Bezlotoxumab: uses, dosing, side effects & brands

Bezlotoxumab is a medicine sold in the U.S. under one brand, for clostridium infections. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesUpdated Jul 24, 2026How we research

Key facts

Treats: Clostridium Infections
Available as: Injectable
Sold as: Zinplava
Prescription?: Prescription only
Generic available?: Not in our catalog

How bezlotoxumab is dosed

From the FDA label for Zinplava (application BLA761046). Other bezlotoxumab products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

Administer ZINPLAVA during antibacterial drug treatment for CDI. ( 2.1 ) The recommended dose is a single dose of 10 mg/kg administered as an intravenous infusion over 60 minutes. ( 2.2 ) Dilute prior to intravenous infusion. Administer via a low-protein binding 0.2 micron to 5 micron in-line or add-on filter. See Full Prescribing Information for dilution and administration instructions. ( 2.3 ) 2.1 Important Administration Instructions Administer ZINPLAVA during antibacterial drug treatment for CDI. 2.2 Dosing Recommendations in Adults and Pediatric Patients 1 year of age and older The recommended dose of ZINPLAVA is a single dose of 10 mg/kg administered as an intravenous infusion over 60 minutes. The safety and efficacy of repeat administration of ZINPLAVA in patients with CDI have not been studied. 2.3 Preparation and Administration Preparation of Diluted Solution ZINPLAVA must be diluted prior to intravenous infusion. Prepare the diluted solution immediately after removal of the vial(s) from refrigerated storage, or the vial(s) may be stored at room temperature protected from light for up to 24 hours prior to preparation of the diluted solution. Inspect vial contents for discoloration and particulate matter prior to dilution. ZINPLAVA is a clear to moderately opalescent, colorless to pale yellow solution. Do not use the vial if the solution is discolored or contains…

Bezlotoxumab side effects

Adult Patients : The most common adverse reactions (reported in ≥4% of adult patients) included nausea, pyrexia, and headache. ( 6.1 ) Pediatric Patients : The most common adverse reactions (reported in >10% of pediatric patients) were pyrexia and headache ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 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. Clinical Trials Experience in Adults The safety of ZINPLAVA was evaluated in two placebo-controlled Phase 3 trials (Trial 1 n=390 and Trial 2 n=396). Patients received a single 10 mg/kg intravenous infusion of ZINPLAVA and concomitant standard of care (SoC) antibacterial drugs (metronidazole, vancomycin or fidaxomicin) for CDI. Adverse reactions reported within the first 4 weeks after ZINPLAVA was administered are described for the pooled Phase 3 trial population of 786 patients. The median age of patients receiving ZINPLAVA was 65 years (range 18 to 100), 50% were age 65 years or older, 56% were female, and 83% were white. Serious Adverse Reactions in Adults Serious adverse reactions…

Who shouldn’t take bezlotoxumab

None. None ( 4 )

Bezlotoxumab drug interactions

Since ZINPLAVA is eliminated by catabolism, no metabolic drug-drug interactions are expected [see Clinical Pharmacology (12.3) ] .

Every bezlotoxumab product we track (1)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Only one: Zinplava.

Bezlotoxumab and breastfeeding

From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.

No information is available on the use of bezlotoxumab during breastfeeding. Because bezlotoxumab is a large protein molecule with a molecular weight of about 148,200 Da, the amount in milk is likely to be very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. Waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant. If bezlotoxumab is required by the mother, it is not a reason to discontinue breastfeeding. Until more data become available, bezlotoxumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.

Full LactMed record for bezlotoxumab: levels in milk, effects in breastfed infants, and the drugs it would consider instead

National Institute of Child Health and Human Development, record revised November 15, 2023. LactMed states its information is not a substitute for professional judgement.

What people report to the FDA about bezlotoxumab

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 60 reports naming bezlotoxumab, and the FDA flagged 85% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

clostridium difficile infection23 reports
clostridium difficile colitis13 reports
diarrhoea11 reports
nausea11 reports
colitis ulcerative10 reports
vomiting10 reports
diabetic gastroparesis9 reports
enthesopathy9 reports

Read these as a signal, not a rate. A report does not mean bezlotoxumab caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.

Source: openFDA drug/event (FAERS), retrieved July 25, 2026.

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Frequently asked questions

What is bezlotoxumab?

Zinplava (Bezlotoxumab) is a medication used to treat Clostridium Infections.

Can you take bezlotoxumab with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run bezlotoxumab against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What forms does bezlotoxumab come in?

Across the brands we track, bezlotoxumab is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic bezlotoxumab?

We do not currently list a generic-labelled bezlotoxumab product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.

Cite this page

APA: pharmaranks. (2026, July 24). Bezlotoxumab: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/bezlotoxumab
MLA: “Bezlotoxumab: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/bezlotoxumab.

We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.

Read the full FDA label for bezlotoxumab on DailyMed (NIH) ↗.