Oxaliplatin

Oxaliplatin undergoes nonenzymatic conversion in physiologic solutions to active derivatives via displacement of the labile oxalate ligand. Several transient reactive species are formed, including monoaquo and diaquo DACH platinum, which covalently bind with macromolecules.

• Oxaliplatin Injection, in combination with infusional fluorouracil and leucovorin, is indicated for: adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. treatment of advanced colorectal cancer.ICD-10: C18.9

• Oxaliplatin is contraindicated in patients with a history of a hypersensitivity reaction to oxaliplatin or other platinum-based drugs. Reactions have included anaphylaxis [see Warnings and Precautions ( 5.1 )] .contraindicated

Administer oxaliplatin 85 mg/m 2 as an intravenous infusion over 120 minutes concurrently with leucovorin over 120 minutes in separate bags, followed by fluorouracil on Day 1 of each 14-day cycle. Administer fluorouracil and leucovorin on Day 2 as recommended. ( 2.1 ) Adjuvant Treatment : Continue treatment for up to 12 cycles or unacceptable toxicity. ( 2.1 ) Advanced Colorectal Cancer : Continue treatment until disease progression or unacceptable toxicity. ( 2.1 ) 2.1 Recommended Dosage Administer oxaliplatin injection in combination with fluorouracil and leucovorin every 2 weeks. For adjuvant treatment, continue treatment for up to 12 cycles or unacceptable toxicity. For advanced colorectal cancer, continue treatment until disease progression or unacceptable toxicity. Day 1 Administer oxaliplatin injection 85 mg/m 2 as an intravenous infusion over 120 minutes and leucovorin 200 mg/m 2 as an intravenous infusion over 120 minutes at the same time in separate bags, followed by fluorouracil 400 mg/m 2 as intravenous bolus over 2-4 minutes, followed by fluorouracil 600 mg/m 2 as a 22-hour continuous infusion. Day 2 Administer leucovorin 200 mg/m 2 as an intravenous infusion over 120 minutes, followed by fluorouracil 400 mg/m 2 as intravenous bolus over 2-4 minutes, followed by fluorouracil 600 mg/m 2 as a 22-hour continuous infusion. Refer to the prescribing information for fluorouracil and leucovorin for additional information.

Peripheral Sensory Neuropathy : Acute and delayed neuropathy can occur. Avoid topical application of ice. Reduce the dose or permanently discontinue oxaliplatin as recommended. ( 5.2 ) Severe Myelosuppression : Delay oxaliplatin until neutrophils are greater than or equal to 1.5 × 10 9 /L and platelets are greater than or equal to 75 × 10 9 /L. Withhold oxaliplatin for sepsis or septic shock. Dose reduce after recovery from grade 4 neutropenia, febrile neutropenia, or grade 3 to 4 thrombocytopenia as recommended. ( 5.3 ) Posterior Reversible Encephalopathy Syndrome (PRES) : Permanently discontinue oxaliplatin in patients who develop PRES. ( 5.4 ) Pulmonary Toxicity : Withhold oxaliplatin until investigation excludes interstitial lung disease or pulmonary fibrosis. ( 5.5 ) Hepatotoxicity : Monitor liver function tests at baseline, before each subsequent cycle, and as clinically indicated. ( 5.6 ) QT Interval Prolongation : Avoid in patients with congenital long QT syndrome. Monitor electrocardiograms in patients with congestive heart failure, bradyarrhythmias, and electrolyte abnormalities, and in patients taking drugs known to prolong the QT interval. Correct electrolyte abnormalities prior to initiating oxaliplatin and periodically during treatment. ( 5.7 ) Rhabdomyolysis : Permanently discontinue oxaliplatin if rhabdomyolysis occurs. ( 5.8 ) Hemorrhage : Increase frequency of monitoring in patients who are receiving oxaliplatin with fluorouracil/leucovorin and oral anticoagulants ( 5.9 ) Embryo-Fetal Toxicity : Can cause fetal harm.

