FDA Adverse Events Reports (FAERS) Summary for CYKLOKAPRON

These tables and charts are based on 537 total reports for CYKLOKAPRON (TRANEXAMIC ACID) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through July 30, 2026.

This FAERS total includes 536 pharmaceutical company-submitted and non-U.S. FAERS reports and 1 U.S. consumer or healthcare provider-submitted MedWatch reports. Adverse events listed on this page represent serious and sometimes rare adverse events reported to pharmaceutical companies, and often do not represent typical side effects for the medication. Find common side effects in the most recent official drug label.

Top 20 Adverse Effects Associated with CYKLOKAPRON (reported in FAERS Database)

	Side Effect	# of FDA Reports
1	NAUSEA	33
2	OFF LABEL USE	28
3	PULMONARY EMBOLISM	28
4	FEVER	28
5	FATIGUE	27
6	BLEEDING	24
7	VOMITING	23
8	DRUG INEFFECTIVE	22
9	FEBRILE NEUTROPENIA	22
10	DIZZINESS	20
11	ANEMIA	19
12	LOW BLOOD PRESSURE	19
13	PAIN	19
14	PNEUMONIA	18
15	THROMBOCYTOPENIA	18
16	SHORTNESS OF BREATH	17
17	NOSEBLEED	16
18	HEADACHE	15
19	CONFUSIONAL STATE	14
20	COUGH	14
21	DEATH	14
22	SWELLING OF LIMBS	14
23	TOXICITY TO VARIOUS AGENTS	14
24	DIARRHEA	13
25	INTENTIONAL OVERDOSE	13
26	INTENTIONAL SELF-INJURY	13
27	MALAISE	13
28	WEIGHT DECREASED	13
29	GASTROINTESTINAL BLEEDING	12
30	HYPOVENTILATION	12
31	JOINT PAIN	11
32	DRUG INTERACTION	11
33	FALL	11
34	HEREDITARY ANGIOEDEMA	11
35	HYPOKALAEMIA	11
36	INFECTION	11
37	HEART ATTACK (MYOCARDIAL INFARCTION)	11
38	ABDOMINAL PAIN	10
39	BLOOD PRESSURE DECREASED	10
40	C-REACTIVE PROTEIN INCREASED	10
41	COVID-19	10
42	GENERAL PHYSICAL HEALTH DETERIORATION	10
43	HYPERSENSITIVITY	10
44	MUSCLE SPASMS	10
45	PANCYTOPENIA	10
46	FAINTING	10
47	STROKE	9
48	BRUISING	9
49	HAEMOGLOBIN DECREASED	9
50	INSOMNIA	9
51	METABOLIC ACIDOSIS	9
52	PRODUCT USE IN UNAPPROVED INDICATION	9
53	STRESS	9
54	ARRHYTHMIA	8
55	CONVULSION	8
56	GAIT DISTURBANCE	8
57	HIGH BLOOD PRESSURE	8
58	HYPONATRAEMIA	8
59	MUSCLE TWITCHING	8
60	PLATELET COUNT DECREASED	8
61	KIDNEY IMPAIRMENT	8
62	TREMOR	8
63	HIVES	8
64	ACUTE KIDNEY INJURY	7
65	COMMUNICATION DISORDER (APHASIA)	7
66	LACK OF STRENGTH AND ENERGY (ASTHENIA)	7
67	BLOOD PRESSURE INCREASED	7
68	STROKE	7
69	CHEST PAIN	7
70	CONGENITAL ORAL MALFORMATION	7
71	CONSTIPATION	7
72	FEELING ABNORMAL	7
73	HALLUCINATION	7
74	HEART RATE INCREASED	7
75	LOSS OF CONSCIOUSNESS	7
76	MESENTERIC VASCULAR INSUFFICIENCY	7
77	OXYGEN SATURATION DECREASED	7
78	PALPITATIONS	7
79	PRODUCT USE ISSUE	7
80	KIDNEY FAILURE	7
81	URINARY TRACT INFECTION	7
82	ANAPHYLACTIC REACTION	6
83	CHILLS	6
84	DECREASED APPETITE	6
85	COUGHING UP BLOOD	6
86	NUMBNESS	6
87	INFLUENZA	6
88	MUSCLE PAIN	6
89	COMMON COLD	6
90	LOW WHITE BLOOD CELL COUNTS	6
91	SEPSIS	6
92	VASCULITIS	6
93	WEIGHT INCREASED	6
94	WOUND	6
95	ABDOMINAL PAIN UPPER	5
96	HEART ATTACK	5
97	AGGRESSION	5
98	BRONCHITIS	5
99	HEART FAILURE	5
100	BRUISE	5

