Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Beractant
Drug ID BADD_D00255
Description Beractant is a pulmonary surfactant used for the treatment of Respiratory Distress Syndrome (RDS) in premature infants. Considered a natural source of surfactant as it is made from bovine lung extract, beractant contains a mixture of phospholipids, neutral lipids, fatty acids, and surfactant-associated proteins such as SP-B and SP-C. The final composition provides 25 mg/mL phospholipids (including 11.0-15.5 mg/mL disaturated phosphatidylcholine), 0.5-1.75 mg/mL triglycerides, 1.4-3.5 mg/mL free fatty acids, and less than 1.0 mg/mL protein. It is suspended in 0.9% sodium chloride solution, and heat-sterilized. In anticipation of birth, endogenous lung surfactant is produced to lower the surface tension on alveolar surfaces and to stabilize the alveoli against collapse at resting transpulmonary pressures. However, in Respiratory Distress Syndrome, developmental deficiency of surfactant results collapse of the alveoli causing fast breathing, increased heart rate, apoxia, and sometimes death. Administration of lung surfactant remains the cornerstone of therapy in this condition that is currently the leading cause of death in preterm infants. In comparison to synthetic forms of surfacant, natural forms such as Beractant have been found to have a reduced incidence of pneumothorax and reduced mortality.
Indications and Usage Beractant is indicated for prevention and treatment of Respiratory Distress Syndrome (RDS) in premature infants.
Marketing Status approved
ATC Code Not Available
DrugBank ID DB06761
KEGG ID D03096
MeSH ID C072197
PubChem ID Not Available
TTD Drug ID D02VLX
NDC Product Code 0074-1040
UNII S866O45PIG
Synonyms beractant | surfactant-TA | Survanta
Chemical Information
Molecular Formula Not Available
CAS Registry Number 108778-82-1
SMILES Not Available
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal distension07.01.04.001--
Adrenal haemorrhage12.01.17.003; 24.07.01.023; 05.01.03.002--Not Available
Air embolism24.01.01.001; 12.02.05.008--Not Available
Aortic thrombosis24.01.09.001--Not Available
Apnoea22.02.01.001--
Bradycardia02.03.02.002--Not Available
Cardiac failure02.05.01.001--
Cardio-respiratory arrest22.02.06.007; 02.03.04.002--Not Available
Coagulopathy01.01.02.001--Not Available
Diaphragmatic paralysis17.01.04.014; 22.09.02.002--Not Available
Disseminated intravascular coagulation24.01.01.010; 01.01.02.002--
Haematuria21.10.01.018; 24.07.01.047; 20.02.01.006--
Haemorrhage intracranial24.07.04.003; 17.08.01.008--
Hepatic failure09.01.03.002--
Hypercapnia22.02.02.002; 14.01.04.001--Not Available
Hyperphosphataemia14.04.03.007--
Hypertension24.08.02.001--
Hypocapnia22.02.02.008--Not Available
Hypotension24.06.03.002--
Infection11.01.08.002--Not Available
Inguinal hernia07.16.02.001--Not Available
Intestinal infarction24.04.08.008; 07.15.02.006--Not Available
Intestinal perforation07.04.06.002--Not Available
Laryngeal stenosis12.02.07.014; 22.04.02.004--
Lung consolidation22.01.02.010--Not Available
Pallor24.03.04.001; 23.03.03.031; 08.01.03.032--Not Available
Persistent foetal circulation24.03.03.004; 18.04.07.001; 03.07.01.002; 02.08.02.001--Not Available
Pulmonary haemorrhage22.12.01.009; 24.07.01.016--
Pulmonary interstitial emphysema syndrome22.01.02.012--Not Available
Pulse abnormal13.14.04.004--Not Available
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