Drug
Norethindrone Acetate And Ethinyl Estradiol
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 | 31 | 16.7 | 16.9 | signal |
| 2 | Menstruation Irregular | 37 | 13.0 | 13.2 | signal |
| 3 | Coeliac Disease | 13 | 12.3 | 12.4 | signal |
| 4 | Menstruation Delayed | 13 | 11.7 | 11.7 | signal |
| 5 | Dermatitis Atopic | 57 | 10.6 | 10.9 | signal |
| 6 | Sleep Disorder Due To A General Medical Condition | 17 | 9.8 | 9.9 | signal |
| 7 | Menorrhagia | 20 | 9.4 | 9.4 | signal |
| 8 | Dysmenorrhoea | 12 | 8.5 | 8.6 | signal |
| 9 | Bursitis | 11 | 8.5 | 8.5 | signal |
| 10 | Vaginal Haemorrhage | 38 | 8.3 | 8.4 | signal |
| 11 | Inflammatory Bowel Disease | 8 | 7.6 | 7.6 | signal |
| 12 | Cholecystectomy | 9 | 7.4 | 7.4 | signal |
| 13 | Amenorrhoea | 13 | 7.3 | 7.3 | signal |
| 14 | Injection Site Urticaria | 18 | 6.9 | 7.0 | signal |
| 15 | Pharyngitis Streptococcal | 8 | 6.9 | 6.9 | signal |
| 16 | Product Packaging Quantity Issue | 8 | 6.8 | 6.8 | signal |
| 17 | Helicobacter Infection | 7 | 6.4 | 6.4 | signal |
| 18 | Product Substitution Issue | 39 | 6.3 | 6.4 | signal |
| 19 | Ear Infection | 17 | 6.0 | 6.0 | signal |
| 20 | Foot Deformity | 7 | 5.9 | 5.9 | signal |
| 21 | Embedded Device | 6 | 5.7 | 5.7 | signal |
| 22 | Poor Quality Sleep | 13 | 5.7 | 5.7 | signal |
| 23 | Product Dose Omission In Error | 16 | 5.5 | 5.6 | signal |
| 24 | Middle Insomnia | 11 | 5.5 | 5.5 | signal |
| 25 | Folliculitis | 6 | 5.4 | 5.4 | signal |
| 26 | Laryngitis | 6 | 5.1 | 5.2 | signal |
| 27 | Pulmonary Thrombosis | 6 | 5.1 | 5.1 | signal |
| 28 | Migraine | 52 | 5.1 | 5.2 | signal |
| 29 | Abortion Induced | 5 | 4.9 | 4.9 | signal |
| 30 | Night Sweats | 17 | 4.9 | 4.9 | signal |
| 31 | Autoimmune Disorder | 5 | 4.9 | 4.9 | signal |
| 32 | Intentional Dose Omission | 14 | 4.8 | 4.8 | signal |
| 33 | Body Temperature Decreased | 5 | 4.7 | 4.7 | signal |
| 34 | Mood Swings | 16 | 4.7 | 4.7 | signal |
| 35 | Pelvic Pain | 9 | 4.6 | 4.6 | signal |
| 36 | Initial Insomnia | 5 | 4.6 | 4.6 | signal |
| 37 | Impaired Quality Of Life | 7 | 4.5 | 4.5 | signal |
| 38 | Hypokinesia | 7 | 4.5 | 4.5 | signal |
| 39 | Breast Pain | 5 | 4.4 | 4.4 | signal |
| 40 | Paranoia | 8 | 4.3 | 4.3 | signal |
| 41 | Hand Deformity | 6 | 4.3 | 4.3 | signal |
| 42 | Bipolar Disorder | 5 | 4.3 | 4.3 | signal |
| 43 | Thirst | 8 | 4.2 | 4.2 | signal |
| 44 | Hunger | 6 | 4.2 | 4.2 | signal |
| 45 | Disease Recurrence | 21 | 4.1 | 4.1 | signal |
| 46 | Injection Site Warmth | 9 | 4.1 | 4.1 | signal |
| 47 | Product Packaging Issue | 4 | 4.0 | 4.0 | signal |
| 48 | Madarosis | 5 | 4.0 | 4.0 | signal |
| 49 | Skin Fissures | 8 | 3.9 | 4.0 | signal |
| 50 | Eczema | 21 | 3.9 | 3.9 | signal |
| 51 | Product Dispensing Error | 9 | 3.9 | 3.9 | signal |
| 52 | Vitreous Floaters | 4 | 3.8 | 3.8 | signal |
| 53 | Injection Site Pruritus | 27 | 3.8 | 3.8 | signal |
| 54 | Mood Altered | 11 | 3.8 | 3.8 | signal |
| 55 | Insurance Issue | 6 | 3.8 | 3.8 | signal |
| 56 | Libido Decreased | 5 | 3.8 | 3.8 | signal |
| 57 | Glossodynia | 9 | 3.7 | 3.8 | signal |
| 58 | Hot Flush | 29 | 3.6 | 3.6 | signal |
