Flector Patch Side Effects

Please note - some side effects for Flector Patch may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects by Body System - for Healthcare Professionals

Local

Local application site reactions have been reported in 75% to 86% of patients and have included rash (35% to 36%), pruritus (31% to 52%), dry skin (25% to 27%), contact dermatitis (19% to 33%), pain (15% to 26%), paresthesia (8% to 20%), exfoliation (6% to 24%), vesiculobullous rash (4%), edema (3% to 4%), hyperesthesia (3%), photosensitivity reaction (3%), acne (1%), alopecia (1% to 2%), erythema (less than 1%), irritation (less than 1%), and papules (less than 1%).

The gel vehicle has also been associated with a high incidence of application site reactions (71% to 86%), including pruritus (45% to 59%), pain (22% to 30%), rash (17% to 20%), dry skin (12% to 17%), exfoliation (4% to 13%), and paresthesia (4% to 20%). Other local reactions have included skin carcinoma, hypertonia, lacrimation disorder, maculopapular rash, purpuric rash, skin hypertrophy, and vasodilation in less than 1% of patients.

Dermatologic

Dermatologic side effects have included pruritus (4%), rash (2% to 4%), dry skin (3%), contact dermatitis (2%), pain (1% to 2%), skin carcinoma (2%), and skin ulcer (1% to 2%). Other dermatologic side effects have included skin hypertrophy, paresthesia, seborrhea, urticaria in less than 1% of patients, and skin discoloration. The gel vehicle has been associated with acne (1% to 2%), herpes simplex (2%), maculopapular rash (2%), and skin nodule (2%).

Cardiovascular

Cardiovascular side effects have included hypertension (1% to 2%), migraine (1%), and palpitation. The gel vehicle has been associated with phlebitis (2%).

Endocrine

Endocrine side effects have included hyperglycemia (greater than 1%).

Gastrointestinal

Gastrointestinal side effects have included dyspepsia (2% to 3%), diarrhea (2%), abdominal pain (1% to 2%), dry mouth, gastroenteritis, mouth ulceration, nausea, rectal hemorrhage, and ulcerative stomatitis. The gel vehicle has been associated with constipation (2%).

Genitourinary

Genitourinary side effects have included hematuria (2%).

Hepatic

Hepatic side effects have included elevations in serum transaminases in up to 15% of patients as well as rare cases of hepatitis, jaundice, and fatal fulminant hepatitis. Liver injury is most likely to occur in older females in the first 6 months of use.

Immunologic

Immunologic side effects have included infection and flu syndrome (greater than 1%).

Metabolic

Metabolic side effects have included increased creatine phosphokinase (4%), increased SGOT (3%), increased SGPT (2%), increased creatinine (2%), hypercholesterolemia (1%), hyperglycemia (1%), and creatinine increased. The gel vehicle has been associated with edema (2%).

Musculoskeletal

Musculoskeletal side effects have included myalgia (2 to 3%), arthralgia (2%), arthrosis (2%), and leg cramps.

Nervous system

Nervous system side effects have included headache (7%), hypokinesia (2%), depression, dizziness, drowsiness, lethargy, paresthesia, and paresthesia at application site. The gel vehicle has been associated with dizziness (4%) and anxiety (1% to 2%).

Ocular

Ocular side effects have included conjunctivitis (2 to 4%) eye pain (2%), blurred or abnormal vision, cataract, and eye disorder.

Respiratory

Respiratory side effects have included asthma, dyspnea, pharyngitis, pneumonia, rhinitis, and sinusitis in 2% of patients.

Renal

Renal side effects have included increased creatinine (2%).

Other

Other side effects have included flu syndrome (1 to 10%), accidental injury (4%), infection (4%), back pain (2 to 4%), asthenia (2%), neck pain (2%), pain (2%), chest pain (1 to 2%), ear pain, and taste perversion.

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