Prescription medicine
Praziquantel Brand names: Biltricide
Praziquantel (Biltricide) is a prescription medicine with an FDA approval on record since 1982. FDA's NDC Directory lists it from 1 generic labeler, and pharmacies paid $53.25 per praziquantel 600 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the praziquantel FDA label on DailyMed (effective March 2, 2026, Bayer HealthCare Pharmaceuticals Inc.); the NDA 18714 record on Drugs@FDA; every praziquantel label on DailyMed.
Highlights of the record
FDA label of March 2, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageBiltricide is indicated in patients aged 1 year and older for the treatment of the following infections:
Schistosomiasis due to all species of schistosoma (for example, Schistosoma mekongi, Schistosoma japonicum, Schistosoma mansoni and Schistosoma hematobium ), and
Clonorchiasis and Opisthorchiasis due to the liver flukes, Clonorchis sinensis/Opisthorchis viverrini (approval of this indication was based on studi
Forms and strengths
- 600 mg
Film-coated tablet.
On the market
- Earliest approval on file
- December 29, 1982 Biltricide, Bayer Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first November 27, 2017; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 1 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $53.25 per tablet Praziquantel 600 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2013 0 Class I among all firms' recalls; 2 more by firms not listed as its makers
- FAERS reports
- 301 through July 30, 2026
What is praziquantel used for?
From the label: indications and usageBiltricide is indicated in patients aged 1 year and older for the treatment of the following infections:
Schistosomiasis due to all species of schistosoma (for example, Schistosoma mekongi, Schistosoma japonicum, Schistosoma mansoni and Schistosoma hematobium ), and
Clonorchiasis and Opisthorchiasis due to the liver flukes, Clonorchis sinensis/Opisthorchis viverrini (approval of this indication was based on studies in which the two species were not differentiated) Biltricide is an anthelmintic indicated in patients aged one year and older for the treatment of the following infections:
Schistosomiasis due to all species of schistosoma (for example, Schistosoma mekongi, Schistosoma japonicum, Schistosoma mansoni and Schistosoma hematobium ), and,
Clonorchiasis and Opisthorchiasis due to the liver flukes, Clonorchis sinensis and Opisthorchis viverrini […]
FDA pharmacologic class: Anthelmintic.
Source: FDA drug label (Biltricide), Bayer HealthCare Pharmaceuticals Inc., effective March 2, 2026 (SPL set 34ce1cdd-648e-4f1e-8512-bf3d4cc22eb9), via openFDA; the full label on DailyMed
Is there a generic for praziquantel (Biltricide)?
The FDA approved the first generic praziquantel on November 27, 2017. 1 generic application is approved; 1 of it carries 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 praziquantel from 1 labeler 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.
- 1982 earliest approval on file
- 2017 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for praziquantel (Biltricide)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $53.25 per Praziquantel 600 mg tablet, down 3% from $54.92 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Praziquantel 600 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Praziquantel 600 mg tablet | Generic | $53.25 per tablet | $1,597.43 | -3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has praziquantel been recalled?
The FDA's Enforcement Report lists 2 recalls naming praziquantel since 2013: 0 Class I (the most serious), 2 Class II, 0 Class III; 1 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of praziquantel and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 29, 2013 | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy not a listed maker | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes |
| May 2, 2013 | Class II | THE COMPOUNDING SHOP, INC. not a listed maker | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the praziquantel label say about other medicines?
The praziquantel label names 7 other medicines in its interaction, contraindication or warning sections. The labels of 8 other medicines name praziquantel. 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 |
|---|---|---|
| Cimetidine | drug interactions | CYP450 inhibitors Concomitant administration of drugs that decrease the activity of drug metabolizing liver enzymes (CYP450 inhibitors), for example, cimetidine, ketoconazole, itraconazole, erythromycin, and ritonavir may increase plasma concentrations of praziquantel. |
| Efavirenz | drug interactions | DRUG INTERACTIONS Moderate CYP 3A Inducers: Avoid concomitant administration of moderate CYP 3A inducers, for example, efavirenz |
| Erythromycin | drug interactions | CYP450 inhibitors Concomitant administration of drugs that decrease the activity of drug metabolizing liver enzymes (CYP450 inhibitors), for example, cimetidine, ketoconazole, itraconazole, erythromycin, and ritonavir may increase plasma concentrations of praziquantel. |
| Itraconazole | drug interactions | CYP450 inhibitors Concomitant administration of drugs that decrease the activity of drug metabolizing liver enzymes (CYP450 inhibitors), for example, cimetidine, ketoconazole, itraconazole, erythromycin, and ritonavir may increase plasma concentrations of praziquantel. |
| Ketoconazole | drug interactions | CYP450 inhibitors Concomitant administration of drugs that decrease the activity of drug metabolizing liver enzymes (CYP450 inhibitors), for example, cimetidine, ketoconazole, itraconazole, erythromycin, and ritonavir may increase plasma concentrations of praziquantel. |
| Rifampin | contraindications | Patients taking strong Cytochrome P450 3A enzyme (CYP3A) inducers, such as rifampin, [see Warnings and Precautions ( 5.6 ) and Drug Interactions ( 7.1 , 7.2 )]. Known hypersensitivity to Biltricide or any of its ingredients. |
| Ritonavir | drug interactions | CYP450 inhibitors Concomitant administration of drugs that decrease the activity of drug metabolizing liver enzymes (CYP450 inhibitors), for example, cimetidine, ketoconazole, itraconazole, erythromycin, and ritonavir may increase plasma concentrations of praziquantel. |
Other labels that name praziquantel
Source: FDA drug label (Biltricide), Bayer HealthCare Pharmaceuticals Inc., effective March 2, 2026 (SPL set 34ce1cdd-648e-4f1e-8512-bf3d4cc22eb9), via openFDA; the full label on DailyMed
What do FAERS reports show for praziquantel?
The FDA Adverse Event Reporting System holds 301 reports that list praziquantel among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 26 are coded as a death and 105 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 anthelmintics
- the pharmacologic class, with prices and generics
- Praziquantel side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other