Drug Safety Information for PULMICORT RESPULES (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 PULMICORT RESPULES* (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 PULMICORT RESPULES
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dyspnoea2251
2Drug ineffective1470
3Asthma1310
4Cough1082
5Nausea1019
6Headache*943
7Off label use922
8Diarrhoea908
9Malaise905
10Fatigue902
11Drug dose omission769
12Dizziness766
13Pneumonia745
14Vomiting724
15Pain722
16Pyrexia677
17Crohn's disease604
18Abdominal pain588
19Asthenia567
20Weight decreased515

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

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

Reason # of FDA Reports
1Product used for unknown indication9754
2Asthma*9528
3Crohn's disease*5589
4Chronic obstructive pulmonary disease2928
5Colitis ulcerative836
6Hypersensitivity*833
7Multiple allergies718
8Dyspnoea561
9Sinusitis*481
10Bronchitis473

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


Types of Adverse Events for PULMICORT RESPULES

Total Reports Filed with FDA: 94087


Number of FDA Adverse Event Reports by Patient Age for PULMICORT RESPULES

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.

Click to go back to search results and PULMICORT RESPULES Reviews and Review Summary .

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.

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