Latest Known Outcomes for Reactions Reported for CYKLOKAPRON

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	208
2	Patient recovered	201
3	Patient has not recovered/symtoms have not resolved	107
4	Patient died	73
5	Patient is recovering/symptoms resolving	47
6	Patient has recovered but has consequent health issues	28

Yearly FDA Adverse Event Reports (Table)

Year	Number of Reports
2004	4
2005	7
2006	2
2007	7
2008	6
2009	14
2010	14
2011	15
2012	29
2013	29
2014	26
2015	22
2016	15
2017	41
2018	41
2019	51
2020	37
2021	50
2022	33
2023	27
2024	34
2025	24
2026	9

Reports by Patient Age Group (Table)

Age Group	Number of Reports
0-10	17
11-20	17
21-30	22
31-40	45
41-50	59
51-60	50
61-70	78
71-80	71
81-90	30
91+	7

Based on 396 reports that included a patient age.

CYKLOKAPRON Total Reports

Male	Female	Unknown	Total
189	275	73	537

Top Countries Reporting

	Country	Number of Reports
1	Sweden	82
2	Germany	66
3	Canada	63
4	Switzerland	47
5	United States	43
6	Norway	37
7	Netherlands	35
8	EU	17
9	Austria	10
10	Australia	8

Outcomes for Reports

Serious: 510
Not Serious: 27
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Top Indications

Top Companies Reporting

Safety-Related FDA Updates

FDA Approval Date: 1986-12-30

CYKLOKAPRON (TRANEXAMIC ACID) Rx Drug:
Safety-related Labeling Changes

Have experience (good or bad) with CYKLOKAPRON? Rate CYKLOKAPRON at Ask a Patient.

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

Notes

Events listed on this page represent serious and often rare adverse events reported to pharmaceutical companies, and do not represent typical side effects for the medication. Find common side effects on the most recent official drug label This report, created by AskaPatient.com, is derived from the cases for CYKLOKAPRON reported to the United States Food and Drug Administration (FDA) FDA Safety Information and Adverse Event Reporting System (FAERS) and obtained from Open FDA. Data was last updated with reports received through July 30, 2026.

This summary includes ALL reports where the drug is a "primary OR secondary OR suspected interacting" drug. Typically, reports are filed for the most serious type or "event" and do not represent incidental or minor side effects. The majority of these reports are mandatory reports submitted by pharmaceutical companies, who receive complaints from consumers. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event. This report also features counts of latest known outcomes associated with reported side effects, but does not provide the specific outcomes for specific adverse events.

Adverse Event Reports are submitted to the FAERS database by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers). Health care providers such as doctors (voluntary reporting), and patients themselves (voluntary reporting) report to the FDA directly through the MedWatch program. Those MedWatch reports are coded and included in the FAERS database. This report mainly consists of the mandatory reports, because the MedWatch reports are a small percentage (3 - 5%) of total reports. Link to the MedWatch summary report at the top of the page for a summary of the directly reported (voluntary) adverse events for this drug.The number of reports included here might differ somewhat from the number of reports in the downloadable quarterly FAERS reports and in the online FAERS dashboard, due to lags in reporting, drug name differences, duplicates, and other factors. Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions or comments about this report.