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PvPI reveals new adverse drug reaction of Tacrolimus

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PvPI reveals new adverse drug reaction of Tacrolimus

The preliminary analysis of Adverse Drug Reaction (ADR) from the PvPI database reveals that Tacrolimus is associated with Gingival Hypertrophy.

Tacrolimus is sold under the brand name Prograf, is an immunosuppressive drug which is used for prophylaxis of transplant rejection in liver, pancreas, lung, heart and kidney allograft recipients and treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products. It is also used by nephrologists for the prophylaxis of organ rejection in patients receiving allogenic kidney transplant. And dermatologists use it for treatment of patients with moderate to severe atopic dermatitis in whom the use of alternative conventional therapy is advisable.

The adverse effect by Tacrolimus, Gingival hyperplasia is an oral condition that causes your gums to overgrow. In more severe cases, your gums can completely cover your teeth, making it difficult to maintain effective oral hygiene habits.

The Pharmacovigilance Programme of India (PvPI) identifies and responds to drug safety problems. The purpose of the PvPI is to collate data, analyze it and use the inferences to recommend informed regulatory interventions, besides communicating risks to healthcare professionals and the public


Healthcare Professionals, Patients or Consumers are advised to closely monitor the possibility of the above ADR associated with the use of Tacrolimus. If such reaction is encountered, please report to the NCC-PvPI, IPC by filling out the Suspected Adverse Drug Reactions Reporting Form/ Medicines Side Effect Reporting Form.

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