OpenPV Signal Explorer
FAERS disproportionality dashboard
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Drug

Norethindrone Acetate And Ethinyl Estradiol, Ethinyl Estradiol And Ferrous Fumarate

118 flagged reaction(s) · 2,679 total co-reports · max PRR 88.1
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 Amenorrhoea 220 88.1 94.6 signal
2 Metrorrhagia 156 60.1 63.1 signal
3 Menstruation Irregular 108 27.0 27.9 signal
4 Menorrhagia 80 26.6 27.3 signal
5 Dysmenorrhoea 46 23.3 23.6 signal
6 Menstruation Delayed 29 18.5 18.6 signal
7 Coeliac Disease 23 15.5 15.6 signal
8 Pregnancy 27 8.8 8.9 signal
9 Ovarian Cyst 13 8.5 8.6 signal
10 Vaginal Haemorrhage 55 8.5 8.7 signal
11 Product Dose Omission 77 7.7 7.8 signal
12 Libido Decreased 14 7.5 7.5 signal
13 Pelvic Pain 20 7.3 7.3 signal
14 Genital Haemorrhage 14 7.1 7.2 signal
15 Mood Swings 32 6.6 6.7 signal
16 Vaginal Discharge 10 6.6 6.6 signal
17 Breast Pain 10 6.2 6.2 signal
18 Embedded Device 9 6.0 6.1 signal
19 Therapeutic Response Unexpected 40 5.9 5.9 signal
20 Mood Altered 22 5.3 5.4 signal
21 Intentional Dose Omission 20 4.8 4.9 signal
22 Complication Of Device Removal 12 4.7 4.7 signal
23 Panic Attack 25 4.5 4.6 signal
24 Migraine 62 4.3 4.4 signal
25 Complication Of Device Insertion 12 4.3 4.3 signal
26 Product Packaging Quantity Issue 7 4.2 4.2 signal
27 Autoimmune Disorder 6 4.1 4.1 signal
28 Acne 45 3.9 3.9 signal
29 Initial Insomnia 6 3.9 3.9 signal
30 Inappropriate Schedule Of Product Administration 104 3.9 4.0 signal
31 Impaired Quality Of Life 8 3.7 3.7 signal
32 Impaired Gastric Emptying 7 3.6 3.6 signal
33 Infusion Site Pain 7 3.6 3.6 signal
34 Blood Thyroid Stimulating Hormone Increased 5 3.6 3.6 signal
35 Dermatitis Contact 6 3.5 3.5 signal
36 Cholecystectomy 6 3.5 3.5 signal
37 Depression 120 3.5 3.6 signal
38 Crying 19 3.4 3.5 signal
39 Product Taste Abnormal 7 3.4 3.4 signal
40 Knee Operation 5 3.4 3.4 signal
41 Anxiety 142 3.3 3.4 signal
42 Ear Discomfort 5 3.2 3.2 signal
43 Expired Product Administered 16 3.2 3.2 signal
44 Brain Fog 7 3.2 3.2 signal
45 Deep Vein Thrombosis 31 3.1 3.2 signal
46 Insurance Issue 7 3.1 3.1 signal
47 Pulmonary Embolism 44 3.0 3.1 signal
48 Surgery 26 3.0 3.0 signal
49 Hunger 6 2.9 2.9 signal
50 Drug Effect Less Than Expected 6 2.8 2.8 signal
51 Suicidal Ideation 39 2.8 2.8 signal
52 Injury 30 2.8 2.8 signal
53 Feeling Jittery 8 2.8 2.8 signal
54 Device Dislocation 18 2.7 2.7 signal
55 Affect Lability 4 2.7 2.7 no signal
56 Apathy 6 2.7 2.7 signal
57 Product Administration Error 8 2.6 2.7 signal
58 Abdominal Pain Lower 10 2.6 2.6 signal
59 Sluggishness 4 2.6 2.6 no signal
60 Poor Quality Product Administered 4 2.6 2.6 no signal
61 Euphoric Mood 4 2.6 2.6 no signal
62 Inappropriate Schedule Of Drug Administration 28 2.6 2.6 signal
63 Product Substitution Issue 22 2.5 2.5 signal
64 Product Prescribing Error 9 2.5 2.5 signal
65 Product Dose Omission Issue 106 2.5 2.5 signal
66 Unevaluable Event 28 2.4 2.5 signal
67 Irritability 22 2.4 2.4 signal
68 Product Storage Error 31 2.4 2.4 signal
69 Drug Dose Omission 60 2.4 2.4 signal
70 Paranoia 6 2.3 2.3 no signal
71 Impaired Work Ability 7 2.2 2.2 no signal
72 Procedural Pain 9 2.1 2.2 signal
73 Product Packaging Issue 3 2.1 2.1 no signal
74 Eczema 16 2.1 2.1 signal
75 Drug Prescribing Error 6 2.0 2.0 no signal
76 Device Breakage 12 2.0 2.0 signal
77 Product Physical Issue 6 2.0 2.0 no signal
78 Incorrect Product Storage 4 2.0 2.0 no signal
79 Product Dose Omission In Error 8 2.0 2.0 no signal
80 Intentional Self-injury 6 2.0 2.0 no signal
81 Incorrect Product Administration Duration 6 2.0 2.0 no signal
82 Unintended Pregnancy 3 1.9 1.9 no signal
83 Abortion Spontaneous 11 1.8 1.8 no signal
84 Circumstance Or Information Capable Of Leading To Medication Error 9 1.8 1.8 no signal
85 Anger 9 1.7 1.8 no signal
86 Mania 4 1.6 1.6 no signal
87 Dermatitis Atopic 12 1.6 1.6 no signal
88 Injection Site Irritation 3 1.6 1.6 no signal
89 Injection Site Rash 7 1.5 1.5 no signal
90 Ankylosing Spondylitis 3 1.5 1.5 no signal
91 Injection Site Swelling 17 1.5 1.5 no signal
92 Wrong Technique In Product Usage Process 45 1.5 1.5 no signal
93 Hair Texture Abnormal 3 1.5 1.5 no signal
94 Aggression 11 1.4 1.4 no signal
95 Injection Site Reaction 15 1.4 1.4 no signal
96 Device Issue 19 1.4 1.4 no signal
97 Emotional Distress 26 1.4 1.4 no signal
98 Withdrawal Syndrome 9 1.4 1.4 no signal
99 Injection Site Urticaria 5 1.4 1.4 no signal
100 Extra Dose Administered 8 1.3 1.3 no signal
101 Device Failure 3 1.3 1.3 no signal
102 Injection Site Bruising 15 1.3 1.3 no signal
103 Multiple Sclerosis Relapse 13 1.2 1.2 no signal
104 Premature Delivery 3 1.2 1.2 no signal
105 Application Site Pain 4 1.2 1.2 no signal
106 Product Quality Issue 24 1.2 1.2 no signal
107 Skin Irritation 8 1.2 1.2 no signal
108 Injection Site Pruritus 11 1.1 1.1 no signal
109 Product Complaint 4 1.1 1.1 no signal
110 Skin Burning Sensation 11 1.0 1.0 no signal
111 Device Expulsion 9 0.9 0.9 no signal
112 Injection Site Mass 5 0.9 0.9 no signal
113 Application Site Pruritus 3 0.9 0.9 no signal
114 Device Difficult To Use 8 0.8 0.8 no signal
115 Incorrect Dose Administered By Device 3 0.8 0.8 no signal
116 Application Site Erythema 3 0.8 0.8 no signal
117 Injection Site Haemorrhage 9 0.7 0.7 no signal
118 Accidental Exposure To Product 10 0.7 0.7 no signal