic cancers and AIDS-related Kaposi's sarcoma; it locks microtubules (the scaffolding cells use to divide) so cancer cells cannot split, and it has been a cornerstone since the 1990s, available generically. Expect a demanding course; most people notice hair loss, tiredness, aches and tingling or numbness in the hands and feet. The boxed warning covers severe, sometimes fatal allergic reactions, so standard paclitaxel comes after premedication and only where emergency care is ready. It also drops infection-fighting white blood cells, so counts are checked before each dose and fever or new breathlessness means calling your team immediately.
Clinical pearls
- Albumin-bound versions such as Abraxane are not interchangeable with standard paclitaxel, which needs a steroid, antihistamine and acid reducer first.
- Tell every prescriber you get paclitaxel, since clarithromycin, ketoconazole, ritonavir, rifampin and gemfibrozil can push its levels up or down.
- Mention numbness that makes buttoning a shirt or walking harder at each visit, because a dose change may be needed.
- Women should use birth control for at least 6 months after the last dose, and men for at least 3 months.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Paclitaxel must be given under the supervision of a doctor experienced in cancer chemotherapy, and only where emergency treatment is immediately available. Severe allergic reactions — including life-threatening drops in blood pressure, difficulty breathing, swelling, and hives — have occurred in 2–4% of patients, and some have been fatal even in patients who received pre-medications. If you have a severe reaction, you must not receive paclitaxel again. Paclitaxel also causes significant drops in white blood cells (neutropenia), which can lead to serious infections. It should not be given if your neutrophil (infection-fighting white blood cell) count is too low at the start of treatment. Regular blood tests are required throughout treatment to monitor for this.
Patient information guide A plain-language walkthrough of Paclitaxel, written from its FDA label.
What Paclitaxel is used for
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Paclitaxel is a chemotherapy medicine given intravenously to treat several types of cancer. Specific approvals depend on the product formulation:
- Abraxane and albumin-bound paclitaxel products: Metastatic breast cancer after combination chemotherapy has failed; locally advanced or metastatic non-small cell lung cancer (first-line, with carboplatin); metastatic adenocarcinoma of the pancreas (first-line, with gemcitabine)
- Paclitaxel injection (solution/concentrate): Advanced ovarian cancer (as subsequent therapy, or first-line with cisplatin); breast cancer after chemotherapy failure; adjuvant treatment of node-positive breast cancer (given sequentially with standard chemotherapy); first-line non-small cell lung cancer in combination with cisplatin; second-line AIDS-related Kaposi's sarcoma
How Paclitaxel works
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Paclitaxel is a microtubule inhibitor. Microtubules are tiny structural rods inside cells that cells use to pull their chromosomes apart when dividing. Paclitaxel locks these rods in place, preventing the normal reorganization that must happen for a cell to divide. With the division machinery jammed, cancer cells cannot multiply and instead die off. It disrupts this process both during cell division (mitosis) and during the day-to-day life of the cell.
Paclitaxel dosage
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Paclitaxel is always given as an intravenous (IV) infusion in a clinic or hospital — never taken by mouth. The schedule varies by product and the condition being treated: it may be administered once every three weeks or on specific days within a multi-week cycle. Your oncologist will determine your schedule based on which product you are receiving and what you are being treated for.
- Before each infusion of standard paclitaxel injection, pre-medications are required to reduce the risk of serious allergic reactions
- Albumin-bound formulations such as Abraxane must not be substituted for other paclitaxel products — they are different and not interchangeable
- Always follow your prescriber's and infusion team's instructions exactly; do not adjust your schedule without talking to your doctor
Dosing details from the FDA-approved label
From the Paclitaxel 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.
