Tranexamic acid
Pooled trials found tranexamic acid tablets cut menstrual blood loss by 47 to 53 mL a cycle more than placebo, about a 40% drop, including in women with fibroids. A hormonal IUD cut bleeding more in one small trial. Its effect on anemia is untested. A Danish cohort linked it to more clots, which pooled trials did not find.
- Status
- Prescription drug in the US. The tablet label covers the treatment of cyclic heavy menstrual bleeding in females of reproductive potential, at 1,300 mg three times a day for up to 5 days of each period. The label contraindicates use with combined hormonal contraceptives and in women with active clots or a history of clots.
- Also called
- tranexamic acid, TXA, tranexamic acid tablets, Lysteda, Cyklokapron, antifibrinolytic
- Taken for
- heavy periods, heavy menstrual bleeding, menorrhagia, bleeding from fibroids, anemia from heavy periods, a non-hormonal option for heavy periods, bleeding after childbirth, melasma
Strong several reviews agree · Moderate one review or consistent trials · Limited one or a few small studies · Untested no study in people, listed with what it rests on
Shown to help5
- StrongShown to cut menstrual blood loss by about 47 to 53 mL a cycle more than placebo in women with heavy periods, about a 40% drop on the approved dose.Very common
- ModerateShown to ease limits on social, leisure and physical activities during periods in women with heavy bleeding, compared with placebo.
- ModerateShown to lower melasma severity scores and recurrence when oral tranexamic acid was added to a triple combination cream, against the cream alone.
- LimitedOne pooled analysis of the two label trials found blood loss fell more than on placebo in women with fibroids, as it did in women without them.
- LimitedOne large trial found intravenous tranexamic acid lowered death from bleeding in women bleeding after childbirth, 1.5% against 1.9% on placebo. Hysterectomy did not change.
Reported risks6
- ModerateShown to raise headache, sinus symptoms, back pain and muscle pain slightly over placebo. Headache affected 50% on the drug and 47% on placebo.Very common
- ModerateMixed results: a Danish cohort linked oral tranexamic acid to 4 times the rate of venous clots, about 1 extra per 78,549 five-day courses. Pooled trials found no rise.How often is not known
- LimitedThe label contraindicates use with combined hormonal contraceptives, citing US postmarketing reports of venous and arterial clots in women taking both. No trial tested the combination.How often is not known
- LimitedThe label reports retinal vein and artery occlusion, impaired color vision and ligneous conjunctivitis with tranexamic acid, from postmarketing and published reports.How often is not known
- LimitedThe label warns factor IX complex concentrates, anti-inhibitor coagulant concentrates and oral tretinoin (all-trans retinoic acid) may raise clot risk with tranexamic acid.How often is not known
- LimitedCase reports: one severe allergic reaction occurred in the tablet trials, and anaphylactic shock has been reported after an intravenous dose.How often is not known
What people take it for, and what was found
Shown to help5
Heavy menstrual bleeding, against placebo
Shown to cut menstrual blood loss by about 47 to 53 mL a cycle more than placebo in women with heavy periods, about a 40% drop on the approved dose.
Compared with placebo [1][2][3][4][5]
The numbers and sources
- How common
- Very common: more than 1 in 10 people.
- Effect
- Against placebo, antifibrinolytics cut mean blood loss by 53.20 mL a cycle (95% CI 43.70 to 62.70, 4 RCTs, 565 women) and raised the share of women who improved (RR 3.34, 95% CI 1.84 to 6.09). If 11% improve without treatment, 43% to 63% improved on an antifibrinolytic [1]. A 2026 review found blood loss fell 47.0 mL more than on placebo (95% CI 37.4 to 56.6, 6 trials, I² 13%) [2]. In a network meta-analysis of first-line treatments, tranexamic acid cut blood loss by 80.32 mL a cycle against placebo (95% CI 32.98 to 127.67, moderate certainty) [3]. In the label trials, 3,900 mg a day cut blood loss by 65 mL (39%) against 7 mL (5%) on placebo over 3 cycles, and by 66 mL (38%) against 18 mL (12%) over 6 cycles. A 1,950 mg dose did not meet the trial's success criteria [4]. In the 6-cycle trial the drop was 69.6 mL (40.4%) against 12.6 mL (8.2%) [5].
