Medical illustration for Based on FDA | Is it safe to take amlodipine if I have a soy allergy, and do any formulations of amlodipine contain soy-derived ingredients? - Persly Health Information
Persly Medical TeamPersly Medical Team
February 13, 20265 min read

Based on FDA | Is it safe to take amlodipine if I have a soy allergy, and do any formulations of amlodipine contain soy-derived ingredients?

Key Takeaway:

Most single-ingredient amlodipine tablets do not contain soy-derived excipients and are generally suitable for people with soy allergy. Some combination products, such as amlodipine/atorvastatin, include soybean lecithin, so verify the exact formulation and excipient list with your pharmacist, especially if you have severe soy reactions.

Is Amlodipine Safe for People with Soy Allergy?

Most standard amlodipine (amlodipine besylate) tablets do not list soy-derived ingredients in their inactive components and are generally considered suitable for people with soy allergy. [1] [2] However, some combination products that include amlodipine particularly certain amlodipine/atorvastatin tablets do list soybean-derived lecithin as an inactive ingredient, which may be relevant for those with soy allergy. [3] [4] Because inactive ingredients can vary by manufacturer and product, it’s wise to check the specific product label or ask a pharmacist to confirm the excipient list for your brand and dose. [5] [6]


Key Takeaways

  • Most single-ingredient amlodipine tablets (amlodipine besylate) do not contain soy-derived excipients such as soybean oil or lecithin, according to multiple publicly available product labels. [1] [2]
  • Some amlodipine combination products (e.g., amlodipine with atorvastatin) do contain soybean lecithin among their inactive ingredients. [3] [4]
  • Product labels advise avoiding a formulation if you are allergic to any inactive ingredient and recommend asking your pharmacist or doctor for the full ingredient list. [5] [7]
  • Highly refined soybean oils typically have very low protein content and are less likely to trigger IgE-mediated allergic reactions, but sensitive individuals should still exercise caution with any soy-derived excipient. [8] [9]

What Official Labels Say

  • Consumer and professional labeling for amlodipine besylate tablets commonly list excipients such as calcium phosphate, microcrystalline cellulose, sodium starch glycolate, silicon dioxide, stearic acid, or magnesium stearate without mention of soy. [1] [2]
  • These labels clearly advise: do not use amlodipine if you are allergic to amlodipine or to any inactive ingredients, and they encourage consulting a pharmacist for a detailed ingredient list. [5] [6]

Soy in Specific Amlodipine Products

Some products that combine amlodipine with atorvastatin list soybean lecithin among inactive ingredients, which indicates the presence of a soy-derived component. [3] [4] This is not universal across all brands or doses, but its inclusion demonstrates that not all amlodipine-containing formulations are soy-free. [10] [11]


Understanding Allergy Risk from Soy-Derived Excipients

  • Research indicates that highly refined oils (including soybean oil) generally contain very low levels of residual protein and have not triggered reactions in controlled challenges among soybean-sensitive individuals. [8] [12]
  • Separate analyses have shown detectable but very low protein levels can be present in excipients derived from allergenic foods, underscoring the need for caution and individualized risk assessment in food-allergic patients. [9]
  • In practice, many people with soy allergy tolerate medications that use refined soy-derived excipients, but sensitivity varies, and the safest approach is to choose a soy-free formulation when possible. [9]

Practical Guidance for Soy-Allergic Individuals

  • Ask your pharmacist to verify the exact inactive ingredient list for the brand and strength you receive; excipients can differ by manufacturer and by lot. [5] [6]
  • Prefer single-ingredient amlodipine besylate tablets from manufacturers that do not list soy-derived excipients, based on their published ingredient lists. [1] [2]
  • Be cautious with combination products (e.g., amlodipine/atorvastatin), as some list soybean lecithin. If you need a combination therapy, your clinician may be able to select a brand without soy-derived excipients or use separate components. [3] [4]
  • Report any symptoms after starting a new formulation (hives, swelling, wheezing, or GI symptoms), and seek immediate care if severe reactions occur. [6]

Examples of Inactive Ingredient Lists

Below are representative examples from publicly available labels; actual products can vary by manufacturer.

Product nameActive ingredient(s)Notable inactive ingredients listedSoy-derived excipient present
Amlodipine besylate tablet (single-ingredient)AmlodipineAnhydrous dibasic calcium phosphate, microcrystalline cellulose, sodium starch glycolate, silicon dioxide, stearic acid or magnesium stearateNo soy listed on label [1] [2]
Amlodipine besylate 10 mg (generic label example)AmlodipineMagnesium stearate, microcrystalline cellulose, sodium starch glycolate, anhydrous dibasic calcium phosphateNo soy listed on label [13] [14]
Amlodipine and atorvastatin tablet (film-coated)Amlodipine + atorvastatinSodium carbonate, silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, arginine, soybean lecithinYes, soybean lecithin listed [3] [4]

Bottom Line

For most people with soy allergy, standard amlodipine besylate tablets are likely acceptable because they typically do not include soy-derived excipients on their labels. [1] [2] Some amlodipine-containing combination products do include soybean lecithin, so verifying the exact formulation you receive is important. [3] [4] If you have a history of severe soy reactions, choose a soy-free amlodipine formulation and confirm excipients with your pharmacist or prescriber before starting. [5] [6]

Related Questions

Related Articles

Sources

  1. 1.^abcdefAMLODIPINE BESYLATE- amlodipine besylate tablet(dailymed.nlm.nih.gov)
  2. 2.^abcdefDailyMed - AMLODIPINE BESYLATE tablet(dailymed.nlm.nih.gov)
  3. 3.^abcdefAMLODIPINE AND ATORVASTATIN tablet, film coated(dailymed.nlm.nih.gov)
  4. 4.^abcdefAMLODIPINE AND ATORVASTATIN tablet, film coated(dailymed.nlm.nih.gov)
  5. 5.^abcdeThese highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE besylate tablets for oral administration Initial U.S. Approval: 1992(dailymed.nlm.nih.gov)
  6. 6.^abcdeDailyMed - AMLODIPINE- amlodipine besylate tablet(dailymed.nlm.nih.gov)
  7. 7.^These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administrationInitial U.S. Approval: 1992(dailymed.nlm.nih.gov)
  8. 8.^abSoybean oil is not allergenic to soybean-sensitive individuals.(pubmed.ncbi.nlm.nih.gov)
  9. 9.^abc[Studies on the food allergenic proteins contained in pharmaceutical excipients].(pubmed.ncbi.nlm.nih.gov)
  10. 10.^AMLODIPINE AND ATORVASTATIN tablet, film coated(dailymed.nlm.nih.gov)
  11. 11.^AMLODIPINE AND ATORVASTATIN tablet, film coated(dailymed.nlm.nih.gov)
  12. 12.^Soybean oil is not allergenic to soybean-sensitive individuals.(pubmed.ncbi.nlm.nih.gov)
  13. 13.^AMLODIPINE BESYLATE 10 MG- amlodipine besylate tablet(dailymed.nlm.nih.gov)
  14. 14.^AMLODIPINE BESYLATE 10 MG- amlodipine besylate tablet(dailymed.nlm.nih.gov)

Important Notice: This information is provided for educational purposes only and is not intended to replace professional medical advice, diagnosis, or treatment. Always consult with a qualified healthcare provider before making any medical decisions.