Balcoltra Side Effects Center

Last updated on RxList: 6/1/2022
Balcoltra Side Effects Center

What Is Balcoltra?

Balcoltra (levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets) is a progestin/estrogen combined oral contraceptive (COC) indicated for use by females of reproductive potential to prevent pregnancy.

What Are Side Effects of Balcoltra?

Common side effects of Balcoltra include:

  • headache,
  • abnormal menstrual bleeding,
  • menstrual cramping,
  • nausea,
  • abdominal pain,
  • breast pain,
  • mood changes,
  • acne,
  • depression,
  • missed menstrual periods, and
  • vaginal yeast infection

Cigarette smoking increases the risk of serious cardiovascular side effects from use of oral contraceptives such as Balcoltra. Women who use oral contraceptives including Balcoltra are strongly advised not to smoke.

Dosage for Balcoltra

The dose of Balcoltra is one tablet taken by mouth at the same time every day. Take Balcoltra tablets in the order directed on the blister pack.

What Drugs, Substances, or Supplements Interact with Balcoltra?

Balcoltra may interact with henytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, St. John's wort, colesevelam, atorvastatin, rosuvastatin, azole antifungals, grapefruit juice, HIV/HCV protease inhibitors, HCV drug combinations containing ombitasvir/ paritaprevir/ritonavir (with or without dasabuvir), non-nucleoside reverse transcriptase inhibitors (NNRTIs), cyclosporine, prednisolone, theophylline, tizanidine, acetaminophen, clofibric acid, morphine, salicylic acid, temazepam, and lamotrigine, or thyroid hormone replacement therapy. Tell your doctor all medications and supplements you use.

Balcoltra During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Balcoltra.

Additional Information

Discontinue Balcoltra if pregnancy occurs. Balcoltra passes into breast milk and may reduce milk production. Nursing women are advised to use other methods of contraception until the child is weaned.

Our Balcoltra (levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets) for Oral Administration 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.

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Balcoltra Consumer Information

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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 Balcoltra (Levonorgestrel and Ethinyl Estradiol and Ferrous Bisglycinate Tablets )

QUESTION

Which of the following are methods for contraception? See Answer
Balcoltra Professional Information

SIDE EFFECTS

The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:

  • Serious cardiovascular events and stroke [see BOXED WARNING and WARNINGS AND PRECAUTIONS]
  • Vascular events [see WARNINGS AND PRECAUTIONS]
  • Liver disease [see WARNINGS AND PRECAUTIONS]

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 the rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In a clinical trial with levonorgestrel 0.1 mg and ethinyl estradiol 0.02 mg tablets, a total of 1477 healthy women of child-bearing potential were enrolled and had 7870 cycles of exposure. Of these, 792 subjects had completed 6 cycles of treatment. The women ranged in age from 17 to 49 years and 87% were Caucasian.

Common Adverse Reactions (≥ 2% of women)
  • headache (14%)
  • metrorrhagia (8%)
  • dysmenorrhea (7%)
  • nausea (7%)
  • abdominal pain (4%)
  • breast pain (4%)
  • emotional lability (3%)
  • acne (3%)
  • depression (2%)
  • amenorrhea (2%)
  • vaginal moniliasis (2%)

At the time of the report, 133 (9%) subjects had withdrawn from the study due to adverse events. The most frequent were due to headache and metrorrhagia (1% each). Other adverse events occurring in < 1% of those who discontinued included amenorrhea, depression, emotional lability, hypertension, acne, menorrhagia, nausea, hypercholesterolemia, weight gain, dysmenorrhea, and flatulence. All other reasons for discontinuation were reported by 3 or fewer subjects.

Postmarketing Experience

Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 - 1.12 (Figure 1).

Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 1). One of these studies reported no association between breast cancer risk and COC use. The other two studies found an increased relative risk of 1.19 - 1.33 with current or recent use. Both of these studies found an increased risk of breast cancer with current use of longer duration, with relative risks ranging from 1.03 with less than one year of COC use to approximately 1.4 with more than 8-10 years of COC use.

