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Beractant: uses, dosing, side effects & brands

Beractant is a medicine sold in the U.S. under one brand, for premature infant and newborn respiratory distress syndrome. 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
Premature Infant and Newborn Respiratory Distress Syndrome
Available as
Suspension
Sold as
Survanta
Prescription?
Prescription only
Generic available?
Not in our catalog

How beractant is dosed

From the FDA label for Survanta (application BLA020032). Other beractant products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

Important Administration Instructions For intratracheal administration only. SURVANTA should be administered by or under the supervision of clinicians experienced in intubation, ventilator management, and general care of premature infants. The administration of SURVANTA is facilitated if one person administers the dose while another person positions and monitors the infant. Before administering SURVANTA, assure proper placement and patency of the endotracheal tube. At the discretion of the clinician, the endotracheal tube may be suctioned before administering SURVANTA. The infant should be allowed to stabilize before proceeding with dosing. Administer SURVANTA intratracheally by instillation through a 5 French end-hole catheter. Recommended Dosage Each dose of SURVANTA is 100 mg of phospholipids/kg birth weight (4 mL/kg). In the prevention strategy, in premature infants with evidence of surfactant deficiency, give the first dose of SURVANTA as soon as possible, preferably within 15 minutes of birth. To treat infants with RDS confirmed by radiographic and clinical findings, give the first dose of SURVANTA as soon as possible, preferably by 8 hours of age. Four doses of SURVANTA can be administered in the first 48 hours of life. Doses should be given no more frequently than every 6 hours. The need for additional doses of SURVANTA is determined by evidence of continuing…

Beractant side effects

The most commonly reported adverse experiences were associated with the dosing procedure. In the multiple-dose controlled clinical trials, each dose of SURVANTA was divided into four quarter-doses which were instilled through a catheter inserted into the endotracheal tube by briefly disconnecting the endotracheal tube from the ventilator. Transient bradycardia occurred with 11.9% of doses . Oxygen desaturation occurred with 9.8% of doses . Other reactions during the dosing procedure occurred with fewer than 1% of doses and included endotracheal tube reflux, pallor, vasoconstriction, hypotension, endotracheal tube blockage, hypertension, hypocarbia, hypercarbia, and apnea. No deaths occurred during the dosing procedure, and all reactions resolved with symptomatic treatment. The occurrence of concurrent illnesses common in premature infants was evaluated in the controlled trials. The rates in all controlled studies are in Table 3. Table 3. All Controlled Studies Concurrent Event SURVANTA (%) Control (%) P -Value a Patent ductus arteriosus 46.9 47.1 0.814 Intracranial hemorrhage 48.1 45.2 0.241 Severe intracranial hemorrhage 24.1 23.3 0.693 Pulmonary air leaks 10.9 24.7 < 0.001 Pulmonary interstitial emphysema 20.2 38.4 < 0.001 Necrotizing enterocolitis 6.1 5.3 0.427 Apnea 65.4 59.6 0.283 Severe apnea 46.1 42.5 0.114 Post-treatment sepsis 20.7 16.1 0.019 Post-treatment infection…

Who shouldn’t take beractant

None

Every beractant 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: Survanta.

What people report to the FDA about beractant

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 88 reports naming beractant, and the FDA flagged 100% 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:

  • neurodevelopmental disorder36 reports
  • neonatal disorder10 reports
  • pulmonary haemorrhage10 reports
  • pulmonary interstitial emphysema syndrome8 reports
  • drug exposure during pregnancy7 reports
  • intestinal perforation5 reports
  • hyperglycaemia4 reports
  • respiratory disorder neonatal4 reports

Read these as a signal, not a rate. A report does not mean beractant 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 beractant?

SURVANTA ® contains beractant, a pulmonary surfactant, which is a natural bovine lung extract containing phospholipids, neutral lipids, fatty acids, and surfactant-associated proteins (SP) to which colfosceril palmitate (dipalmitoylphosphatidylcholine), palmitic acid, and tripalmitin are added to standardize the composition and to mimic surface-tension lowering properties of natural lung surfactant.

Can you take beractant 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 beractant 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 beractant come in?

Across the brands we track, beractant is currently marketed as suspension, 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 beractant?

We do not currently list a generic-labelled beractant 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). Beractant: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/beractant
MLA
“Beractant: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/beractant.

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 beractant on DailyMed (NIH) ↗.