Drug Safety Information for DOBUTAMINE Hydrochloride IN DEXTROSE 5% IN PLASTIC CONTAINER (Dobutamine hydrochloride)

Safety-related Labeling Changes for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER (DOBUTAMINE HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER (DOBUTAMINE HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for DOBUTAMINE Hydrochloride IN DEXTROSE 5% IN PLASTIC CONTAINER* (Dobutamine hydrochloride)

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 DOBUTAMINE Hydrochloride IN DEXTROSE 5% IN PLASTIC CONTAINER
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Death489
2Renal failure426
3Pain363
4Injury347
5Anxiety333
6Unevaluable event320
7Multi-organ failure294
8Fear281
9Emotional distress272
10Renal injury250
11Renal impairment232
12Anhedonia217
13Stress217
14Hypotension193
15Renal failure acute136
16Cardiac failure134
17Ventricular tachycardia125
18Cardiogenic shock117
19Atrial fibrillation114
20Cardiac failure congestive112

* This side effect also appears in "Top 10 Side Effects of DOBUTAMINE Hydrochloride IN DEXTROSE 5% IN PLASTIC CONTAINER " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking DOBUTAMINE Hydrochloride IN DEXTROSE 5% IN PLASTIC CONTAINER
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication1645
2Stress echocardiogram395
3Cardiac failure298
4Cardiac stress test296
5Hypotension*169
6Cardiac pharmacologic stress test158
7Cardiac failure congestive122
8Cardiogenic shock99
9Off label use97
10Shock84

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


Types of Adverse Events for DOBUTAMINE Hydrochloride IN DEXTROSE 5% IN PLASTIC CONTAINER

Total Reports Filed with FDA: 16140


Number of FDA Adverse Event Reports by Patient Age for DOBUTAMINE Hydrochloride IN DEXTROSE 5% IN PLASTIC CONTAINER

Total Reports Filed with FDA: 16140*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Dobutamine hydrochloride (Dobutrex, Dobutamine, Dobutamina, Dobuject)

Charts are based on 16140 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.