Drug
Norelgestromin 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 | Product Adhesion Issue | 691 | 227.1 | 363.5 | signal |
| 2 | Application Site Rash | 118 | 98.5 | 105.2 | signal |
| 3 | Application Site Irritation | 104 | 96.2 | 102.0 | signal |
| 4 | Application Site Pruritus | 166 | 84.1 | 92.4 | signal |
| 5 | Metrorrhagia | 111 | 73.8 | 78.4 | signal |
| 6 | Application Site Erythema | 120 | 52.3 | 55.9 | signal |
| 7 | Application Site Pain | 73 | 38.0 | 39.5 | signal |
| 8 | Product Packaging Quantity Issue | 26 | 27.3 | 27.6 | signal |
| 9 | Dysmenorrhoea | 23 | 20.1 | 20.4 | signal |
| 10 | Wrong Technique In Product Usage Process | 340 | 19.3 | 23.4 | signal |
| 11 | Menorrhagia | 27 | 15.5 | 15.7 | signal |
| 12 | Menstruation Irregular | 32 | 13.8 | 14.0 | signal |
| 13 | Dermatitis Contact | 12 | 12.1 | 12.2 | signal |
| 14 | Vaginal Haemorrhage | 37 | 9.9 | 10.1 | signal |
| 15 | Menstruation Delayed | 9 | 9.9 | 9.9 | signal |
| 16 | Mood Swings | 25 | 9.0 | 9.1 | signal |
| 17 | Product Quality Issue | 98 | 8.3 | 8.7 | signal |
| 18 | Breast Pain | 7 | 7.5 | 7.5 | signal |
| 19 | Product Substitution Issue | 37 | 7.3 | 7.5 | signal |
| 20 | Device Adhesion Issue | 9 | 6.8 | 6.8 | signal |
| 21 | Amenorrhoea | 8 | 5.5 | 5.5 | signal |
| 22 | Vaginal Discharge | 4 | 4.5 | 4.6 | signal |
| 23 | Incorrect Drug Administration Duration | 11 | 4.4 | 4.4 | signal |
| 24 | Product Dose Omission | 25 | 4.3 | 4.4 | signal |
| 25 | Product Packaging Issue | 3 | 3.7 | 3.7 | no signal |
| 26 | Coeliac Disease | 3 | 3.5 | 3.5 | no signal |
| 27 | Skin Irritation | 14 | 3.5 | 3.5 | signal |
| 28 | Inappropriate Schedule Of Drug Administration | 21 | 3.3 | 3.4 | signal |
| 29 | Product Administered At Inappropriate Site | 5 | 3.1 | 3.2 | signal |
| 30 | No Adverse Event | 45 | 2.9 | 2.9 | signal |
| 31 | Abortion Spontaneous | 9 | 2.6 | 2.6 | signal |
| 32 | Acne | 17 | 2.5 | 2.6 | signal |
| 33 | Complication Of Device Insertion | 4 | 2.5 | 2.5 | no signal |
| 34 | Drug Dose Omission | 28 | 1.9 | 1.9 | no signal |
| 35 | Drug Effect Decreased | 9 | 1.9 | 1.9 | no signal |
| 36 | Wrong Technique In Device Usage Process | 7 | 1.7 | 1.8 | no signal |
| 37 | Dermatitis Atopic | 7 | 1.6 | 1.6 | no signal |
| 38 | Product Storage Error | 11 | 1.5 | 1.5 | no signal |