Drug Safety Information for PRECOSE (Acarbose)

Adverse Drug Reactions for PRECOSE* (Acarbose)

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 PRECOSE
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Hypoglycaemia	228
2	Blood glucose increased	176
3	Renal failure acute	147
4	Nausea	135
5	Vomiting	126
6	Pyrexia	115
7	Diarrhoea	106
8	Weight decreased	104
9	Dizziness	99
10	Dyspnoea	98
11	Fall	89
12	Drug interaction	89
13	Decreased appetite	88
14	Diabetes mellitus inadequate control	85
15	Renal failure	82
16	Asthenia	81
17	Anaemia	80
18	Oedema peripheral	79
19	Malaise	75
20	Drug ineffective	70

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

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

	Reason	# of FDA Reports
1	Diabetes mellitus	2273
2	Type 2 diabetes mellitus	1199
3	Product used for unknown indication	675
4	Obesity	57
5	Hyperglycaemia	54
6	Ill-defined disorder	48
7	Hypoglycaemia	38
8	Unevaluable event	29
9	Blood glucose abnormal	22
10	Blood glucose increased	19

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

Types of Adverse Events for PRECOSE

Total Reports Filed with FDA: 12347

Number of FDA Adverse Event Reports by Patient Age for PRECOSE

Total Reports Filed with FDA: 12347*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Acarbose (Glucor, Glucobay, Prandase, Glumida, Precose, Acarbose)

Charts are based on 12347 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.