Figure 1: Relevant Studies of Risk of Breast Cancer with Combined Oral Contraceptives

BALCOLTRA® (levonorgestrel and ethinyl estradiol tablets and ferrous
bisglycinate tablets) for oral administration Structural Formula - Illustration

RR = relative risk; OR = odds ratio; HR = hazard ratio. “ever COC” are females with current or past COC use; “never COC use” are females that never used COCs.

The following additional adverse drug reactions have been reported from worldwide postmarketing experience with levonorgestrel 0.1 mg and ethinyl estradiol 0.02 mg tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiac disorder: chest pain, dyspnea, palpitations

Gastrointestinal disorders: abdominal pain, nausea, vomiting, diarrhea

General disorders and administration site conditions: chest pain, fatigue, pain, malaise, injection site pain or erythema, feeling abnormal, pyrexia, condition aggravated, asthenia

Immune system disorders: hypersensitivity reactions, including pruritus, rash, urticaria, erythema

Injury, poisoning, and procedural complications: injury

Investigations: weight decreased

Musculoskeletal and connective tissue disorders: pain in extremity, arthralgia, back pain, muscle spasm

Nervous system disorders: headache, migraine, dizziness, hypoesthesia, paresthesia

Psychiatric disorders: depression, insomnia, anxiety

Reproductive system and breast disorders: metrorrhagia, menorrhagia, hot flush, vaginal hemorrhage

Respiratory, thoracic, and mediastinal disorders: nasopharyngitis, cough

Sleep disorders and disturbances: somnolence

Vascular disorders: deep vein thrombosis, pulmonary embolism

DRUG INTERACTIONS

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

Effects Of Other Drugs On Combined Oral Contraceptives

Substances Decreasing The Plasma Concentrations Of COCs And Potentially Diminishing The Efficacy Of COCs

Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of COCs and potentially diminish the effectiveness of COCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John's wort. Interactions between hormonal contraceptives and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use an alternative method of contraception or a back-up method when enzyme inducers are used with COCs, and to continue back-up contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability.

Colesevelam: Colesevelam, a bile acid sequestrant, given together with a COC, has been shown to significantly decrease the AUC of ethinyl estradiol (EE). The drug interaction between the contraceptive and colesevelam was decreased when the two drug products were given 4 hours apart.

Substances Increasing The Plasma Concentrations Of COCs

Co-administration of atorvastatin or rosuvastatin and certain COCs containing EE increase AUC values for EE by approximately 20-25%. Ascorbic acid and acetaminophen may increase plasma EE concentrations, possibly by inhibition of conjugation. CYP3A4 inhibitors, such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase plasma hormone concentrations.

Human Immunodeficiency Virus (HIV)/ Hepatitis C Virus (HCV) Protease Inhibitors And Nonnucleoside

Reverse Transcriptase Inhibitors

Significant changes (increase or decrease) in the plasma concentrations of estrogen and/or progestin have been noted in some cases of co-administration with HIV/HCV protease inhibitors and non-nucleoside reverse transcriptase inhibitors (decrease [e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, tipranavir/ritonavir, boceprevir, telaprevir, nevirapine and efavirenz] or increase [e.g., indinavir, atazanavir/ritonavir and etravirine]).

Effects Of Combined Oral Contraceptives On Other Drugs

Combined oral contraceptives containing EE may inhibit the metabolism of other compounds (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole) and increase their plasma concentrations. Combined oral contraceptives have been shown to decrease plasma concentrations of acetaminophen, clofibric acid, morphine, salicylic acid, temazepam and lamotrigine. Significant decrease in plasma concentration of lamotrigine has been shown, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.

Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because the serum concentration of thyroid-binding globulin increases with use of COCs [see WARNINGS AND PRECAUTIONS].

Concomitant Use With HCV Combination Therapy - Liver Enzyme Elevation

Do not co-administer Balcoltra with HCV drug combinations containing ombitasvir/ paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations [see WARNINGS AND PRECAUTIONS].

Interactions With Laboratory Tests

The use of contraceptive steroids may influence the results of certain laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins.

Read the entire FDA prescribing information for Balcoltra (Levonorgestrel and Ethinyl Estradiol and Ferrous Bisglycinate Tablets )

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

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