warnings
Use of Anti-Inflammatory Agents The use of beta-adrenergic agonist bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids.
ALBUTEROL SULFATE
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- ALBUTEROL SULFATE
- Generic name
- ALBUTEROL SULFATE
- Manufacturer
- QUAGEN PHARMACEUTICALS LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 99a490cc-e41d-436b-9cf3-8facb7ac714f
- SPL ID
- f8b35fdc-741f-4ebd-91d5-a55a7ef8e261
- Version
- 3
- Effective date
- 2025-07-03
- Source export date
- 2026-10-22
- Source partition
- 13
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-22/e902d457a1761a44fd3a30c39db9aa876f06b0835423db5444f8d1a30fdfcfa1/drug-label-0013-of-0014.json.zip
- Source manifest SHA-256
- 5de9d3c3492926d1703b492ae4d29b036ac5be73edfcb92a6cd5eb95a2acef9c
- Import run
- 20261023T001338Z
- Imported at
- 2026-10-23 01:42:05
| Harmonized routes |
|---|
| ORAL |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | ANDA | 212197 | derived:openfda.application_number |
| application number | ANDA212197 | openfda.application_number | |
| brand name | ALBUTEROL SULFATE | openfda.brand_name | |
| generic name | ALBUTEROL SULFATE | openfda.generic_name | |
| manufacturer name | QUAGEN PHARMACEUTICALS LLC | openfda.manufacturer_name | |
| ndc | package | 70752-102-12 | openfda.package_ndc |
| ndc | product | 70752-102 | openfda.product_ndc |
| ndc11 | package | 70752010212 | derived:openfda.package_ndc |
| rxcui | 755497 | openfda.rxcui | |
| spl id | f8b35fdc-741f-4ebd-91d5-a55a7ef8e261 | id | |
| spl set id | 99a490cc-e41d-436b-9cf3-8facb7ac714f | set_id | |
| unii | 021SEF3731 | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
Immediate Hypersensitivity Reactions Immediate hypersensitivity reactions may occur after administration of albuterol, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema. Albuterol, like other beta-adrenergic agonists, can produce a significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, symptoms, and/or electrocardiographic changes. Rarely, erythema multiforme and Stevens-Johnson syndrome have been associated with the administration of albuterol sulfate in children.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS In clinical trials, the most frequent adverse reactions to albuterol sulfate syrup in adults and older children were: Percent Incidence of Adverse Reactions in Adults and Children (6-14 Years of Age) Reaction Percent Incidence Central nervous system Tremor 10% Nervousness 9% Shakiness 9% Headache 4% Dizziness 3% Hyperactivity 2% Excitement 2% Sleeplessness 1% Disturbed sleep <1% Irritable behavior <1% Dilated pupils <1% Weakness <1% Cardiovascular Tachycardia 1% Palpitations <1% Sweating <1% Chest pain <1% Ear, nose, and throat Epistaxis 1% Gastrointestinal Increased appetite 3% Epigastric pain <1% Stomachache <1% Musculoskeletal Muscle spasm <1% Respiratory Cough <1% In clinical trials, the following adverse reactions to albuterol sulfate syrup were noted more frequently in young children 2 to 6 years of age than in older children and adults: Percent Incidence of Adverse Reactions Noted More Frequently in Children 2 to 6 Years of Age Than in Older Children and Adults Reaction Percent Incidence Central nervous system Excitement 20% Nervousness 15% Hyperkinesia 4% Sleeplessness 2% Emotional lability 1% Fatigue 1% Cardiovascular Tachycardia 2% Pallor 1% Gastrointestinal Gastrointestinal symptoms 2% Loss of Appetite 1% Ophthalmologic Conjunctivitis 1% Cases of urticaria, angioedema, rash, bronchospasm, hoarseness, oropharyngeal edema, and arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles) have been reported after the use of albuterol sulfate syrup. In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as hypertension, angina, vomiting, vertigo, central nervous system stimulation, unusual taste, and drying or irritation of the oropharynx. The reactions are generally transient in nature, and it is usually not necessary to discontinue treatment with albuterol sulfate syrup. In selected cases, however, dosage may be reduced temporarily; after the reaction has subsided, dosage should be increased in small increments to the optimal dosage.
