Skip to main content
PlainMeds

What the label lists and what reports show

Ethinyl estradiol and norgestimate side effects

Ethinyl estradiol and norgestimate's FDA label: “The most common adverse reactions reported during clinical trials (≥2%) were: Norgestimate and ethinyl estradiol tablets, 0.25 mg/0.035 mg: headache/migraine, abdominal/gastrointestinal pain, vaginal infection, genital discharge, breast issues (including …” FAERS holds 4,557 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (417 reports).

  • Generic listed
  • Boxed warning

Check it at the source: the ethinyl estradiol and norgestimate FDA label on DailyMed (effective February 6, 2026, Glenmark Pharmaceuticals Inc., USA); the FDA FAERS public dashboard.

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible serious side effects of norgestimate and ethinyl estradiol tablets?

Like pregnancy, norgestimate and ethinyl estradiol tablets may cause serious side effects, including blood clots in your lungs, heart attack, or a stroke that may lead to death. Some other examples of serious blood clots include blood clots in the legs or eyes. Serious blood clots can happen especially if you smoke, are obese, or are older than 35 years of age. […]

Source: FDA drug label, Glenmark Pharmaceuticals Inc., USA, effective February 6, 2026 (SPL set 8b247e46-203e-4f5b-b5a7-cbd57341c735), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions

The most common adverse reactions reported during clinical trials (≥2%) were: Norgestimate and ethinyl estradiol tablets, 0.25 mg/0.035 mg: headache/migraine, abdominal/gastrointestinal pain, vaginal infection, genital discharge, breast issues (including breast pain, discharge, and enlargement), mood disorders (including depression and mood altered), flatulence, nervousness, rash.

From the label: adverse reactions, continued

The following serious adverse reactions with the use of COCs are discussed elsewhere in labeling: • Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions ( 5.1 )] • Vascular events [see Warnings and Precautions ( 5.1 )] • Liver disease [see Warnings and Precautions ( 5.2 )] The most common adverse reactions reported during clinical trials (≥2%) were: Norgestimate and ethinyl estradiol tablets, 0.25 mg/0.035 mg: headache/migraine, abdominal/gastrointestinal pain, vaginal infection, genital discharge, breast issues (including breast pain, discharge, and enlargement), mood disorders (including depression and mood altered), flatulence, nervousness, rash. ( 6.1 ) Norgestimate and ethinyl estradiol tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg: headache/migraine, breast issues (including breast pain, enlargement, and discharge), vaginal infection, abdominal/gastrointestinal pain, mood disorders (including mood alteration and depression), genital discharge, changes in weight (including weight increased or decreased). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

Source: FDA drug label, Glenmark Pharmaceuticals Inc., USA, effective February 6, 2026 (SPL set 8b247e46-203e-4f5b-b5a7-cbd57341c735), via openFDA; the full label on DailyMed

What do FAERS reports show?

4,557 reports list ethinyl estradiol and norgestimate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 43 are coded as a death and 672 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Nausea (named in the label)417
  • Headache (named in the label)282
  • Drug Ineffective (a use or a product term, not a reaction)258
  • Fatigue245
  • Vomiting (named in the label)231
  • Anxiety (named in the label)209
  • Pain208
  • Depression177
  • Dizziness (named in the label)160
  • Rash (named in the label)157
  • Pruritus (named in the label)144
  • Off Label Use (a use or a product term, not a reaction)138
  • Diarrhoea (named in the label)131
  • Product Dose Omission Issue (a use or a product term, not a reaction)118
  • Product Substitution Issue116
  • Abdominal Pain Upper114
  • Abdominal Pain107
  • Dyspnoea (named in the label)106
  • Pulmonary Embolism (named in the label)106
  • Injection Site Pain104
  • Malaise103
  • Vaginal Haemorrhage102
  • Menstruation Irregular100
  • Feeling Abnormal91
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)91

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Ethinyl estradiol and norgestimate: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions