Conditions and symptoms
What Are Congenital Malformations? Medicine Label Warnings
Congenital malformations · say it: kon-JEN-ih-tul mal-for-MAY-shunzAlso written: birth defects, congenital anomalies, congenital abnormalities
Short answer
Congenital malformations are differences in the structure of the body that are present at birth, such as heart, spine or lip and palate defects.
What it means
Congenital means present at birth. A malformation is a difference in how a part of the body formed while the baby was developing in the womb. Examples include some heart defects, cleft lip and palate, and neural tube defects affecting the spine. Many have no known cause; some are linked to genes, infections, or substances the developing baby was exposed to.
Medicine labels mention congenital malformations in the pregnancy section when studies or reports have linked a medicine to a higher chance of birth defects if taken during pregnancy, especially in the first weeks when organs are forming. The warning helps people who are pregnant, or could become pregnant, plan with their doctor. Some labels also advise reliable contraception during treatment.
Congenital malformation is related to the word teratogenic, which describes a substance that can cause birth defects. Fetotoxicity is different: it usually means harm to the baby's growth or organs later in pregnancy, not a structural defect formed early.
Where you may see it
- The 'Use in Specific Populations: Pregnancy' section of medicine labels
- Boxed warnings on some medicines known to cause birth defects
- Pregnancy scan reports and genetic counselling letters
📄 How it looks on a report
Use during pregnancy has been associated with an increased risk of major congenital malformations.
🙅 What it does not mean
- A warning about birth defects does not mean every pregnancy exposed to the medicine will be affected.
- It does not mean you should stop a medicine suddenly if you find out you are pregnant. Some conditions are risky to leave untreated, so speak to your doctor quickly.
- A congenital malformation is not always caused by something the parent did. Many have no known cause.
🎯 Check yourself
Which of these is the right meaning of “Congenital malformations”?
🗒️ Questions to ask your doctor
💊 Medicines whose labels mention “Congenital malformations”
Plain-English explanations of each medicine, from its official FDA label.
- Acyclovir
An antiviral medicine of the nucleoside analogue type, used against herpesviruses
- Albendazole
an anthelmintic drug, a medicine used to treat infections caused by parasitic worms
- Allopurinol
a xanthine oxidase inhibitor, a prescription medicine that acts on uric acid
- Amlodipine
a calcium channel blocker, a type of medicine that relaxes blood vessels
- Amoxicillin and Clavulanate Potassium
A penicillin-class antibacterial combined with a beta-lactamase inhibitor, as the label describes it
- Aripiprazole
an atypical antipsychotic medicine
- Artemether and Lumefantrine
an antimalarial medicine, which is a fixed combination of two blood-stage antimalarial ingredients (artemether, an artemisinin derivative, and lumefantrine)
- Atorvastatin
a statin, a cholesterol-lowering medicine of the HMG-CoA reductase inhibitor type
- Azithromycin
a macrolide antibacterial (antibiotic) medicine
- Bupropion Hydrochloride
an aminoketone antidepressant, a type of medicine used to treat depression
🔗 Read more from trusted sources
- “Congenital malformations” on MedlinePlus ↗
US National Library of Medicine
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