OpenPV Signal Explorer
FAERS disproportionality dashboard
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Drug

Danazol

164 flagged reaction(s) · 6,020 total co-reports · max PRR 164.5
Important: Reactions below are the flagged terms from this drug’s FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate disproportionality in spontaneous reporting, not causation. Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
Reaction Co-reports (a) PRR ROR Signal
1 Hereditary Angioedema 226 164.5 178.8 signal
2 Swollen Tongue 228 54.9 59.7 signal
3 Angioedema 248 42.2 46.3 signal
4 Dysphonia 233 29.9 32.6 signal
5 Drug Ineffective For Unapproved Indication 204 27.5 29.5 signal
6 Swelling Face 233 26.9 29.2 signal
7 Splenomegaly 38 24.3 24.7 signal
8 Myelodysplastic Syndrome 40 20.7 21.0 signal
9 Platelet Count Increased 34 19.5 19.7 signal
10 Drug Intolerance 236 18.4 20.0 signal
11 Petechiae 21 15.1 15.2 signal
12 Gingival Bleeding 27 14.8 14.9 signal
13 Platelet Count Decreased 193 13.6 14.5 signal
14 Therapeutic Product Effect Decreased 76 12.8 13.2 signal
15 Blood Lactate Dehydrogenase Increased 27 12.7 12.8 signal
16 Hepatic Enzyme Increased 110 12.1 12.6 signal
17 Incorrect Route Of Product Administration 27 12.0 12.1 signal
18 Infusion Related Reaction 98 11.1 11.5 signal
19 Body Height Decreased 16 11.1 11.1 signal
20 Haemoglobin Decreased 147 10.7 11.2 signal
21 Hepatomegaly 14 10.6 10.7 signal
22 Rhabdomyolysis 58 10.4 10.6 signal
23 Hypersensitivity 247 10.0 10.8 signal
24 Acute Myeloid Leukaemia 20 9.6 9.7 signal
25 Nephropathy Toxic 12 8.1 8.1 signal
26 Thrombocytopenia 120 8.1 8.4 signal
27 Bone Marrow Failure 22 8.0 8.1 signal
28 Transfusion 11 7.8 7.9 signal
29 Acute Myocardial Infarction 30 7.6 7.7 signal
30 Migraine 94 7.4 7.6 signal
31 Blood Count Abnormal 15 7.3 7.3 signal
32 Posterior Reversible Encephalopathy Syndrome 9 7.1 7.1 signal
33 Hypercalcaemia 11 6.7 6.7 signal
34 Therapy Non-responder 39 6.5 6.6 signal
35 Multiple Organ Dysfunction Syndrome 24 6.4 6.5 signal
36 Product Availability Issue 19 6.3 6.4 signal
37 Full Blood Count Decreased 17 6.3 6.3 signal
38 Insurance Issue 12 6.0 6.1 signal
39 White Blood Cell Count Increased 31 6.0 6.1 signal
40 Dermatitis Allergic 10 6.0 6.0 signal
41 Chromaturia 18 6.0 6.0 signal
42 Therapeutic Response Decreased 46 5.7 5.8 signal
43 Neutropenia 103 5.7 5.9 signal
44 Increased Tendency To Bruise 7 5.7 5.7 signal
45 Limb Injury 20 5.5 5.6 signal
46 Pharyngeal Swelling 7 5.5 5.5 signal
47 Cardiomegaly 9 5.4 5.4 signal
48 Leukocytosis 13 5.4 5.4 signal
49 Decreased Immune Responsiveness 7 5.4 5.4 signal
50 Mass 10 5.3 5.4 signal
51 Contusion 68 5.3 5.4 signal
52 Infusion Site Pain 9 5.3 5.3 signal
53 Haematocrit Decreased 14 5.2 5.3 signal
54 Red Blood Cell Count Decreased 20 5.2 5.3 signal
55 Quality Of Life Decreased 9 5.0 5.0 signal
56 Cytopenia 8 5.0 5.0 signal
57 Cytomegalovirus Infection 11 4.9 5.0 signal
58 Decreased Activity 7 4.9 4.9 signal
59 Renal Failure Acute 28 4.9 4.9 signal
60 Skin Laceration 7 4.8 4.9 signal
61 Gastritis 17 4.8 4.9 signal
62 Grand Mal Convulsion 6 4.8 4.8 signal
63 Product Use In Unapproved Indication 156 4.8 5.0 signal
64 Epistaxis 46 4.6 4.7 signal
65 Joint Injury 13 4.5 4.6 signal
66 Blood Pressure Abnormal 12 4.5 4.5 signal
67 Bladder Disorder 6 4.5 4.5 signal
68 Vasculitis 7 4.5 4.5 signal
69 Constipation 129 4.5 4.6 signal
70 Liver Disorder 26 4.4 4.4 signal
71 Pallor 16 4.4 4.4 signal
72 Ear Discomfort 6 4.4 4.4 signal
73 Device Related Infection 9 4.4 4.4 signal
74 Hyperbilirubinaemia 6 4.4 4.4 signal
75 Anaemia 110 4.3 4.4 signal
