Tecovirimat: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: March 6, 2026🚩 Report this page

Tecovirimat

Other Antivirals

Sold as TPOXX

EU EMAGB MHRACA Health Canada

Drug class: Other Antivirals
Availability: See label
Routes: Oral
Markets covered: 3
Products on record: 3

Overview

Tecovirimat is an active pharmaceutical ingredient in the Other Antivirals group (J05AX). 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
EU European Union	EMA	1	November 10, 2025
GB United Kingdom	MHRA	1	March 6, 2026
CA Canada	Health Canada	1	August 6, 2025

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised November 10, 2025[1]

1). Tecovirimat SIGA should be used in accordance with official recommendations.

How to take

EUOfficial regulatory label

GBUnited Kingdom· MHRA

1 product

1 product on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [2].

CACanada· Health Canada

1 product

1 product on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [3].

Brands in Canada (1)

TPOXXSIGA TECHNOLOGIES, INC.

Sources & citations

[1]European Medicines Agency · EMEA/H/C/005248 · revised November 10, 2025
[2]MHRA (UK) · PLGB567080001 · revised March 6, 2026
[3]Health Canada (DPD) · 02522772 · revised August 6, 2025

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

EUOfficial regulatory label· Adverse reactions· revised November 10, 2025[1]

5%). Tabulated summary of adverse reactions Adverse reactions are classified according to System Organ Class and frequency. Frequency categories are defined as: 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), very rare (<1/10,000) and not known (cannot be estimated from the available data).
9 Table 4: Frequency of Adverse Reactions by System Organ Class from Clinical Trials System organ class Very common Common Uncommon Blood and lyphatic system disorders Haematocrit Decreased Haemoglobin Decreased Leucopoenia Thrombocytopenia Metabolism and nutrician disorders Decreased appetite Hepatobiliary disorders Elevated LFT Psychiatric disorders Anxiety Depression Dysphoria Irritability Panic attack Nervous system disorders Headache Dizziness Disturbance in attention Dysgeusia Electroencephalogram abnormal Insomnia Migraine Somnolence Paraesthesia Cardiac disorders Heart Rate Increased Palpitations Respiratory, thoracic and mediastinal disorders Oropharyngeal pain Gastrointestinal disorders Abdominal pain upper Abdominal discomfort Diarrhoea Nausea Vomiting Abdominal distention Aphthous ulcer Chapped lips Constipation Dry mouth Dyspepsia Eructation Flatulence Gastrooesophageal reflux disease Infrequent bowel movements Paraesthesia oral Skin and subcutaneous tissue disorders Palpable purpura Pruritus generalised Rash Rash pruritic Musculoskeletal and connective tissue disorders Arthralgia Osteoarthritis General disorders and administration site conditions Chills Fatigue Feeling jittery Malaise Pain Pyrexia Thirst Paediatric population Tecovirimat has not been studied in the paediatric population.
10 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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

EUOfficial regulatory label· Warnings and precautions· revised November 10, 2025[1]

5). Blood glucose and hypoglycaemic symptoms should be monitored when administering tecovirimat with repaglinide. 5). Effectiveness of midazolam should be monitored when administering tecovirimat with midazolam. Renal impairment Tecovirimat should be used with caution in patients with severe renal impairment as there is limited clinical data in this population and higher unbound drug and metabolites levels may be observed.
2). 2). Immunocompromised population The safety and efficacy of tecovirimat has not been evaluated in immunocompromised individuals. Nonclinical studies using animal models indicate that tecovirimat may have reduced efficacy in immunocompromised individuals.
1). Excipients This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. This medicine contains sunset yellow (E110).
May cause allergic reactions.

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

Overview

Regulatory status by market

EUEuropean Union· EMA

GBUnited Kingdom· MHRA

CACanada· Health Canada

Drugs in the same class

Sources & citations