- Metastatic Breast Cancer (MBC)
- 260 mg/m2 intravenously over 30 minutes every 3 weeks
- For moderate or severe hepatic impairment, reduce starting dose to 200 mg/m2; not recommended with AST > 10 x ULN or bilirubin > 5 x ULN
- Non-Small Cell Lung Cancer (NSCLC)
- 100 mg/m2 intravenously over 30 minutes on Days 1, 8, and 15 of each 21-day cycle
- Administer carboplatin on Day 1 of each 21-day cycle immediately after paclitaxel protein-bound particles
- For moderate or severe hepatic impairment, reduce starting dose to 80 mg/m2; not recommended with AST > 10 x ULN or bilirubin > 5 x ULN
- Adenocarcinoma of the Pancreas
- 125 mg/m2 intravenously over 30-40 minutes on Days 1, 8, and 15 of each 28-day cycle
- Administer gemcitabine on Days 1, 8, and 15 of each 28-day cycle immediately after paclitaxel protein-bound particles
- Not recommended in patients with moderate to severe hepatic impairment
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION • Do not substitute Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) for other paclitaxel products. (2.1) • Extravasation : Closely monitor the infusion site for extravasation and infiltration. ( 2.1 ) • Metastatic Breast Cancer (MBC) : Recommended dosage of Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is 260 mg/m 2 intravenously over 30 minutes every 3 weeks. ( 2.2 ) • Non-Small Cell Lung Cancer (NSCLC) : Recommended dosage of Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is 100 mg/m 2 intravenously over 30 minutes on Days 1, 8, and 15 of each 21-day cycle; administer carboplatin on Day 1 of each 21-day cycle immediately after Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound). ( 2.2 ) • Adenocarcinoma of the Pancreas : Recommended dosage of Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is 125 mg/m 2 intravenously over 30-40 minutes on Days 1, 8, and 15 of each 28-day cycle; administer gemcitabine on Days 1, 8, and 15 of each 28-day cycle immediately after Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound). ( 2.4 ) • Use in Patients with Hepatic Impairment: Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is not recommended for use in patients with AST > 10 × ULN; or bilirubin > 5 × ULN or with metastatic adenocarcinoma of the pancreas who have moderate to severe hepatic impairment. For MBC or NSCLC, reduce starting dose in patients with moderate to severe hepatic impairment. ( 2.5 ) • Dose Reductions for Adverse Reactions : Dose reductions or discontinuation may be needed based on severe hematologic, neurologic, cutaneous, or gastrointestinal toxicities. ( 2.6 ) 2.1 Important Administration Instructions DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS. Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) has different dosage and administration instructions from other paclitaxel products. Closely monitor the infusion site for extravasation or drug infiltration during administration. Limiting the infusion of Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) to 30 minutes may reduce the risk of infusion-related reactions [see Adverse Reactions (6.2) ] .
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Paclitaxel side effects
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Paclitaxel commonly causes a range of side effects because it affects both cancer cells and some healthy cells:
Common side effects
- Low white blood cell counts (neutropenia), raising infection risk
- Numbness, tingling, or pain in hands and feet (peripheral neuropathy)
- Hair loss
- Nausea and vomiting
- Joint and muscle aches
- Fatigue
- Diarrhea
- Mouth sores (mucositis)
When to get medical help
- Signs of a severe allergic reaction: trouble breathing, sudden drop in blood pressure, swelling of the face or throat, or widespread hives — seek emergency help immediately
- Signs of serious infection or sepsis: fever (even without low white blood cell counts), chills, or feeling very unwell — call your care team right away
- Severe numbness, tingling, or weakness in hands or feet that gets worse — tell your doctor; dose adjustment may be needed
- Breathing problems such as new or worsening shortness of breath or cough — may signal pneumonitis (lung inflammation)
- Signs of bone marrow suppression: unusual bruising, bleeding, or signs of infection
Contact your care team right away if you develop a fever, have trouble breathing, notice severe or worsening numbness or weakness in your limbs, or experience signs of an allergic reaction — these can be serious and need prompt attention.
Paclitaxel warnings and precautions
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- Severe bone marrow suppression (neutropenia): The most common serious risk — low white blood cell counts can lead to life-threatening infections. Blood counts must be checked regularly, and treatment may need to be paused or the dose reduced.
- Severe allergic reactions (hypersensitivity/anaphylaxis): Can be life-threatening. Fatal reactions have occurred even with pre-medications. Anyone who has had a severe reaction must not receive paclitaxel again.
- Severe nerve damage (sensory neuropathy): Worsening numbness or tingling may require dose reduction or treatment breaks.
- Sepsis (bloodstream infection): Especially when albumin-bound paclitaxel is combined with gemcitabine; fever should be reported immediately.
- Pneumonitis (lung inflammation): Has occurred with albumin-bound paclitaxel plus gemcitabine, including fatal cases; any new breathing problems should be reported right away.
- Fetal harm: Paclitaxel can seriously harm an unborn baby. Effective contraception is required during treatment and for months after the last dose.
- Liver impairment: Can increase paclitaxel exposure and toxicity; dose reduction may be needed and certain uses are not recommended in severe liver impairment.
