Prescription medicine
Irinotecan Brand names: Camptosar, Onivyde
Irinotecan (Onivyde) is a prescription medicine with an FDA approval on record since 1996. FDA's NDC Directory lists it from 12 generic labelers.
- Generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the irinotecan FDA label on DailyMed (effective May 12, 2026, Pharmacia & Upjohn Company LLC); the NDA 20571 record on Drugs@FDA; every irinotecan label on DailyMed.
Highlights of the record
FDA label of May 12, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 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. Interrupt CAMPTOSAR and reduce subsequent doses if severe diarrhea occurs [see Dosage and Administration (2.2) and Warnings and Precautions (5.1) ].
Severe myelosuppression may occur [see Warnings and Precautions (5.2) ]. WARNING: DIARRHEA and MYELOSUPPRESSION See full prescribing information for complete boxed warning.
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. Interrupt CAMPTOSAR and reduce subsequent doses if severe diarrhea occurs. ( 2.2 , 5.1 )
Severe myelosuppression may occur.
Used for
From the label: indications and usageCAMPTOSAR 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.
Forms and strengths
- 4.3 mg/ml
- 20 mg/ml
Injection (solution); injection; injection (powder) for solution.
On the market
- Earliest approval on file
- June 14, 1996 Camptosar, Pfizer Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 27 first February 20, 2008; 17 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 14 of which 12 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- October 15, 2036 Onivyde injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- None current 2 past records
- Recalls by its makers (FDA)
- 9 since 2013 0 Class I among all firms' recalls; latest November 19, 2020
- FAERS reports
- 12,786 through July 30, 2026
What is irinotecan used for?
From the label: indications and usageCAMPTOSAR 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. CAMPTOSAR is a topoisomerase inhibitor indicated for:
First-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum. ( 1 )
Patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.
Conditions named in the indications of irinotecan's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Topoisomerase Inhibitor.
Source: FDA drug label (Camptosar), NDA020571 (Pfizer Inc), as published by Pharmacia & Upjohn Company LLC, effective May 12, 2026 (SPL set e518dfc6-7e93-4fee-a66c-51e1ab71c056), via openFDA; the full label on DailyMed
Is there a generic for irinotecan (Onivyde)?
The FDA approved the first generic irinotecan on February 20, 2008. 27 generic applications are approved; 17 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists irinotecan from 12 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 14 patents for Onivyde injection: the compound patent runs to August 29, 2028, and the last listed entry to October 15, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1996 earliest approval on file
- 2008 first generic approved
- 2036 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is irinotecan in shortage?
No irinotecan presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 2 records are all marked to be discontinued, the latest updated February 24, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Irinotecan Hydrochloride, Injection, 100 mg/5 mL (NDC 50742-402-05) | Ingenus Pharmaceuticals LLC | To Be Discontinued | February 24, 2026 |
| Irinotecan Hydrochloride, Injection, 40 mg/2 mL (NDC 50742-401-02) | Ingenus Pharmaceuticals LLC | To Be Discontinued | February 24, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has irinotecan been recalled?
The FDA's Enforcement Report lists 9 recalls naming irinotecan since 2013: 0 Class I (the most serious), 9 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| November 19, 2020 | Class II | Areva Pharmaceuticals Inc | CGMP Deviations: based on a Warning Letter received by the manufacturer of the recalled product for inadequate out-of specification investigations, complaint … |
| June 11, 2020 | Class II | Hikma Pharmaceuticals USA Inc. | Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use. |
| June 12, 2019 | Class II | Infusion Options, Inc. | Lack of Assurance of Sterility |
| June 8, 2018 | Class II | Ingenus Pharmaceuticals Llc | Superpotent Drug: High out of specification assay value results for potency. |
| September 23, 2013 | Class II | West-Ward Pharmaceutical Corp. | Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which … |
| January 22, 2013 | Class II | Fresenius Kabi USA LLC (FK USA) | Crystallization: Active pharmaceutical ingredient is precipitating in product solution. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the irinotecan label say about other medicines?
