Proguanil: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: April 10, 2026

Proguanil

Biguanides

GB MHRA

Drug class: Biguanides
Availability: See label
Markets covered: 1
Products on record: 8

P01BBBiguanides

Overview

Proguanil is an active pharmaceutical ingredient in the Biguanides group (P01BB). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	8	April 10, 2026

GBUnited Kingdom· MHRA

8 products

Uses

GBOfficial regulatory label· revised April 10, 2026[1]

Atovaquone/Proguanil Hydrochloride is a fixed dose combination of atovaquone and proguanil hydrochloride which acts as a blood schizonticide and also has activity against hepatic schizonts of Plasmodium falciparum.
It is indicated for:
Prophylaxis of Plasmodium falciparum malaria. Treatment of acute, uncomplicated Plasmodium falciparum malaria. Because atovaquone/proguanil hydrochloride is effective against drug sensitive and drug resistant P. falciparum it is especially recommended for prophylaxis and treatment of P.
falciparum malaria where the pathogen may be resistant to other antimalarials. Official guidelines and local information on the prevalence of resistance to antimalarial medicinal products should be taken into consideration. Official guidelines will normally include WHO and public health authorities' guidelines.

Drug interactions

Known interactions involving Proguanil. Select one for details. This list is informational and not a complete interaction checker.

Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.

Sources & citations

[1]MHRA (UK) · PL045691271 · revised April 10, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised April 10, 2026[1]

In clinical trials of atovaquone/proguanil in the treatment of malaria, the most commonly reported adverse reactions were abdominal pain, headache, anorexia, nausea, vomiting, diarrhoea and coughing. In clinical trials of atovaquone/proguanil for prophylaxis of malaria, the most commonly reported adverse reactions were headache, abdominal pain and diarrhoea.
The following table provides a summary of adverse reactions that have been reported to have a suspected (at least possible) causal relationship to treatment with atovaquone/proguanil in clinical trials and spontaneous post-marketing reports.
The following convention is used for the classification of frequency: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); not known (cannot be estimated from the available data).
There are limited long-term safety data in children. In particular, the long-term effects of atovaquone/proguanil on growth, puberty and general development have not been studied. 4) Vasculitis3 Metabolism and nutrition disorders Hyponatraemia1 Anorexia Elevated amylase levels1 Psychiatric disorders Abnormal dreams Depression Anxiety Hallucinations Panic attack Crying Nightmares Psychotic disorder Nervous system disorders Headache Insomnia Dizziness Seizure Cardiac disorders Palpitations Tachycardia Respiratory, thoracic and mediastinal disorders Cough Gastrointestinal disorders Nausea1 Vomiting Diarrhoea Abdominal pain Stomatitis Gastric intolerance3 Oral ulceration3 Hepatobiliary disorders Elevated liver enzymes1 Hepatitis Cholestasis3 Skin and subcutaneous tissue disorders Pruritus Rash Hair loss Urticaria Stevens- Johnson Syndrome Erythema multiforme Blister Skin exfoliation Photosensitivity reactions General disorders and administration site conditions Fever 1.
Frequency taken from atovaquone label. Patients participating in clinical trials with atovaquone have received higher doses and have often had complications of advanced Human Immunodeficiency Virus (HIV) disease. These events may have been seen at a lower frequency or not at all in clinical trials with atovaquone/proguanil.
2. Observed from post-marketing spontaneous reports and the frequency is therefore unknown. 3. Observed with proguanil. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

GBOfficial regulatory label· Warnings and precautions· revised April 10, 2026[1]

The safety and effectiveness of atovaquone/proguanil hydrochloride tablets for prophylaxis of malaria in patients who weigh less than 40 kg, or in the treatment of malaria in paediatric patients who weigh less than 11 kg has not been established.
Persons taking atovaquone/proguanil hydrochloride for prophylaxis or treatment of malaria should take a repeat dose if they vomit within 1 hour of dosing. In the event of diarrhoea, normal dosing should be continued. Absorption of atovaquone may be reduced in patients with diarrhoea or vomiting, but diarrhoea or vomiting was not associated with reduced efficacy in clinical trials of atovaquone/proguanil for malaria prophylaxis.
However, as with other antimalarial agents, subjects with diarrhoea or vomiting should be advised to continue with malaria prevention measures by complying with personal protection measures (repellents, impregnated bednets). In patients with acute malaria who present with diarrhoea or vomiting, alternative therapy should be considered.
If atovaquone/proguanil hydrochloride is used to treat malaria in these patients, parasitaemia and the patient’s clinical condition should be closely monitored. Atovaquone/proguanil has not been evaluated for the treatment of cerebral malaria or other severe manifestations of complicated malaria including hyperparasitaemia, pulmonary oedema or renal failure.
Occasionally, severe allergic reactions (including anaphylaxis) have been reported in patients taking atovaquone/proguanil. 8) atovaquone/proguanil hydrochloride should be discontinued promptly and appropriate treatment initiated. Atovaquone/proguanil has been shown to have no efficacy against hypnozoites of Plasmodium vivax as parasite relapse occurred commonly when P.
vivax malaria was treated with atovaquone/proguanil alone. Travellers with intense exposure to P. vivax or P. ovale, and those who develop malaria caused by either of these parasites, will require additional treatment with a drug that is active against hypnozoites.
In the event of recrudescent infections due to P. falciparum after treatment with atovaquone/proguanil hydrochloride, or failure of chemoprophylaxis with atovaquone/proguanil, patients should be treated with a different blood schizonticide as such events can reflect a resistance of the parasite.

This is not medical advice. Consult a qualified healthcare professional.