Forvic 300 Side Effects

Summary of the safety profile: HIV-1 (Adult and Adolescents aged 12 to <18 years and weighing >35 Kg) and Hepatitis B (Adults): In patients receiving Tenofovir disoproxil fumarate, rare events of renal impairment, renal failure and uncommon events of proximal renal tubulopathy (including Fanconi syndrome) sometimes leading to bone abnormalities (infrequently contributing to fractures). Monitoring of renal function is recommended for patients receiving Tenofovir disoproxil fumarate.
HIV-1 (Adult and Adolescents aged 12 to <18 years and weighing >35 Kg): Approximately one third of patients can be expected to experience adverse reactions following treatment with Tenofovir disoproxil fumarate in combination with other antiretroviral agents. These reactions are usually mild to moderate gastrointestinal events. Approximately 1% of Tenofovir disoproxil fumarate-treated adult patients discontinued treatment due to the gastrointestinal events.
Hepatitis B (Adults): Approximately one quarter of patients can be expected to experience adverse reactions following treatment with Tenofovir disoproxil fumarate, most of which are mild. In clinical trials of HBV infected patients, the most frequently occurring adverse reaction to Tenofovir disoproxil fumarate was nausea (5.4%).
Acute exacerbation of hepatitis has been reported in patients on treatment as well as in patients who have discontinued Hepatitis B therapy.
The adverse reactions with suspected (at least possible) relationship to treatment are listed as follows by body system organ class and frequency. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) or rare (≥1/10,000 to <1/1,000).
Tabulated summary of adverse reactions: See Table 1.

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Description of selected adverse reactions: HIV-1 (Adult and Adolescents aged 12 to <18 years and weighing >35 Kg) and Hepatitis B (Adults): Renal impairment: As Tenofovir disoproxil fumarate may cause renal damage monitoring of renal function is recommended (see Summary of the safety profile as previously mentioned and Precautions). Proximal renal tubulopathy generally resolved or improved after Tenofovir disoproxil fumarate discontinuation. However, in some patients, declines in creatinine clearance did not completely resolve despite Tenofovir disoproxil fumarate discontinuation. Patients at risk of renal impairment (such as patients with baseline renal risk factors, advanced HIV disease, or patients receiving concomitant nephrotoxic medications) are at increased risk of experiencing incomplete recovery of renal function despite Tenofovir disoproxil fumarate discontinuation (see Precautions).
Lactic acidosis: Cases of lactic acidosis have been reported with Tenofovir disoproxil fumarate alone or in combination with other antiretrovirals. Patients with predisposing factors such as patients with decompensated liver disease, or patients receiving concomitant medications known to induce lactic acidosis are at increased risk of experiencing severe lactic acidosis during Tenofovir disoproxil fumarate treatment, including fatal outcomes.
HIV-1 (Adult and Adolescents aged 12 to <18 years and weighing >35 Kg): Metabolic parameters: Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see Precautions).
Immune reactivation syndrome: In HIV infected patients with severe immune deficiency at the time of initiation of CART, an inflammatory reaction to asymptomatic or residual opportunistic infections may arise. Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see Precautions).
Osteonecrosis: Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to CART. The frequency of this is unknown (see Precautions).
Hepatitis B (Adults): Exacerbations of hepatitis during treatment: In studies with nucleoside-naïve patients, on-treatment ALT elevations >10 times ULN (upper limit of normal) and >2 times baseline occurred in 2.6% of Tenofovir disoproxil fumarate-treated patients. ALT elevations had a median time to onset of 8 weeks, resolved with continued treatment, and, in a majority of cases, were associated with a ≥2 log₁₀ copies/mL reduction in viral load that preceded or coincided with the ALT elevation. Periodic monitoring of hepatic function is recommended during treatment (see Precautions).
Exacerbations of hepatitis after discontinuation of treatment: In HBV infected patients, clinical and laboratory evidence of exacerbations of hepatitis have occurred after discontinuation of HBV therapy (see Precautions).
Other special population(s): Elderly: Tenofovir disoproxil fumarate has not been studied in patients over the age of 65. Elderly patients are more likely to have decreased renal function, therefore caution should be exercised when treating elderly patients with Tenofovir disoproxil fumarate (see Precautions).
Patients with renal impairment: Since Tenofovir disoproxil fumarate can cause renal toxicity, close monitoring of renal function is recommended in adult patients with renal impairment treated with Tenofovir disoproxil fumarate (see Dosage & Administration, Precautions, and Pharmacology: Pharmacokinetics under Actions). The use of Tenofovir disoproxil fumarate is not recommended in pediatric patients with renal impairment (see Dosage & Administration and Precautions).