The following clinically significant adverse reactions are described elsewhere in labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Peripheral Sensory Neuropathy [see Warnings and Precautions ( 5.2 )] Severe Myelosuppression [see Warnings and Precautions ( 5.3 )] Reversible Posterior Leukoencephalopathy Syndrome [see Warnings and Precautions ( 5.4 )] Pulmonary Toxicity [see Warnings and Precautions ( 5.5 )] Hepatotoxicity [see Warnings and Precautions ( 5.6 )] QT Interval Prolongation and Ventricular Arrhythmias [see Warnings and Precautions ( 5.7 )] Rhabdomyolysis [see Warnings and Precautions ( 5.8 )] Hemorrhage [see Warnings and Precautions ( 5.9 )] Most common adverse reactions (incidence greater than or equal to 40%) were peripheral sensory neuropathy, neutropenia, thrombocytopenia, anemia, nausea, increase in transaminases and alkaline phosphatase, diarrhea, emesis, fatigue, and stomatitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Meitheal Pharmaceuticals Inc. at 1-844-824-8426 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. More than 1100 patients with stage II or III colon cancer and more than 4,000 patients with advanced colorectal cancer were treated in trials with oxaliplatin.

Females : Advise female patients of reproductive potential to use effective contraception while receiving oxaliplatin and for 9 months after the final dose. ( 8.3 ) Males : Based on its mechanism action as a genotoxic drug, advise males with female partners of reproductive potential to use effective contraception while receiving oxaliplatin and for 6 months after the final dose [see Nonclinical Toxicology (13.1) ] . 8.1 Pregnancy Risk Summary Based on its direct interaction with DNA, oxaliplatin can cause fetal harm when administered to a pregnant woman. The available human data do not establish the presence or absence of major birth defects or miscarriage related to the use of oxaliplatin. Reproductive toxicity studies demonstrated adverse effects on embryo-fetal development in rats at maternal doses that were below the recommended human dose based on body surface area (see Data ) . Advise a pregnant woman of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal data Pregnant rats were administered oxaliplatin at less than one-tenth the recommended human dose based on body surface area during gestation days (GD)1 to 5 (preimplantation), GD 6 to 10, or GD 11 to 16 (during organogenesis).

Metabolism

The reactive oxaliplatin derivatives are present as a fraction of the unbound platinum in plasma ultrafiltrate. After a single 2-hour intravenous infusion of oxaliplatin at a dose of 85 mg/m 2 , pharmacokinetic parameters expressed as ultrafiltrable platinum were C max of 0.814 mcg/mL and volume of distribution of 440 L.

The maximum dose of oxaliplatin that has been administered in a single infusion is 825 mg. Several cases of overdoses have been reported with oxaliplatin. Adverse reactions observed following an overdosage were grade 4 thrombocytopenia (less than 25,000/mm 3 ) without bleeding, anemia, sensory neuropathy (including paresthesia, dysesthesia, laryngospasm and facial muscle spasms), gastrointestinal disorders (including nausea, vomiting, stomatitis, flatulence, abdomen enlarged and grade 4 intestinal obstruction), grade 4 dehydration, dyspnea, wheezing, chest pain, respiratory failure, severe bradycardia, and death. Closely monitor patients suspected of receiving an overdose, including for the adverse reactions described above and administer appropriate supportive treatment.

• Jan 31, 2005NDANDA021759Sanofi Aventis Us
• Aug 7, 2009ANDAANDA078813Hospira Worldwide
• Jun 10, 2010ANDAANDA078811Fresenius Kabi Usa
• Jan 24, 2011ANDAANDA078817Sandoz
• Aug 7, 2012ANDAANDA091358Mylan Labs Ltd
• Jun 18, 2014ANDAANDA203869Hengrui Pharma
• May 11, 2016ANDAANDA204616Qilu Pharm Hainan
• Jun 7, 2016ANDAANDA204368Qilu Pharm Hainan

Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

• Oxaliplatin, Injection, 5 mg/1 mL (NDC 0781-3315-70)To be discontinued
  Sponsor: Sandoz Inc.
  Updated Oct 20, 2025
• Oxaliplatin, Injection, 5 mg/1 mL (NDC 0781-3317-80)To be discontinued
  Sponsor: Sandoz Inc.
  Updated Oct 20, 2025
• Oxaliplatin, Injection, 5 mg/mL (NDC 63323-750-10)To be discontinued
  Sponsor: Fresenius Kabi USA, LLC
  Updated Feb 25, 2026
• Oxaliplatin, Injection, 5 mg/mL (NDC 63323-750-20)To be discontinued
  Sponsor: Fresenius Kabi USA, LLC
  Updated Feb 25, 2026

1. 1Diarrhoea6,7409.4%
2. 2Nausea5,2827.4%
3. 3Off Label Use4,5126.3%
4. 4Vomiting4,3016.0%
5. 5Disease Progression4,2335.9%
6. 6Neuropathy Peripheral4,1585.8%
7. 7Neutropenia4,1295.7%
8. 8Thrombocytopenia3,4584.8%
9. 9Dyspnoea2,9984.2%
10. 10Pyrexia2,8183.9%
11. 11Fatigue2,6973.8%
12. 12Anaemia2,3653.3%
13. 13Asthenia2,3123.2%
14. 14Death2,2893.2%
15. 15Drug Ineffective2,0962.9%

Recent PubMed references pinned to Oxaliplatin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• An explainable predictive machine learning model of oxaliplatin induced peripheral neuropathy based on clinical data: a retrospective single center.
  Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026 · Lv J, Xie F, Wu R, et al.
  PMID 42257819DOI 10.1007/s00520-026-10877-7
• Protective Effect of Lycopene Against Oxaliplatin-Induced Nephrotoxicity by Modulation NF-κB/TNF-α/IL-1β, P53/Bax/Bcl2, and PI3K/AKT/mTOR Signaling Pathway.
  Journal of biochemical and molecular toxicology · 2026 · Kandemir Ö, Küçükler S, Çomaklı S, et al.
  PMID 42257501DOI 10.1002/jbt.70963
• Clinical characteristics, treatment, and outcomes of Oxaliplatin-induced immune thrombocytopenia.
  Frontiers in immunology · 2026 · Huang N, Liu Z, Li R, et al.
  PMID 42220484DOI 10.3389/fimmu.2026.1809508
• Artesunate overcomes oxaliplatin resistance in colorectal cancer by inducing ferroptosis through inhibition of the CDK5/Nrf2/GPX4 pathway.
  Apoptosis : an international journal on programmed cell death · 2026 · Lv F, Li XH, Li SQ, et al.
  PMID 42178429DOI 10.1007/s10495-026-02362-7
• Supramolecular Visualized Chemotherapy Based on OxPt-TTVP@CB[8]: Activating Oxidative Damage to Induce ICD for Enhancing the Killing of Tumor Cells.
  Langmuir : the ACS journal of surfaces and colloids · 2026 · Liu Q, Li Z, Ye T, et al.
  PMID 42120969DOI 10.1021/acs.langmuir.6c01088
• Oxaliplatin-associated nephrotoxicity: clinical patterns, renal pharmacokinetics, and mechanistic insights.
  Cancer chemotherapy and pharmacology · 2026 · Chetia A, Das L, Baro MR, et al.
  PMID 42118356DOI 10.1007/s00280-026-04889-7
• Ketotifen for Preventing Oxaliplatin-Induced Neuropathy in Stage III Colorectal Cancer: a Randomized Controlled Trial.
  Journal of gastrointestinal cancer · 2026 · Wahby SS, Mostafa TM, El-Din MAA, et al.
  PMID 42096115DOI 10.1007/s12029-026-01456-4
• Impact of Physical Frailty on Early Intolerance to CAPOX Chemotherapy in Patients With Colon, Rectal, and Gastric Cancer.
  Cancer medicine · 2026 · Lima IPGP, Carrozzi NM, Silva TO, et al.
  PMID 42092992DOI 10.1002/cam4.71800

