OpenPV Signal Explorer
FAERS disproportionality dashboard
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Drug

Norgestimate And Ethinyl Estradiol

213 flagged reaction(s) · 6,134 total co-reports · max PRR 23.0
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 Metrorrhagia 86 23.0 23.4 signal
2 Menstruation Irregular 100 17.4 17.8 signal
3 Dysmenorrhoea 47 16.6 16.8 signal
4 Menorrhagia 68 15.8 16.0 signal
5 Menstruation Delayed 31 13.8 13.9 signal
6 Vaginal Haemorrhage 102 11.0 11.3 signal
7 Coeliac Disease 23 10.8 10.9 signal
8 Ovarian Cyst 21 9.6 9.7 signal
9 Product Substitution Issue 116 9.3 9.5 signal
10 Unintended Pregnancy 21 9.3 9.3 signal
11 Mood Swings 52 7.5 7.6 signal
12 Gallbladder Disorder 29 7.5 7.5 signal
13 Breast Pain 17 7.3 7.4 signal
14 Pelvic Pain 28 7.1 7.1 signal
15 Cholelithiasis 50 7.0 7.1 signal
16 Product Packaging Issue 14 7.0 7.0 signal
17 Cholecystectomy 17 6.9 6.9 signal
18 Dermatitis Atopic 74 6.8 6.9 signal
19 Complication Of Device Insertion 26 6.5 6.5 signal
20 Vaginal Discharge 14 6.4 6.4 signal
21 Amenorrhoea 23 6.3 6.4 signal
22 Initial Insomnia 14 6.3 6.3 signal
23 Affect Lability 13 6.2 6.2 signal
24 Abortion Induced 12 5.9 5.9 signal
25 Cholecystitis 15 5.8 5.8 signal
26 Abdominal Pain Lower 31 5.6 5.7 signal
27 Mood Altered 33 5.6 5.6 signal
28 Panic Attack 41 5.2 5.2 signal
29 Injury 79 5.1 5.2 signal
30 Sleep Disorder Due To A General Medical Condition 18 5.1 5.1 signal
31 Pulmonary Embolism 106 5.1 5.2 signal
32 Product Dose Omission 71 4.9 5.0 signal
33 Impaired Work Ability 21 4.5 4.5 signal
34 Deep Vein Thrombosis 62 4.4 4.4 signal
35 Genital Haemorrhage 12 4.3 4.3 signal
36 Vitamin D Deficiency 9 4.3 4.3 signal
37 Pharmaceutical Product Complaint 24 4.2 4.2 signal
38 Pregnancy 18 4.1 4.1 signal
39 Maternal Exposure During Pregnancy 78 4.1 4.1 signal
40 Mydriasis 11 4.0 4.0 signal
41 Acne 65 3.9 4.0 signal
42 Crying 31 3.9 3.9 signal
43 Intentional Dose Omission 23 3.9 3.9 signal
44 Pharyngitis Streptococcal 9 3.8 3.8 signal
45 Injection Site Urticaria 20 3.8 3.8 signal
46 Bipolar Disorder 9 3.8 3.8 signal
47 Hunger 11 3.8 3.8 signal
48 Hallucination, Auditory 13 3.8 3.8 signal
49 Libido Decreased 10 3.7 3.7 signal
50 Emotional Disorder 25 3.7 3.7 signal
51 Depression 177 3.6 3.7 signal
52 Exposure During Pregnancy 48 3.6 3.6 signal
53 Skin Haemorrhage 11 3.5 3.5 signal
54 Scar 13 3.5 3.5 signal
55 Anxiety 209 3.4 3.5 signal
56 Sleep Apnoea Syndrome 13 3.1 3.1 signal
57 Eczema 34 3.1 3.1 signal
58 Migraine 64 3.1 3.1 signal
59 Thrombosis 54 3.1 3.1 signal
60 Decreased Activity 7 3.0 3.0 signal
61 Procedural Pain 18 3.0 3.0 signal
62 Middle Insomnia 12 3.0 3.0 signal
63 Pulmonary Thrombosis 7 2.9 3.0 signal
64 Eye Infection 7 2.9 2.9 signal
65 Therapy Change 6 2.9 2.9 signal
66 Suicidal Ideation 57 2.9 2.9 signal
67 Dermatitis Contact 7 2.8 2.8 signal
68 Stress 44 2.8 2.8 signal
69 Embedded Device 6 2.8 2.8 signal
70 Product Dose Omission In Error 16 2.7 2.7 signal
71 Eye Swelling 22 2.7 2.7 signal
72 Complication Of Device Removal 10 2.7 2.7 signal