adverse reactions table
<table width="55%" border="1" cellspacing="5" cellpadding="5"><colgroup><col width="10%"/><col width="20%"/><col width="20%"/></colgroup><tbody><tr><td styleCode="Botrule Lrule Rrule" colspan="3" align="center" valign="top"><paragraph><content styleCode="bold">Percent Incidence of Adverse Reactions in Adults and Children (6-14 Years of Age)</content></paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule" colspan="2" align="center" valign="top"><paragraph>Reaction</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"><paragraph>Percent Incidence</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule" colspan="2" valign="top"><paragraph>Central nervous system</paragraph></td><td styleCode="Botrule Lrule Rrule" valign="top"/></tr><tr><td styleCode="Botrule Lrule Rrule" valign="top"/><td styleCode="Botrule Lrule Rrule" valign="top"><paragraph>Tremor</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"><paragraph>10%</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/><td styleCode="Botrule Lrule Rrule" valign="top"><paragraph>Nervousness</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center"><paragraph>9%</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/><td styleCode="Botrule Lrule Rrule" valign="top"><paragraph>Shakiness</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"><paragraph>9%</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule" valign="top"/><td styleCode="Botrule Lrule Rrule" valign="top"><paragraph>Headache</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"><paragraph>4%</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/><td styleCode="Botrule Lrule Rrule" valign="top"><paragraph>Dizziness</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"><paragraph>3%</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/><td styleCode="Botrule Lrule Rrule" valign="top"><paragraph>Hyperactivity</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"><paragraph>2%</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/><td styleCode="Botrule Lrule Rrule" valign="top"><paragraph>Excitement</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"><paragraph>2%</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/><td styleCode="Botrule Lrule Rrule" valign="top"><paragraph>Sleeplessness</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"><paragraph>1%</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/><td styleCode="Botrule Lrule Rrule" valign="top"><paragraph>Disturbed sleep</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"><paragraph><1%</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/><td styleCode="Botrule Lrule Rrule" valign="top"><paragraph>Irritable behavior</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"><paragraph><1%</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/><td styleCode="Botrule Lrule Rrule" valign="top"><paragraph>Dilated pupils</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"><paragraph><1%</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/><td styleCode="Botrule Lrule Rrule" valign="top"><paragraph>Weakness</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"><paragraph><1%</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule" colspan="2" valign="top"><paragraph>Cardiovascular</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/></tr><tr><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/><td styleCode="Botrule Lrule Rrule" valign="top"><paragraph>Tachycardia</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"><paragraph>1%</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/><td styleCode="Botrule Lrule Rrule" valign="top"><paragraph>Palpitations</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"><paragraph><1%</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/><td styleCode="Botrule Lrule Rrule" valign="top"><paragraph>Sweating</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"><paragraph><1%</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/><td styleCode="Botrule Lrule Rrule" valign="top"><paragraph>Chest pain</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"><paragraph><1%</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule" colspan="2" valign="top"><paragraph>Ear, nose, and throat</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/></tr><tr><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/><td styleCode="Botrule Lrule Rrule" valign="top"><paragraph>Epistaxis</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"><paragraph>1%</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule" colspan="2" valign="top"><paragraph>Gastrointestinal</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/></tr><tr><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/><td styleCode="Botrule Lrule Rrule" valign="top"><paragraph>Increased appetite</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"><paragraph>3%</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/><td styleCode="Botrule Lrule Rrule" valign="top"><paragraph>Epigastric pain</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"><paragraph><1%</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/><td styleCode="Botrule Lrule Rrule" valign="top"><paragraph>Stomachache</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"><paragraph><1%</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule" colspan="2" valign="top"><paragraph>Musculoskeletal</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/></tr><tr><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/><td styleCode="Botrule Lrule Rrule" valign="top"><paragraph>Muscle spasm</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"><paragraph><1%</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule" colspan="2" valign="top"><paragraph>Respiratory</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/></tr><tr><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/><td styleCode="Botrule Lrule Rrule" valign="top"><paragraph>Cough</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"><paragraph><1%</paragraph></td></tr></tbody></table>
adverse reactions table
<table width="55%" border="1" cellspacing="5" cellpadding="5"><colgroup><col width="10%"/><col width="20%"/><col width="20%"/></colgroup><tbody><tr><td styleCode="Botrule Lrule Rrule" colspan="3" align="center" valign="top"><paragraph><content styleCode="bold">Percent Incidence of Adverse Reactions Noted More Frequently in Children 2 to 6 Years of Age Than in Older Children and Adults</content></paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule" colspan="2" align="center" valign="top"><paragraph>Reaction</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"><paragraph>Percent Incidence</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule" colspan="2" valign="top"><paragraph>Central nervous system</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/></tr><tr><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/><td styleCode="Botrule Lrule Rrule" valign="top"><paragraph>Excitement</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"><paragraph>20%</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/><td styleCode="Botrule Lrule Rrule" valign="top"><paragraph>Nervousness</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"><paragraph>15%</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/><td styleCode="Botrule Lrule Rrule" valign="top"><paragraph>Hyperkinesia</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"><paragraph>4%</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/><td styleCode="Botrule Lrule Rrule" valign="top"><paragraph>Sleeplessness</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"><paragraph>2%</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/><td styleCode="Botrule Lrule Rrule" valign="top"><paragraph>Emotional lability</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"><paragraph>1%</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/><td styleCode="Botrule Lrule Rrule" valign="top"><paragraph>Fatigue</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"><paragraph>1%</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule" colspan="2" valign="top"><paragraph>Cardiovascular</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/></tr><tr><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/><td styleCode="Botrule Lrule Rrule" valign="top"><paragraph>Tachycardia</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"><paragraph>2%</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/><td styleCode="Botrule Lrule Rrule" valign="top"><paragraph>Pallor</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"><paragraph>1%</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule" colspan="2" valign="top"><paragraph>Gastrointestinal</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/></tr><tr><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/><td styleCode="Botrule Lrule Rrule" valign="top"><paragraph>Gastrointestinal symptoms</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"><paragraph>2%</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/><td styleCode="Botrule Lrule Rrule" valign="top"><paragraph>Loss of Appetite</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"><paragraph>1%</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule" colspan="2" valign="top"><paragraph>Ophthalmologic</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/></tr><tr><td styleCode="Botrule Lrule Rrule" align="center" valign="top"/><td styleCode="Botrule Lrule Rrule" valign="top"><paragraph>Conjunctivitis</paragraph></td><td styleCode="Botrule Lrule Rrule" align="center" valign="top"><paragraph>1%</paragraph></td></tr></tbody></table>
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.