The irinotecan label names 21 other medicines in its interaction, contraindication or warning sections. The labels of 17 other medicines name irinotecan. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Atazanavir | drug interactions | Coadministration of CAMPTOSAR with other inhibitors of CYP3A4 (e.g., clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole) or UGT1A1 (e.g., atazanavir, gemfibrozil, indinavir) may increase systemic exposure to irinotecan or SN-38. |
| Atropine | boxed warning | Early diarrhea may be accompanied by cholinergic symptoms which may be prevented or ameliorated by atropine. |
| Carbamazepine | drug interactions | Exposure to irinotecan or its active metabolite SN-38 is substantially reduced in adult and pediatric patients concomitantly receiving the CYP3A4 enzyme-inducing anticonvulsants phenytoin, phenobarbital, carbamazepine, or St. John's wort. |
| Clarithromycin | drug interactions | Coadministration of CAMPTOSAR with other inhibitors of CYP3A4 (e.g., clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole) or UGT1A1 (e.g., atazanavir, gemfibrozil, indinavir) may increase systemic exposure to irinotecan or SN-38. |
| Fluorouracil | boxed warning | SEVERE 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. |
| Gemfibrozil | drug interactions | Coadministration of CAMPTOSAR with other inhibitors of CYP3A4 (e.g., clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole) or UGT1A1 (e.g., atazanavir, gemfibrozil, indinavir) may increase systemic exposure to irinotecan or SN-38. |
| Itraconazole | drug interactions | Coadministration of CAMPTOSAR with other inhibitors of CYP3A4 (e.g., clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole) or UGT1A1 (e.g., atazanavir, gemfibrozil, indinavir) may increase systemic exposure to irinotecan or SN-38. |
| Ketoconazole | drug interactions | Patients receiving concomitant ketoconazole, a CYP3A4 and UGT1A1 inhibitor, have increased exposure to irinotecan and its active metabolite SN-38. |
| Leucovorin | drug interactions | Strong CYP3A4 Inhibitors: Do not administer strong CYP3A4 inhibitors with CAMPTOSAR. ( 7.3 ) 7.1 5-Fluorouracil (5-FU) and Leucovorin (LV) In a phase 1 clinical study involving irinotecan, 5-fluorouracil (5-FU), and leucovorin (LV) in 26 patients with solid tumors, the disposition of irinotecan was not substantially … |
| Loperamide | boxed warning | Late diarrhea can be life threatening and should be treated promptly with loperamide. |
| Nefazodone | drug interactions | Coadministration of CAMPTOSAR with other inhibitors of CYP3A4 (e.g., clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole) or UGT1A1 (e.g., atazanavir, gemfibrozil, indinavir) may increase systemic exposure to irinotecan or SN-38. |
| Nelfinavir | drug interactions | Coadministration of CAMPTOSAR with other inhibitors of CYP3A4 (e.g., clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole) or UGT1A1 (e.g., atazanavir, gemfibrozil, indinavir) may increase systemic exposure to irinotecan or SN-38. |
| Octreotide | warnings and precautions | Local institutional guidelines should be followed for the treatment of diarrhea that does not improve within 48 hours and may include the addition of diphenoxylate hydrochloride plus atropine sulfate or octreotide. |
| Oxaliplatin | boxed warning | SEVERE 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. |
Every other medicine the irinotecan label names
| Medicine named | Section | What the label says |
|---|---|---|
| Phenobarbital | drug interactions | … concomitantly receiving the CYP3A4 enzyme-inducing anticonvulsants phenytoin, phenobarbital, carbamazepine, or St. John's wort. |
| Phenytoin | drug interactions | … concomitantly receiving the CYP3A4 enzyme-inducing anticonvulsants phenytoin, phenobarbital, carbamazepine, or St. John's wort. |
| Rifabutin | drug interactions | The appropriate starting dose for patients taking these or other strong inducers such as rifampin and rifabutin has not been defined. |
| Rifampin | drug interactions | The appropriate starting dose for patients taking these or other strong inducers such as rifampin and rifabutin has not been defined. |
| Rifapentine | drug interactions | Avoid the use of strong CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, rifabutin, rifapentine, phenobarbital, St. John's wort) if possible. |
| Ritonavir | drug interactions | Coadministration of CAMPTOSAR with other inhibitors of CYP3A4 (e.g., clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole) or … |
| Voriconazole | drug interactions | … lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole) or UGT1A1 (e.g., atazanavir, gemfibrozil, indinavir) may increase systemic exposure to irinotecan or SN-38. |
Other labels that name irinotecan
Source: FDA drug label (Camptosar), NDA020571 (Pfizer Inc), as published by Pharmacia & Upjohn Company LLC, effective May 12, 2026 (SPL set e518dfc6-7e93-4fee-a66c-51e1ab71c056), via openFDA; the full label on DailyMed
What do FAERS reports show for irinotecan?
The FDA Adverse Event Reporting System holds 12,786 reports that list irinotecan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,639 are coded as a death and 5,216 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as irinotecan?
8 other medicines are given the same way (intravenous) and in the same FDA class as irinotecan or labeled mainly for the same use (colorectal cancer), the same class first. Colorectal cancer lists all 23 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Oxaliplatin | Colorectal cancer | 17 labelers | n/a | A presentation being discontinued |
| Fluorouracil | Colorectal cancer | 12 labelers | n/a | No current entry |
| Levoleucovorin | Colorectal cancer | 8 labelers | n/a | No current entry |
| Bevacizumab | Colorectal cancer | none listed | n/a | No current entry |
| Aflibercept | Colorectal cancer | none listed | n/a | No current entry |
| Bevacizumab-maly | Colorectal cancer | none listed | n/a | No current entry |
| Cetuximab | Colorectal cancer | none listed | n/a | No current entry |
| Panitumumab | Colorectal cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as irinotecan
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does irinotecan compare with medicines for the same use?
1 side-by-side page set irinotecan beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to irinotecan
- 8 medicines for the same use
- Other topoisomerase inhibitors
- the pharmacologic class, with prices and generics
- Irinotecan side effects
- the label's list beside FAERS reports
- Irinotecan shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other