Norgestimate (Ortho Tri-Cyclen)

Oral Contraceptive

The following side effects are expected to occur with the use of oral contraceptives containing norgestimate. Contact your doctor if these symptoms are severe and/or do not go away:

How Common (based on clinical studies)

HeadacheUp to 33.6% of all users
Breast enlargement, tenderness, or dischargeUp to 10.3% of all users
Spotting or bleeding between normal menstrual periodsUp to 9.2% of all users
Changes to menstrual flowUp to 9.2% of all users
Pain during menstruation or missed periodsUp to 9.2% of all users
Abdominal painUp to 9.2% of all users
Vaginal irritation, redness, itching, burning, swelling or dischargeUp to 8.4% of all users
Changes in moodUp to 7.6% of all users
Nausea and vomitingUp to 5.5% of all users
FlatulenceUp to 3.2% of all users
Increase or decrease in body weightUp to 2.5% of all users
Fatigue or tirednessUp to 2.1% of all users
Abnormal pap smear resultsUp to 0.7% of all users
Cysts in the ovariesUp to 0.3% of all users
Changes in appetiteUnknown
Bloating or abdominal crampsUnknown
Swelling and inflammation of the gumsUnknown
Unusual hair growthUnknown
Diarrhea or constipationUnknown
Patches of hyperpigmented skinUnknown

Oral contraceptives containing norgestimate may cause some side effects that are serious. If you experience any of the following uncommon symptoms, get in touch with your doctor immediately or seek emergency medical treatment:

  • Unusually heavy menstrual bleeding or bleeding lasting longer than 7 days
  • Severe headaches
  • Double vision or other changes in vision
  • Problems with speech
  • Feeling faint or dizzy
  • Fever
  • Rash in any part of the body
  • Severe vomiting episodes
  • Abnormal bleeding or bruising
  • Symptoms of depression, particularly extreme tiredness, low energy levels, trouble sleeping, or mood changes
  • Severe chest pain or heaviness over the chest
  • Feeling short of breath
  • Dark yellow-brown urine
  • Pale stools
  • Yellowish discoloration of eyes or skin
  • Coughing blood
  • Bulging eyes
  • Severe abdominal pain
  • Loss of appetite
  • Pain in the legs
  • Tingling, numbness, or weakness in the arms or legs
  • Extreme fatigue, tiredness, or low energy
  • Swelling of any part of the body, particularly the hands, lower legs, ankles, or feet

Oral contraceptives containing norgestimate may also cause other side effects that are not mentioned here. Contact your doctor if you experience any other troublesome symptoms when using oral contraceptives containing norgestimate.

References
  1. UpToDate. Ethinyl estradiol and drosperinone: drug information. Available from: https://eresources.library.mssm.edu:3285/contents/ethinyl-estradiol-and-drospirenone-drug-information?source=search_result&search=drospirenone%20ethinyl%20estradiol&selectedTitle=1~18. Cited 14 March 2017.
  2. UpToDate. Ethinyl estradiol and norgestimate: drug information. Available from: https://eresources.library.mssm.edu:3285/contents/ethinyl-estradiol-and-norgestimate-drug-information?source=search_result&search=norgestimate&selectedTitle=1~17. Cited 14 March 2017.
  3. UpToDate. Ethinyl estradiol and norethindrone: drug information. Available from: https://eresources.library.mssm.edu:3285/contents/ethinyl-estradiol-and-norethindrone-drug-information?source=preview&search=estrostep&anchor=F168438#F168438. Cited 14 March 2017.
  4. Maloney JM, et al. Treatment of acne using a 3-milligram drospirenone/20-microgram ethinyl estradiol oral contraceptive administered in a 24/4 regimen: a randomized controlled trial. Obstet Gynecol. 112(4), 773-81 (2008).
  5. Koltun W, et al. Efficacy and safety of 3 mg drospirenone/20 mcg ethinylestradiol oral contraceptive administered in 24/4 regimen in the treatment of acne vulgaris: a randomized, double-blind, placebo-controlled trial. Contraception, 77(4), 249-56 (2008).
  6. Mansour D, et al. Efficacy and tolerability of a monophasic combined oral contraceptive containing nomegestrol acetate and 17β-oestradiol in a 24/4 regimen, in comparison to an oral contraceptive containing ethinylestradiol and drospirenone in a 21/7 regimen. Eur J Contracept Reprod Health Care, 16(6), 430-43 (2011).
  7. Palli MB, Reyes-Habito CM, Lima XT, and Kimball AB. A single-center, randomized double-blind, parallel-group study to examine the safety and efficacy of 3mg drospirenone/0.02 mg ethinyl estradiol compared with placebo in the treatment of moderate truncal acne vulgaris. J Drugs Dermatol., 12(6), 633-7 (2013).
  8. Thorneycroft IH, Gollnick H, and Schellschmidt I. Superiority of a combined contraceptive containing drospirenone to a triphasic preparation containing norgestimate in acne treatment. Cutis. 74(2), 123-30 (2004).
  9. Jaisamrarn U, Chaovisitsaree S, Angsuwathana S, and Nerapusee O. A comparison of multiphasic oral contraceptives containing norgestimate or desogestrel in acne treatment: a randomized trial. Contraception. 90(5), 535-41 (2014).
  10. DailyMed. Drosperinone and ethinyl estradiol. Available from: https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=DROSPIRENONE+AND+ETHINYL+ESTRADIOL&pagesize=20&page=1. Cited 10 January 2019.
  11. DailyMed. Norgestimate and ethinyl estradiol. Available from: https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=norgestimate+AND+ETHINYL+ESTRADIOL&pagesize=20&page=1. Cited 10 january 2019
  12. DailyMed. Norethindrone and ethinyl estradiol. Available from: https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=NORETHINDRONE+AND