Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Summary of the safety profile

The most common adverse reactions reported during treatment with Paxlovid (nirmatrelvir/ritonavir 300 mg/100 mg) were dysgeusia (4.6%), diarrhoea (3.0%), headache (1.2%) and vomiting (1.2%).

Tabulated summary of adverse reactions

The safety profile of the product is based on adverse reactions reported in clinical trials and spontaneous reporting.

The adverse reactions in Table 2 are listed below by system organ class and frequency. Frequencies are defined as follows: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); not known (frequency cannot be estimated from the available data).

Table 2:     Adverse reactions with Paxlovid
Frequency
System organ class                          category                    Adverse reactions Immune system disorders                        Uncommon                 Hypersensitivity Rare                     Anaphylaxis
Nervous system disorders                       Common                   Dysgeusia, headache Vascular disorders                             Uncommon                 Hypertension Gastrointestinal disorders                     Common                   Diarrhoea, vomiting, nausea Uncommon                 Abdominal pain
Skin and subcutaneous tissue disorders         Uncommon                 Rash* Rare                     Toxic epidermal necrolysis,
Stevens-Johnson syndrome,
Pruritus*
Musculoskeletal and connective tissue     Uncommon                      Myalgia disorders
General disorders and administration site Rare                    Malaise conditions
* These ADRs are also manifestations of hypersensitivity reaction.

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.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/