norethindrone Side Effects
Also known as: Camila, Errin
Analysis of 5,342 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
5,342
Death-Related
80
1.5% of reports
Hospitalizations
945
17.7% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 80 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 22 |
| PNEUMONIA | 11 |
| OFF LABEL USE | 10 |
| RESPIRATORY FAILURE | 10 |
| CARDIAC ARREST | 7 |
| DYSPNOEA | 6 |
| DRUG INEFFECTIVE | 5 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 5 |
| HYPERTENSION | 5 |
| PAIN | 5 |
| RENAL FAILURE | 5 |
| ACUTE KIDNEY INJURY | 4 |
| BREAST CANCER METASTATIC | 4 |
| INTENTIONAL PRODUCT MISUSE | 4 |
| LUNG DISORDER | 4 |
| MALIGNANT NEOPLASM PROGRESSION | 4 |
| NAUSEA | 4 |
| PANCREATITIS | 4 |
| PULMONARY FIBROSIS | 4 |
| VOMITING | 4 |
Reactions in Hospitalization Reports
Top reactions in 945 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| HEADACHE | 85 |
| NAUSEA | 82 |
| OFF LABEL USE | 79 |
| PAIN | 77 |
| DYSPNOEA | 76 |
| VOMITING | 68 |
| ABDOMINAL PAIN | 63 |
| FATIGUE | 61 |
| DIARRHOEA | 55 |
| PYREXIA | 55 |
| DRUG INEFFECTIVE | 50 |
| PULMONARY EMBOLISM | 50 |
| ARTHRALGIA | 45 |
| VAGINAL HAEMORRHAGE | 45 |
| MALAISE | 44 |
| ANXIETY | 43 |
| HAEMOGLOBIN DECREASED | 41 |
| MIGRAINE | 38 |
| DIZZINESS | 37 |
| HYPERTENSION | 37 |
Nearby — Related Medications
What the FAERS Data Reveals About norethindrone Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 5,342 voluntary reports linked to norethindrone and its brand equivalents (Camila, Errin), spanning 2004 through 2025. Of those, 80 (1.5%) listed death as an outcome and 945 (17.7%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 99% were female and 1% male; age distribution skews toward 18-44, with 2,242 reports in that bracket. The single most reported reaction is nausea with 449 submissions, followed by headache and hot flush.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.