Drug Safety Information for AGRYLIN (Anagrelide hydrochloride)

FDA Safety-related Labeling Changes for AGRYLIN (ANAGRELIDE HYDROCHLORIDE) Rx Drug: Safety Information Link

Adverse Drug Reactions for AGRYLIN* (Anagrelide 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 AGRYLIN
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Platelet count increased	53
2	Dyspnoea	53
3	Anaemia	49
4	Haemoglobin decreased	48
5	Diarrhoea*	38
6	Fatigue	37
7	Headache*	36
8	Oedema peripheral	32
9	Palpitations*	32
10	Myelofibrosis	31
11	Drug ineffective	30
12	Nausea	30
13	Asthenia	29
14	Acute myeloid leukaemia	29
15	Dizziness	29
16	Hypotension	27
17	Death	27
18	Myocardial infarction*	25
19	Cardiac failure congestive	25
20	Vomiting*	24

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

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

	Reason	# of FDA Reports
1	Essential thrombocythaemia*	1043
2	Thrombocytosis	325
3	Thrombocytopenia	217
4	Product used for unknown indication	182
5	Platelet count increased	175
6	Polycythaemia vera	74
7	Myeloproliferative disorder	56
8	Platelet disorder	30
9	Polycythaemia	23
10	Type 2 diabetes mellitus	16

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

Types of Adverse Events for AGRYLIN

Total Reports Filed with FDA: 3755

Number of FDA Adverse Event Reports by Patient Age for AGRYLIN

Total Reports Filed with FDA: 3755*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Anagrelide hydrochloride (Agrylin, Agrelin, Anagrelide)

Charts are based on 3755 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.