Once a viable API is developed, extensive clinical trials are conducted to evaluate its safety and efficacy in humans. Regulatory bodies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), require comprehensive data on the API before granting approval for the drug's market release. These regulatory frameworks ensure that only safe and effective medicines reach patients.
Common side effects of pentoxifylline include gastrointestinal discomfort, such as nausea, vomiting, and diarrhea. Some patients may also experience headaches, dizziness, or flushing. While these effects are usually mild, it is crucial for individuals to report any severe or persistent side effects to their healthcare provider. Rarely, pentoxifylline may lead to more serious complications, including changes in blood pressure or heart rhythm, necessitating immediate medical attention.