- Population
- Women of reproductive age with heavy menstrual bleeding in 13 RCTs (1,312 analyzed) [1]; 17 trials of women with heavy or abnormal uterine bleeding [2]; 26 studies with 1,770 participants in the first-line network [3]; 294 and 187 evaluable women with blood loss of 80 mL or more a cycle, mean age about 40, 40% with fibroids [4][5].
- Sources
- [1], [2], [3], [4], [5]
- Caveats
- The Cochrane review rated the evidence very low to moderate quality, mainly for lack of blinding and poor reporting [1]. Women using hormonal contraception were excluded from the label trials [4].
Quality of life and daily limits from heavy periods
Shown to ease limits on social, leisure and physical activities during periods in women with heavy bleeding, compared with placebo.
Compared with placebo [2][4][5]
The numbers and sources
- Effect
- In two trials, quality of life scores improved more than on placebo (MD 0.5, 95% CI 0.4 to 0.7, I² 0%, moderate certainty) [2]. On a 1 to 5 scale of limits, social and leisure limits fell 0.98 and 0.85 points against 0.39 and 0.44 on placebo, and physical limits fell 0.94 and 0.87 against 0.34 and 0.40 [4]. Work inside and outside the home and self-perceived blood loss also improved against placebo [5].
- Population
- Women with heavy menstrual bleeding in 2 pooled trials [2]; 112 and 115 women on 3,900 mg a day against 66 and 72 on placebo [4]; 187 women in the 6-cycle trial [5].
- Sources
- [2], [4], [5]
- Caveats
- The label trials were the trials behind the drug's approval. Soiling beyond underwear (large stains) did not differ from placebo [4].
Heavy bleeding in women with fibroids
One pooled analysis of the two label trials found blood loss fell more than on placebo in women with fibroids, as it did in women without them.
Compared with placebo [6]
The numbers and sources
- Effect
- In women with and without fibroids on ultrasound, mean menstrual blood loss fell more than on placebo in every treatment cycle (p < 0.001). The reduction against placebo was larger in women with fibroids than in women without. Adverse events were similar between groups [6]. About 40% of the women in the label trials had fibroids [4].
- Population
- Women with heavy menstrual bleeding in the two pivotal phase 3 trials, with fibroids assessed by transvaginal ultrasound [6].
- Sources
- [6], [4]
- Caveats
- The abstract gives no blood loss volumes, and the full text could not be read. The trials did not report fibroid size or location, so the result may not hold for large or submucosal fibroids.
Bleeding after childbirth (intravenous)
One large trial found intravenous tranexamic acid lowered death from bleeding in women bleeding after childbirth, 1.5% against 1.9% on placebo. Hysterectomy did not change.
Compared with placebo, on top of usual care [7]
The numbers and sources
- Effect
- Death due to bleeding occurred in 155 of 10,036 women (1.5%) on tranexamic acid and 191 of 9,985 (1.9%) on placebo (RR 0.81, 95% CI 0.65 to 1.00), and 1.2% against 1.7% when given within 3 hours of birth (RR 0.69). Hysterectomy (3.6% against 3.5%) and the combined end point of death or hysterectomy did not differ. Adverse events, including clots, did not differ significantly [7].
- Population
- 20,060 women with postpartum hemorrhage in 193 hospitals in 21 countries [7].
- Sources
- [7]
- Caveats
- This is 1 g given into a vein, not the tablets. One trial, with funding that included Pfizer [7].
- Why limited
- This rests on one trial, of 20,060 people. Strength counts independent studies that agree, so one trial is limited at any size.
Melasma
Shown to lower melasma severity scores and recurrence when oral tranexamic acid was added to a triple combination cream, against the cream alone.
Compared with triple combination cream alone [8]
The numbers and sources
- Effect
- Adding oral tranexamic acid lowered the Melasma Area and Severity Index more than the cream alone (MD -3.10, 95% CI -5.85 to -0.35) and lowered recurrence (RR 0.28, 95% CI 0.16 to 0.49). Erythema and burning did not differ [8].
- Population
- 490 patients with melasma in 4 trials [8].
- Sources
- [8]
- Caveats
- Four trials. This use is outside the US tablet label, which covers heavy menstrual bleeding [4].
