Drug Safety Information for SYMBICORT (Budesonide; formoterol fumarate dihydrate)

Safety-related Labeling Changes for SYMBICORT (BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE) Rx Drug: FDA Link

Adverse Drug Reactions for SYMBICORT* (Budesonide; formoterol fumarate dihydrate)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with SYMBICORT
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dyspnoea4896
2Drug dose omission2404
3Asthma1827
4Drug ineffective1619
5Cough1569
6Malaise1516
7Off label use1392
8Chronic obstructive pulmonary disease1378
9Pneumonia1342
10Headache*993
11Fatigue930
12Nausea904
13Dizziness836
14Intentional drug misuse768
15Wheezing756
16Dysphonia*732
17Pain*719
18Chest discomfort677
19Chest pain651
20Diarrhoea646

* This side effect also appears in "Top 10 Side Effects of SYMBICORT " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking SYMBICORT
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Asthma*15978
2Chronic obstructive pulmonary disease*15955
3Product used for unknown indication8878
4Emphysema*2271
5Dyspnoea1665
6Bronchitis*1063
7Bronchitis chronic*502
8Cough416
9Respiratory disorder344
10Wheezing339

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for SYMBICORT

Total Reports Filed with FDA: 102041


Number of FDA Adverse Event Reports by Patient Age for SYMBICORT

Total Reports Filed with FDA: 102041*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Budesonide; formoterol fumarate dihydrate (Symbicort)

Charts are based on 102041 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and SYMBICORT Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.