Drug
Estradiol And Levonorgestrel
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 | 668 | 199.3 | 297.2 | signal |
| 2 | Product Physical Issue | 329 | 174.2 | 207.8 | signal |
| 3 | Device Adhesion Issue | 245 | 169.9 | 193.2 | signal |
| 4 | Application Site Rash | 189 | 144.1 | 158.8 | signal |
| 5 | Application Site Irritation | 89 | 74.7 | 78.1 | signal |
| 6 | Application Site Pruritus | 107 | 49.1 | 51.8 | signal |
| 7 | Application Site Erythema | 98 | 38.8 | 40.7 | signal |
| 8 | Hot Flush | 226 | 31.2 | 35.0 | signal |
| 9 | Metrorrhagia | 51 | 30.7 | 31.4 | signal |
| 10 | Genital Haemorrhage | 31 | 24.9 | 25.3 | signal |
| 11 | Device Breakage | 92 | 24.4 | 25.5 | signal |
| 12 | Device Use Issue | 30 | 18.0 | 18.3 | signal |
| 13 | Vaginal Haemorrhage | 73 | 17.8 | 18.4 | signal |
| 14 | Wrong Technique In Device Usage Process | 71 | 16.1 | 16.7 | signal |
| 15 | Device Defective | 25 | 16.1 | 16.2 | signal |
| 16 | Application Site Pain | 31 | 14.6 | 14.8 | signal |
| 17 | Breast Pain | 15 | 14.6 | 14.7 | signal |
| 18 | Night Sweats | 43 | 13.9 | 14.2 | signal |
| 19 | Wrong Technique In Product Usage Process | 259 | 13.3 | 15.1 | signal |
| 20 | Product Packaging Issue | 11 | 12.3 | 12.4 | signal |
| 21 | Product Prescribing Issue | 21 | 10.7 | 10.8 | signal |
| 22 | Product Quality Issue | 134 | 10.3 | 11.0 | signal |
| 23 | Product Availability Issue | 20 | 9.3 | 9.3 | signal |
| 24 | Poor Quality Product Administered | 9 | 9.1 | 9.2 | signal |
| 25 | Dermatitis Contact | 9 | 8.2 | 8.3 | signal |
| 26 | Abdominal Pain Lower | 17 | 7.0 | 7.0 | signal |
| 27 | Mood Swings | 18 | 5.9 | 5.9 | signal |
| 28 | Middle Insomnia | 10 | 5.6 | 5.6 | signal |
| 29 | Incorrect Drug Administration Duration | 15 | 5.5 | 5.5 | signal |
| 30 | Drug Dose Omission | 87 | 5.4 | 5.6 | signal |
| 31 | Affect Lability | 5 | 5.4 | 5.4 | signal |
| 32 | Mood Altered | 13 | 5.0 | 5.0 | signal |
| 33 | Incorrect Dose Administered By Device | 12 | 4.9 | 4.9 | signal |
| 34 | Vaginal Discharge | 4 | 4.1 | 4.1 | signal |
| 35 | Skin Irritation | 18 | 4.1 | 4.1 | signal |
| 36 | Amenorrhoea | 6 | 3.7 | 3.7 | signal |
| 37 | Menorrhagia | 7 | 3.6 | 3.7 | signal |
| 38 | Adverse Event | 29 | 3.3 | 3.3 | signal |
| 39 | Crying | 11 | 3.1 | 3.1 | signal |
| 40 | Device Use Error | 10 | 3.0 | 3.1 | signal |
| 41 | Drug Effect Less Than Expected | 4 | 2.9 | 2.9 | no signal |
| 42 | Drug Administered At Inappropriate Site | 3 | 2.9 | 2.9 | no signal |
| 43 | Product Packaging Quantity Issue | 3 | 2.9 | 2.9 | no signal |
| 44 | Inappropriate Schedule Of Drug Administration | 19 | 2.7 | 2.7 | signal |
| 45 | Pharmaceutical Product Complaint | 6 | 2.4 | 2.4 | no signal |
| 46 | No Adverse Event | 36 | 2.1 | 2.1 | signal |
| 47 | Complication Of Device Removal | 3 | 1.8 | 1.8 | no signal |
| 48 | Menstruation Irregular | 3 | 1.2 | 1.2 | no signal |
| 49 | Wrong Technique In Drug Usage Process | 4 | 1.1 | 1.1 | no signal |
| 50 | Breast Cancer | 9 | 1.0 | 1.0 | no signal |