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What the label lists and what reports show

Ethinyl estradiol and norgestrel side effects

Ethinyl estradiol and norgestrel's FDA label lists its adverse reactions in its own words. FAERS holds 904 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 headache (68 reports).

  • Generic listed
  • Boxed warning

Check it at the source: the ethinyl estradiol and norgestrel FDA label on DailyMed (effective December 5, 2025, Lupin Pharmaceuticals, Inc.); 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 Turqoz ?

Like pregnancy, Turqoz 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, Lupin Pharmaceuticals, Inc., effective December 5, 2025 (SPL set 5eecfd2c-4bda-4349-b634-199a354fa996), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions

An increased risk of the following serious adverse reactions (see Warnings section for additional information) has been associated with the use of oral contraceptives: Serious cardiovascular events and stroke [see Boxed Warning ] Vascular events Liver disease Adverse reactions commonly reported by COC users are: Irregular uterine bleeding Nausea Breast tenderness Headache Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of Turqoz was evaluated in 1,343 healthy women of child-bearing potential who participated in 9 clinical trials and received at least one dose of Turqoz for contraception. …

Source: FDA drug label, Lupin Pharmaceuticals, Inc., effective December 5, 2025 (SPL set 5eecfd2c-4bda-4349-b634-199a354fa996), via openFDA; the full label on DailyMed

What do FAERS reports show?

904 reports list ethinyl estradiol and norgestrel among the medicines taken, each a report of something that happened, not proof the medicine caused it; 12 are coded as a death and 139 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 20 reactions below, 3 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

  • Drug Ineffective (a use or a product term, not a reaction)94
  • Headache (named in the label)68
  • Nausea (named in the label)66
  • Product Quality Issue (a use or a product term, not a reaction)65
  • Fatigue (named in the label)55
  • Pain47
  • Unintended Pregnancy45
  • Metrorrhagia43
  • Anxiety40
  • Diarrhoea38
  • Vomiting35
  • Rash34
  • Depression30
  • Muscle Spasms28
  • Condition Aggravated (a use or a product term, not a reaction)27
  • Vaginal Haemorrhage27
  • Dyspnoea26
  • Insomnia26
  • Off Label Use (a use or a product term, not a reaction)26
  • Dizziness25
  • Product Dose Omission Issue (a use or a product term, not a reaction)25
  • Arthralgia22
  • Menorrhagia22
  • Malaise21
  • Pyrexia21

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

What next?

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