Mixed results2
Heavy bleeding, against other medicines
Limited evidence: more women improved on tranexamic acid than on NSAIDs or luteal progestogens, and fewer than with a hormonal IUD, in small trials.
Compared with NSAIDs, including mefenamic acid [1]; oral luteal progestogens [1]; a levonorgestrel IUD [1][3]; ethamsylate [1]; herbal medicines (Safoof Habis, Punica granatum) [1]; long-cycle progestogens and combined pills, indirectly in a network [3]
The numbers and sources
- Effect
- Against NSAIDs, tranexamic acid cut blood loss 73.00 mL a cycle more (95% CI 22.65 to 123.35, 1 RCT, 49 women) and more women improved (RR 1.43, 2 RCTs, 161 women). If 61% improve on an NSAID, 71% to 100% improved on tranexamic acid. Against progestogens, more women improved (RR 1.54, 5 RCTs, 422 women): if 46% improve on a progestogen, 61% to 83% did on tranexamic acid, with fewer adverse events (RR 0.66). Against a levonorgestrel IUD, fewer women improved (RR 0.43, 95% CI 0.24 to 0.77, 1 RCT, 42 women): if 85% improve with the IUD, 20% to 65% did on tranexamic acid [1]. In the network, the levonorgestrel IUD ranked first (MD -105.71 mL against placebo), tranexamic acid second (-80.32 mL), long-cycle progestogen third (-76.93 mL) and NSAIDs lower (-40.67 mL) [3].
- Population
- Women of reproductive age with heavy menstrual bleeding, 42 to 422 women per comparison [1]; 26 studies in the first-line network [3].
- Sources
- [1], [3]
- Caveats
- Most comparisons rest on one or two small trials rated low or very low quality [1]. The network ranks are indirect comparisons [3].
Anemia and hemoglobin
Limited evidence: trials have not reported whether tranexamic acid changes hemoglobin, and one small trial was too imprecise to show an effect on anemia.
Compared with placebo or standard care [2]
The numbers and sources
- Effect
- Of 17 trials, none reported adequate data on hemoglobin concentration. For anemia, one small trial contributed data (RR 0.15, 95% CI 0.01 to 2.74, very low certainty) [2].
- Population
- Women of reproductive age with normal or abnormal uterine bleeding in 17 randomized trials [2].
- Sources
- [2]
- Caveats
- The interval is so wide that both a large benefit and none are possible. The review's authors call for trials in menstruating women with anemia [2].
Doses studied
The label trials used 1,300 mg three times a day (3,900 mg a day) for up to 5 days during each period, over 3 or 6 cycles, and the label lowers the dose when serum creatinine is above 1.4 mg/dL. A 1,950 mg daily dose was also tested and did not meet the trial's success criteria [4]. The postpartum trial gave 1 g intravenously, with a second 1 g dose if bleeding continued after 30 minutes or restarted within 24 hours [7]. The pooled melasma abstract does not give the doses its trials used [8].
Risks
Reported risks5
Common side effects
Shown to raise headache, sinus symptoms, back pain and muscle pain slightly over placebo. Headache affected 50% on the drug and 47% on placebo.
The numbers and sources
- How common
- Very common: more than 1 in 10 people.
- Effect
- In the two label trials, headache affected 50.4% on 3,900 mg a day and 46.8% on placebo, nasal and sinus symptoms 25.4% and 17.3%, back pain 20.7% and 15.1%, abdominal pain 19.8% and 18.0%, musculoskeletal pain 11.2% and 2.9%, joint pain 6.9% and 5.0%, muscle cramps 6.5% and 5.8%, migraine 6.0% and 5.8%, anemia 5.6% and 3.6%, and fatigue 5.2% and 4.3%. In a 27-cycle open-label study, 12.4% withdrew for adverse reactions [4]. Overall adverse events did not differ from placebo in one trial (RR 1.05, 95% CI 0.93 to 1.18) and were less common than on progestogens (RR 0.66) [1]. Nausea or vomiting did not differ from placebo (RR 1.0, 95% CI 0.6 to 1.8, 4 trials) [2].
- Population
- 232 women on 3,900 mg a day and 139 on placebo; 781 women in the long-term study [4]; women in the trials pooled in [1] and [2].
- Sources
- [4], [1], [2]
- Caveats
- Most events were mild to moderate [5]. Rates near placebo mean most of these were not caused by the drug.
Use with combined hormonal birth control
The label contraindicates use with combined hormonal contraceptives, citing US postmarketing reports of venous and arterial clots in women taking both. No trial tested the combination.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- The label states the clot risk of combined hormonal contraceptives may increase further with tranexamic acid, and is of particular concern in women who are obese or smoke, especially smokers over 35. Women using combined hormonal contraception were excluded from the clinical trials, and there are no trial data on the combination. The label cites US postmarketing reports of venous and arterial clots in women using both [4].
- Population
- Postmarketing reports summarized in the label [4].
- Sources
- [4]
- Caveats
- Reports without a denominator cannot give a rate. The contraindication names combined (estrogen-containing) methods.
Eye problems and retinal clots
The label reports retinal vein and artery occlusion, impaired color vision and ligneous conjunctivitis with tranexamic acid, from postmarketing and published reports.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- The label states retinal venous and arterial occlusion have been reported, and that ligneous conjunctivitis resolved after the drug was stopped. Postmarketing reports include impaired color vision and other visual disturbances [4].
- Population
- Postmarketing reports summarized in the label [4].
- Sources
- [4]
- Caveats
- Reports without a denominator. No rate is available.
Use with clotting concentrates or oral tretinoin
The label warns factor IX complex concentrates, anti-inhibitor coagulant concentrates and oral tretinoin (all-trans retinoic acid) may raise clot risk with tranexamic acid.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- In a study of 28 patients with acute promyelocytic leukemia, all 4 given all-trans retinoic acid with intravenous tranexamic acid died, 3 of them from clots. The label does not recommend tranexamic acid with factor IX complex concentrates or anti-inhibitor coagulant concentrates [4].
- Population
- 28 patients with acute promyelocytic leukemia, and label statements [4].
- Sources
- [4]
- Caveats
- Four patients in one small study. A share counted in so few people is not a rate.
Severe allergic reaction
Case reports: one severe allergic reaction occurred in the tablet trials, and anaphylactic shock has been reported after an intravenous dose.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- One woman in the trials had shortness of breath, throat tightening and facial flushing that needed emergency care. A case of anaphylactic shock after an intravenous bolus is reported in the literature [4].
- Population
- Trial participants and published case reports summarized in the label [4].
- Sources
- [4]
- Caveats
- Single cases. No rate is available.
Mixed results1
Blood clots
Mixed results: a Danish cohort linked oral tranexamic acid to 4 times the rate of venous clots, about 1 extra per 78,549 five-day courses. Pooled trials found no rise.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- In 2.0 million Danish women aged 15 to 49, venous clots occurred at 11.8 per 10,000 person-years during oral tranexamic acid use and 2.5 during non-use (adjusted IRR 4.0, 95% CI 1.8 to 8.8). Arterial clots did not differ (IRR 1.3, 95% CI 0.4 to 4.2). The number needed to harm was 78,549 women per 5 days of treatment [9]. In a UK case-control study of women with heavy periods, the odds ratio for recent use was 3.20 (95% CI 0.65 to 15.78), not significant, while mefenamic acid (OR 5.54) and norethisterone (OR 2.41) and a diagnosis of anemia (OR 2.23) were also linked to clots [10]. In 22 randomized trials of non-surgical bleeding (49,538 patients), tranexamic acid did not raise deep vein thrombosis (RR 0.99, 95% CI 0.70 to 1.41), pulmonary embolism (RR 0.97), stroke (RR 1.10) or heart attack (RR 0.88) [11]. In heavy menstrual bleeding trials, one clot was reported across two trials that recorded clots [1], and one in a control arm in a 2026 review [2].
- Population
- 63,896 Danish women who filled prescriptions, among 2.0 million followed 13.8 million person-years [9]; 134 cases and 552 controls in the UK General Practice Research Database [10]; 49,538 patients in 22 RCTs, mostly not menstrual bleeding [11]; women in heavy menstrual bleeding trials [1][2].
