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WHO guideline for the treatment of visceral leishmaniasis in HIV co-infected patients in East Africa and South-East Asia [Internet]. Geneva: World Health Organization; 2022.

Cover of WHO guideline for the treatment of visceral leishmaniasis in HIV co-infected patients in East Africa and South-East Asia

WHO guideline for the treatment of visceral leishmaniasis in HIV co-infected patients in East Africa and South-East Asia [Internet].

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Annex 3Adverse effects of antileishmanial medicines

DrugOrgan systemVery common side-effects (≥ 1/10 patients)Common side-effects (≥ 1/100 to < 1/10 patients)Uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10 000 to < 1/1000); very rare (< 1/10 000)
Miltefosine Gastroinstestinal disordersVomiting, diarrhoeaAnorexia, nauseaAbdominal pain, thrombocytopenia
Hepatobiliary disordersIncreased activity of liver enzymes
Renal and urinary disordersIncreased blood urea nitrogen, creatinine
Immune disordersSteven–Johnson syndrome
Paromomycin SkinPruritus
Gastrointestinal disordersNausea, metallic tasteVomiting
GeneralHeadache, lethargy, mild injection-site painPyrexia, reversible abnormal audiogramInjection site swelling, abscess, ototoxicity, conductive deafness, proteinuria
Hepatobiliary disordersTransient increases in alanine and aspartate transaminasesIncreased alkaline phosphatase, blood bilirubin
Liposomal amphotericin B SkinPruritus
General and infusion relatedChills/rigor, fever, nausea, vomiting, hypertension, tachycardia, breathlessness, hypoxia, rash, anaemia, insomnia, malaise, fatigue, confusion, muscle weakness or crampsChest tightness, chest pain, breathlessness, difficulty in breathing (possibly with wheeze), flushing, vasodilation lowering blood pressure, musculoskeletal pain (described as joint pain, back pain or bone pain), stomach pain, headache, bleeding into skin, unusual bruising and prolonged bleeding after injury, fits or seizures, pain and swelling around the infusion siteHeart attack, severe swelling around lip, eyes or tongue, muscle breakdown, bone and joint pain
Hepatobiliary disordersIncreased alkaline phosphatase
Gastrointestinal disordersDiarrhoea, nausea, vomiting
Blood disordersHigh blood sugar, low potassium, low magnesium, low calcium, low sodiumAnaemia with symptoms of excessive fatigue and breathlessness after light activity, a pale complexion, interference in blood phosphorus test results
Renal and urinarydisordersIncreased blood urea nitrogen, increased creatinineKidney failure
Amphotericin B deoxycholate General and infusion relatedFever (sometimes accompanied by shaking chills, usually within 15–20 min of initiation of treatment), malaise, weight loss, hypotension, tachypnoea, pain at the injection site with or without phlebitis or thrombophlebitis, generalized pain, including muscle and joint painsFlushing, anaphylactoid and other allergic reactions, bronchospasm, wheezing, rash, in particular maculopapular, pruritus
CardiopulmonaryCardiac arrest, shock, cardiac failure, pulmonary oedema, hypersensitivity pneumonitis, arrhythmia, including ventricular fibrillation, dyspnoea, hypertension
Hepatobiliary disorders
Gastrointestinal disordersAnorexia, nausea, vomiting, diarrhoea, dyspepsia, cramping, epigastric painAcute liver failure, hepatitis, jaundice, haemorrhagic gastroenteritis, melena
Blood disordersNormochromic, normocytic anaemiaAgranulocytosis, coagulation defects, thrombocytopenia, leukopenia, eosinophilia, leukocytosis
Renal and urinary disordersDecreased renal function and renal function abnormalities, including azotaemia, hypokalaemia, hyposthenuria, renal tubular acidosis and nephrocalcinosis. Usually improves with interruption of therapy but some permanent impairment, especially in patients receiving large amounts (> 5 g) of amphotericin B or other nephrotoxic agentsAcute renal failure, anuria, oliguria
Neurological symptomsConvulsions, hearing loss, tinnitus, transient vertigo, visual impairment, diplopia, peripheral neuropathy, encephalopathy, other neurological symptoms
Sodium stibogluconate General and infusion relatedFlushing, sweating, fever, rash, yellow skin and eyes, pain and thrombosis on intravenous administration, pain at injection site if given intramuscularly, abdominal pain, anorexia, malaise, myalgia, arthralgia, headache and lethargyAnaphylaxis, rigor, exacerbation of lesions on the cheek, substernal pain
CardiopulmonaryFatal cardiac arrhythmia, changes in electrocardiogram, including reduction in T-wave amplitude, T-wave inversion and QT prolongation, transient coughingPneumonia
Hepatobiliary disordersTransient rise in serum lipase and amylase, symptomatic pancreatitis
Gastrointestinal disordersBleeding from nose or gums
Blood disordersTransient reductions in platelets, white blood cells and haemoglobin
Neurological symptomsVertigo
Meglumine antimoniate General and infusion relatedHeadache, general malaise, difficulty in breathing, skin rash, facial oedema. Precautions to be taken before systemic administration: a protein-rich diet throughout treatment, correction of iron-deficiency anaemia or specific deficiencies to be corrected before treatment. Cardiac, hepatic and renal functions must be monitored throughout the treatment (instructions from product package insert)
CardiopulmonaryCardiac changes (dose dependent and generally reversible): T-wave insertion and QT interval prolongationCardiac arrhythmia
Gastrointestinal disordersAbdominal pain, increased liver enzyme activityPancreatitis
Renal and urinary disordersAcute renal insufficiency
Pentamidine GeneralLocal pain at injection site, induration, sterile abscess, nausea, vomiting, abdominal pain, hypotension, syncope, hypoglycaemia, diabetes mellitus
Blood and lymphatic systemLeukopenia, thrombocytopenia, anaemia
Metabolism and nutritionAzotaemiaHypoglycaemia, hyperglycaemia, hyperkalaemia, hypocalcaemia, hypomagnesaemia
Nervous systemSyncope, dizziness
VascularHypotension, flushing
CardiopulmonaryQT interval prolongation, cardiac arrhythmia
GastrointestinalNausea, vomiting, taste disturbancePancreatitis (rare)
HepatobiliaryAbnormal liver function
Skin and subcutaneous tissueRashStevens-Johnson syndrome (frequency unknown)
Renal and urinaryAcute renal failure, macroscopic haematuria
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