Good question. There’s no specific public moment when Tadalista 40 (i.e. tadalafil 40 mg) was rebranded or relaunched with an emphasis purely on “safety.” But we can talk about how and when its safety profile emerged in clinical studies and regulatory labeling:
Tadalafil’s safety concerns, such as with vision (NAION) and hearing loss, led to updated warnings on its label. In 2005, the FDA added warnings for vision impairment.
Later, in October 2007, the FDA required stronger warnings for the risk of sudden hearing loss associated with PDE‑5 inhibitors like tadalafil.
For the 40 mg dose, safety was specifically studied in clinical trials, especially in pulmonary arterial hypertension (PAH) patients. In the PHIRST‑1 study, adverse events at 40 mg were mostly mild or moderate, and discontinuation rates were similar to placebo.
Regulatory safety information for 40 mg is also in its product label: for instance, in a clinical trials summary, discontinuation due to adverse events was modest and common side‑effects included headache, flushing, and myalgia.
In patient-use guidance, the 40 mg version carries standard precautions: avoiding use with nitrates, careful use in patients with heart problems, and avoiding if you have severe liver issues.
The emphasis on safety for Tadalista 40 mg has been present since its clinical development and regulatory approval — especially around vision/hearing risks and cardiovascular considerations. These safety cautions were formalized by regulators in the mid-2000s and are maintained in the drug’s detailed prescribing information.
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