Tecovirimat side effects

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible side effects of TPOXX?

TPOXX may cause serious side effects, including: Low blood sugar (hypoglycemia). Low blood sugar can happen when TPOXX is taken or received with repaglinide, a medicine used to treat type 2 diabetes. Tell your healthcare provider if you get any of the following symptoms of low blood sugar: • headache • drowsiness • hunger • feeling jittery or shaky • dizziness • confusion • sweating • weakness • fast heartbeat • irritability The most common side effects of TPOXX capsules include: • headache • nausea • stomach pain • vomiting The most common side effects of TPOXX injection include: • reactions at the site of your IV infusion These are not all the possible side effects of TPOXX. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What does the label list?

From the label: adverse reactions

The most common adverse reactions are: TPOXX Capsules (incidence ≥ 2%): headache, nausea, abdominal pain, and vomiting.

Table 4: Treatment-Related Adverse Reactions Reported in ≥ 4% of Healthy Adult Subjects Receiving at Least One Dose of TPOXX Injection 240 mg

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

From the label: adverse reactions, continued

The most common adverse reactions are: TPOXX Capsules (incidence ≥ 2%): headache, nausea, abdominal pain, and vomiting. ( 6.1 ) TPOXX Injection (incidence ≥ 4%): administration site reactions and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact SIGA Technologies Inc. at 1-888-899-3472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of TPOXX has not been studied in patients with smallpox disease. TPOXX Clinical Trial (Oral Administration) The safety of TPOXX was evaluated in 359 healthy adult subjects ages 18-79 years in a Phase 3 clinical trial. Of the subjects who received at least one 600 mg dose of TPOXX, 59% were female, 69% were White, 28% were Black/African American, 1% were Asian, and 12% were Hispanic or Latino. Ten percent of the subjects who participated in the study were age 65 or older. Of these 359 subjects, 336 subjects received at least 23 of 28 doses of 600 mg TPOXX in a twice daily (every 12 hours) regimen for 14 days. Most Frequently Reported Adverse Reactions The most frequently reported adverse reactions were headache and nausea. …

What do FAERS reports show?

103 reports list tecovirimat among the medicines taken, each a report of something that happened, not proof the medicine caused it; 13 are coded as a death and 23 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

The 25 most reported reactions

• Drug Resistance19
• Headache (named in the label)14
• Nausea (named in the label)14
• Fatigue12
• Diarrhoea (named in the label)10
• Acute Kidney Injury6
• Alanine Aminotransferase Increased6
• Decreased Appetite5
• Off Label Use (a use or a product term, not a reaction)5
• Abdominal Pain (named in the label)4
• Dizziness (named in the label)4
• Drug Ineffective (a use or a product term, not a reaction)4
• Skin Lesion4
• Vomiting (named in the label)4
• Abdominal Discomfort (named in the label)3
• Hepatic Cytolysis3
• Monkeypox3
• Pruritus (named in the label)3
• Back Pain (named in the label)2
• Cd4 Lymphocytes Decreased2
• Chest Discomfort2
• Chills (named in the label)2
• Condition Aggravated (a use or a product term, not a reaction)2
• Drug Interaction (a use or a product term, not a reaction)2
• Hypersensitivity2

What next?

Tecovirimat: the full record

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