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Flector Patch

Last reviewed on RxList: 5/11/2021
Flector Patch Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Flector Patch?

Flector Patch (diclofenac epolamine) contains a nonsteroidal anti-inflammatory medication (NSAID) used as a pain reliver indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions.

What Are Side Effects of Flector Patch?

Side effects of Flector Patch include:

  • dryness
  • itching
  • peeling
  • scaling
  • burning
  • redness, or
  • other skin irritation where the patch is applied

Other side effects of Flector Patch include:

Dosage for Flector Patch

The recommended dose of Flector Patch is one (1) patch to the most painful area twice a day.

What Drugs, Substances, or Supplements Interact with Flector Patch?

Flector Patch may interact with alcohol, other NSAIDs, blood thinners, cyclosporine, lithium, methotrexate, diuretics (water pills), steroids, or heart or blood pressure medications. Tell your doctor all medications and supplements you use.

Flector Patch During Pregnancy or Breastfeeding

Starting at 30 weeks gestation, Flector Patch and other NSAIDs should be avoided by pregnant women as premature closure of the ductus arteriosus in the fetus may occur. It is not known whether this drug is excreted in human milk. Consult your doctor before breastfeeding.

Additional Information

Our Flector patch 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.

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Flector Patch Consumer Information

Get emergency medical help if you have signs of an allergic reaction (runny or stuffy nose, hives, wheezing, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.

Stop using diclofenac and call your doctor at once if you have:

  • a skin rash, no matter how mild;
  • shortness of breath (even with mild exertion);
  • swelling or rapid weight gain;
  • signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • liver problems--nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or
  • low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common side effects may include:

  • heartburn, gas, stomach pain, nausea, vomiting;
  • diarrhea, constipation; or
  • mild itching, burning, redness, or other skin irritation where the patch was worn.

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 Flector Patch (Diclofenac Epolamine Topical Patch)

QUESTION

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Flector Patch Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

  • Cardiovascular Thrombotic Events [see WARNINGS AND PRECAUTIONS]
  • GI Bleeding, Ulceration and Perforation [see WARNINGS AND PRECAUTIONS]
  • Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
  • Hypertension [see WARNINGS AND PRECAUTIONS]
  • Heart Failure and Edema [see WARNINGS AND PRECAUTIONS]
  • Renal Toxicity and Hyperkalemia [see WARNINGS AND PRECAUTIONS]
  • Anaphylactic Reactions [see WARNINGS AND PRECAUTIONS]
  • Serious Skin Reactions [see WARNINGS AND PRECAUTIONS]
  • Hematologic Toxicity [see WARNINGS AND PRECAUTIONS]

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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adult Clinical Trials Experience

In controlled trials during the premarketing development of FLECTOR, approximately 600 patients with minor strains, sprains, and contusions were treated with FLECTOR for up to two weeks.

Adverse Events Leading To Discontinuation Of Treatment

In the controlled trials, 3% of patients in both the FLECTOR and placebo groups discontinued treatment due to an adverse event. The most common adverse events leading to discontinuation were application site reactions, occurring in 2% of both the FLECTOR and placebo groups. Application site reactions leading to dropout included pruritus, dermatitis, and burning.

Common Adverse Events

Overall, the most common adverse events associated with FLECTOR treatment were skin reactions at the site of treatment. Table 1 lists all adverse events, regardless of causality, occurring in ≥ 1% of patients in controlled trials of FLECTOR. A majority of patients treated with FLECTOR had adverse events with a maximum intensity of “mild” or “moderate.”

Table 1: Common Adverse Events (by body system and preferred term) in ≥ 1% of Patients treated with FLECTOR or Placebo1

Category Diclofenac
N=572
Placebo
N=564
N Percent N Percent
Application Site Conditions 64 11 70 12
Pruritus 31 5 44 8
Dermatitis 9 2 3 <1
Burning 2 <1 8 1
Other2 22 4 15 3
Gastrointestinal Disorders 49 9 33 6
Nausea 17 3 11 2
Dysgeusia 10 2 3 <1
Dyspepsia 7 1 8 1
Other3 15 3 11 2
Nervous System Disorders 13 2 18 3
Headache 7 1 10 2
Paresthesia 6 1 8 1
Somnolence 4 1 6 1
Other 4 4 1 3 <1
1 The table lists adverse events occurring in placebo-treated patients because the placebo-was comprised of the same ingredients as FLECTOR except for diclofenac. Adverse events in the placebo group may therefore reflect effects of the non-active ingredients.
2 Includes: application site dryness, irritation, erythema, atrophy, discoloration, hyperhidriosis, and vesicles.
3 Includes: gastritis, vomiting, diarrhea, constipation, upper abdominal pain, and dry mouth.
4 Includes: hypoesthesia, dizziness, and hyperkinesias.

Foreign labeling describes that dermal allergic reactions may occur with FLECTOR treatment. Additionally, the treated area may become irritated or develop itching, erythema, edema, vesicles, or abnormal sensation.

Pediatric Clinical Trials Experience

In one open-label trial, 104 male and female pediatric patients 6 years and older presenting with minor strains, sprains, and contusions received FLECTOR twice a day for as many as 16 days. The most commonly reported adverse events (incidence ≥ 2%) were headache (9%), application site pruritus (7%), nausea (3%), and dyspepsia (3%). No adverse events led to discontinuation of treatment.

Read the entire FDA prescribing information for Flector Patch (Diclofenac Epolamine Topical Patch)

Related Resources for Flector Patch

Read the Flector Patch User Reviews »

© Flector Patch Patient Information is supplied by Cerner Multum, Inc. and Flector Patch Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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