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Demulen Side Effects

Generic name: ethinyl estradiol / ethynodiol

Medically reviewed by Drugs.com. Last updated on Dec 20, 2023.

Note: This document provides detailed information about Demulen Side Effects associated with ethinyl estradiol / ethynodiol. Some dosage forms listed on this page may not apply specifically to the brand name Demulen.

Applies to ethinyl estradiol / ethynodiol: oral tablet.

Important warnings This medicine can cause some serious health issues

Oral route (tablet)

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use.

This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age.

Women who use oral contraceptives should be strongly advised not to smoke.

Serious side effects of Demulen

Along with its needed effects, ethinyl estradiol/ethynodiol may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ethinyl estradiol / ethynodiol:

Incidence not known

  • absent, missed, or irregular menstrual periods
  • anxiety
  • bloody stools
  • blurred vision
  • breast tenderness, enlargement, discharge
  • changes in skin color, pain, tenderness, or swelling of the foot or leg
  • chest pain or discomfort
  • chills
  • clay-colored stools
  • confusion
  • cough
  • dark or cloudy urine
  • decrease in urine output or decrease in urine-concentrating ability
  • diarrhea
  • difficulty in speaking
  • dizziness or lightheadedness
  • double vision
  • fainting
  • fast heartbeat
  • fever
  • headache, severe and throbbing
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • itching of the vagina or outside the genitals
  • loss of appetite
  • nausea
  • nervousness
  • pain during sexual intercourse
  • pain or discomfort in the arms, jaw, back or neck
  • pounding in the ears
  • slow or fast heartbeat
  • slow speech
  • stomach pain and tenderness
  • stopping of menstrual bleeding
  • sweating
  • swelling
  • swelling, pain, or tenderness in the upper abdominal area
  • tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
  • thick, white curd-like vaginal discharge without odor or with mild odor
  • troubled breathing
  • unpleasant breath odor
  • unusual tiredness or weakness
  • vomiting
  • vomiting of blood
  • yellow eyes or skin

Other side effects of Demulen

Some side effects of ethinyl estradiol / ethynodiol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

  • acne
  • changes in appetite
  • changes in weight
  • decreased interest in sexual intercourse
  • decreased milk production
  • light vaginal bleeding between regular menstrual periods
  • loss in sexual ability, desire, drive, or performance
  • mental depression
  • patchy brown or dark brown discoloration of the skin

Managing side effects (general information)

For healthcare professionals

Applies to ethinyl estradiol / ethynodiol: oral tablet.

General adverse events

The more commonly reported adverse events with combined oral contraceptives include nausea, vomiting, and headache.[Ref]

Cardiovascular

Combined Oral Contraceptives:

Nervous system

Combined Oral Contraceptives:

Genitourinary

Combined Oral Contraceptives:

Gastrointestinal

Combined Oral Contraceptives:

Respiratory

Combined Oral Contraceptives:

Endocrine

Combined Oral Contraceptives:

Hepatic

Combined Oral Contraceptives:

Dermatologic

Combined Oral Contraceptives:

Psychiatric

Combined Oral Contraceptives:

Oncologic

Combined Oral Contraceptives:

A number of studies have examined a possible relationship between the use of oral contraceptives and the development of breast cancer. Many of the studies have reported conflicting results. A committee of the World Health Organization evaluated these studies and the risks of breast cancer and concluded that: "Numerous studies have found no overall association between oral contraceptive use and risk of breast cancer." In addition, the same committee also examined a possible relationship between oral contraceptive use and neoplasms of the uterine cervix and concluded that: "There are insufficient data to draw any firm conclusions regarding the effects of combined oral contraceptives on the risk of cervical adenocarcinoma."

The World Health Organization committee also noted that some studies "have found a weak association between long-term use of oral contraceptives and breast cancer diagnosed before the age of 36, and perhaps up to the age 45....It is unclear whether this observed association is attributable to bias, the development of new cases of cancer, or accelerated growth of existing cancers."

The World Health Organization committee further concluded that there is no increased risk of breast cancer in women over the age of 45 who have previously taken oral contraceptives. In addition, studies suggest that use of oral contraceptives does not place specific groups of women (like those with a family history of breast cancer) at higher or lower risk, and variations in the hormonal content of oral contraceptives do not influence the risk of breast cancer.

In general, studies evaluating the potential risk of cervical cancer in patients taking oral contraceptives have been complicated by the large number of confounding factors which make investigations into the epidemiology of this neoplasm difficult. Some studies have suggested that women taking oral contraceptives are at increased risk of dysplasia, epidermoid carcinoma, and adenocarcinoma of the cervix. However, other studies have not found such an association.

The rate of death due to hepatocellular carcinoma in the United States has not changed during the last 25 years (a time during which use of oral contraceptive hormones has increased dramatically).

A committee of the World Health Organization has reported that in developing countries where hepatitis B virus infection and hepatocellular carcinoma are common, "short term use of oral contraceptives does not appear to be associated with an increased risk. Data on the effects of long term use are scarce."

A recent Italian case-control study of women with hepatocellular carcinoma has suggested that the relative risk of hepatocellular carcinoma is 2.2 for oral contraceptive users compared to women who never used oral contraceptives.

A similar American case-control study from 1989 also reported a strong association between oral contraceptive use and hepatocellular carcinoma but concluded that: "If this observed association is causal, the actual number of cases of liver cancer in the United States attributable to oral contraceptive use is small. Therefore, these findings do not have public health importance in the United States and other Western nations."[Ref]

Ocular

Combined Oral Contraceptives:

Metabolic

Combined Oral Contraceptives:

Renal

Combined Oral Contraceptives:

References

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Further information

Demulen side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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