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Drug side effects

norethindrone Side Effects

The reactions most often reported to the FDA for norethindrone (also sold as Camila, Errin), with demographics, serious outcomes, and reporting trends.

Data updated 2026-05-15

5,342
FAERS reports

Data from the FDA Adverse Event Reporting System (FAERS), 2004 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.

The most commonly reported side effects of norethindrone come from 5,342 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.

This page analyzes 5,342 reports to the FDA Adverse Event Reporting System (FAERS) for norethindrone (Camila): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.

Total Reports

5,342

Reports Mentioning Death

80

1.5% of reports — not proof the medicine caused the death

Hospitalizations

945

17.7% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

NAUSEA
449
HEADACHE
424
HOT FLUSH
370
FATIGUE
322
PAIN
308
VAGINAL HAEMORRHAGE
278
ABDOMINAL PAIN
268
ARTHRALGIA
228
DIARRHOEA
224
DIZZINESS
221
ANXIETY
204
MIGRAINE
202
DEPRESSION
199
VOMITING
199
PELVIC PAIN
181
DYSPNOEA
175
INSOMNIA
175
WEIGHT INCREASED
170

Who Reports Side Effects

Gender Distribution

Female 4,688 (99%)
Male 40 (1%)
Unknown 19

Age Distribution

0-17 261 (8%)
18-44 2,242 (69%)
45-64 697 (21%)
65-74 51 (2%)
75+ 10 (0%)

Reporting Trend by Year

2004 2025

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
RESPIRATORY FAILURE 10
CARDIAC ARREST 7
DYSPNOEA 6
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
PAIN 77
DYSPNOEA 76
VOMITING 68
ABDOMINAL PAIN 63
FATIGUE 61
DIARRHOEA 55
PYREXIA 55
PULMONARY EMBOLISM 50
ARTHRALGIA 45
VAGINAL HAEMORRHAGE 45
MALAISE 44
ANXIETY 43
HAEMOGLOBIN DECREASED 41
MIGRAINE 38
DIZZINESS 37
HYPERTENSION 37

Compare norethindrone vs abiraterone →

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.

How to read these numbers

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.