What the label lists and what reports show
Tranexamic acid side effects
Tranexamic acid's FDA label: “Most common adverse reactions are nausea, vomiting, diarrhea, allergic dermatitis, giddiness, hypotension, and thromboembolic events.” FAERS holds 8,840 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pyrexia (366 reports).
- Generic listed
- Boxed warning
Check it at the source: the tranexamic acid FDA label on DailyMed (effective September 3, 2025, Pfizer Laboratories Div Pfizer Inc); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of t ranexamic acid tablets ?Tranexamic acid tablets can cause serious side effects, including: Blood clots. You may have a higher risk of having serious blood clots if you take tranexamic acid tablets with: medicines used to help your blood form clots some medicines used to treat leukemia Eye changes. Stop taking tranexamic acid tablets and promptly report any eye problems you have while taking tranexamic acid tablets. Your doctor will refer you to an eye doctor who will examine your eyes. Allergic reaction. If you have severe shortness of breath and your throat feels tight, stop taking tranexamic acid tablets and get medical care right away. The most common side effects of tranexamic acid tablets include: Headaches Sinus and nasal problems Back pain Pain in your abdomen Pain in your muscles or joints Anemia Fatigue Tell your healthcare provider if you have any side effect that bothers you or does not go away. […]
Source: FDA drug label (Tranexamic Acid), Actavis Pharma, Inc., effective July 15, 2025 (SPL set 3f07e93b-3568-487e-894f-8f90e5a0960a), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions are nausea, vomiting, diarrhea, allergic dermatitis, giddiness, hypotension, and thromboembolic events.
Table 2. Adverse Reactions* Reported in Women with Heavy Menstrual Bleeding (Studies 1 and 2)
This table is printed in the Tranexamic Acid label published by Actavis Pharma, Inc. of July 15, 2025; the label quoted above does not print one.
| Reaction | Tranexamic Acid Tablets 3900 mg/day n (%) (N=232) | Placebo n (%) (N=139) |
|---|---|---|
| Number of Subjects with at Least One Adverse Reaction | 208 (89.7%) | 122 (87.8%) |
| Headache a | 117 (50.4%) | 65 (46.8%) |
| Nasal & sinus symptoms b | 59 (25.4%) | 24 (17.3%) |
| Back pain | 48 (20.7%) | 21 (15.1%) |
| Abdominal pain c | 46 (19.8%) | 25 (18.0%) |
| Musculoskeletal pain d | 26 (11.2%) | 4 (2.9%) |
| Arthralgia e | 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%) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: • Risk of Medication Errors Due to Incorrect Route of Administration [see Warnings and Precautions (5.1) ] • Thromboembolic Risk [see Warnings and Precautions (5.2) ] • Seizures [see Warnings and Precautions (5.3) ] • Hypersensitivity Reactions [see Warnings and Precautions (5.4) ] • Visual Disturbances [see Warnings and Precautions (5.5) ] • Dizziness [see Warnings and Precautions (5.6) ] Most common adverse reactions are nausea, vomiting, diarrhea, allergic dermatitis, giddiness, hypotension, and thromboembolic events. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of 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. Gastrointestinal disturbances (nausea, vomiting, diarrhea) may occur and may resolve with dose-reduction. Allergic dermatitis and giddiness have been reported. Hypotension has been reported when intravenous injection is too rapid.
Source: FDA drug label, Pfizer Laboratories Div Pfizer Inc, effective September 3, 2025 (SPL set 6e89a7d9-4da4-42aa-b7f8-c602c24eefe5), via openFDA; the full label on DailyMed
What do FAERS reports show?
8,840 reports list tranexamic acid among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,316 are coded as a death and 3,999 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 11 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Tranexamic acid: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions