Drug Safety Information for BUDESONIDE (Budesonide)
Safety-related Labeling Changes for PULMICORT RESPULES (BUDESONIDE) Rx Drug: FDA Link
Safety-related Labeling Changes for ENTOCORT EC (BUDESONIDE) Rx Drug: FDA Link
Safety-related Labeling Changes for SYMBICORT (BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE) Rx Drug: FDA Link
Safety-related Labeling Changes for PULMICORT FLEXHALER (BUDESONIDE) Rx Drug: FDA Link
Safety-related Labeling Changes for UCERIS (BUDESONIDE) Rx Drug: FDA Link
Adverse Drug Reactions for BUDESONIDE* (Budesonide)
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 BUDESONIDE
(reported in FDA Medwatch/FAERS Reports)
Side Effect | # of FDA Reports | |
---|---|---|
1 | Dyspnoea | 2251 |
2 | Drug ineffective | 1470 |
3 | Asthma | 1310 |
4 | Cough | 1082 |
5 | Nausea | 1019 |
6 | Headache* | 943 |
7 | Off label use | 922 |
8 | Diarrhoea | 908 |
9 | Malaise | 905 |
10 | Fatigue | 902 |
11 | Drug dose omission | 769 |
12 | Dizziness | 766 |
13 | Pneumonia | 745 |
14 | Vomiting | 724 |
15 | Pain | 722 |
16 | Pyrexia | 677 |
17 | Crohn's disease | 604 |
18 | Abdominal pain | 588 |
19 | Asthenia | 567 |
20 | Weight decreased | 515 |
* This side effect also appears in "Top 10 Side Effects of BUDESONIDE " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking BUDESONIDE
(associated with FDA Medwatch/FAERS Reports)
Reason | # of FDA Reports | |
---|---|---|
1 | Product used for unknown indication | 9754 |
2 | Asthma* | 9528 |
3 | Crohn's disease* | 5589 |
4 | Chronic obstructive pulmonary disease | 2928 |
5 | Colitis ulcerative | 836 |
6 | Hypersensitivity* | 833 |
7 | Multiple allergies | 718 |
8 | Dyspnoea | 561 |
9 | Sinusitis* | 481 |
10 | Bronchitis | 473 |
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for BUDESONIDE
Total Reports Filed with FDA: 94087
Number of FDA Adverse Event Reports by Patient Age for BUDESONIDE
Total Reports Filed with FDA: 94087*
* Reports for drugs with the same active ingredients have been aggregated in this analysis: Budesonide (Rhinocort aqua, Entocort, Rhinocort allergy, Pulmicort flexhaler, Budesonide nasal, Pulmicort respules, Budesonide, Uceris, Entocort ec, Pulmicort, Rhinocort)
Charts are based on 94087 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.
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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.