FDA Adverse Events Reports (FAERS) Summary for AGRYLIN

These tables and charts are based on 761 total reports for AGRYLIN (ANAGRELIDE HYDROCHLORIDE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 750 pharmaceutical company-submitted and non-U.S. FAERS reports and 11 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 11 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch AGRYLIN summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

Top 20 Adverse Effects Associated with AGRYLIN (reported in FAERS Database)

	Side Effect	# of FDA Reports
1	STROKE	50
2	ANEMIA	46
3	PLATELET COUNT INCREASED	44
4	OFF LABEL USE	38
5	HEADACHE	36
6	LACK OF STRENGTH AND ENERGY (ASTHENIA)	29
7	DIARRHEA	28
8	HAEMOGLOBIN DECREASED	28
9	DIZZINESS	27
10	PALPITATIONS	27
11	FATIGUE	25
12	NAUSEA	25
13	SWELLING OF LIMBS	24
14	CEREBRAL HAEMORRHAGE	23
15	KIDNEY IMPAIRMENT	23
16	PLATELET COUNT DECREASED	22
17	SHORTNESS OF BREATH	21
18	CONGESTIVE HEART FAILURE	20
19	DRUG INEFFECTIVE	20
20	DIFFICULTY SWALLOWING	19
21	FEVER	19
22	STROKE	18
23	HOSPITALIZATION	18
24	MYELOFIBROSIS	18
25	DEATH	17
26	FALL	16
27	ATRIAL FIBRILLATION	15
28	CHEST PAIN	15
29	NOSEBLEED	15
30	VOMITING	15
31	WHITE BLOOD CELL COUNT INCREASED	15
32	HEART ATTACK (MYOCARDIAL INFARCTION)	14
33	BRUISE	13
34	INSOMNIA	13
35	HEART FAILURE	12
36	HIGH BLOOD PRESSURE	12
37	PNEUMONIA	12
38	RASH	12
39	KIDNEY FAILURE	12
40	DRUG INTOLERANCE	11
41	PAIN IN EXTREMITY	11
42	PRODUCT AVAILABILITY ISSUE	11
43	STROKE	11
44	BLOOD COUNT ABNORMAL	10
45	ESSENTIAL THROMBOCYTHAEMIA	10
46	HAEMATOCRIT DECREASED	10
47	MALAISE	10
48	PAIN	10
49	SEPSIS	10
50	BLOOD CREATININE INCREASED	9
51	DEPRESSION	9
52	FEELING ABNORMAL	9
53	BLEEDING	9
54	PRODUCT USE ISSUE	9
55	THROMBOCYTOPENIA	9
56	WEIGHT DECREASED	9
57	WHITE BLOOD CELL COUNT DECREASED	9
58	ABDOMINAL DISCOMFORT	8
59	ANXIETY	8
60	BLOOD UREA INCREASED	8
61	CARDIAC ARREST	8
62	FLATULENCE	8
63	HEART RATE INCREASED	8
64	NUMBNESS	8
65	LOW BLOOD PRESSURE	8
66	PRODUCT DOSE OMISSION ISSUE	8
67	SKIN ULCER	8
68	SPLEEN ENLARGED	8
69	ABDOMINAL PAIN	7
70	HEART ATTACK	7
71	CHRONIC MYELOID LEUKAEMIA	7
72	INDIGESTION	7
73	LIVER FUNCTION ABNORMAL	7
74	PLEURAL EFFUSION	7
75	PULMONARY EMBOLISM	7
76	RED BLOOD CELL COUNT DECREASED	7
77	ABDOMINAL PAIN UPPER	6
78	BLOOD POTASSIUM INCREASED	6
79	BONE PAIN	6
80	CARDIOMYOPATHY	6
81	CELLULITIS	6
82	DEHYDRATION	6
83	GASTROINTESTINAL BLEEDING	6
84	GENERAL PHYSICAL HEALTH DETERIORATION	6
85	BRUISING	6
86	INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION	6
87	INTERNATIONAL NORMALISED RATIO INCREASED	6
88	INTERSTITIAL LUNG DISEASE	6
89	NO ADVERSE EVENT	6
90	LOWER LIMBS SWELLING	6
91	PNEUMONIA ASPIRATION	6
92	PRINZMETAL ANGINA	6
93	PRODUCT DOSE OMISSION	6
94	PULMONARY HYPERTENSION	6
95	RENAL FAILURE ACUTE	6
96	SUBARACHNOID HAEMORRHAGE	6
97	FACIAL SWELLING	6
98	THROMBOCYTOSIS	6
99	MISCARRIAGE	5
100	ACUTE CORONARY SYNDROME	5

Latest Known Outcomes for Reactions Reported for AGRYLIN

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	329
2	Patient recovered	175
3	Patient has not recovered/symtoms have not resolved	101
4	Patient is recovering/symptoms resolving	79
5	Patient died	63
6	Patient has recovered but has consequent health issues	11

Search all MedWatch and FAERS by keyword:

AGRYLIN Total Reports

Male	Female	Unknown	Total
241	364	156	761

Top Countries Reporting

	Country	Number of Reports
1	Japan	350
2	United States	185
3	Australia	7
4	Brazil	6
5	South Korea	6
6	Canada	4
7	Taiwan	3
8	Venezuela	3
9	Greece	2
10	United Kingdom	1

Outcomes for Reports

Serious: 637
Not Serious: 124
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Top Indications

Essential thrombocythaemia
Polycythaemia vera

Top Companies Reporting

TAKEDA

Safety-Related FDA Updates

FDA Approval Date: 1997-03-14

AGRYLIN (ANAGRELIDE HYDROCHLORIDE) Rx Drug:
Safety-related Labeling Changes

Have experience (good or bad) with AGRYLIN? Rate AGRYLIN at Ask a Patient.

AGRYLIN (ANAGRELIDE HYDROCHLORIDE) Rx Drug:
Safety-related Labeling Changes

Have experience (good or bad) with AGRYLIN? Rate AGRYLIN at Ask a Patient.

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

Notes

This report, created by AskaPatient.com, is derived from the cases for AGRYLIN reported to the United States Food and Drug Administration (FDA) FDA Safety Information and Adverse Event Reporting System (FAERS) and obtained from Open FDA. Data was last updated with reports received through April 28, 2026.

This summary includes ALL reports where the drug is a "primary OR secondary OR suspected interacting" drug. Typically, reports are filed for the most serious type or "event" and do not represent incidental or minor side effects. The majority of these reports are mandatory reports submitted by pharmaceutical companies, who receive complaints from consumers. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event. This report also features counts of latest known outcomes associated with reported side effects, but does not provide the specific outcomes for specific adverse events.

Adverse Event Reports are submitted to the FAERS database by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers). Health care providers such as doctors (voluntary reporting), and patients themselves (voluntary reporting) report to the FDA directly through the MedWatch program. Those MedWatch reports are coded and included in the FAERS database. This report mainly consists of the mandatory reports, because the MedWatch reports are a small percentage (3 - 5%) of total reports. Link to the MedWatch summary report at the top of the page for a summary of the directly reported (voluntary) adverse events for this drug.The number of reports included here might differ somewhat from the number of reports in the downloadable quarterly FAERS reports and in the online FAERS dashboard, due to lags in reporting, drug name differences, duplicates, and other factors. Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions or comments about this report.