ADRs (Adverse Drug Reactions)

Adverse Drug Reactions (ADRs) are an important part of drug safety monitoring. According to the World Health Organization (WHO), Pharmacovigilance refers to the science and activities focused on identifying, evaluating, understanding, and preventing adverse effects or any other problems related to medicines. Ensuring the safety of medicines while maintaining public trust has become more challenging over time. Pharmaceutical and biotechnology companies are responsible not only for monitoring medicines but also for actively evaluating and managing potential risks during the entire lifecycle of a product, from its development stage to post-marketing use.

DRUG SAFETY – ADVERSE EVENT REPORTING

For reporting an adverse event due to our manufactured products, please download the Adverse Event Reporting form below and mail it to pharmacovigilence@ultradrugs.co.in

What is an adverse event?

An adverse event is any undesirable experience associated with the use of a medicinal product in a patient. It is commonly referred to as a “side effect”.

Why should I report an adverse event?

We don’t want to miss out on important data which could help us use our medicines more effectively and safely. If you report an adverse event, it would also help us to identify rare adverse effects, unexpected/unknown adverse effects, drug/food interactions with medications, unknown risk factors and long-term safety profile of the medications. This will help in protecting public health by identifying, assessing, and mitigating safety concerns effectively.

What to report:

All types of adverse events (side effects occurring after administration of our manufactured drug).

Where to report:

Email Id: pharmacovigilence@ultradrugs.co.in

Confidentiality:

The patient’s identity is held in strict confidence and protected to the fullest extent. The company shall not disclose the reporter’s identity in response to a request from the public.