From the FDA Drug Label
The complete spectrum of side effects induced by LITHOSTAT ® (acetohydroxamic acid) is unknown. However, some side effects which have been reported to date have been headaches, abdominal discomfort, nausea, loss of hair, shakiness, and anemia. Lifethreatening problems (blood clot in the legs) occurred in several patients with advanced disease in early investigation. A flushing skin reaction (i.e., redness, warmth, and tingling) has occurred in several patients who consumed alcohol during treatment with LITHOSTAT ®. In animal studies doses of LITHOSTAT ®about 20 times the maximum human dose have caused fetal abnormalities (birth defects) indicating a potential for such an adverse effect in an exposed human fetus. An acceptable long-term study of the cancer causing potential of LITHOSTAT ®has not been conducted, but a known metabolite of LITHOSTAT ®, acetamide, is carcinogenic (cancer-causing) to the liver in rats at doses about 80 times the maximum human dose of LITHOSTAT ®. LITHOSTAT ®thus must be considered a potential human carcinogen. LITHOSTAT ®kills tissue cells grown in tissue culture and alters genetic material in cells grown in culture. LITHOSTAT ® may induce other adverse reactions which have not yet been recognized.
The side effects of acetohydroxamic acid include:
- Headaches
- Abdominal discomfort
- Nausea
- Loss of hair
- Shakiness
- Anemia
- Blood clots in the legs (in patients with advanced disease)
- Flushing skin reaction (when consuming alcohol during treatment)
- Fetal abnormalities (in animal studies, at high doses)
- Potential human carcinogen (based on animal studies and metabolite data) 1 1
From the Research
Acetohydroxamic acid can cause several side effects, but the most recent and highest quality study does not provide direct information on its side effects in humans, however, based on the available evidence, it is recommended to exercise caution when using this medication, especially in patients with kidney disease or those taking oral iron supplements 2.
Side Effects of Acetohydroxamic Acid
The available evidence does not provide a comprehensive list of side effects associated with acetohydroxamic acid. However, it is known that the medication works by inhibiting the enzyme urease, which can affect various metabolic pathways in the body beyond its intended therapeutic target in treating certain urinary tract infections and stones.
- Common side effects may include headache, nausea, vomiting, abdominal pain, and rash, although these are not directly supported by the provided evidence.
- More serious side effects, such as anemia, deep vein thrombosis, and hemolytic anemia, are also possible, but not directly mentioned in the studies.
- Patients with kidney disease should use this medication with caution, as it may accumulate in the body, and women of childbearing age should avoid this medication as it can cause birth defects, although these warnings are not explicitly stated in the provided studies.
Importance of Caution
The lack of direct evidence on the side effects of acetohydroxamic acid highlights the need for caution when using this medication. Patients should be closely monitored for any adverse reactions, and the medication should be used only under the guidance of a healthcare professional.
- The medication may interact with oral iron supplements, leading to the formation of iron complexes that can be harmful, although this is not directly supported by the provided evidence.
- The studies provided do not offer a clear understanding of the side effects of acetohydroxamic acid, emphasizing the need for further research and caution when using this medication 2.