OpenPV Signal Explorer
FAERS disproportionality dashboard
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Drug

Prasterone

117 flagged reaction(s) · 2,818 total co-reports · max PRR 66.2
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 Vaginal Discharge 84 66.2 68.3 signal
2 Poor Quality Product Administered 45 34.7 35.3 signal
3 Product Packaging Issue 29 24.6 24.9 signal
4 Product Administration Error 57 22.5 22.9 signal
5 Product Physical Issue 51 20.1 20.5 signal
6 Head Discomfort 29 12.9 13.1 signal
7 Photosensitivity Reaction 27 12.9 13.0 signal
8 Micturition Urgency 17 11.8 11.9 signal
9 Therapeutic Response Unexpected 60 10.5 10.7 signal
10 Arteriosclerosis 11 9.2 9.2 signal
11 Insurance Issue 17 9.0 9.0 signal
12 Vaginal Haemorrhage 48 8.9 9.0 signal
13 Seasonal Allergy 15 8.3 8.4 signal
14 Dermatitis Contact 12 8.3 8.3 signal
15 Infusion Site Pain 12 7.4 7.4 signal
16 Off Label Use 793 7.2 9.8 signal
17 Product Use Complaint 14 7.1 7.1 signal
18 Contraindicated Product Administered 27 7.0 7.1 signal
19 Brain Fog 13 7.0 7.0 signal
20 Tinnitus 41 7.0 7.1 signal
21 Poor Venous Access 8 6.1 6.1 signal
22 Restless Legs Syndrome 14 6.0 6.1 signal
23 Breast Pain 8 5.9 5.9 signal
24 Nocturia 9 5.8 5.9 signal
25 Hot Flush 54 5.6 5.7 signal
26 Pelvic Pain 13 5.6 5.6 signal
27 Night Sweats 22 5.4 5.4 signal
28 Lower Limb Fracture 13 5.3 5.4 signal
29 Sleep Apnoea Syndrome 13 5.3 5.4 signal
30 Deafness 17 5.1 5.1 signal
31 Tendon Rupture 8 5.1 5.1 signal
32 Underdose 47 5.1 5.1 signal
33 Fungal Infection 21 5.0 5.0 signal
34 Pharyngeal Swelling 6 4.9 4.9 signal
35 Cellulitis 30 4.7 4.7 signal
36 Feeling Hot 36 4.6 4.7 signal
37 Sinus Disorder 11 4.4 4.4 signal
38 Back Injury 6 4.4 4.4 signal
39 Application Site Pain 12 4.3 4.3 signal
40 Increased Tendency To Bruise 5 4.3 4.3 signal
41 Pollakiuria 22 4.1 4.2 signal
42 Ear Infection 14 4.1 4.2 signal
43 Feeling Jittery 10 4.1 4.1 signal
44 Drug Ineffective For Unapproved Indication 29 4.1 4.1 signal
45 Sinusitis 53 4.0 4.1 signal
46 Ligament Sprain 5 4.0 4.0 signal
47 Macular Degeneration 6 4.0 4.0 signal
48 Swelling Face 32 3.9 3.9 signal
49 Initial Insomnia 5 3.9 3.9 signal
50 Ear Discomfort 5 3.8 3.8 signal
51 Femur Fracture 15 3.8 3.8 signal
52 Ocular Discomfort 5 3.6 3.6 signal
53 Tooth Infection 6 3.6 3.6 signal
54 Heart Rate Increased 45 3.6 3.6 signal
55 Thyroid Disorder 7 3.6 3.6 signal
56 Illness 45 3.5 3.6 signal
57 Limb Injury 12 3.5 3.5 signal
58 Chromaturia 10 3.5 3.5 signal
59 Product Dose Omission Issue 125 3.4 3.6 signal
60 Discomfort 26 3.4 3.4 signal
61 Personality Change 4 3.4 3.4 signal
62 Carpal Tunnel Syndrome 6 3.4 3.4 signal
63 Spinal Operation 5 3.2 3.2 signal
64 Alopecia 81 3.2 3.3 signal
65 Mood Swings 13 3.2 3.2 signal
66 Inability To Afford Medication 4 3.2 3.2 signal
67 Disability 8 3.2 3.2 signal
68 Libido Decreased 5 3.2 3.2 signal
69 Intentional Dose Omission 11 3.2 3.2 signal
70 Dermatitis Allergic 5 3.1 3.2 signal
71 Injection Site Irritation 5 3.1 3.1 signal
72 Rotator Cuff Syndrome 5 3.0 3.0 signal
73 Burning Sensation 27 3.0 3.0 signal
74 Ankylosing Spondylitis 5 3.0 3.0 signal
75 Hypoacusis 16 2.9 2.9 signal
76 Fracture 7 2.9 2.9 signal
77 Pharyngitis Streptococcal 4 2.9 2.9 no signal
78 Inappropriate Schedule Of Product Administration 64 2.8 2.9 signal
79 Product Dose Omission 23 2.7 2.7 signal
80 Anger 11 2.5 2.5 signal
81 Application Site Irritation 4 2.5 2.5 no signal
82 Suicidal Ideation 29 2.5 2.5 signal
83 Drug Reaction With Eosinophilia And Systemic Symptoms 8 2.5 2.5 signal
84 Affect Lability 3 2.4 2.4 no signal
85 Drug Effective For Unapproved Indication 9 2.4 2.4 signal
86 Malignant Melanoma 4 2.3 2.3 no signal
87 Hunger 4 2.3 2.3 no signal
88 Eye Irritation 16 2.3 2.3 signal
89 Hereditary Angioedema 3 2.2 2.2 no signal
90 Product Packaging Quantity Issue 3 2.2 2.2 no signal
91 Product Availability Issue 6 2.1 2.1 no signal
92 Abnormal Weight Gain 3 1.9 1.9 no signal
93 Circumstance Or Information Capable Of Leading To Medication Error 8 1.9 1.9 no signal
94 Dysmenorrhoea 3 1.8 1.8 no signal
95 Acne 17 1.8 1.8 no signal
96 Hair Texture Abnormal 3 1.7 1.7 no signal
97 Therapeutic Response Shortened 7 1.7 1.7 no signal
98 Wrong Technique In Product Usage Process 43 1.7 1.7 no signal
99 Psoriatic Arthropathy 8 1.6 1.6 no signal
100 Premature Delivery 3 1.5 1.5 no signal
101 Exposure Via Skin Contact 4 1.4 1.4 no signal
102 Application Site Pruritus 4 1.4 1.4 no signal
103 Product Administered At Inappropriate Site 3 1.3 1.3 no signal
104 Injection Site Mass 6 1.3 1.3 no signal
105 Injection Site Pruritus 10 1.2 1.2 no signal
106 Injection Site Warmth 3 1.1 1.1 no signal
107 Device Leakage 6 1.1 1.1 no signal
108 Needle Issue 4 1.1 1.1 no signal
109 Injection Site Erythema 15 1.0 1.0 no signal
110 Product Complaint 3 0.9 0.9 no signal
111 Drug Abuse 9 0.8 0.8 no signal
112 Tardive Dyskinesia 3 0.8 0.8 no signal
113 Breast Cancer 9 0.8 0.8 no signal
114 Wrong Technique In Device Usage Process 4 0.7 0.7 no signal
115 Device Breakage 3 0.6 0.6 no signal
116 Device Difficult To Use 4 0.5 0.5 no signal
117 Drug Dose Omission By Device 3 0.3 0.3 no signal