Drug
Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate
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 | Coeliac Disease | 26 | 21.9 | 22.1 | signal |
| 2 | Metrorrhagia | 35 | 16.7 | 16.9 | signal |
| 3 | Dysmenorrhoea | 23 | 14.5 | 14.6 | signal |
| 4 | Menstruation Irregular | 42 | 13.0 | 13.3 | signal |
| 5 | Menstruation Delayed | 16 | 12.7 | 12.8 | signal |
| 6 | Amenorrhoea | 22 | 10.9 | 10.9 | signal |
| 7 | Menorrhagia | 25 | 10.3 | 10.4 | signal |
| 8 | Cholecystectomy | 13 | 9.4 | 9.5 | signal |
| 9 | Vaginal Haemorrhage | 48 | 9.3 | 9.4 | signal |
| 10 | Dermatitis Atopic | 56 | 9.2 | 9.4 | signal |
| 11 | Sleep Disorder Due To A General Medical Condition | 18 | 9.2 | 9.2 | signal |
| 12 | Impaired Quality Of Life | 15 | 8.6 | 8.6 | signal |
| 13 | Inflammatory Bowel Disease | 8 | 6.7 | 6.7 | signal |
| 14 | Dermatitis Contact | 9 | 6.5 | 6.5 | signal |
| 15 | Initial Insomnia | 8 | 6.5 | 6.5 | signal |
| 16 | Impaired Gastric Emptying | 10 | 6.5 | 6.5 | signal |
| 17 | Skin Fissures | 14 | 6.1 | 6.1 | signal |
| 18 | Gallbladder Disorder | 13 | 6.0 | 6.0 | signal |
| 19 | Pelvic Pain | 13 | 5.9 | 5.9 | signal |
| 20 | Cholecystitis | 8 | 5.5 | 5.6 | signal |
| 21 | Product Substitution Issue | 38 | 5.4 | 5.5 | signal |
| 22 | Injection Site Urticaria | 16 | 5.4 | 5.5 | signal |
| 23 | Poor Quality Sleep | 14 | 5.4 | 5.4 | signal |
| 24 | Mood Swings | 19 | 4.9 | 4.9 | signal |
| 25 | Blood Iron Decreased | 7 | 4.9 | 4.9 | signal |
| 26 | Migraine | 56 | 4.9 | 4.9 | signal |
| 27 | Hereditary Angioedema | 6 | 4.7 | 4.7 | signal |
| 28 | Pharyngitis Streptococcal | 6 | 4.6 | 4.6 | signal |
| 29 | Intentional Dose Omission | 15 | 4.5 | 4.5 | signal |
| 30 | Injury | 38 | 4.4 | 4.5 | signal |
| 31 | Ear Infection | 14 | 4.3 | 4.4 | signal |
| 32 | Panic Attack | 19 | 4.3 | 4.3 | signal |
| 33 | Product Taste Abnormal | 7 | 4.3 | 4.3 | signal |
| 34 | Eczema | 26 | 4.3 | 4.3 | signal |
| 35 | Mood Altered | 14 | 4.2 | 4.3 | signal |
| 36 | Impaired Work Ability | 11 | 4.2 | 4.2 | signal |
| 37 | Embedded Device | 5 | 4.2 | 4.2 | signal |
| 38 | Vaginal Discharge | 5 | 4.1 | 4.1 | signal |
| 39 | Complication Of Device Removal | 8 | 3.9 | 3.9 | signal |
| 40 | Breast Pain | 5 | 3.9 | 3.9 | signal |
| 41 | Surgery | 26 | 3.7 | 3.7 | signal |
| 42 | Drug Effect Less Than Expected | 6 | 3.5 | 3.5 | signal |
| 43 | Abortion Induced | 4 | 3.5 | 3.5 | signal |
| 44 | Product Dispensing Error | 9 | 3.4 | 3.4 | signal |
| 45 | Vitreous Floaters | 4 | 3.4 | 3.4 | signal |
| 46 | Paranoia | 7 | 3.3 | 3.3 | signal |
| 47 | Insurance Issue | 6 | 3.3 | 3.3 | signal |
| 48 | Procedural Pain | 11 | 3.3 | 3.3 | signal |
| 49 | Ovarian Cyst | 4 | 3.3 | 3.3 | signal |
| 50 | Product Prescribing Issue | 8 | 3.2 | 3.2 | signal |
| 51 | Disturbance In Attention | 21 | 3.2 | 3.2 | signal |
| 52 | Injection Site Discomfort | 4 | 3.2 | 3.2 | signal |
| 53 | Tendonitis | 6 | 3.2 | 3.2 | signal |
| 54 | Therapeutic Response Unexpected | 17 | 3.1 | 3.1 | signal |
| 55 | Product Dose Omission | 25 | 3.1 | 3.1 | signal |
| 56 | Middle Insomnia | 7 | 3.1 | 3.1 | signal |
| 57 | Incorrect Product Storage | 5 | 3.1 | 3.1 | signal |
| 58 | Product Dose Omission In Error | 10 | 3.1 | 3.1 | signal |
| 59 | Hunger | 5 | 3.1 | 3.1 | signal |
| 60 | Feeling Jittery | 7 | 3.0 | 3.0 | signal |
| 61 | Pulmonary Thrombosis | 4 | 3.0 | 3.0 | no signal |
| 62 | Injection Site Reaction | 25 | 3.0 | 3.0 | signal |
| 63 | Injection Site Rash | 11 | 3.0 | 3.0 | signal |
