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Pimtrea Side Effects

Generic Name: desogestrel / ethinyl estradiol

Note: This document contains side effect information about desogestrel / ethinyl estradiol. Some of the dosage forms listed on this page may not apply to the brand name Pimtrea.

For the Consumer

Applies to desogestrel / ethinyl estradiol: oral tablet

Along with its needed effects, desogestrel / ethinyl estradiol 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 desogestrel / ethinyl estradiol:

Incidence not known
  • Abdominal or stomach pain
  • absent, missed, or irregular menstrual periods
  • anxiety
  • change in vision
  • changes in skin color
  • chest pain or discomfort
  • chills
  • clay-colored stools
  • constipation
  • cough
  • dark urine
  • diarrhea
  • dizziness, lightheadedness, fainting
  • fever
  • hives or welts
  • itching skin or rash
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • nausea and vomiting
  • pain or discomfort in the arms, jaw, back, or neck
  • pain, tenderness, or swelling of the foot or leg
  • pains in the chest, groin, or legs, especially in the calves of the legs
  • severe headaches of sudden onset
  • slow or fast heartbeat
  • sudden loss of coordination or slurred speech
  • sudden onset of shortness of breath for no apparent reason
  • sudden shortness of breath or troubled breathing
  • sweating
  • unusual tiredness or weakness
  • vomiting of blood

Some side effects of desogestrel / ethinyl estradiol 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
  • Bloating
  • blotchy spots on the exposed skin
  • breast enlargement or tenderness
  • feeling sad or empty
  • irritability
  • itching of the vagina or outside the genitals
  • loss of interest or pleasure
  • pain during sexual intercourse
  • thick, white curd-like vaginal discharge without odor or with mild odor
  • trouble wearing contact lenses

For Healthcare Professionals

Applies to desogestrel / ethinyl estradiol: oral tablet

Genitourinary

Common (1% to 10%): Breast pain/tenderness, amenorrhea, irregular bleeding
Uncommon (0.1% to 1%): Breast enlargement/hypertrophy, metrorrhagia
Rare (0.01% to 0.1%): Vaginal/breast discharge, vaginal candidiasis
Frequency not reported: Breakthrough bleeding, spotting, menstrual flow change, cervical ectropion and secretion, temporary infertility (after discontinuation), vaginitis, candidiasis, lactation diminution, premenstrual syndrome, dysmenorrhea, endometriosis, uterine myoma[Ref]

Diminution of lactation may theoretically occur when this drug is given immediately postpartum.[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, abdominal pain
Uncommon (0.1% to 1%): Vomiting, diarrhea
Frequency not reported: Gallbladder disease, mesenteric thrombosis, gastrointestinal symptoms (e.g., abdominal pain, cramps, bloating), pancreatitis, colitis, Crohn's disease, ulcerative colitis[Ref]

Psychiatric

Common (1% to 10%): Depressed mood, altered mood
Uncommon (0.1% to 1%): Decreased libido, nervousness
Rare (0.01% to 0.1%): Increased libido
Frequency not reported: Depression/mental depression[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness
Uncommon (0.1% to 1%): Migraine
Frequency not reported: Stroke, transient ischemic attack, cerebral hemorrhage/thrombosis, chorea exacerbation, Sydenham's chorea, epilepsy[Ref]

Metabolic

Common (1% to 10%): Increased weight
Uncommon (0.1% to 1%): Fluid retention
Rare (0.01% to 0.1%): Decreased weight
Frequency not reported: Decreased serum folate, porphyria exacerbation, decreased carbohydrate tolerance, increased/decreased folate[Ref]

Dermatologic

Uncommon (0.1% to 1%): Rash/allergic rash, urticaria, acne
Rare (0.01% to 0.1%): Erythema nodosum/multiforme, pruritus, alopecia, hirsutism
Frequency not reported: Scalp hair loss, melasma/chloasma or persistent melasma/chloasma, gestational herpes gestationis, hemorrhagic eruption[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Hypertension, fluid retention/edema
Rare (0.01% to 0.1%): Arterial/venous thromboembolism
Frequency not reported: Myocardial infarction, venous thrombosis, arterial/venous thromboembolic disorders, varicose vein aggravation, thrombophlebitis and venous thrombosis with/without embolism[Ref]

Ocular

Rare (0.01% to 0.1%): Contact lens intolerance, cataract
Frequency not reported: Retinal thrombosis, optic neuritis, partial/complete vision loss, corneal curvature change/steepening[Ref]

Hypersensitivity

Rare (0.01% to 0.1%): Hypersensitivity
Frequency not reported: Anaphylactic/anaphylactoid reactions, hereditary angioedema/angioedema, severe reactions with respiratory and circulatory symptoms[Ref]

Other

Rare (0.01% to 0.1%): Otosclerosis[Ref]

Hepatic

Frequency not reported: Cholestatic jaundice, Budd-Chiari syndrome, acute/chronic liver function disturbances, liver tumors/hepatic adenomas or benign liver tumors[Ref]

Oncologic

Frequency not reported: Hormone-dependent tumors, breast cancer[Ref]

Renal

Frequency not reported: Cystitis-like syndrome, impaired renal function[Ref]

Respiratory

Frequency not reported: Pulmonary embolism[Ref]

Hematologic

Frequency not reported: Hemolytic uremic syndrome[Ref]

Musculoskeletal

Frequency not reported: Systemic lupus erythematosus[Ref]

References

1. "Product Information. Ortho-Cept (desogestrel-ethinyl estradiol)." Ortho Pharmaceutical Corporation, Raritan, NJ.

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

4. "Product Information. Cyclessa (desogestrel-ethinyl estradiol)" Organon, West Orange, NJ.

Some side effects of Pimtrea may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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