Beclomethasone, inhaled

>10%

≥ 12 years (MDI)

• Pharyngitis (5-27%)
• Headache (8-25%)
• Upper respiratory tract infection (URI) (5-11%)

1-10%

4-12 years (RediHaler)

• Vomiting, 80-160 mcg (1.6%)
• Headache, 80 mcg (1.6%)
• URI, 80 mcg (2.4%)
• Cough, 160 mcg (2.4%)
• Pyrexia, 160 mcg (3.2%)
• Pharyngitis, 80-160 mcg (3.2%)
• Nasopharyngitis, 80 mcg (4%)
• Viral URI, 80-160 mcg (4%)
• Headache, 160 mcg (4%)
• Nasopharyngitis, 160 mcg (8.8%)

≥12 years (RediHaler)

• Increased asthma symptoms (2-4%)
• URI, 320 mcg (4%)
• Nasopharyngitis, 80 mcg (4%)
• Nasopharyngitis, 80 mcg (4%)
• Viral URI, 80 mcg (3%)
• Sinusitis, 80 mcg (3%)
• URI, 640 mcg (3%)
• Oral candidiasis, 320 mcg (3%)
• URI, 80-160 mcg (3%)
• Rhinitis allergic, 160 mcg (3%)
• Sinusitis (3%) Oral symptoms (2-3%)
• Nasopharyngitis, 160 mcg (2%)
• Oropharyngeal pain, 80-160 mcg (2%)
• Oral candidiasis, 160 mcg (2%)
• Nasopharyngitis, 320-640 mcg (1%)

<1%

4-12 years (RediHaler)

• Cough, 80 mcg (0.8%)
• URI, 80 mcg (0.8%)
• Pyrexia, 80 mcg (0.8%)

≥12 years (RediHaler)

• Oropharyngeal pain, 320 mcg (<1%)
• Viral URI, 80 mcg (<1%)
• Sinusitis, 320-640 mcg (<1%)
• Rhinitis allergic, 640 mcg (<1%)

Postmarketing Reports

Psychiatric events and behavioral changes (eg, aggression, depression, sleep disorders, psychomotor hyperactivity, and suicidal ideation [primarily in children])

Blurred vision, central serous chorioretinopathy

Pregnancy

There are no adequate and well-controlled in pregnant women; there are clinical considerations with use of inhaled corticosteroids (ICS), including beclomethasone dipropionate, in pregnant women; available human data do not establish presence or absence of drug- associated risk to fetus; in animal reproduction studies, beclomethasone dipropionate resulted in adverse developmental effects in mice and rabbits at subcutaneous doses equal to or greater than approximately 0.75 times maximum recommended human daily inhalation dose (MRHDID) in adults (0.64 mg/day); in rats exposed to beclomethasone dipropionate by inhalation, dose-related gross injury to fetal adrenal glands was observed at doses greater than 180 times the MRHDID, but there was no evidence of external or skeletal malformations or embryo lethality at inhalation doses up to 440 times the MRHDID

The risk of complications to mother and developing fetus from inadequate control of asthma must be balanced against risks from exposure to beclomethasone dipropionate

Labor or delivery

• There are no specific human data regarding any adverse effects of inhaled beclomethasone dipropionate on labor and delivery

Fertility

• Impairment of fertility was observed in rats and dogs at oral doses corresponding to 250 and 25 times the MRHDID for adults on a mg/ m² basis, respectively

Lactation

There are no data available on presence in human milk, effects on breastfed child, or on milk production; however, other inhaled corticosteroids have been detected in human milk

The developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from beclomethasone dipropionate or from underlying maternal condition

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.