What the label lists and what reports show
Beractant side effects
Beractant's FDA label: “The most commonly reported adverse experiences were associated with the dosing procedure.” FAERS holds 367 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pulmonary haemorrhage (125 reports).
- No generic listed
Check it at the source: the beractant FDA label on DailyMed (effective October 15, 2020, AbbVie Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most commonly reported adverse experiences were associated with the dosing procedure.
Table 3.
| 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 | 10.2 | 9.1 | 0.345 |
| Pulmonary hemorrhage | 7.2 | 5.3 | 0.166 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe 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. …
Source: FDA drug label, AbbVie Inc., effective October 15, 2020 (SPL set 7ef9e3a5-fc39-4ae1-0dad-6b47a1684635), via openFDA; the full label on DailyMed
What do FAERS reports show?
367 reports list beractant among the medicines taken, each a report of something that happened, not proof the medicine caused it; 221 are coded as a death and 72 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. Of the 22 reactions below, 6 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Beractant: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions