Portia Side Effects Center

Last updated on RxList: 3/29/2022
Portia Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Portia?

Portia (levonorgestrel and ethinyl estradiol kit) is a combined oral contraceptive (COC) indicated to prevent pregnancy in women who elect to use this product as a method of contraception.

What Are Side Effects of Portia?

Side effects of Portia include:

  • nausea,
  • vomiting,
  • gastrointestinal symptoms (such as abdominal pain, cramps and bloating),
  • breakthrough bleeding,
  • spotting,
  • change in menstrual flow,
  • missed menstrual periods,
  • temporary infertility after discontinuation of treatment,
  • fluid retention (edema),
  • dark spots/freckles on skin which may persist,
  • breast tenderness/pain/enlargement,
  • nipple secretion,
  • changes in weight or appetite,
  • changes in vaginal discharge,
  • diminished in lactation when given immediately postpartum,
  • cholestatic jaundice,
  • rash (allergic),
  • mood changes (including depression),
  • vaginitis (including vaginal yeast infection),
  • aggravation of varicose veins
  • anaphylactic/anaphylactoid reactions (including hives, skin swelling, and severe reactions with respiratory and circulatory symptoms),
  • excess unwanted hair growth,
  • loss of scalp hair,
  • acne,
  • changes in libido, and
  • menstrual cramps

Dosage for Portia

The dosage of Portia is one pink tablet daily for 21 consecutive days, followed by one white inert tablet daily for 7 consecutive days, according to prescribed schedule.

Portia In Children

Safety and efficacy of Portia have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. Use of this product before menarche is not indicated.

What Drugs, Substances, or Supplements Interact with Portia?

Portia may interact with other medicines such as:

  • lamotrigine,
  • rifampin,
  • rifabutin,
  • barbiturates,
  • phenylbutazone,
  • phenytoin sodium,
  • griseofulvin,
  • topiramate,
  • some protease inhibitors,
  • modafinil,
  • St. John's wort,
  • ampicillin and other penicillins,
  • tetracycline antibiotics,
  • ascorbic acid (vitamin C),
  • acetaminophen,
  • indinavir,
  • fluconazole,
  • troleandomycin,
  • atorvastatin,
  • cyclosporine,
  • theophylline,
  • corticosteroids, and
  • HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir

Tell your doctor all medications and supplements you use.

Portia During Pregnancy and Breastfeeding

Portia is intended to prevent pregnancy and is not indicated for use during pregnancy. There is little or no increased risk of birth defects in women who inadvertently use combined oral contraceptive (COCs) during early pregnancy. Women who do not breastfeed may start COCs no earlier than four to six weeks postpartum. Small amounts of oral contraceptive steroids and/or metabolites are present in breast milk. Estrogen-containing COCs such as Portia can reduce milk production in breastfeeding mothers. Nursing mothers are advised when possible to use other forms of contraception until they have weaned their children. Consult your doctor before breastfeeding.

Additional Information

Our Portia (levonorgestrel and ethinyl estradiol kit) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Which of the following are methods for contraception? See Answer
Portia Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using birth control pills and call your doctor at once if you have:

  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, balance problems;
  • signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, swelling or redness in an arm or leg;
  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • liver problems--loss of appetite, upper stomach pain, tiredness, fever, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • increased blood pressure--severe headache, blurred vision, pounding in your neck or ears;
  • swelling in your hands, ankles, or feet;
  • changes in the pattern or severity of migraine headaches;
  • a breast lump; or
  • symptoms of depression--sleep problems, weakness, tired feeling, mood changes.

Common side effects may include:

  • nausea, vomiting (especially when you first start taking this medicine);
  • breast tenderness;
  • breakthrough bleeding;
  • acne, darkening of facial skin;
  • weight gain; or
  • problems with contact lenses.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Portia (Levonorgestrel and Ethinyl Estradiol Tablets)

SLIDESHOW

Choosing Your Birth Control Method See Slideshow
Portia Professional Information

SIDE EFFECTS

An increased risk of the following serious adverse reactions (see WARNINGS section for additional information) has been associated with the use of oral contraceptives:

Thromboembolic disorders and other vascular problems (including thrombophlebitis, arterial thromboembolism, pulmonary embolism, myocardial infarction, cerebral hemorrhage, cerebral thrombosis), carcinoma of the reproductive organs, hepatic neoplasia (including hepatic adenomas or benign liver tumors), ocular lesions (including retinal vascular thrombosis), gallbladder disease, carbohydrate and lipid effects, elevated blood pressure, and headache.

The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related:

  • Nausea
  • Vomiting
  • Gastrointestinal symptoms (such as abdominal pain, cramps and bloating)
  • Breakthrough bleeding
  • Spotting
  • Change in menstrual flow
  • Amenorrhea
  • Temporary infertility after discontinuation of treatment
  • Edema/fluid retention
  • Melasma/chloasma which may persist
  • Breast changes: tenderness, pain, enlargement, secretion
  • Change in weight or appetite (increase or decrease)
  • Change in cervical erosion and secretion
  • Diminution in lactation when given immediately postpartum
  • Cholestatic jaundice
  • Rash (allergic)
  • Mood changes, including depression
  • Vaginitis, including candidiasis
  • Change in corneal curvature (steepening)
  • Intolerance to contact lenses
  • Mesenteric thrombosis
  • Decrease in serum folate levels
  • Exacerbation of systemic lupus erythematosus
  • Exacerbation of porphyria
  • Exacerbation of chorea
  • Aggravation of varicose veins
  • Anaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms.

The following adverse reactions have been reported in users of oral contraceptives, and the association has been neither confirmed nor refuted:

  • Congenital anomalies
  • Premenstrual syndrome
  • Cataracts
  • Optic neuritis, which may lead to partial or complete loss of vision
  • Cystitis-like syndrome
  • Nervousness
  • Dizziness
  • Hirsutism
  • Loss of scalp hair
  • Erythema multiforme
  • Erythema nodosum
  • Hemorrhagic eruption
  • Impaired renal function
  • Hemolytic uremic syndrome
  • Budd-Chiari syndrome
  • Acne
  • Changes in libido
  • Colitis
  • Sickle-cell disease
  • Cerebral-vascular disease with mitral valve prolapse
  • Lupus-like syndromes
  • Pancreatitis
  • Dysmenorrhea

DRUG INTERACTIONS

Interactions between ethinyl estradiol and other substances may lead to decreased or increased serum ethinyl estradiol concentrations. Decreased ethinyl estradiol plasma concentrations may cause an increased incidence of breakthrough bleeding and menstrual irregularities and may possibly reduce efficacy of the combination oral contraceptive.

Combined hormonal contraceptives have been shown to significantly decrease plasma concentrations of lamotrigine when coadministered, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.

Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.

Reduced ethinyl estradiol concentrations have been associated with concomitant use of substances that induce hepatic microsomal enzymes, such as rifampin, rifabutin, barbiturates, phenylbutazone, phenytoin sodium, griseofulvin, topiramate, some protease inhibitors, modafinil, and possibly St. John's wort.

Substances that may decrease plasma ethinyl estradiol concentrations by other mechanisms include any substance that reduces gut transit time and certain antibiotics (e.g. ampicillin and other penicillins, tetracyclines) by a decrease of enterohepatic circulation of estrogens.

During concomitant use of ethinyl estradiol containing products and substances that may lead to decreased plasma steroid hormone concentrations, it is recommended that a nonhormonal back-up method of birth control be used in addition to the regular intake of Portia (levonorgestrel and ethinyl estradiol tablets). If the use of a substance which leads to decreased ethinyl estradiol plasma concentrations is required for a prolonged period of time, combination oral contraceptives should not be considered the primary contraceptive.

After discontinuation of substances that may lead to decreased ethinyl estradiol plasma concentrations, use of a nonhormonal backup method of birth control is recommended for 7 days. Longer use of a back-up method is advisable after discontinuation of substances that have led to induction of hepatic microsomal enzymes, resulting in decreased ethinyl estradiol concentrations. It may take several weeks until enzyme induction has completely subsided, depending on dosage, duration of use, and rate of elimination of the inducing substance.

Some substances may increase plasma ethinyl estradiol concentrations. These include:

  • Competitive inhibitors for sulfation of ethinyl estradiol in the gastrointestinal wall, such as ascorbic acid (vitamin C) and acetaminophen.
  • Substances that inhibit cytochrome P450 3A4 isoenzymes such as indinavir, fluconazole, and troleandomycin. Troleandomycin may increase the risk of intrahepatic cholestasis during co-administration with combination oral contraceptives.
  • Atorvastatin (unknown mechanism)

Ethinyl estradiol may interfere with the mechanism of other drugs by inhibiting hepatic microsomal enzymes or by inducing hepatic drug conjugation, particularly glucuronidation. Accordingly, tissue concentrations may be either increased (e.g. cyclosporine, theophylline, corticosteroids) or decreased.

The prescribing information of concomitant medications should be consulted to identify potential interactions.

Concomitant Use With HCV Combination Therapy - Liver Enzyme Elevation

Do not co-administer Portia with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations (see WARNINGS, Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment).

Read the entire FDA prescribing information for Portia (Levonorgestrel and Ethinyl Estradiol Tablets)

© Portia Patient Information is supplied by Cerner Multum, Inc. and Portia Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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