"Investigators from the Women's Health Initiative (WHI) Hormone Trials are reaffirming conclusions that hormone therapy is not recommended for the prevention of chronic disease, but may remain a reasonable option for the short-term management "...
Lysteda Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Lysteda (tranexamic acid) is used to treat heavy bleeding during the menstrual period. It is an antifibrinolytic. Common side effects include nausea, vomiting, diarrhea, and muscle pain.
The recommended dose of Lysteda for women with normal renal function is two 650 mg tablets taken three times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation. Lysteda may interact with blood thinners, drugs that prevent bleeding, tretinoin, drugs that can cause blood clots, or pain relievers/fever reducers (NSAIDs such as aspirin, ibuprofen, naproxen). Low-dose aspirin should be continued if prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention. Tell your doctor all medications and supplements you use. Lysteda is usually used during a menstrual period and is unlikely to be used during pregnancy. During pregnancy, this medication should be used only when prescribed. This drug passes into breast milk. Consult your doctor before breastfeeding.
Our Lysteda (tranexamic acid) 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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Lysteda in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop taking Lysteda and call your doctor at once if you have a serious side effect such as:
- problems with your vision (including color vision);
- sudden numbness or weakness, especially on one side of the body;
- sudden headache, confusion, problems with vision, speech, or balance;
- sudden chest pain or trouble breathing;
- pain or swelling in one or both legs;
- migraine headache;
- pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
- feeling like you might pass out.
Less serious side effects include:
- mild headache;
- runny or stuffy nose;
- stomach pain;
- tired feeling;
- eye redness; or
- back pain, joint or muscle pain.
Read the entire detailed patient monograph for Lysteda (Tranexamic Acid Tablets)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Lysteda Overview - Patient Information: Side Effects
Nausea, vomiting, diarrhea, and muscle pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: eye/eyelid problems.
Although unlikely, this medication may cause serious blood clot problems. Stop taking tranexamic acid and get medical help right away if any of these unlikely but serious side effects occur: coughing up blood, fainting, pain/swelling/warmth in the groin/calf, swelling/weakness/redness/pain in the arms/legs, signs of a stroke (such as weakness on one side of the body, slurred speech, sudden vision changes, confusion), change in the amount of urine, vision changes (such as color vision changes, decreased vision/blindness).
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Lysteda (Tranexamic Acid Tablets)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Lysteda FDA Prescribing Information: Side Effects
Clinical Trial 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.
The safety of LYSTEDA in the treatment of heavy menstrual bleeding (HMB) was studied in two randomized, double-blind, placebo-controlled studies [see Clinical Studies]. One study compared the effects of two doses of LYSTEDA (1950 mg and 3900 mg given daily for up to 5 days during each menstrual period) versus placebo over a 3-cycle treatment duration. A total of 304 women were randomized to this study, with 115 receiving at least one dose of 3900 mg/day of LYSTEDA. A second study compared the effects of LYSTEDA (3900 mg/day) versus placebo over a 6-cycle treatment duration. A total of 196 women were randomized to this study, with 117 receiving at least one dose of LYSTEDA. In both studies, subjects were generally healthy women who had menstrual blood loss of ≥ 80 mL.
In these studies, subjects were 18 to 49 years of age with a mean age of approximately 40 years, had cyclic menses every 21-35 days, and a BMI of approximately 32 kg/m² . On average, subjects had a history of HMB for approximately 10 years and 40% had fibroids as determined by transvaginal ultrasound. Approximately 70% were Caucasian, 25% were Black, and 5% were Asian, Native American, Pacific Islander, or Other. Seven percent (7%) of all subjects were of Hispanic origin. Women using hormonal contraception were excluded from the trials.
The rates of discontinuation due to adverse events during the two clinical trials were comparable between LYSTEDA and placebo. In the 3-cycle study, the rate in the 3900 mg LYSTEDA dose group was 0.8% as compared to 1.4% in the placebo group. In the 6-cycle study, the rate in the LYSTEDA group was 2.4% as compared to 4.1% in the placebo group. Across the studies, the combined exposure to 3900 mg/day LYSTEDA was 947 cycles and the average duration of use was 3.4 days per cycle.