73 Anger 20 2.7 2.7 signal
74 Skin Fissures 11 2.7 2.7 signal
75 Central Nervous System Lesion 8 2.7 2.7 signal
76 Abnormal Dreams 16 2.6 2.7 signal
77 Cold Sweat 10 2.6 2.6 signal
78 Disease Recurrence 27 2.6 2.6 signal
79 Injection Site Discolouration 7 2.6 2.6 signal
80 Product Quality Issue 76 2.6 2.6 signal
81 Cyst 7 2.6 2.6 signal
82 Poor Quality Sleep 12 2.6 2.6 signal
83 Abdominal Distension 58 2.6 2.6 signal
84 Muscle Tightness 9 2.6 2.6 signal
85 Impaired Quality Of Life 8 2.6 2.6 signal
86 Abdominal Pain Upper 114 2.6 2.6 signal
87 Injection Site Swelling 42 2.6 2.6 signal
88 Injection Site Irritation 7 2.5 2.5 signal
89 Device Dislocation 24 2.5 2.6 signal
90 Mental Disorder 24 2.5 2.5 signal
91 Impaired Gastric Emptying 7 2.5 2.5 signal
92 Pruritus Generalised 12 2.5 2.5 signal
93 Abortion Spontaneous 22 2.5 2.5 signal
94 Injection Site Warmth 11 2.5 2.5 signal
95 Drug Dose Omission 89 2.4 2.5 signal
96 Nausea 417 2.4 2.6 signal
97 Discomfort 32 2.4 2.4 signal
98 Impaired Driving Ability 6 2.4 2.4 no signal
99 Inappropriate Schedule Of Drug Administration 38 2.4 2.4 signal
100 Quality Of Life Decreased 7 2.4 2.4 signal
101 Paranoia 9 2.4 2.4 signal
102 Irritable Bowel Syndrome 11 2.4 2.4 signal
103 Irritability 31 2.4 2.4 signal
104 Fungal Infection 17 2.3 2.4 signal
105 Thirst 9 2.3 2.3 signal
106 Sinus Disorder 10 2.3 2.3 signal
107 Product Administration Error 10 2.3 2.3 signal
108 Flushing 51 2.3 2.3 signal
109 Eye Discharge 5 2.3 2.3 no signal
110 Urticaria 81 2.2 2.3 signal
111 Swelling Face 31 2.2 2.2 signal
112 Retching 10 2.2 2.2 signal
113 Surgery 27 2.1 2.2 signal
114 Injection Site Pruritus 31 2.1 2.2 signal
115 Toxic Epidermal Necrolysis 7 2.1 2.1 no signal
116 Multiple Sclerosis Relapse 32 2.1 2.1 signal
117 Palpitations 53 2.1 2.1 signal
118 Drug Dispensing Error 7 2.1 2.1 no signal
119 Headache 282 2.1 2.1 signal
120 Therapy Cessation 23 2.1 2.1 signal
121 Nerve Injury 5 2.1 2.1 no signal
122 Product Taste Abnormal 6 2.1 2.1 no signal
123 Fear 12 2.0 2.0 signal
124 Therapeutic Response Shortened 14 2.0 2.0 signal
125 Muscle Twitching 10 2.0 2.0 no signal
126 Nightmare 15 2.0 2.0 no signal
127 Aphonia 6 2.0 2.0 no signal
128 Injection Site Rash 13 2.0 2.0 no signal
129 Caesarean Section 5 2.0 2.0 no signal
130 Muscle Spasms 78 2.0 2.0 no signal
131 Accident 5 1.9 1.9 no signal
132 Pharyngeal Swelling 4 1.9 1.9 no signal
133 Product Dose Omission Issue 118 1.9 1.9 no signal
134 Oral Herpes 8 1.9 1.9 no signal
135 Dry Skin 54 1.9 1.9 no signal
136 Injection Site Reaction 28 1.9 1.9 no signal
137 Inappropriate Schedule Of Product Administration 72 1.9 1.9 no signal
138 Disturbance In Attention 22 1.9 1.9 no signal
139 Rash Erythematous 19 1.9 1.9 no signal
140 Product Physical Issue 8 1.8 1.8 no signal
141 Device Issue 35 1.8 1.9 no signal
142 Therapeutic Response Unexpected 18 1.8 1.8 no signal
143 Activities Of Daily Living Impaired 8 1.8 1.8 no signal
144 Hot Flush 30 1.8 1.8 no signal
145 Injection Site Erythema 48 1.8 1.8 no signal
146 Ankylosing Spondylitis 5 1.8 1.8 no signal
