Symbicort

N/A

Manufactured by AstraZeneca Pharmaceuticals LP

240,442 FDA adverse event reports analyzed

Last updated: 2026-05-19

About Symbicort

Symbicort is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by AstraZeneca Pharmaceuticals LP. The most commonly reported adverse reactions for Symbicort include DYSPNOEA, ASTHMA, COUGH, DRUG INEFFECTIVE, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for Symbicort.

Top Adverse Reactions

DYSPNOEA17,588 reports
ASTHMA11,964 reports
COUGH7,830 reports
DRUG INEFFECTIVE6,733 reports
OFF LABEL USE5,866 reports
PNEUMONIA5,750 reports
WHEEZING5,696 reports
FATIGUE5,337 reports
MALAISE4,564 reports
HEADACHE4,497 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE4,016 reports
NAUSEA3,946 reports
DEATH3,782 reports
DRUG DOSE OMISSION3,643 reports
INTENTIONAL PRODUCT MISUSE3,552 reports
PAIN3,284 reports
DIZZINESS3,282 reports
DIARRHOEA3,106 reports
CHEST DISCOMFORT3,019 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE2,960 reports
WEIGHT DECREASED2,847 reports
PRODUCT DOSE OMISSION ISSUE2,799 reports
NASOPHARYNGITIS2,768 reports
DEVICE MALFUNCTION2,712 reports
PRODUCTIVE COUGH2,643 reports
ASTHENIA2,567 reports
ARTHRALGIA2,564 reports
FALL2,535 reports
VOMITING2,411 reports
BRONCHITIS2,341 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES2,323 reports
PYREXIA2,228 reports
WEIGHT INCREASED2,219 reports
PRODUCT USE ISSUE2,211 reports
CONDITION AGGRAVATED2,192 reports
SINUSITIS2,181 reports
HYPERTENSION2,155 reports
ANXIETY2,132 reports
RASH2,095 reports
DYSPHONIA2,068 reports
CHEST PAIN2,039 reports
INSOMNIA2,014 reports
FEELING ABNORMAL1,991 reports
PRURITUS1,989 reports
OBSTRUCTIVE AIRWAYS DISORDER1,960 reports
PAIN IN EXTREMITY1,940 reports
BACK PAIN1,881 reports
HYPERSENSITIVITY1,791 reports
OROPHARYNGEAL PAIN1,772 reports
BLOOD PRESSURE INCREASED1,769 reports
PRODUCT QUALITY ISSUE1,744 reports
INFLUENZA1,721 reports
SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION1,662 reports
GASTROOESOPHAGEAL REFLUX DISEASE1,607 reports
DYSPNOEA EXERTIONAL1,572 reports
MUSCLE SPASMS1,563 reports
NASAL CONGESTION1,532 reports
DEVICE ISSUE1,506 reports
WRONG TECHNIQUE IN DEVICE USAGE PROCESS1,483 reports
TREMOR1,453 reports
COVID 191,443 reports
DEPRESSION1,437 reports
GAIT DISTURBANCE1,421 reports
LUNG DISORDER1,415 reports
PRODUCT USE IN UNAPPROVED INDICATION1,412 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS1,352 reports
DEVICE DELIVERY SYSTEM ISSUE1,328 reports
INCORRECT DOSE ADMINISTERED1,325 reports
HEART RATE INCREASED1,322 reports
INTENTIONAL DEVICE MISUSE1,304 reports
ABDOMINAL PAIN1,272 reports
PERIPHERAL SWELLING1,259 reports
DRUG HYPERSENSITIVITY1,239 reports
URTICARIA1,231 reports
DECREASED APPETITE1,221 reports
MEMORY IMPAIRMENT1,208 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION1,197 reports
FULL BLOOD COUNT ABNORMAL1,186 reports
VISUAL IMPAIRMENT1,185 reports
DEVICE USE ISSUE1,184 reports
OXYGEN SATURATION DECREASED1,177 reports
LOWER RESPIRATORY TRACT INFECTION1,173 reports
OEDEMA PERIPHERAL1,162 reports
RHINORRHOEA1,140 reports
ABDOMINAL PAIN UPPER1,133 reports
URINARY TRACT INFECTION1,120 reports
ILLNESS1,107 reports
CONSTIPATION1,103 reports
MYALGIA1,097 reports
BLOOD COUNT ABNORMAL1,086 reports
INFECTION1,064 reports
ACUTE KIDNEY INJURY1,050 reports
MYOCARDIAL INFARCTION978 reports
PRODUCT DOSE OMISSION972 reports
PALPITATIONS967 reports
THROAT IRRITATION957 reports
HYPOTENSION956 reports
SPUTUM DISCOLOURED956 reports
CATARACT955 reports
ATRIAL FIBRILLATION953 reports

Report Outcomes

Out of 95,119 classified reports for Symbicort:

  • Serious: 57,737 reports (60.7%) — includes hospitalization, disability, life-threatening events, or death
  • Non-Serious: 37,382 reports (39.3%)
Serious 60.7%Non-Serious 39.3%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female56,063 (63.9%)
Male31,541 (36.0%)
Unknown108 (0.1%)

Reports by Age

Age 651,502 reports
Age 671,464 reports
Age 621,445 reports
Age 611,433 reports
Age 681,416 reports
Age 641,415 reports
Age 701,413 reports
Age 601,388 reports
Age 661,383 reports
Age 691,361 reports
Age 631,332 reports
Age 711,291 reports
Age 721,282 reports
Age 741,268 reports
Age 591,213 reports
Age 731,211 reports
Age 561,176 reports
Age 751,160 reports
Age 571,144 reports
Age 581,119 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with Symbicort?

This profile reflects 240,442 FDA FAERS reports that mention Symbicort. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for Symbicort?

Frequently reported terms in FAERS include DYSPNOEA, ASTHMA, COUGH, DRUG INEFFECTIVE, OFF LABEL USE, PNEUMONIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures Symbicort?

Labeling and FAERS entries often list AstraZeneca Pharmaceuticals LP in connection with Symbicort. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.