Lariam Side Effects

Generic Name: mefloquine

Please note - some side effects for Lariam may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Lariam - for the Consumer

Lariam

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lariam:

Diarrhea; dizziness; drowsiness; headache; lightheadedness; loss of appetite; muscle aches; nausea; stomach pain or upset; strange dreams; tiredness; trouble sleeping; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Lariam:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bizarre behavior; chest pain; fainting; fast, slow, or irregular heartbeat; flu-like symptoms (eg, chills, fever, headache, muscle pain); loss of balance or coordination; memory problems; mental or mood changes (eg, anxiety, confusion, depression, hallucinations, mood changes, paranoia, restlessness); numbness or tingling of the hands or feet; red, swollen or blistered skin; ringing in the ears; seizures; severe or persistent cough; shortness of breath; suicidal thoughts or attempts; symptoms of liver problems (eg, dark urine, pale stools, persistent stomach pain or loss of appetite, persistent tiredness, yellowing of the skin or eyes); tremor; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Lariam Side Effects - for the Professional

Lariam

Clinical

At the doses used for treatment of acute malaria infections, the symptoms possibly attributable to drug administration cannot be distinguished from those symptoms usually attributable to the disease itself.

Among subjects who received mefloquine for prophylaxis of malaria, the most frequently observed adverse experience was vomiting (3%). Dizziness, syncope, extrasystoles and other complaints affecting less than 1% were also reported.

Among subjects who received mefloquine for treatment, the most frequently observed adverse experiences included: dizziness, myalgia, nausea, fever, headache, vomiting, chills, diarrhea, skin rash, abdominal pain, fatigue, loss of appetite, and tinnitus. Those side effects occurring in less than 1% included bradycardia, hair loss, emotional problems, pruritus, asthenia, transient emotional disturbances and telogen effluvium (loss of resting hair). Seizures have also been reported.

Two serious adverse reactions were cardiopulmonary arrest in one patient shortly after ingesting a single prophylactic dose of mefloquine while concomitantly using propranolol, and encephalopathy of unknown etiology during prophylactic mefloquine administration. The relationship of encephalopathy to drug administration could not be clearly established.

Postmarketing

Postmarketing surveillance indicates that the same kind of adverse experiences are reported during prophylaxis, as well as acute treatment. Because these experiences are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to Lariam exposure.

The most frequently reported adverse events are nausea, vomiting, loose stools or diarrhea, abdominal pain, dizziness or vertigo, loss of balance, and neuropsychiatric events such as headache, somnolence, and sleep disorders (insomnia, abnormal dreams). These are usually mild and may decrease despite continued use. In a small number of patients it has been reported that dizziness or vertigo and loss of balance may continue for months after discontinuation of the drug.

Occasionally, more severe neuropsychiatric disorders have been reported such as: sensory and motor neuropathies (including paresthesia, tremor and ataxia), convulsions, agitation or restlessness, anxiety, depression, mood swings, panic attacks, memory impairment, confusion, hallucinations, aggression, psychotic or paranoid reactions and encephalopathy. Rare cases of suicidal ideation and suicide have been reported though no relationship to drug administration has been confirmed.

Other less frequently reported adverse events include:

Cardiovascular Disorders: circulatory disturbances (hypotension, hypertension, flushing, syncope), chest pain, tachycardia or palpitation, bradycardia, irregular heart rate, extrasystoles, A-V block, and other transient cardiac conduction alterations

Skin Disorders: rash, exanthema, erythema, urticaria, pruritus, edema, hair loss, erythema multiforme, and Stevens-Johnson syndrome

Musculoskeletal Disorders: muscle weakness, muscle cramps, myalgia, and arthralgia

Respiratory Disorders: dyspnea, pneumonitis of possible allergic etiology

Other Symptoms: visual disturbances, vestibular disorders including tinnitus and hearing impairment, asthenia, malaise, fatigue, fever, hyperhidrosis, chills, dyspepsia and loss of appetite

Laboratory

The most frequently observed laboratory alterations which could be possibly attributable to drug administration were decreased hematocrit, transient elevation of transaminases, leukopenia and thrombocytopenia. These alterations were observed in patients with acute malaria who received treatment doses of the drug and were attributed to the disease itself.

During prophylactic administration of mefloquine to indigenous populations in malaria-endemic areas, the following occasional alterations in laboratory values were observed: transient elevation of transaminases, leukocytosis or thrombocytopenia.

Because of the long half-life of mefloquine, adverse reactions to Lariam may occur or persist up to several weeks after discontinuation of the drug.