Paclitaxel interactions
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Paclitaxel is broken down by liver enzymes (CYP2C8 and CYP3A4), so medicines that affect those enzymes can change how much paclitaxel is in your body:
- Cisplatin: Giving cisplatin before paclitaxel (rather than after) can reduce paclitaxel clearance by about one-third, increasing its effects and side effects — the order of administration matters
- CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, saquinavir, nefazodone): May increase paclitaxel levels, raising the risk of toxicity
- CYP3A4 inducers (e.g., rifampin, carbamazepine): May lower paclitaxel levels, potentially reducing effectiveness
- CYP2C8 inhibitors (e.g., gemfibrozil): May increase paclitaxel exposure
- CYP2C8 inducers (e.g., rifampin): May decrease paclitaxel exposure
- Doxorubicin: Blood levels of doxorubicin and its active breakdown product may be higher when used alongside paclitaxel
Interactions listed in the FDA-approved label
From the Paclitaxel prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Cisplatin: Myelosuppression was more profound when paclitaxel was given after cisplatin than with the alternate sequence, and paclitaxel clearance decreased by approximately 33% when given following cisplatin.
- CYP3A4 substrates, inhibitors and inducers (substrates e.g. midazolam, buspirone, felodipine, lovastatin, eletriptan, sildenafil, simvastatin, triazolam; inhibitors e.g. atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin; inducers e.g. rifampin, carbamazepine): Paclitaxel metabolism is catalyzed by CYP3A4; no formal clinical drug interaction studies were done. Caution should be exercised when administering paclitaxel concomitantly.
- CYP2C8 substrates, inhibitors and inducers (substrates e.g. repaglinide, rosiglitazone; inhibitor e.g. gemfibrozil; inducer e.g. rifampin): Paclitaxel metabolism is catalyzed by CYP2C8; no formal clinical drug interaction studies were done. Caution should be exercised when administering paclitaxel concomitantly.
- Protease inhibitors (ritonavir, saquinavir, indinavir, nelfinavir): Potential interactions with paclitaxel, a CYP3A4 substrate, have not been evaluated in clinical trials.
- Doxorubicin: Literature reports suggest plasma levels of doxorubicin and its active metabolite doxorubicinol may be increased when used in combination with paclitaxel.
Read the label’s full interactions text
Drug Interactions: In a Phase I trial using escalating doses of paclitaxel (110 to 200 mg/m 2 ) and cisplatin (50 or 75 mg/m 2 ) given as sequential infusions, myelosuppression was more profound when paclitaxel was given after cisplatin than with the alternate sequence (i.e., paclitaxel before cisplatin). Pharmacokinetic data from these patients demonstrated a decrease in paclitaxel clearance of approximately 33% when paclitaxel was administered following cisplatin. The metabolism of paclitaxel is catalyzed by cytochrome P450 isoenzymes CYP2C8 and CYP3A4. In the absence of formal clinical drug interaction studies, caution should be exercised when administering paclitaxel concomitantly with known substrates or inhibitors of the cytochrome P450 isoenzymes CYP2C8 and CYP3A4. Caution should be exercised when paclitaxel is concomitantly administered with known substrates (e.g., midazolam, buspirone, felodipine, lovastatin, eletriptan, sildenafil, simvastatin, and triazolam), inhibitors (e.g., atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin), and inducers (e.g., rifampin and carbamazepine) of CYP3A4. (See CLINICAL PHARMACOLOGY section.) Caution should also be exercised when paclitaxel is concomitantly administered with known substrates (e.g., repaglinide and rosiglitazone), inhibitors (e.g., gemfibrozil), and inducers (e.g., rifampin) of CYP2C8. (See CLINICAL PHARMACOLOGY . ) Potential interactions between paclitaxel, a substrate of CYP3A4, and protease inhibitors (ritonavir, saquinavir, indinavir, and nelfinavir), which are substrates and/or inhibitors of CYP3A4, have not been evaluated in clinical trials. Reports in the literature suggest that plasma levels of doxorubicin (and its active metabolite doxorubicinol) may be increased when paclitaxel and doxorubicin are used in combination.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
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 Paclitaxel
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- Your neutrophil (white blood cell) count must be above a safe minimum before each treatment — paclitaxel cannot be given if counts are too low
- Tell your doctor about any prior severe allergic reaction to paclitaxel or other taxane medicines (such as docetaxel) — this may be a contraindication
- Tell your doctor if you have liver disease or abnormal liver tests — dose reduction or avoiding certain formulations may be necessary
- Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding — paclitaxel can cause serious harm to a developing baby and should not be used in pregnancy; breastfeeding should be stopped during treatment and for two weeks after the last dose
- Women of childbearing potential must use effective contraception during treatment and for at least 6 months after the last dose; men with female partners of reproductive potential should use contraception during treatment and for at least 3 months after the last dose
- Safety and effectiveness in pediatric patients have not been established for approved indications
- Older adults (65+) may experience more side effects, including bone marrow suppression, nerve effects, fatigue, diarrhea, and dehydration — closer monitoring is important
- Mild to moderate kidney impairment does not require a starting dose adjustment; severe renal impairment has not been studied
Paclitaxel overdose
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There is no known antidote for paclitaxel overdose. The main risks from too much paclitaxel are severe bone marrow suppression (very low blood counts), nerve damage, and mouth sores. If an overdose is suspected, emergency medical care is needed right away.
