Two medicines, side by side
Irinotecan vs oxaliplatin
Irinotecan and oxaliplatin are both labeled for colorectal cancer. Drugs@FDA records approvals of irinotecan since 1996 and of oxaliplatin since 2002. In FDA's classes, irinotecan is a topoisomerase inhibitor and oxaliplatin a platinum-based drug.
Check it at the source: the irinotecan FDA label on DailyMed (effective May 12, 2026); the oxaliplatin FDA label on DailyMed (effective August 24, 2026).
Highlights of the irinotecan record
Irinotecan (Onivyde) · label of May 12, 2026
DIARRHEA and MYELOSUPPRESSION
Early and late forms of diarrhea can occur. Early diarrhea may be accompanied by cholinergic symptoms which may be prevented or ameliorated by atropine. Late diarrhea can be life threatening and should be treated promptly with loperamide. Monitor patients with diarrhea and give fluid and electrolytes as needed. Institute antibiotic therapy if patients develop ileus, fever, or severe neutropenia.
Used for
From the label: indicationsCAMPTOSAR is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum. • CAMPTOSAR is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. […]
On the market
- Earliest approval on file
- June 14, 1996
- Generic labelers
- 12 labelers
- Pharmacy cost
- Not in the survey
Supply and safety
- Shortage
- A presentation being discontinued
- Recalls
- 9
Highlights of the oxaliplatin record
Oxaliplatin (Eloxatin) · label of August 24, 2026
HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS Serious and fatal hypersensitivity adverse reactions, including anaphylaxis, can occur with oxaliplatin within minutes of administration and during any cycle. Oxaliplatin is contraindicated in patients with hypersensitivity reactions to oxaliplatin and other platinum-based drugs [see Contraindications (4) ].
Used for
From the label: indicationsOxaliplatin 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. […]
On the market
- Earliest approval on file
- August 9, 2002
- Generic labelers
- 16 labelers
- Pharmacy cost
- Not in the survey
Supply and safety
- Shortage
- A presentation being discontinued
- Recalls
- 0
Source: FDA drug labels via openFDA (Irinotecan label of May 12, 2026, Oxaliplatin label of August 24, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do irinotecan and oxaliplatin differ on the record?
In FDA's classes, irinotecan is a topoisomerase inhibitor and oxaliplatin a platinum-based drug.
How each works, in its label's words: Irinotecan, “Camptothecins interact specifically with the enzyme topoisomerase I, which relieves torsional strain in DNA by inducing reversible single-strand breaks.”; Oxaliplatin, “Oxaliplatin undergoes nonenzymatic conversion in physiologic solutions to active derivatives via displacement of the labile oxalate ligand.”
Both labels carry a boxed warning; the records quote them.
Generics: irinotecan since 2008; oxaliplatin since 2009 (Drugs@FDA).
| Irinotecan | Oxaliplatin | |
|---|---|---|
| Labeled for | Colorectal cancer | Colorectal cancer |
| Pharmacologic class | Topoisomerase Inhibitor | Platinum-based Drug |
| How it works (label) | Irinotecan is a derivative of camptothecin. Camptothecins interact specifically with the enzyme topoisomerase I, which relieves torsional strain in DNA by inducing reversible single-strand breaks. | Oxaliplatin undergoes nonenzymatic conversion in physiologic solutions to active derivatives via displacement of the labile oxalate ligand. |
| Half-life (label) | 12.3 Pharmacokinetics After intravenous infusion of irinotecan in humans, irinotecan plasma concentrations decline in a multiexponential manner, with a mean terminal elimination half-life of about 6 to 12 hours. | n/a |
| Earliest approval on file (Drugs@FDA) | June 14, 1996 | August 9, 2002 |
| First generic approved | February 20, 2008 | August 7, 2009 |
| Generic labelers (NDC) | 12 labelers | 16 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | n/a | n/a |
| 12-month price change | n/a | n/a |
| Boxed warning | Yes | Yes |
| Shortage now | A presentation being discontinued | A presentation being discontinued |
| Recalls recorded | 9 | 0 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 12,786 | 73,749 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
Do their labels mention each other?
Irinotecan label, boxed warningSEVERE NEUTROPENIA AND SEVERE DIARRHEA Neutropenia Severe and life-threatening neutropenia, including fatal neutropenic sepsis and fatal neutropenic fever, has occurred in patients receiving ONIVYDE in combination with oxaliplatin, fluorouracil and leucovorin and in combination with fluorouracil and leucovorin.
Irinotecan label, warnings and precautionsIn NAPOLI 3, Grade 3 and 4 neutropenia occurred in 26% of patients receiving ONIVYDE in combination with oxaliplatin, fluorouracil, and leucovorin (NALIRIFOX) and fatal neutropenic fever in 0.3% of patients [see Adverse Reactions (6.1) ].
Source: FDA drug labels via openFDA
What next?
- Alternatives to irinotecan
- every medicine labeled for the same conditions