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Side Effects by Body System - for Healthcare Professionals

Psychiatric

Psychiatric side effects have frequently included strange or vivid dreams (14%), depression (4%), anxiety (4%), mania, nightmares, delusions, paranoia, aggressive behavior, psychotic behavior, agitation, restlessness, mood swings, panic attacks, memory impairment, confusion, tension, anger, fatigue, hallucinations, and organic psychosis. These symptoms have sometimes been reported to continue long after mefloquine has been stopped. Dysphoria has also been reported. Rarely, an acute but self-limiting neuropsychiatric syndrome that manifest by transient psychosis, convulsions, or an encephalopathy (1 in 1700) has been reported, in addition to cases of encephalopathy, suicidal ideation, and suicide.

Psychotic reactions to mefloquine have occurred in patients with and without a history of psychiatric disorders. These reactions have occurred during the prophylactic use of mefloquine and while using it to treat malaria. Reactions typically occur after 1 to 4 weeks of use and usually resolve within a few days to a few months following drug discontinuation. They tend to occur more frequently in females and in first-time users. The estimated incidence of severe psychiatric reactions associated with prophylaxis is 1:10000 to 1:20000.

Gastrointestinal

Gastrointestinal side effects have commonly included gastrointestinal distress. Nausea, mouth ulcers, anorexia, and vomiting have been associated with the use of mefloquine in up to 25% of patients. Abdominal pain and diarrhea have been associated with the use of this drug in 4% to 20% of patients. Dyspepsia and loss of appetite have also been reported.

Nervous system

Seizures associated with mefloquine use have occurred in patients with and without a history of seizure disorder. Seizures have been reported during the prophylactic use of mefloquine and while using mefloquine to treat malaria. In 26 cases, seizures occurred between week 1 and 11 of mefloquine prophylaxis. Seizures may be part of an acute brain syndrome which includes psychiatric reactions.

Nervous system side effects have frequently included insomnia (13%), dizziness (9%), vertigo (9%), headache (7%), loss of balance, somnolence, paresthesias, fatigue, weakness, visual problems, tremor, ataxia, and headaches. Behavioral changes, confusion, seizures, myoclonus, and encephalopathy have been reported less commonly. Tinnitus and hearing impairment have also been reported.

Cardiovascular

Cardiovascular side effects have included sinus bradycardia (18%), circulatory disturbances (hypotension, hypertension, flushing, syncope), chest pain, tachycardia, palpitations, irregular heart rate, extrasystoles, AV block, atrial flutter, prolonged QT interval, and other transient cardiac conduction disturbances.

Hypersensitivity

Hypersensitivity side effects have rarely been associated with the use of mefloquine. These reactions typically manifest themselves as pruritus and rash. Stevens-Johnson syndrome has also been reported.

Hematologic

Hematologic side effects have included anemia and (rarely) aplastic anemia. At least 8 cases of isolated thrombocytopenia have been reported, in addition to five cases of hemolytic anemia, and one case of thrombotic thrombocytopenic purpura.

A 56-year-old male experienced thrombotic thrombocytopenic purpura (TTP) coincident with mefloquine therapy. One week before admission, the patient developed weakness, followed some days later by anorexia, myalgia, and lethargy, and, finally, by fever, confusion, and blurred vision. A central venous catheter was placed in the right jugular vein and two plasmapheresis sessions (12 units of fresh frozen plasma) were conducted in the first 24 hours. Neurological status improved after the first plasmapheresis; hematological abnormalities disappeared in the first few days of therapy. For this patient, the presence of severe neurological symptoms together with fever, thrombocytopenia, and microangiopathic anemia suggested a more complex hematological abnormality, such as TTP. The causal relation between drug and disease is supported by the temporal relation of drug intake with the onset of the clinical symptoms and laboratory abnormalities, as well as by their prompt improvement after the aphaeretic therapy and drug withdrawal.

Dermatologic

Dermatologic side effects have included itching (3%), rash, exanthema, urticaria, pruritus, edema, hair loss, erythema multiforme, and cutaneous vasculitis.

Musculoskeletal

Musculoskeletal side effects have included muscle weakness, muscle cramps, and moderately severe arthralgias and myalgias.

Ocular

Ocular side effects have included visual disturbances (3%).

Respiratory

Respiratory side effects have included dyspnea and pneumonitis of possible allergic etiology. At least one case of eosinophilic pneumonia has been reported.

A 67-year-old female with a history of pityriasis versicolor experienced eosinophilic pneumonia coincident with infliximab therapy. She was admitted because she had experienced high-grade fever (39 degrees Celsius), malaise, productive cough, and dyspnea on exertion during the previous week. She had traveled to South Africa for 8 weeks and had taken oral mefloquine 250 mg once every week as malaria prophylaxis. The therapy was continued for 4 weeks after she returned home. A thorough workup led to the diagnosis of eosinophilic pneumonia due to the mefloquine therapy. Her condition improved after the drug was withdrawn.

Endocrine

Endocrine side effects have included hyperhidrosis.

Other

Other side effects have included asthenia, malaise, fatigue, fever, and chills.

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