Diabetic Dyslipidemia

Adverse Event Reporting

We at Zydus believe that patient safety is our prime concern ahead of commercial or other interests.

The aim of Pharmacovigilance is to protect public health by identifying, evaluating and minimizing safety issues in all possible ways.

So, we encourage consumers, health care professionals, our employees and others to report the following to our Pharmacovigilance department:

Medical occurrence temporally associated with the use of our medicinal product, including an abnormal laboratory finding but not necessarily causally related.

Any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the usage of the vaccine. The adverse event may be any unfavourable or unintended sign, abnormal laboratory finding, symptom or disease. AEFIs can be related to the vaccine itself (product or quality defect-related reactions), to the vaccination process (error or stress related reactions) or can occur independently from vaccination (coincidental).

A response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for modification of physiological function.
The phrase "responses to a medicinal products" means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e., the relationship cannot be ruled out.

The patient has taken, (accidentally or intentionally) above/below the maximal /minimal recommended dose as stated in the product label/authorized product information or as prescribed

Includes an interaction with another drug, device, disease, food or alcohol

Accidental exposure to Zydus product may or may not be a result of one’s occupation

Use of a Zydus product during pregnancy/lactation even though there are no adverse events/adverse drug reactions

Drug exposure of embryo or foetus via semen due to father taking Zydus product

Inappropriate use of Zydus product that was not intended. This may be an actual error that occurred, an error that was intercepted (near miss) or an error that could occur (potential).

Medication errors are captured whether or not the product was ingested or administered

Medication errors are captured whether or not it resulted in an adverse event

→ Injection for intravenous use prescribed as intramuscular or subcutaneous.
→ Prescribing a drug to which the patient is allergic.
→ Wrong drug dispensed, due to illegibility of prescription or drug/brand sounds alike.

Type of medication error involving confusion between Zydus products or confusion between a Zydus product with another manufacturer’s product.

May involve similar packaging, the image of a dosage form, the sound of a product's name, or unclear labeling or instructions for use

May be intentional (e.g., off label use, misuse, or abuse), unintentional (e.g., medication error), or the intention is not known

Zydus drug was ineffective (did not work) or the expected effect was not achieved

Beneficial effect of a product aside from the use for which it has been given

Concern/issue with product quality

→ Tablet was broken
→ Tablet colour changed
→ Tablet was missing or blister was empty
→ Label is illegible/Font is very small to read

Points to Consider :

  1. 1. Provide as many details as possible. This will help us to understand the case better.
  2. 2. The patient/reporter's identity is held in strict confidence and protected to the fullest extent. The company shall not disclose the patient/reporter’s identity in response to a request from the public.
  3. 3. The data may be shared with the competent authorities as required to comply with the regulatory requirements.
  4. 4. Submission of a report does not constitute an admission that medical personnel or manufacturer or the product caused or contributed to the reaction.

Adverse Event Reporting Form


Patient Details


Adverse Event Details


Suspect Drug Details


Reporter Details

Patient Details

Adverse event Details

Suspect drug details

Please Enter Your Name ! Please Enter Valid Name ! Please Enter Your Email ID ! Please Enter Valid Email ID ! Please Enter Your Contact No. ! Please Enter Valid Contact No. ! Please Enter Captcha. ! please Read and accept Policy !

Reporter Details

You Must Select This Check Box.

*The form is not Compatible on IE 8 & IE 9, Request you to kindly Update Your browser in order to access the Form.

If you wish to report by any other means like Telephone, Email, Postal Mail, Etc., you may select one from the following options:

→ 24X7 Medical Information Contact Center: Dial 1800 419 1141 (Toll free throughout India)

→ Simply send an email at:  drugsafety@zyduslife.com

→ Download the adverse event reporting form (Click here to download the form for vaccines, Click here to download the form for products other than vaccines), fill and send it to us in any of the following ways:

→ Send the completed form to:
     Zydus Lifesciences Limited
     Zydus Corporate Park,
     Scheme No. 63, Survey No.536,
     Khoraj (Gandhinagar), Nr. Vaishnodevi Circle
     Sarkhej – Gandhinagar Highway,
     Ahmedabad – 382481, Gujarat, India

→ Scan and E-mail the completed form to:  drugsafety@zyduslife.com