Lithostat Side Effects
Generic Name: acetohydroxamic acid
Note: This page contains information about the side effects of acetohydroxamic acid. Some of the dosage forms included on this document may not apply to the brand name Lithostat.
Not all side effects for Lithostat may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to acetohydroxamic acid: oral tablet
Get emergency medical help if you have any of these signs of an allergic reaction while taking acetohydroxamic acid (the active ingredient contained in Lithostat) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
pounding heartbeats or fluttering in your chest;
signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs; or
signs of a red blood cell disorder--pale or yellowed skin, dark colored urine, fever, confusion or weakness.
Common side effects may include:
headache during the first 2 days of treatment;
skin rash, warmth, tingling or redness (especially if you drink alcohol while taking acetohydroxamic acid);
upset stomach, nausea, loss of appetite;
anxiety, tremors, nervousness; or
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
For Healthcare Professionals
Applies to acetohydroxamic acid: oral tablet
Gastrointestinal side effects including nausea, vomiting, anorexia, and malaise have been reported in 20% to 25% of patients.[Ref]
In most patients the symptoms were mild, transitory, and did not result in interruption of treatment.[Ref]
In most patients the symptoms were mild and transitory, but in about 6% of patients the symptoms were sufficiently distressing to warrant interruption or discontinuation of treatment.[Ref]
Psychiatric side effects including depression, anxiety, nervousness, and tremulousness have been observed in approximately 20% of patients.[Ref]
Hematologic side effects including hemolytic anemia (15%) have been reported. Approximately 3% of patients developed a hemolytic anemia of sufficient magnitude to warrant interruption in treatment. A mild reticulocytosis (5% to 6%) without anemia, has also been reported.[Ref]
The laboratory findings are occasionally accompanied by systemic symptoms such as malaise, lethargy and fatigue, and gastrointestinal symptoms. Symptoms and laboratory findings have invariably improved following cessation of treatment with acetohydroxamic acid. The hematological abnormalities are more prevalent in patients with advanced renal failure.[Ref]
These headaches are mild, responsive to oral salicylate-type analgesics, and usually disappear spontaneously. The headaches have not been associated with vertigo, tinnitus, or visual or auditory abnormalities.[Ref]
Nervous system side effects have included mild headaches during the first 48 hours of treatment. Tremulousness and nervousness have also been reported.[Ref]
The macular skin rash has usually occurred when acetohydroxamic acid (the active ingredient contained in Lithostat) has been taken concomitantly with alcoholic beverages, but in a few patients in the absence of alcohol consumption. The rash commonly appeared 30 to 45 minutes after ingestion of alcoholic beverages; it characteristically disappeared spontaneously in 30 to 60 minutes. The rash may be associated with a general sensation of warmth. In some patients the rash is sufficiently severe to warrant discontinuation of treatment, but most patients have continued treatment, avoiding alcohol or using smaller quantities of it.[Ref]
A macular skin rash has occurred in the upper extremities and on the face of several patients taking acetohydroxamic acid on a long-term basis. Alopecia has also been reported.[Ref]
Several of the affected patients had phlebitic episodes prior to treatment.
The patient with phlebothrombosis had an associated traumatic injury to the groin. It is unclear whether the phlebitis was related to or exacerbated by treatment with acetohydroxamic acid (the active ingredient contained in Lithostat) No patient in the three year controlled (Phase III) clinical trial developed phlebitis. In all instances these vascular abnormalities returned to normal following appropriate medical therapy.
The phlebitis and emboli resolved following discontinuation of acetohydroxamic acid and implementation of appropriate medical therapy. Several patients have resumed treatment with acetohydroxamic acid without ill effect.[Ref]
Cardiovascular side effects including superficial phlebitis involving the lower extremities has been reported in several patients on acetohydroxamic acid during clinical trials. Palpitations have also been reported. Embolic phenomena have been reported in three patients taking acetohydroxamic acid in the Phase II trial. One patient developed deep vein thrombosis of the lower extremities.[Ref]
1. "Product Information. Lithostat (acetohydroxamic acid)." Mission Pharmaceutical Company, San Antonio, TX.
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