A list of adverse events occurring in ≥ 5% of subjects and more frequently in LYSTEDA treated subjects receiving 3900 mg/day compared to placebo is provided in Table 2.
Table 2: Adverse Events Reported by ≥ 5% of
Subjects Treated with LYSTEDA and More Frequently in LYSTEDA-treated Subjects
|LYSTEDA 3900 mg/day
|Total Number of Adverse Events||1500||923|
|Number of Subjects with at Least One Adverse Event||208 (89.7%)||122 (87.8%)|
|HEADACHEa||117 (50.4%)||65 (46.8%)|
|NASAL & SINUS SYMPTOMSb||59 (25.4%)||24 (17.3%)|
|BACK PAIN||48 (20.7%)||21 (15.1%)|
|ABDOMINAL PAINc||46 (19.8%)||25 (18.0%)|
|MUSCULOSKELETAL PAINd||26 (11.2%)||4 (2.9%)|
|ARTHRALGIe||16 (6.9%)||7 (5.0%)|
|MUSCLE CRAMPS & SPASMS||15 (6.5%)||8 (5.8%)|
|MIGRAINE||14 (6.0%)||8 (5.8%)|
|ANEMIA||13 (5.6%)||5 (3.6%)|
|FATIGUE||12 (5.2%)||6 (4.3%)|
|aIncludes headache and tension headache
bNasal and sinus symptoms include nasal, respiratory tract and sinus congestion, sinusitis, acute sinusitis, sinus headache, allergic sinusitis and sinus pain, and multiple allergies and seasonal allergies
cAbdominal pain includes abdominal tenderness and discomfort
dMusculoskeletal pain includes musculoskeletal discomfort and myalgia
eArthralgia includes joint stiffness and swelling
Long-term safety of LYSTEDA was studied in two open-label studies. In one study, subjects with physician-diagnosed heavy menstrual bleeding (not using the alkaline hematin methodology) were treated with 3900 mg/day for up to 5 days during each menstrual period for up to 27 menstrual cycles. A total of 781 subjects were enrolled and 239 completed the study through 27 menstrual cycles. A total of 12.4% of the subjects withdrew due to adverse events. Women using hormonal contraception were excluded from the study. The total exposure in this study to 3900 mg/day LYSTEDA was 10,213 cycles. The average duration of LYSTEDA use was 2.9 days per cycle.
A long-term open-label extension study of subjects from the two short-term efficacy studies was also conducted in which subjects were treated with 3900 mg/day for up to 5 days during each menstrual period for up to 9 menstrual cycles. A total of 288 subjects were enrolled and 196 subjects completed the study through 9 menstrual cycles. A total of 2.1% of the subjects withdrew due to adverse events. The total exposure to 3900 mg/day LYSTEDA in this study was 1,956 cycles. The average duration of LYSTEDA use was 3.5 days per cycle.
The types and severity of adverse events in these two long-term open-label trials were similar to those observed in the double-blind, placebo-controlled studies although the percentage of subjects reporting them was greater in the 27-month study, most likely because of the longer study duration.
A case of severe allergic reaction to LYSTEDA was reported in the extension trial, involving a subject on her fourth cycle of treatment, who experienced dyspnea, tightening of her throat, and facial flushing that required emergency medical treatment.
The following adverse reactions have been identified from postmarketing experience with tranexamic acid. 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.
Based on US and worldwide postmarketing reports, the following have been reported in patients receiving tranexamic acid for various indications:
- Nausea, vomiting, and diarrhea
- Allergic skin reactions
- Anaphylactic shock and anaphylactoid reactions
- Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, cerebral thrombosis, acute renal cortical necrosis, and central retinal artery and vein obstruction); cases have been associated with concomitant use of combination hormonal contraceptives
- Impaired color vision and other visual disturbances
Read the entire FDA prescribing information for Lysteda (Tranexamic Acid Tablets)
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