Drug Safety Information for DANAZOL (Danazol)

Adverse Drug Reactions for DANAZOL* (Danazol)

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 DANAZOL
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Drug ineffective	78
2	Death	65
3	Anaemia	52
4	Thrombocytopenia	52
5	Asthenia	48
6	Hereditary angioedema	48
7	Fatigue	46
8	Platelet count decreased	46
9	Haemoglobin decreased	45
10	Drug interaction	43
11	Rhabdomyolysis	42
12	Renal failure acute	40
13	Therapeutic response decreased	40
14	Nausea*	38
15	Dyspnoea	36
16	Vomiting	34
17	Pneumonia	29
18	Pyrexia	29
19	Headache	29
20	Alanine aminotransferase increased	28

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

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

	Reason	# of FDA Reports
1	Idiopathic thrombocytopenic purpura	472
2	Product used for unknown indication	361
3	Hereditary angioedema*	241
4	Thrombocytopenia	140
5	Endometriosis*	104
6	Paroxysmal nocturnal haemoglobinuria	82
7	Aplastic anaemia	66
8	Anaemia	65
9	Angioedema	48
10	Autoimmune thrombocytopenia	34

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

Types of Adverse Events for DANAZOL

Total Reports Filed with FDA: 4270

Number of FDA Adverse Event Reports by Patient Age for DANAZOL

Total Reports Filed with FDA: 4270*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Danazol (Azol, Danol, Ladogal, Danatrol, Cyclomen, Danazol, Danocrine)

Charts are based on 4270 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.