Qualaquin Side Effects

Generic name: quinine

Note: This document contains side effect information about quinine. Some of the dosage forms listed on this page may not apply to the brand name Qualaquin.

Some side effects of Qualaquin 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 quinine: oral capsule

Get emergency medical help if you have any of these signs of an allergic reaction while taking quinine (the active ingredient contained in Qualaquin) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• fever, chills, body aches, flu symptoms, sores in your mouth and throat;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;

• sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with balance;

• chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;

• problems with vision or hearing;

• pain, swelling, warmth, or redness in one or both legs;

• severe pain in your side or lower back, blood in your urine, little or no urine;

• low blood sugar (more common in pregnant women)--headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery;

• loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• headache, blurred vision, changes in color vision;

• sweating or flushing (warmth, redness, or tingly feeling);

• mild dizziness, spinning sensation, ringing in your ears; or

• upset stomach, vomiting, stomach pain.

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 quinine: compounding powder, oral capsule, oral tablet

Hematologic

Disseminated intravascular coagulation has been reported in a 79-year-old female within 12 hours following a second dose of quinine (the active ingredient contained in Qualaquin) 300 mg.

Hematologic side effects have included thrombocytopenia, purpura, neutropenia, thrombotic thrombocytopenic purpura-hemolytic uremic syndrome, disseminated intravascular coagulation, petechiae, and ecchymosis. At least 7 cases of immune thrombocytopenia have been reported.

Dermatologic

Dermatologic side effects have included flushing, pruritus, and skin rashes. Fixed drug eruption (nummular skin lesion) and fatal cutaneous vasculitis have been reported.

Fixed drug eruption (nummular skin lesion) has been reported in a 23-year-old female following exposure to quinine in tonic water. An open oral challenge, approved by the patient, with 30 mg quinine sulfate triggered the appearance of pruritus, erythema, and edema at the usual sites within 40 minutes of ingestion of the dose.

Gastrointestinal

Gastrointestinal side effects have included abdominal pain, nausea, vomiting, diarrhea, and gastrointestinal upset.

Renal

Renal side effects have included renal failure secondary to thrombotic thrombocytopenic purpura-hemolytic uremic syndrome.

Respiratory

Respiratory side effects have included asthma symptoms, hemoptysis, and a case report of transient bilateral pulmonary infiltrates.

Transient bilateral pulmonary infiltrates have been reported in a 45-year-old woman following a single dose of quinine sulfate 325 mg for nocturnal cramps. Approximately 45 minutes after she took the single dose of quinine the following symptoms were present: sudden onset of dyspnea, wheezing, cough, breathlessness, severe anxiety, dry nonproductive cough, orthopnea, mild fever, chills, and pleuritic chest discomfort.

Ocular

Ocular side effects have included visual disturbances including blurred vision with scotomata, photophobia, diplopia, diminished visual fields, disturbed color vision, and blindness.

Cardiovascular

Cardiovascular side effects have included cardiac dysrhythmias, including prolongation of the QT-interval.

Hepatic

Hepatic side effects have included changes in the hepatic enzyme system that synthesizes vitamin K dependent factors. At least one case report of hepatotoxicity with elevated alkaline phosphatase, lactate dehydrogenase, aspartate aminotransferase, alanine aminotransferase, and gamma-glutamyltranspeptidase has been reported.

Within 24 hours of taking the first dose of quinine 260 mg for leg cramps, a 57-year-old Native American female presented to the hospital with symptoms of nausea, vomiting, generalized myalgia, headache, fever, chills, and rigor. The following liver enzymes were dramatically elevated: alkaline phosphatase, lactate dehydrogenase, aspartate aminotransferase, alanine aminotransferase, and gamma-glutamyltranspeptidase. Following discontinuation of quinine, the patient's symptoms resolved within 48 hours and the liver enzyme concentrations declined within 72 hours.

Nervous system

Nervous system side effects have included apprehension, restlessness, confusion, syncope, dizziness, vertigo, tinnitus, hearing loss, and nystagmus. Cinchonism has been reported with repeated doses or high serum levels in 25% to 100% of patients. Signs and symptoms of cinchonism have been commonly reported. The clinical presentation of cinchonism have included temporary deafness/slight deafness, tinnitus, headache, dizziness, rash, mental dullness, depression, confusion, and nausea. Fatalities have been reported from single oral doses of 2 to 8 grams.

Tinnitus and impaired hearing may occur at plasma concentrations over 10 mcg/mL.

Hypersensitivity

Hypersensitivity side effects have been reported in a few patients who experienced severe side effects after a single dose of quinine (the active ingredient contained in Qualaquin)

Metabolic

Metabolic side effects have included hypoglycemia and electrolyte imbalance.

Other

Other side effects have included mucosal bleeding (gingival, gastrointestinal, epistaxis).

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