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Regranex Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 12/2/2015

Regranex (becaplermin) Gel is a recombinant human platelet-derived growth factor used to treat lower extremity diabetic ulcers. Common side effects of Regranex Gel include red skin rash and burning at the application site. Rare but serious side effects of Regranex Gel may include allergic reactions such as rash, itching, swelling (especially of the face/tongue/throat), dizziness, and trouble breathing.

The recommended dose of Regranex Gel is to apply to the ulcer(s) once per day. Talk to your doctor about your individual dosage recommendation of Regranex Gel. Other drugs may interact with Regranex Gel. Tell your doctor all medications you take. Do not apply Regranex Gel over any wound that has been closed with stitches, staples, or surgical tape. If you are pregnant only use Regranex Gel if the potential benefits outweigh the potential risk to the fetus. Exercise caution when using Regranex Gel and you are breastfeeding.

Our Regranex (becaplermin) Gel Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Regranex in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using becaplermin topical and call your doctor at once if you have severe itching, redness, blistering, peeling, or other skin irritation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Regranex (Becaplermin)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Regranex Overview - Patient Information: Side Effects

SIDE EFFECTS: Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Regranex (Becaplermin)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Regranex FDA Prescribing Information: Side Effects
(Adverse Reactions)


Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In a follow-up study from two randomized, controlled trials, an increased rate of cancer remote from the becaplermin treatment site was observed in subjects treated with REGRANEX Gel. [see WARNINGS AND PRECAUTIONS]

In clinical trials, erythematous rashes occurred in 2% of patients treated with REGRANEX Gel (and good ulcer care) or placebo (and good ulcer care), and none in patients receiving good ulcer care alone. Patients treated with REGRANEX Gel did not develop neutralizing antibodies against becaplermin.

Postmarketing Experience

An increased rate of mortality secondary to malignancy was observed in patients treated with 3 or more tubes of REGRANEX Gel in a postmarketing retrospective cohort study. [see BOXED WARNING and WARNINGS AND PRECAUTIONS]

Burning sensation at the site of application and erythema have been reported during post-approval use of REGRANEX Gel. Because post-approval adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the drug.

Read the entire FDA prescribing information for Regranex (Becaplermin)

Regranex - User Reviews

Regranex User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Regranex sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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