147 No Adverse Event 68 1.8 1.8 no signal
148 Injection Site Mass 14 1.7 1.8 no signal
149 Withdrawal Syndrome 16 1.7 1.7 no signal
150 Emotional Distress 46 1.7 1.7 no signal
151 Feeling Abnormal 91 1.7 1.8 no signal
152 Anhedonia 10 1.7 1.7 no signal
153 Adverse Reaction 5 1.7 1.7 no signal
154 Drug Exposure During Pregnancy 13 1.7 1.7 no signal
155 Thinking Abnormal 7 1.7 1.7 no signal
156 Gastric Disorder 13 1.7 1.7 no signal
157 Colitis Ulcerative 16 1.7 1.7 no signal
158 Drug Effect Less Than Expected 5 1.6 1.6 no signal
159 Rebound Effect 4 1.6 1.6 no signal
160 Convulsion 20 1.6 1.6 no signal
161 Psoriasis 45 1.6 1.6 no signal
162 Apathy 5 1.6 1.6 no signal
163 Product Prescribing Issue 7 1.6 1.6 no signal
164 Unevaluable Event 26 1.6 1.6 no signal
165 Injection Site Pain 104 1.6 1.6 no signal
166 Post Procedural Haemorrhage 4 1.6 1.6 no signal
167 Injection Site Bruising 27 1.6 1.6 no signal
168 Psychotic Disorder 10 1.6 1.6 no signal
169 Skin Exfoliation 27 1.5 1.5 no signal
170 Intentional Product Misuse 28 1.5 1.5 no signal
171 Ocular Hyperaemia 15 1.5 1.5 no signal
172 Device Breakage 12 1.4 1.4 no signal
173 Skin Irritation 14 1.4 1.4 no signal
174 Eye Irritation 17 1.4 1.4 no signal
175 Inflammatory Bowel Disease 3 1.4 1.4 no signal
176 Mania 5 1.4 1.4 no signal
177 Eye Pruritus 10 1.4 1.4 no signal
178 Complication Associated With Device 4 1.4 1.4 no signal
179 Pain Of Skin 8 1.4 1.4 no signal
180 Poor Quality Product Administered 3 1.4 1.4 no signal
181 Injection Site Discomfort 3 1.3 1.3 no signal
182 Hereditary Angioedema 3 1.3 1.3 no signal
183 Product Packaging Quantity Issue 3 1.3 1.3 no signal
184 Injection Site Haematoma 4 1.3 1.3 no signal
185 Application Site Pain 6 1.3 1.3 no signal
186 Serotonin Syndrome 5 1.2 1.2 no signal
187 Drug Prescribing Error 5 1.2 1.2 no signal
188 Product Storage Error 22 1.2 1.2 no signal
189 Device Deployment Issue 3 1.2 1.2 no signal
190 Schizophrenia 3 1.1 1.1 no signal
191 Aggression 12 1.1 1.1 no signal
192 Injection Site Induration 3 1.1 1.1 no signal
193 Device Expulsion 15 1.1 1.1 no signal
194 Anorexia 3 1.1 1.1 no signal
195 Incorrect Product Storage 3 1.0 1.0 no signal
196 Hair Texture Abnormal 3 1.0 1.0 no signal
197 Drug Effect Decreased 12 1.0 1.0 no signal
198 Injection Site Haemorrhage 17 1.0 1.0 no signal
199 Dystonia 4 0.9 0.9 no signal
200 Extra Dose Administered 8 0.9 0.9 no signal
201 Incorrect Dose Administered 45 0.9 0.9 no signal
202 Intentional Self-injury 4 0.9 0.9 no signal
203 Drug Effect Incomplete 7 0.9 0.9 no signal
204 Wrong Technique In Drug Usage Process 7 0.9 0.9 no signal
205 Device Use Issue 3 0.8 0.8 no signal
206 Drug Effective For Unapproved Indication 5 0.8 0.8 no signal
207 Multiple Sclerosis 8 0.8 0.8 no signal
208 Product Complaint 4 0.7 0.7 no signal
209 Application Site Erythema 4 0.7 0.7 no signal
210 Product Preparation Error 3 0.7 0.7 no signal
211 Needle Issue 4 0.6 0.6 no signal
212 Device Difficult To Use 9 0.6 0.6 no signal
213 Device Delivery System Issue 3 0.5 0.5 no signal