Drug Safety Information for BUMEX (Bumetanide)

Adverse Drug Reactions for BUMEX* (Bumetanide)

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 BUMEX
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Dyspnoea	624
2	Renal failure acute	462
3	Renal failure	457
4	Cardiac failure congestive	400
5	Nausea	371
6	Pain	349
7	Asthenia	334
8	Diarrhoea	327
9	Death	321
10	Oedema peripheral	308
11	Pneumonia	291
12	Hypotension	280
13	Fall	274
14	Anaemia	273
15	Vomiting	272
16	Dizziness	269
17	Fatigue	258
18	Anxiety	237
19	Atrial fibrillation	215
20	Drug interaction	214

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

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

	Reason	# of FDA Reports
1	Product used for unknown indication	3572
2	Hypertension	794
3	Oedema	648
4	Diuretic therapy	622
5	Cardiac failure	613
6	Fluid retention*	489
7	Cardiac failure congestive	467
8	Polyuria	240
9	Oedema peripheral	182
10	Ill-defined disorder	140

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

Types of Adverse Events for BUMEX

Total Reports Filed with FDA: 37755

Number of FDA Adverse Event Reports by Patient Age for BUMEX

Total Reports Filed with FDA: 37755*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Bumetanide (Bumetadine, Burinex, Miccil, Bumetanide, Bumex)

Charts are based on 37755 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.

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.