| 59 | Injection Site Swelling | 29 | 3.6 | 3.6 | signal |
| 60 | Injury | 27 | 3.6 | 3.6 | signal |
| 61 | Hereditary Angioedema | 4 | 3.5 | 3.6 | signal |
| 62 | Injection Site Bruising | 29 | 3.4 | 3.5 | signal |
| 63 | Abdominal Pain Lower | 9 | 3.3 | 3.3 | signal |
| 64 | Emotional Disorder | 11 | 3.3 | 3.3 | signal |
| 65 | Injection Site Reaction | 24 | 3.3 | 3.3 | signal |
| 66 | Product Dose Omission | 23 | 3.2 | 3.3 | signal |
| 67 | Local Swelling | 6 | 3.2 | 3.2 | signal |
| 68 | Injection Site Erythema | 41 | 3.1 | 3.1 | signal |
| 69 | Crying | 12 | 3.1 | 3.1 | signal |
| 70 | Suicidal Ideation | 30 | 3.0 | 3.1 | signal |
| 71 | Product Dose Omission Issue | 93 | 3.0 | 3.1 | signal |
| 72 | Procedural Pain | 9 | 3.0 | 3.0 | signal |
| 73 | Colitis Ulcerative | 14 | 2.9 | 2.9 | signal |
| 74 | Knee Operation | 3 | 2.9 | 2.9 | no signal |
| 75 | Acne | 23 | 2.8 | 2.8 | signal |
| 76 | Product Physical Issue | 6 | 2.8 | 2.8 | signal |
| 77 | Incorrect Product Storage | 4 | 2.8 | 2.8 | no signal |
| 78 | Irritability | 18 | 2.8 | 2.8 | signal |
| 79 | No Adverse Event | 53 | 2.8 | 2.8 | signal |
| 80 | Pregnancy | 6 | 2.8 | 2.8 | signal |
| 81 | Injection Site Rash | 9 | 2.8 | 2.8 | signal |
| 82 | Poor Quality Product Administered | 3 | 2.7 | 2.7 | no signal |
| 83 | Surgery | 17 | 2.7 | 2.7 | signal |
| 84 | Injection Site Discomfort | 3 | 2.7 | 2.7 | no signal |
| 85 | Eye Irritation | 16 | 2.7 | 2.7 | signal |
| 86 | Needle Issue | 8 | 2.6 | 2.6 | signal |
| 87 | Dry Skin | 35 | 2.5 | 2.5 | signal |
| 88 | Anger | 9 | 2.5 | 2.5 | signal |
| 89 | Diabetic Ketoacidosis | 6 | 2.3 | 2.3 | no signal |
| 90 | Pemphigus | 3 | 2.2 | 2.2 | no signal |
| 91 | Injection Site Irritation | 3 | 2.2 | 2.2 | no signal |
| 92 | Injection Site Pain | 68 | 2.1 | 2.1 | signal |
| 93 | Synovitis | 4 | 2.1 | 2.1 | no signal |
| 94 | Therapeutic Response Shortened | 7 | 2.0 | 2.1 | no signal |
| 95 | Akathisia | 3 | 2.0 | 2.0 | no signal |
| 96 | Abortion Spontaneous | 8 | 1.9 | 1.9 | no signal |
| 97 | Drug Dispensing Error | 3 | 1.8 | 1.8 | no signal |
| 98 | Injection Site Mass | 7 | 1.8 | 1.8 | no signal |
| 99 | Complication Of Device Removal | 3 | 1.6 | 1.6 | no signal |
| 100 | Psoriatic Arthropathy | 7 | 1.6 | 1.6 | no signal |
| 101 | Wrong Technique In Drug Usage Process | 6 | 1.5 | 1.5 | no signal |
| 102 | Complication Of Device Insertion | 3 | 1.5 | 1.5 | no signal |
| 103 | Drug Dose Omission | 26 | 1.4 | 1.4 | no signal |
| 104 | Product Storage Error | 12 | 1.3 | 1.3 | no signal |
| 105 | Device Dislocation | 6 | 1.3 | 1.3 | no signal |
| 106 | Device Malfunction | 9 | 1.2 | 1.2 | no signal |
| 107 | Multiple Sclerosis | 6 | 1.2 | 1.2 | no signal |
| 108 | Product Complaint | 3 | 1.1 | 1.1 | no signal |
| 109 | Device Issue | 9 | 1.0 | 1.0 | no signal |
| 110 | Injection Site Haemorrhage | 8 | 0.9 | 0.9 | no signal |
| 111 | Device Expulsion | 6 | 0.9 | 0.9 | no signal |
| 112 | Device Breakage | 3 | 0.7 | 0.7 | no signal |
| 113 | Device Difficult To Use | 5 | 0.7 | 0.7 | no signal |
| 114 | Drug Dose Omission By Device | 3 | 0.4 | 0.4 | no signal |