The 10 most recently updated of 3,302 ClinicalTrials.gov registrations naming Oxaliplatin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Substudy 06E: Umbrella Study of Combination Therapies in Esophageal Cancer (MK-3475-06E/KEYMAKER-U06)
  Recruiting · Phase 1 · Phase 2 · Interventional · 298 enrolled · Merck Sharp & Dohme LLC
  NCT06780111updated 2026-06-12
• A Real-world Study of Immunotherapy Combination Regimens for Treating Liver Cancer in Cold Regions
  Active not recruiting · Observational · 1,000 enrolled · Harbin Medical University
  NCT07645209updated 2026-06-12
• Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
  Recruiting · Phase 2 · Interventional · 2,900 enrolled · National Cancer Institute (NCI)
  NCT05564377updated 2026-06-12
• A Study to Assess Intravenous (IV) Telisotuzumab Adizutecan in Combination With Fluorouracil, Folinic Acid, and Oxaliplatin (FOLFOX) Compared to Standard of Care in Adult Participants With First-Line Metastatic Pancreatic Ductal Adenocarcinoma
  Recruiting · Phase 2 · Phase 3 · Interventional · 900 enrolled · AbbVie
  NCT07490301updated 2026-06-12
• Neratinib In Combination With Chemotherapy/Trastuzumab/Pembrolizumab In HER2 Gastroesophageal Cancer
  Active not recruiting · Phase 2 · Interventional · 8 enrolled · H. Lee Moffitt Cancer Center and Research Institute
  NCT06109467updated 2026-06-12
• A Study to Evaluate the Adverse Events, and Efficacy of Intravenous (IV) of Telisotuzumab Adizutecan in Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid/Leucovorin, Bevacizumab, Panitumumab in Adult Participants With Metastatic Colorectal Cancer
  Recruiting · Phase 2 · Interventional · 390 enrolled · AbbVie
  NCT06820463updated 2026-06-12
• Personalize (Signature Driven) Neoadjuvant Chemotherapy Trial for Patients With Resectable Borderline Pancreatic Ductal Adenocarcinoma.
  Not yet recruiting · Phase 2 · Interventional · 110 enrolled · Federation Francophone de Cancerologie Digestive
  NCT07616362updated 2026-06-11
• A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer
  Active not recruiting · Phase 3 · Interventional · 841 enrolled · Pfizer
  NCT04607421updated 2026-06-11
• Transarterial Neoadjuvant Chemotherapy vs.Traditional Intravenous Chemotherapy For Locally Advanced Gastric Cancer With SOX+PD-1
  Recruiting · Phase 3 · Interventional · 190 enrolled · Zhejiang University
  NCT05593458updated 2026-06-11
• Chemotherapy Followed by Pelvic Reirradiation Versus Chemotherapy Alone as Pre-operative Treatment for Locally Recurrent Rectal Cancer
  Active not recruiting · Phase 3 · Interventional · 58 enrolled · University Hospital, Bordeaux
  NCT03879109updated 2026-06-11

CPIC-curated drug–gene pairs for Oxaliplatin. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

• GSTM1CPIC D (provisional)ClinPGx 3
• GSTP1CPIC D (provisional)ClinPGx 3

Frequently asked questions

How does Oxaliplatin work?

Oxaliplatin undergoes nonenzymatic conversion in physiologic solutions to active derivatives via displacement of the labile oxalate ligand. Several transient reactive species are formed, including monoaquo and diaquo DACH platinum, which covalently bind with macromolecules.

What is Oxaliplatin used for?

According to FDA labeling, Oxaliplatin carries indications including: Oxaliplatin Injection, in combination with infusional fluorouracil and leucovorin, is indicated for: adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. treatment of advanced colorectal cancer.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Oxaliplatin?

Oxaliplatin is classified as Platinum compounds, Platinum-based Drug, Nucleic Acid Synthesis Inhibitors, Physiochemical Activity, Decreased DNA Integrity, Decreased DNA Replication.

What are the contraindications for Oxaliplatin?

Oxaliplatin labeling lists contraindications including: Oxaliplatin is contraindicated in patients with a history of a hypersensitivity reaction to oxaliplatin or other platinum-based drugs. Reactions have included anaphylaxis [see Warnings and Precautions ( 5.1 )] .. Always consult the full prescribing information and a clinician.