76 Lymphopenia 8 4.3 4.3 signal
77 Jaundice 15 4.2 4.2 signal
78 Blood Bilirubin Increased 15 4.1 4.2 signal
79 Headache 340 4.1 4.5 signal
80 Hepatotoxicity 12 4.0 4.1 signal
81 Haematoma 14 4.0 4.0 signal
82 Eye Infection 6 4.0 4.0 signal
83 Haemorrhage Intracranial 8 4.0 4.0 signal
84 Therapy Partial Responder 8 4.0 4.0 signal
85 Nephrolithiasis 24 3.9 4.0 signal
86 Therapy Change 5 3.9 3.9 signal
87 Uveitis 7 3.9 3.9 signal
88 Eating Disorder 11 3.8 3.9 signal
89 Post Procedural Haemorrhage 6 3.8 3.9 signal
90 Liver Function Test Abnormal 15 3.8 3.8 signal
91 Off Label Use 442 3.8 4.3 signal
92 Covid-19 Pneumonia 6 3.8 3.8 signal
93 Gout 9 3.7 3.8 signal
94 Skin Reaction 7 3.7 3.7 signal
95 Ovarian Cyst 5 3.7 3.7 signal
96 Blood Potassium Increased 8 3.7 3.7 signal
97 Dry Throat 5 3.7 3.7 signal
98 No Therapeutic Response 6 3.6 3.6 signal
99 Intentional Product Use Issue 41 3.5 3.5 signal
100 Musculoskeletal Discomfort 8 3.5 3.5 signal
101 Disease Recurrence 22 3.4 3.5 signal
102 Hyperkalaemia 16 3.4 3.4 signal
103 Pulmonary Thrombosis 5 3.4 3.4 signal
104 Cholelithiasis 15 3.4 3.4 signal
105 Depressed Mood 24 3.4 3.4 signal
106 Expired Product Administered 15 3.4 3.4 signal
107 Pregnancy 9 3.3 3.3 signal
108 Head Injury 14 3.3 3.3 signal
109 Haemorrhage 46 3.3 3.3 signal
110 White Blood Cell Count Decreased 47 3.2 3.3 signal
111 Stress 31 3.2 3.2 signal
112 Appendicitis 4 3.2 3.2 signal
113 Neoplasm Progression 15 3.2 3.2 signal
114 Influenza 47 3.1 3.2 signal
115 Blood Urine Present 8 3.1 3.1 signal
116 Myoclonus 5 3.1 3.1 signal
117 Autoimmune Disorder 4 3.1 3.1 no signal
118 Gastrointestinal Haemorrhage 35 3.1 3.1 signal
119 Pancreatitis 22 3.1 3.1 signal
120 Pancytopenia 23 3.1 3.1 signal
121 Bone Pain 24 3.1 3.1 signal
122 Hospice Care 4 3.0 3.0 no signal
123 Poor Venous Access 4 2.9 2.9 no signal
124 Toothache 7 2.9 2.9 signal
125 Full Blood Count Abnormal 4 2.8 2.8 no signal
126 Tooth Infection 5 2.8 2.8 signal
127 Proteinuria 7 2.8 2.8 signal
128 Neutrophil Count Decreased 15 2.8 2.8 signal
129 Fear 10 2.8 2.8 signal
130 Hernia 7 2.7 2.7 signal
131 International Normalised Ratio Increased 10 2.6 2.6 signal
132 Gastric Haemorrhage 4 2.6 2.6 no signal
133 Accident 4 2.5 2.5 no signal
134 Crying 12 2.5 2.5 signal
135 Skin Cancer 7 2.4 2.4 signal
136 Lymphoma 5 2.4 2.4 no signal
137 Erythema Multiforme 3 2.4 2.4 no signal
138 Pharyngeal Oedema 5 2.4 2.4 no signal
139 Leukaemia 3 2.4 2.4 no signal
140 Pneumocystis Jirovecii Pneumonia 3 2.2 2.2 no signal
141 Eye Haemorrhage 4 2.2 2.2 no signal
142 Product Prescribing Error 7 2.2 2.2 no signal
143 Helicobacter Infection 3 2.2 2.2 no signal
144 Acute Hepatic Failure 4 2.2 2.2 no signal
145 Inappropriate Schedule Of Drug Administration 21 2.2 2.2 signal
146 Myocarditis 3 2.0 2.0 no signal
147 Internal Haemorrhage 3 2.0 2.0 no signal
148 Menorrhagia 5 1.9 1.9 no signal
149 Amenorrhoea 4 1.8 1.8 no signal
150 Vaginal Haemorrhage 10 1.8 1.8 no signal
151 Tuberculosis 3 1.7 1.7 no signal
152 Hepatocellular Injury 3 1.6 1.6 no signal
153 Drug Dispensing Error 3 1.4 1.4 no signal
154 Drug Administration Error 6 1.4 1.4 no signal
155 Myelosuppression 6 1.3 1.3 no signal
156 No Adverse Event 30 1.3 1.3 no signal
157 Acne 12 1.2 1.2 no signal
158 Completed Suicide 13 1.2 1.2 no signal
159 Abortion Spontaneous 6 1.1 1.1 no signal
160 Needle Issue 4 1.0 1.0 no signal
161 Drug Effective For Unapproved Indication 4 1.0 1.0 no signal
162 Injection Site Swelling 9 0.9 0.9 no signal
163 Drug Exposure During Pregnancy 4 0.9 0.9 no signal
164 Injection Site Bruising 9 0.9 0.9 no signal