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Acetohydroxamic acid Side Effects

In Summary

Commonly reported side effects of acetohydroxamic acid include: hemolytic anemia, anemia, nausea, vomiting, anorexia, and malaise. Other side effects include: reticulocytosis. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to acetohydroxamic acid: oral tablet

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Chest pain or pressure.
  • Swelling, warmth, numbness, change of color, or pain in a leg or arm.
  • A heartbeat that does not feel normal.
  • Dark urine or yellow skin or eyes.
  • Feeling very tired or weak.
  • Very upset stomach or throwing up.
  • Low mood (depression).

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Feeling nervous and excitable.
  • Anxiety.
  • Feeling tired or weak.
  • Upset stomach or throwing up.
  • Not hungry.
  • Shakiness.
  • Hair loss.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to acetohydroxamic acid: oral tablet

Gastrointestinal

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]

Psychiatric

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

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]

Nervous system

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]

Dermatologic

The macular skin rash has usually occurred when acetohydroxamic acid 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]

Cardiovascular

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. 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]

References

1. "Product Information. Lithostat (acetohydroxamic acid)." Mission Pharmaceutical Company, San Antonio, TX.

Some side effects of acetohydroxamic acid may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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