What Paclitaxel does in the body
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Paclitaxel stabilizes microtubules — the internal scaffolding cells use to divide — by preventing them from breaking down. This blocks the normal reorganization that must occur during and between cell divisions, causing cancer cells to form abnormal microtubule structures and ultimately halting their ability to multiply and survive.
How your body processes Paclitaxel
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After intravenous infusion, paclitaxel (from albumin-bound formulations) distributes rapidly into tissues and is highly bound to proteins in the blood (about 94%). It is mainly broken down by liver enzymes (CYP2C8 and CYP3A4), with the half-life — the time for half the drug to clear — ranging from roughly 13 to 27 hours. Only a small amount leaves the body through the urine; most is cleared through non-kidney pathways, with about 20% exiting via the stool. Albumin-bound paclitaxel has a larger volume of distribution and faster clearance compared to standard solvent-based paclitaxel injection.
How to store Paclitaxel
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Store the vials in original cartons between 20° to 25°C (68° to 77°F). Protect from light.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Paclitaxel: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Paclitaxel — the kind of thing our pharmacy team would talk through with you at the counter.
Why is paclitaxel given as an IV infusion instead of a pill?
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I've heard there are different 'versions' of paclitaxel — does it matter which one I get?
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What side effects should I expect, and which ones mean I need to call my doctor right away?
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Do I need to take anything before my infusion?
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Is it safe to try to get pregnant while on paclitaxel?
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Are there any medicines I should avoid while getting paclitaxel?
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Is Paclitaxel available over the counter?
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When was Paclitaxel first available?
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Who makes Paclitaxel?
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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 Paclitaxel on HelloPharmacist
Paclitaxel forms and strengths (how it comes)
Paclitaxel 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.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Paclitaxel inactive ingredients by manufacturer.
Injection
How this form is used
- Abraxane (and albumin-bound paclitaxel products) is used for metastatic breast cancer after prior combination chemotherapy has failed, first-line non-small cell lung cancer in combination with carboplatin, and first-line metastatic pancreatic adenocarcinoma in combination with gemcitabine
- Paclitaxel injection (solution/concentrate) is used for advanced ovarian cancer, breast cancer after failed chemotherapy, first-line non-small cell lung cancer in combination with cisplatin, adjuvant node-positive breast cancer, and second-line AIDS-related Kaposi's sarcoma
- Abraxane and albumin-bound formulations are given as an intravenous infusion on a schedule set by your oncologist; do not substitute Abraxane or albumin-bound products for other paclitaxel formulations — they are not interchangeable
- Paclitaxel injection (solution) requires pre-medications (a steroid, antihistamine, and acid reducer) before each dose to help prevent serious allergic reactions
- The infusion site must be closely monitored for leakage (extravasation) during and after administration
- Paclitaxel injection solution should be stored and administered using non-PVC containers and tubing to avoid exposure to the plasticizer DEHP
Paclitaxel on the U.S. market: products, makers and brands
How Paclitaxel 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.
22 companies list 41 Paclitaxel product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 1992. Brand names on the directory include Abraxane, Paclitaxel Protein Bound Particles Albumin Bound, Paclitaxel protein-bound particles and 1 more; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (20) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Paclitaxel is used (Medicaid data)
A general measure of how commonly Paclitaxel is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Paclitaxel is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Paclitaxel prescribed? Of the 1,601 medications we measure, Paclitaxel ranks #608 by Medicaid prescriptions — more than 62% of them.
