Quinamm

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Diarrhea
• nausea
• stomach cramps or pain
• vomiting

• Anxiety
• behavior change, similar to drunkenness
• black, tarry stools
• blood in the urine or stools
• blurred vision or change in vision
• cold sweats
• confusion
• convulsions (seizures) or coma
• cool pale skin
• cough or hoarseness
• difficulty concentrating
• drowsiness
• excessive hunger
• fast heartbeat
• fever or chills
• headache
• lower back or side pain
• nervousness
• nightmares
• painful or difficult urination
• pinpoint red spots on the skin
• restless sleep
• shakiness
• slurred speech
• sore throat
• unusual bleeding or bruising
• unusual tiredness or weakness

• Difficulty breathing or swallowing
• disturbed color perception
• double vision
• hives
• increased sweating
• muscle aches
• night blindness
• reddening of the skin, especially around ears
• ringing or buzzing in the ears
• swelling of the eyes, face, or inside of the nose

Get emergency help immediately if any of the following symptoms of overdose occur:

• Blindness
• blurred vision or change in vision
• chest pain
• dizziness
• double vision
• fainting
• lightheadedness
• rapid or irregular heartbeat
• sleepiness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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 300 mg.[Ref]

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.[Ref]

Dermatologic

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.[Ref]

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

Gastrointestinal

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

Renal

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

Respiratory

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

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.[Ref]

Ocular

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

Cardiovascular

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

Hepatic

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.[Ref]

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.[Ref]

Nervous system

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

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.[Ref]

Hypersensitivity

Hypersensitivity side effects have been reported in a few patients who experienced severe side effects after a single dose of quinine.[Ref]

Metabolic

Metabolic side effects have included hypoglycemia and electrolyte imbalance.[Ref]

Other

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

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

Mild or moderate liver dysfunction (Child-Pugh A or B): No adjustment recommended. Patients should be closely monitored for side effects of quinine.
Severe liver dysfunction (Child-Pugh C): Not recommended.