| 64 | Injection Site Pruritus | 24 | 3.0 | 3.0 | signal |
| 65 | Crying | 13 | 2.9 | 2.9 | signal |
| 66 | Suicidal Ideation | 32 | 2.9 | 2.9 | signal |
| 67 | Skin Haemorrhage | 5 | 2.9 | 2.9 | signal |
| 68 | Therapeutic Response Shortened | 11 | 2.8 | 2.9 | signal |
| 69 | Anhedonia | 9 | 2.8 | 2.8 | signal |
| 70 | Local Swelling | 6 | 2.8 | 2.8 | signal |
| 71 | Diabetic Ketoacidosis | 8 | 2.7 | 2.8 | signal |
| 72 | Injection Site Swelling | 25 | 2.7 | 2.7 | signal |
| 73 | Injection Site Bruising | 26 | 2.7 | 2.7 | signal |
| 74 | Acne | 25 | 2.7 | 2.7 | signal |
| 75 | Drug Dispensing Error | 5 | 2.7 | 2.7 | no signal |
| 76 | Emotional Disorder | 10 | 2.7 | 2.7 | signal |
| 77 | Knee Operation | 3 | 2.5 | 2.5 | no signal |
| 78 | Complication Associated With Device | 4 | 2.5 | 2.5 | no signal |
| 79 | Adverse Reaction | 4 | 2.5 | 2.5 | no signal |
| 80 | Injection Site Erythema | 36 | 2.4 | 2.4 | signal |
| 81 | Injection Site Warmth | 6 | 2.4 | 2.4 | no signal |
| 82 | Exposure During Pregnancy | 18 | 2.4 | 2.4 | signal |
| 83 | Dry Skin | 37 | 2.3 | 2.3 | signal |
| 84 | Breast Cancer Metastatic | 3 | 2.3 | 2.3 | no signal |
| 85 | Product Packaging Quantity Issue | 3 | 2.3 | 2.3 | no signal |
| 86 | Eye Pruritus | 9 | 2.2 | 2.3 | signal |
| 87 | Colitis Ulcerative | 12 | 2.2 | 2.2 | signal |
| 88 | Exposure Via Skin Contact | 6 | 2.2 | 2.2 | no signal |
| 89 | Anger | 9 | 2.2 | 2.2 | signal |
| 90 | Device Dislocation | 11 | 2.1 | 2.1 | signal |
| 91 | Product Quality Issue | 34 | 2.1 | 2.1 | signal |
| 92 | Pregnancy | 5 | 2.0 | 2.0 | no signal |
| 93 | Mania | 4 | 2.0 | 2.0 | no signal |
| 94 | Injection Site Discolouration | 3 | 2.0 | 2.0 | no signal |
| 95 | Product Preparation Error | 5 | 2.0 | 2.0 | no signal |
| 96 | Inappropriate Schedule Of Drug Administration | 17 | 1.9 | 1.9 | no signal |
| 97 | Injection Site Pain | 71 | 1.9 | 2.0 | no signal |
| 98 | Genital Haemorrhage | 3 | 1.9 | 1.9 | no signal |
| 99 | Syringe Issue | 4 | 1.9 | 1.9 | no signal |
| 100 | Psoriasis | 29 | 1.8 | 1.8 | no signal |
| 101 | Complication Of Device Insertion | 4 | 1.8 | 1.8 | no signal |
| 102 | Emotional Distress | 25 | 1.7 | 1.7 | no signal |
| 103 | Device Breakage | 8 | 1.7 | 1.7 | no signal |
| 104 | Psoriatic Arthropathy | 8 | 1.6 | 1.6 | no signal |
| 105 | Device Issue | 16 | 1.5 | 1.5 | no signal |
| 106 | Abortion Spontaneous | 7 | 1.4 | 1.4 | no signal |
| 107 | Drug Effect Decreased | 9 | 1.4 | 1.4 | no signal |
| 108 | Multiple Sclerosis Relapse | 11 | 1.3 | 1.3 | no signal |
| 109 | Skin Irritation | 7 | 1.3 | 1.3 | no signal |
| 110 | Product Storage Error | 13 | 1.2 | 1.2 | no signal |
| 111 | Injury Associated With Device | 3 | 1.2 | 1.2 | no signal |
| 112 | Device Malfunction | 10 | 1.2 | 1.2 | no signal |
| 113 | Intentional Self-injury | 3 | 1.2 | 1.2 | no signal |
| 114 | Needle Issue | 4 | 1.2 | 1.2 | no signal |
| 115 | Drug Dose Omission | 23 | 1.1 | 1.1 | no signal |
| 116 | Device Difficult To Use | 9 | 1.1 | 1.1 | no signal |
| 117 | Wrong Technique In Drug Usage Process | 5 | 1.1 | 1.1 | no signal |
| 118 | Injection Site Mass | 5 | 1.1 | 1.1 | no signal |
| 119 | Device Expulsion | 8 | 1.0 | 1.0 | no signal |
| 120 | Application Site Erythema | 3 | 0.9 | 0.9 | no signal |
| 121 | Injection Site Haemorrhage | 8 | 0.8 | 0.8 | no signal |
| 122 | Device Leakage | 4 | 0.8 | 0.8 | no signal |
| 123 | Accidental Exposure To Product | 9 | 0.7 | 0.7 | no signal |
| 124 | Wrong Technique In Device Usage Process | 4 | 0.7 | 0.7 | no signal |