- Sources
- [9], [10], [11], [1], [2]
- Caveats
- The cohort and case-control studies are observational, and heavy bleeding itself may raise clot risk (confounding by indication) [10]. The pooled trials were mostly not of menstrual use, and the menstrual trials were too small to detect rare clots [1][11]. The label contraindicates use in women with active clots or a history of clots, including retinal vein or artery occlusion [4].
Possible, not studied in people1
Use in pregnancy
Not studied in people as a pregnancy treatment. Animal reproduction studies found no adverse developmental outcomes, and the drug crosses the placenta.
No study in people. This rests on animal studies.
The numbers and sources
- Effect
- The label states there are no data on tablet use in pregnant women to evaluate birth defects, miscarriage or other outcomes, that the drug is not indicated in pregnancy, and that animal reproduction studies did not identify adverse developmental outcomes. Cord blood levels after an intravenous dose matched maternal levels [4].
- Population
- Animal reproduction studies and pharmacokinetic data summarized in the label [4].
- Sources
- [4]
- Caveats
- Animal data do not show what happens in human pregnancy. The postpartum trial gave the drug after birth, not during pregnancy [7].
Claims tested and not found
- That tranexamic acid stops soaking through to clothing. In both label trials, the share of women with fewer large stains did not differ significantly from placebo (64% against 52%, and 57% against 51%) [4].
- That tranexamic acid tablets commonly upset the stomach. Gastrointestinal adverse events were comparable with placebo in the 6-cycle trial [5], and nausea or vomiting did not differ from placebo across 4 trials (RR 1.0) [2].
Related
Sources
- Bryant-Smith AC, Lethaby A, Farquhar C, et al. Antifibrinolytics for heavy menstrual bleeding. Cochrane Database of Systematic Reviews. 2018. https://doi.org/10.1002/14651858.cd000249.pub2
- Berendes S, Ker K, Critchley HOD, et al. Tranexamic acid for anemia in women of reproductive age: A systematic review of randomized trials. PLOS One. 2026. https://doi.org/10.1371/journal.pone.0362488
- Bofill Rodriguez M, Dias S, Jordan V, et al. Interventions for heavy menstrual bleeding; overview of Cochrane reviews and network meta-analysis. Cochrane Database of Systematic Reviews. 2022. https://doi.org/10.1002/14651858.cd013180.pub2
- US Food and Drug Administration label. Tranexamic acid tablets, for oral use (Nordic Pharma). DailyMed. 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=031bf7c2-3b07-469d-bc5a-31fc6238e25f
- Lukes AS, Moore KA, Muse KN, et al. Tranexamic acid treatment for heavy menstrual bleeding: a randomized controlled trial. Obstetrics & Gynecology. 2010. https://doi.org/10.1097/aog.0b013e3181f20177
- Eder S, Baker J, Gersten J, et al. Efficacy and safety of oral tranexamic acid in women with heavy menstrual bleeding and fibroids. Women's Health. 2013. https://doi.org/10.2217/whe.13.28
- WOMAN Trial Collaborators (Shakur H, Roberts I, et al.). Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial. The Lancet. 2017. https://doi.org/10.1016/s0140-6736(17)30638-4
- Ribeiro Gonçalves O, de Souza MCF, Rocha AV, et al. Assessing the efficacy of oral tranexamic acid as an adjuvant to triple combination topical treatment in melasma: a meta-analysis of randomized controlled trials. Clinical and Experimental Dermatology. 2024. https://doi.org/10.1093/ced/llae226
- Meaidi A, Mørch L, Torp-Pedersen C, et al. Oral tranexamic acid and thrombosis risk in women. EClinicalMedicine. 2021. https://doi.org/10.1016/j.eclinm.2021.100882
- Sundström A, Seaman H, Kieler H, et al. The risk of venous thromboembolism associated with the use of tranexamic acid and other drugs used to treat menorrhagia: a case-control study using the General Practice Research Database. BJOG. 2009. https://doi.org/10.1111/j.1471-0528.2008.01926.x
- Chornenki NLJ, Um KJ, Mendoza PA, et al. Risk of venous and arterial thrombosis in non-surgical patients receiving systemic tranexamic acid: A systematic review and meta-analysis. Thrombosis Research. 2019. https://doi.org/10.1016/j.thromres.2019.05.003