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Flector Patch

Last reviewed on RxList: 6/7/2016
Flector Patch Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 7/28/2016

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. 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:

  • nausea
  • vomiting
  • diarrhea
  • constipation
  • upset stomach
  • heartburn
  • gas, or
  • dizziness

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

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.

Flector Patch Consumer Information

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.

Although the risk of serious side effects is low when diclofenac is applied to the skin, you should be aware of side effects that can occur if the medication is absorbed into your bloodstream.

Stop using this medicine and call your doctor at once if you have a serious side effect such as:

  • chest pain, slurred speech, problems with vision or balance, and feeling weak or short of breath;
  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • fever, chills, body aches, flu symptoms;
  • pale or yellowed skin, dark colored urine, confusion;
  • swelling or rapid weight gain;
  • urinating less than usual or not at all;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
  • the first sign of any skin rash, no matter how mild.

Less serious side effects may include:

  • mild nausea, vomiting;
  • diarrhea, constipation;
  • upset stomach, heartburn, gas;
  • dizziness; 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)

Flector Patch Professional Information

SIDE EFFECTS

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

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction ratesobserved 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.

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

Adverse Events Leading To Discontinuation Of Treatment

In the controlled trials, 3% of patients in both the FLECTOR PATCH and placebo patch 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 PATCH and placebo patch groups. Application site reactions leading to dropout included pruritus, dermatitis, and burning.

Common Adverse Events

Localized Reactions

Overall, the most common adverse events associated with FLECTOR PATCH 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 PATCH. A majority of patients treated with FLECTOR PATCH 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 PATCH or Placebo Patch

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-patch was comprised of the same ingredients as FLECTOR PATCH 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 PATCH treatment. Additionally, the treated area may become irritated or develop itching, erythema, edema, vesicles, or abnormal sensation.

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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