Side-effects

Common side-effects of darunavir include elevated lipids, diabetes, insomnia, headache, dizziness, peripheral neuropathy, diarrhoea, nausea, vomiting and abdominal pain. Rash, itching, tiredness and fatigue are also common.

A caution has been issued by the European Medicines Agency and the US Food and Drug Administration regarding hepatic issues concerning darunavir. About 0.5% of people taking darunavir/ritonavir during its clinical development were diagnosed with drug-induced hepatitis. People with pre-existing liver problems, including hepatitis B or hepatitis C infection, had a greater risk of developing such a complication. No adjustment in the dose of darunavir/ritonavir is recommended for people with mild or moderate liver problems, but the US product label now notes that the drug is not recommended for people with severe liver problems.

Liver function should be monitored in all people before treatment with darunavir/ritonavir is started, and monitoring of ALT/AST levels should be increased in people with pre-existing liver problems during the first few months of therapy with the drug. If an individual experiences a worsening of their liver function, or if they develop symptoms suggestive of drug-induced hepatitis (tiredness, weight loss, nausea, yellowing of the skin, dark urine, pain in the liver, or an enlarged liver) doctors are recommended to consider either interrupting or stopping treatment with darunavir/ritonavir.