Succimer Side Effects

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

For the Consumer

Applies to succimer: oral capsule

Seek emergency medical attention or contact your doctor immediately if you experience any of the following rare but serious side effects to succimer:

• an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

• skin rash or sores in the mouth; or

• signs of infection such as fever, sore throat, or coughing.

Other, less serious side effects may be more likely to occur. Continue to take succimer and talk to your doctor if you experience

• nausea, vomiting, or decreased appetite;

• diarrhea;

• metallic taste in the mouth;

• drowsiness;

• dizziness;

• watering eyes; or

• headache.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

For Healthcare Professionals

Applies to succimer: oral capsule

Gastrointestinal

Gastrointestinal side effects (12% in children and 20.9% in adults) have included nausea, vomiting, diarrhea, appetite loss, hemorrhoidal symptoms, loose stools, and metallic taste in mouth. Abdominal cramps and stomach pain have also been reported in patients receiving succimer.

General

General side effects (5.2% in children and 15.7% in adults) have included back pain, head pain, rib pain, chills, flank pain, fever, flu-like symptoms, heavy head/tired, head cold, headache, and moniliasis.

Metabolic

Metabolic side effects (4.2% in children and 10.4% in adults) have included elevated serum cholesterol and increased proteinuria.

Hepatic

Hepatic side effects (4.2% in children and 10.4% in adults) have included elevated SGPT, SGOT, and alkaline phosphatase.

Respiratory

Respiratory side effects (3.7% in children and 0.7% in adults) have included rhinorrhea, nasal congestion, and cough.

Genitourinary

Genitourinary side effects (3.7% in adults) have included decreased urination and voiding difficulty.

Other

Other side effects (3.7% in children and 0.7% in adults) have included plugged ears, otitis media, and sore throat.

Dermatologic

Dermatologic side effects (2.6% in children and 11.2% in adults) have included papular rash, herpetic rash, rash, mucocutaneous eruptions, and pruritus.

Musculoskeletal

Musculoskeletal side effects (3.0% in adults) have included kneecap pain and leg pains.

Cardiovascular

Cardiovascular side effects (1.8% in adults) have included arrhythmia.

Nervous system

Nervous system side effects (1.0% in children and 12.7% in adults) have included drowsiness, dizziness, sensorimotor neuropathy, sleepiness, and paresthesia.

Ocular

Ocular side effects (1.0% in children and 3.0% in adults) have included cloudy film in eye and watery eyes.

Hematologic

Hematologic side effects (0.5% in children and 1.5% in adults) have included mild to moderate neutropenia, increased platelet count, and intermittent eosinophilia.

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