Utilization by Paclitaxel product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
paclitaxel 6 MG/ML Injectable Solution Most dispensed
Summed across the 23 of 59 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312199
paclitaxel 100 MG Injection
Summed across the 7 of 12 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 583214
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Paclitaxel, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 30 of 71 listed Paclitaxel NDCs with Medicaid activity.
Compare Paclitaxel products
A representative set of FDA-listed product records for Paclitaxel — 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 |
|---|---|---|---|---|
| 💊Injection | ||||
| 100 mg/20 mL | Intravenous | Abraxis BioScience, LLC | NDA | View NDC → |
| 6 mg/mL | Intravenous | Alembic Pharmaceuticals Inc. × 3 listings | ANDA | View NDC → |
| 6 mg/mL | Intravenous | Alembic Pharmaceuticals Limited × 3 listings | ANDA | View NDC → |
| 100 mg/20 mL | Intravenous | American Regent, Inc. | NDA | View NDC → |
| 6 mg/mL | Intravenous | BluePoint Laboratories × 2 listings | ANDA | View NDC → |
| 100 mg/20 mL | Intravenous | BluePoint Laboratories | ANDA | View NDC → |
| 6 mg/mL | Intravenous | Bryant Ranch Prepack | ANDA | View NDC → |
| 100 mg/20 mL | Intravenous | Cipla USA Inc. | ANDA | View NDC → |
| 100 mg/20 mL | Intravenous | Exelan Pharmaceuticals Inc. | ANDA | View NDC → |
| 6 mg/mL | Intravenous | Fresenius Kabi USA, LLC | ANDA | View NDC → |
| 6 mg/mL | Intravenous | Gland Pharma Limited × 3 listings | ANDA | View NDC → |
| 6 mg/mL | Intravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. × 3 listings | ANDA | View NDC → |
| 6 mg/mL | Intravenous | Hospira, Inc. × 2 listings | ANDA | View NDC → |
| 100 mg/20 mL | Intravenous | Meitheal Pharmaceuticals Inc. | ANDA | View NDC → |
| 100 mg/20 mL | Intravenous | Mylan Institutional LLC | ANDA | View NDC → |
| 6 mg/mL | Intravenous | Natco Pharma USA LLC × 3 listings | ANDA | View NDC → |
| 100 mg/100 mg | Intravenous | Ningbo Shuangcheng Pharmaceutical Co., Ltd | ANDA | View label ↗ |
| 6 mg/mL | Intravenous | Northstar Rx LLC | ANDA | View NDC → |
| 100 mg/20 mL | Intravenous | NorthStar Rx LLC | ANDA | View NDC → |
| 6 mg/mL | Intravenous | Novadoz Pharmaceuticals LLC × 3 listings | ANDA | View NDC → |
| 6 mg/mL | Intravenous | Sagent Pharmaceuticals | ANDA | View NDC → |
| 100 mg/20 mL | Intravenous | Sandoz Inc | ANDA | View NDC → |
| 6 mg/mL | Intravenous | Teva Parenteral Medicines, Inc. × 4 listings | ANDA | View NDC → |
| 100 mg/20 mL | Intravenous | Teva Pharmaceuticals, Inc. | NDA | View NDC → |
Showing 41 of 41 products — FDA National Drug Code Directory. See every product, package size and price: browse all 41 Paclitaxel NDCs →
Paclitaxel 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 Paclitaxel — 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 Paclitaxel 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.
Paclitaxel FDA approval history
How Paclitaxel went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Paclitaxel 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 Paclitaxel recalls since July 2021.
✅No Paclitaxel 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 56946 2 dose forms · 2 strengths
Look up RxCUI 56946 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.
Paclitaxel supply and shortage status
Whether Paclitaxel 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.
Paclitaxel brand names
Paclitaxel is sold under 4 brand names in the FDA directory — Abraxane, Paclitaxel Protein Bound Particles Albumin Bound, Paclitaxel protein-bound particles, Paclitaxel 100mg per vial. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Paclitaxel: manufacturers and labelers
22 companies list Paclitaxel products with the FDA. By number of product records, the largest are Teva Parenteral Medicines, Inc., Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Paclitaxel drug class (RxNorm)
Paclitaxel belongs to the Microtubule 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 Paclitaxel 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. TWi Pharmaceuticals, Inc. 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 →