Albuterol Pregnancy and Breastfeeding Warnings

Brand names: AccuNeb, Airet, ProAir Digihaler, ProAir HFA, ProAir RespiClick, Proventil, Proventil HFA, Respirol, Ventolin, Ventolin HFA, Volmax, Vospire ER

Medically reviewed by Drugs.com. Last updated on Mar 3, 2024.

Albuterol Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

AU TGA pregnancy category: A
US FDA pregnancy category: Not assigned

Comments:
-There are no randomized clinical studies of albuterol use during pregnancy, but available information on pregnancy exposure by inhalation do not consistently show miscarriage or major birth defects.
-This drug is known to cross the placental barrier, as evidenced by increases in fetal heart rate.
-Beta-agonists, including this drug, may potentially interfere with uterine contractility.
-In women with poorly or moderately controlled asthma, there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. Pregnant women should be closely monitored and the dose adjusted as necessary to maintain optimal control.
-In some countries, intravenous injection presentations of this drug have been approved for delay pre-term labor (tocolytic agent) and should not be used in the management of uncomplicated premature labor.

Epidemiological studies and postmarketing case reports following inhaled administration of this drug do not consistently demonstrate a risk of major birth defects or miscarriage. In animal reproduction studies, subcutaneous administration to pregnant mice evidence of cleft palate at less than and up to 9 times the maximum recommended human daily inhalation dose (MRHDID). A study in pregnant rats demonstrated that drug-related material was transferred from the maternal circulation to the fetus. There are no controlled data in human pregnancy.
During worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been reported in the offspring of patients being treated with this drug. Some of the mothers were taking multiple medications during their pregnancies. A relationship between the use of this drug and congenital anomalies has not been established. Profuse uterine bleeding following spontaneous abortion has been reported after the use of this drug. Special care is required in pregnant diabetic women. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.


A pregnancy exposure registry monitors outcomes after exposure to asthma medications during pregnancy. For more information, contact the Mothers To Baby Pregnancy Studies conducted by the Organization of Teratology Information Specialists at http://mothertobaby.org/pregnancystudies/.


AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Albuterol Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

See references

Further information

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