Favipiravir

Author Information

An event is serious (based on the ICH definition) when the patient outcome is:

• * death

• * life-threatening

• * hospitalisation

• * disability

• * congenital anomaly

• * other medically important event

In a study involving 714 COVID-19-infected patients treated since January 2020 till April 2021, five women aged 19-68 years were described who developed maculopapular (MP) rash, urticarial rash or Stevens–Johnson syndrome (SJS) during off label treatment with favipiravir for coronavirus disease 2019 (COVID-19) [routes and dosages not stated].

A 28-year-old woman (Patient 1 from the article) was diagnosed with COVID-19-related pneumonia. She received treatment with unspecified systemic corticosteroid and favipiravir. Additionally, she received amoxicillin/clavulanic acid concomitantly. At day 8 of favipiravir treatment, she reported an itchy rash on her face, which then progressed to her limbs and trunk, there was no fever. Interval between initiating favipiravir and onset of lesions was 7 days. Physical examination revealed a generalised MP rash. Subsequently, drug allergy was suspected. Hence, favipiravir was discontinued following 10 days of treatment. Thereafter, topical corticosteroid and unspecified antihistamine drugs were prescribed, which led to resolution of the rash after 2 days.

A 62-year-old woman (Patient 2 from the article) was diagnosed with COVID-19-related pneumonia. She received treatment with favipiravir. Additionally, she received atenolol and losartan concomitantly.She reported an itchy rash on her face after 7 days. Physical examination showed an urticarial rash on her face and limbs. Favipiravir was stopped on day 3 of the rash. She received unspecified antihistamine, and the cutaneous symptoms resolved within 1 day after favipiravir was stopped.

A 32-year-old woman (Patient 3 from the article) was diagnosed with COVID-19-related pneumonia. Following 3 days of treatment with favipiravir, she reported itchy rashes on her legs and arms. She was observed to have an MP rash on her trunk and limbs. Subsequently, favipiravir was stopped on day 2 of the rash, and treatment with unspecified corticosteroid and unspecified antihistamine was initiated resulting in resolution of the rash within 3 days.

A 19-year-old woman (Patient 4 from the article) was diagnosed with COVID-19 infection. On day 2 of favipiravir treatment, she reported an itchy rash on her trunks, face and limbs. Interval between initiating favipiravir and onset of lesions was 1 day. Physical examination showed a generalised urticarial rash with puffy eyelids. Subsequently, favipiravir was stopped and the rash resolved dramatically following 1 day.

A 64-year-old woman (Patient 5 from the article) was diagnosed with COVID-19-related pneumonia. Following 13 days of treatment with favipiravir, she developed soreness in both eyes and a burning sensation in her mouth, then an itchy rash occurred on her face, neck, chest and both arms. On her trunk, face and limbs, she reported ill-defined erythematous papules, coalescing to plaques in some areas, as well as mild injected conjunctiva of both eyes and erosion with necrosis of both lips. Liver function test revealed transaminitis. Subsequently, SJS associated with favipiravir was diagnosed. Thereafter, favipiravir was discontinued immediately. She received unspecified systemic corticosteroid and unspecified antihistamine. There was an improvement in symptoms following 7 days of favipiravir cessation.