Prescription medicine
Primaquine
Primaquine is a prescription medicine with an FDA approval on record since 1952. FDA's NDC Directory lists it from 4 generic labelers.
- Generic listed
Check it at the source: the primaquine FDA label on DailyMed (effective February 11, 2026, Sanofi-Aventis U.S. LLC); the NDA 8316 record on Drugs@FDA; every primaquine label on DailyMed.
Highlights of the record
FDA label of February 11, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usagePrimaquine phosphate Tablets are indicated for the radical cure (prevention of relapse) of vivax malaria.
Forms and strengths
- 15 mg
Film-coated tablet; tablet.
On the market
- Earliest approval on file
- January 23, 1952 Primaquine, Sanofi Aventis Us; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first February 3, 2014; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 5 of which 4 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 83 through July 30, 2026
What is primaquine used for?
From the label: indications and usagePrimaquine phosphate Tablets are indicated for the radical cure (prevention of relapse) of vivax malaria.
FDA pharmacologic class: Antimalarial.
Source: FDA drug label (Primaquine Phosphate), Sanofi-Aventis U.S. LLC, effective February 11, 2026 (SPL set 1bfbf4ae-81b8-4160-a00d-6322aadd4b59), via openFDA; the full label on DailyMed
Is there a generic for primaquine?
The FDA approved the first generic primaquine on February 3, 2014. 3 generic applications are approved; 2 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 primaquine from 4 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1952 earliest approval on file
- 2014 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the primaquine label say about other medicines?
The primaquine label names 8 other medicines in its interaction, contraindication or warning sections. The labels of 14 other medicines name primaquine. 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 |
|---|---|---|
| Alosetron | drug interactions | Effects of Primaquine on the Pharmacokinetics of Other Drugs CYP1A2 Substrates Published clinical and non-clinical reports indicate primaquine inhibits CYP1A2 enzyme activity and thus may lead to increased exposure of CYP1A2 substrate drugs (e.g., duloxetine, alosetron, theophylline and tizanidine) when … |
| Dabigatran | drug interactions | P-gp Substrates Refer to the Prescribing Information for a P-gp substrate where minimal concentration changes may lead to serious adverse reactions (e.g., digoxin and dabigatran) for the recommended dosage modification and/or monitoring. |
| Digoxin | drug interactions | P-gp Substrates Refer to the Prescribing Information for a P-gp substrate where minimal concentration changes may lead to serious adverse reactions (e.g., digoxin and dabigatran) for the recommended dosage modification and/or monitoring. |
| Duloxetine | drug interactions | Effects of Primaquine on the Pharmacokinetics of Other Drugs CYP1A2 Substrates Published clinical and non-clinical reports indicate primaquine inhibits CYP1A2 enzyme activity and thus may lead to increased exposure of CYP1A2 substrate drugs (e.g., duloxetine, alosetron, theophylline and tizanidine) when … |
| Pimozide | drug interactions | Increase monitoring for adverse reactions associated with CYP3A4 substrate drugs that prolong the QT interval (e.g., pimozide) or where minimal concentration changes may lead to serious adverse reactions when concurrently administered with Primaquine phosphate Tablets. |
| Rivaroxaban | drug interactions | CYP3A4 Substrates Refer to the Prescribing Information for a CYP3A substrate where minimal concentration changes may lead to serious adverse reactions (e.g. rivaroxaban, calcineurin inhibitors, ergot derivatives, tyrosine kinase inhibitors) for the recommended dosage modification and/or monitoring. |
| Theophylline | drug interactions | … enzyme activity and thus may lead to increased exposure of CYP1A2 substrate drugs (e.g., duloxetine, alosetron, theophylline and tizanidine) when co-administered with Primaquine phosphate Tablets. |
| Tizanidine | drug interactions | … thus may lead to increased exposure of CYP1A2 substrate drugs (e.g., duloxetine, alosetron, theophylline and tizanidine) when co-administered with Primaquine phosphate Tablets. |
Other labels that name primaquine
Source: FDA drug label (Primaquine Phosphate), Sanofi-Aventis U.S. LLC, effective February 11, 2026 (SPL set 1bfbf4ae-81b8-4160-a00d-6322aadd4b59), via openFDA; the full label on DailyMed
What do FAERS reports show for primaquine?
The FDA Adverse Event Reporting System holds 83 reports that list primaquine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6 are coded as a death and 30 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.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other antimalarials
- the pharmacologic class, with prices and generics
- Primaquine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other