What the label lists and what reports show
Argatroban side effects
Argatroban's FDA label: “The most common (>5%) adverse reactions were dyspnea, hypotension, fever, diarrhea, sepsis, and cardiac arrest.” FAERS holds 1,496 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 international normalised ratio increased (110 reports).
- Generic listed
Check it at the source: the argatroban FDA label on DailyMed (effective May 3, 2026, Hikma Pharmaceuticals USA Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common (>5%) adverse reactions were dyspnea, hypotension, fever, diarrhea, sepsis, and cardiac arrest.
Table 5 Non-hemorrhagic Adverse Reactions in Patients a With HIT b
| Reaction | Argatroban-treated Patients (Study 1 and Study 2) (n = 568) % | Historical Control c (n = 193) % |
|---|---|---|
| Dyspnea | 8.1 | 8.8 |
| Hypotension | 7.2 | 2.6 |
| Fever | 6.9 | 2.1 |
| Diarrhea | 6.2 | 1.6 |
| Sepsis | 6.0 | 12.4 |
| Cardiac arrest | 5.8 | 3.1 |
| Nausea | 4.8 | 0.5 |
| Ventricular tachycardia | 4.8 | 3.1 |
| Pain | 4.6 | 3.1 |
| Urinary tract infection | 4.6 | 5.2 |
| Vomiting | 4.2 | 0 |
| Infection | 3.7 | 3.6 |
| Pneumonia | 3.3 | 9.3 |
| Atrial fibrillation | 3.0 | 11.4 |
| Coughing | 2.8 | 1.6 |
| Abnormal renal function | 2.8 | 4.7 |
| Abdominal pain | 2.6 | 1.6 |
| Cerebrovascular disorder | 2.3 | 4.1 |
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 adverse reaction is also discussed in other sections of the labeling: Risk of Hemorrhage [see Warnings and Precautions (5.1) ]. HIT patients: The most common (>5%) adverse reactions were dyspnea, hypotension, fever, diarrhea, sepsis, and cardiac arrest. (6.1) PCI patients: The most common (>5%) adverse reactions were chest pain, hypotension, back pain, nausea, vomiting and headache. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-233-2001 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Adverse Reactions in Patients with HIT (With or Without Thrombosis) 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 rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following safety information is based on all 568 patients treated with argatroban in Study 1 and Study 2. The safety profile of the patients from these studies is compared with that of 193 historical controls in which the adverse reactions were collected retrospectively. Adverse reactions are separated into hemorrhagic and non-hemorrhagic reactions. …
Source: FDA drug label, Hikma Pharmaceuticals USA Inc., effective May 3, 2026 (SPL set 0cdf3f67-5bf3-4d58-b330-03febdc652bf), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,496 reports list argatroban among the medicines taken, each a report of something that happened, not proof the medicine caused it; 318 are coded as a death and 636 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 19 reactions below, 7 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?
- Argatroban: 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