September 2013

FDA: Ortiga Contains Undeclared Prescription Drug Diclofenac

The U.S. Food and Drug Administration (FDA) recently issued a warning to consumers regarding Ortiga, an unapproved product marketed for various health conditions.

The FDA advises against the purchase or use of Ortiga, after a laboratory analysis found that this product contains diclofenac, an undeclared prescription drug.

Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) and may increase the risk of heart attack and stroke. This drug may also cause serious damage to the stomach and intestines, including bleeding, ulcers, and perforation. Diclofenac may also interact with other medications and may significantly increase the risk of side effects, especially for consumers who are using multiple NSAIDs at once.

Ortiga is sold on numerous websites, such as Ebay, and is also carried by some retail stores. The product, which is labeled primarily in Spanish, is manufactured in Mexico.

The FDA advises consumers to immediately stop using this product and to dispose of it. Anyone who has experienced negative side effects related to Ortiga is advised to consult a doctor or other healthcare professional immediately. Possible side effects include unusual changes in the color of stools or urine, stomach pain, and signs of bleeding, such as increased bruising.

Consumers may also report side effects related to the product to MedWatch, the FDA Safety Information and Adverse Event Reporting Program.


  1. Natural Standard: The Authority on Integrative Medicine. 
  2. US Food and Drug Administration.

The information in this brief report is intended for informational purposes only, and is meant to help users better understand health concerns. This information should not be interpreted as specific medical advice. Users should consult with a qualified healthcare provider for specific questions regarding therapies, diagnosis and/or health conditions, prior to making therapeutic decisions. Copyright © 2024 NatMed. Commercial distribution or reproduction prohibited. NatMed is the leading provider of high-quality, evidence-based, clinically-relevant information on natural medicine, dietary supplements, herbs, vitamins, minerals, functional foods, diets, complementary practices, CAM modalities, exercises and medical conditions. Monograph sections include interactions with herbs, drugs, foods and labs, contraindications, depletions, dosing, toxicology, adverse effects, pregnancy and lactation data, synonyms, safety and effectiveness.