Actron Side Effects

Generic name: ketoprofen

Note: This document contains side effect information about ketoprofen. Some of the dosage forms listed on this page may not apply to the brand name Actron.

Some side effects of Actron may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to ketoprofen: oral capsule, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking ketoprofen (the active ingredient contained in Actron) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking ketoprofen and seek medical attention or call your doctor at once if you have any of these serious side effects:

• chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;

• black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• confusion, tremors or shaking;

• urinating less than usual or not at all;

• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

• bruising, severe tingling, numbness, pain, muscle weakness.

Less serious side effects of ketoprofen may include:

• upset stomach, mild heartburn or stomach pain, diarrhea, constipation; bloating, gas;

• dizziness, headache, nervousness;

• skin itching or rash;

• dry mouth;

• increased sweating, runny nose;

• blurred vision; or

• ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to ketoprofen: compounding powder, oral capsule, oral capsule extended release, oral tablet

Gastrointestinal

Esophagitis, gastritis, and duodenitis have been associated with the use of ketoprofen (the active ingredient contained in Actron) Patients should be encouraged to take their medication with food to minimize these effects.

One manufacturer reports a less than 1% incidence of peptic ulcer or gastrointestinal (GI) bleeding in controlled clinical trials involving 1,076 patients. However, this incidence was greater than 2% in open-label continuation trials in 1,292 patients.

Pancreatitis developed twelve days after initiation of ketoprofen therapy for hip pain in an 80-year-old man. The patient complained of anorexia, weakness, and severe epigastric pain. Both amylase and lipase levels became extremely elevated and slowly returned to normal following discontinuation of ketoprofen.

Patients with a history of serious gastrointestinal events or alcohol abuse are at increased risk for severe GI side effects. Ketoprofen should be used with caution in these patients.

Gastrointestinal side effects have been reported the most frequently. These have included dyspepsia (11.5%), nausea (>3%), abdominal pain (>3%), diarrhea (>3%), constipation (>3%), flatulence, dysphagia, anorexia, and stomatitis. More serious gastrointestinal effects include peptic ulceration, intestinal ulceration, gastrointestinal bleeding, gastrointestinal perforation, and pancreatitis.

Nervous system

Nervous system side effects have included headache, dizziness, somnolence, malaise, and excitation. These effects may be dose related.

Renal

Renal side effects have included reports of renal impairment, including increases in blood urea nitrogen and serum creatinine as well as acute renal failure, interstitial nephritis, dysuria, and nephrotic syndrome. This impairment may or may not be reversible upon discontinuation of ketoprofen (the active ingredient contained in Actron) In addition, hematuria and signs and symptoms of urinary tract irritation may occur.

At least one case of irreversible renal failure has been reported. The patient experienced proteinuria, peripheral eosinophilia, and eosinophils in the urine. Hemodialysis was required but the patient eventually died. A second case of glomerulonephritis which was reversible following discontinuation of ketoprofen and use of steroid therapy has also been reported.

Ketoprofen may impair the ability of the kidney to cope with low renal blood flow states due to inhibition of prostaglandin-dependent afferent arteriolar vasodilation. Renal function may be further compromised in patients with heart failure, hypovolemia, cirrhosis, nephrotic syndrome, or hypoalbuminemia. Additional risk factors for ketoprofen-induced renal insufficiency are advanced age and concomitant use of diuretics.

A case-control study suggested that patients who consumed 5000 or more pills containing NSAIDs during their lifetime may be at increased risk of end-stage renal disease.

Patients with reduced renal function may be at increased risk for renal side effects.

Hepatic

Hepatic side effects have included elevations in liver function tests, which may occur in up to 15% of patients. Jaundice has been reported rarely.

Elevations in liver function tests three times normal values have been reported in less than 1% of patients receiving ketoprofen during clinical trials.

Hematologic

Hematologic side effects have included reversible inhibition of platelet aggregation, hypocoagulability, agranulocytosis, anemia, hemolysis, purpura, and thrombocytopenia.

Hematologic side effects have included reports of increase in bleeding time in patients receiving ketoprofen. This is seen in conjunction with a reversible inhibition of platelet aggregation which is restored within 24 hours of the last dose. No consistent effects on other coagulation parameters have been noted.

Dermatologic

Dermatologic side effects have included rash (1% to 3%), alopecia, eczema, pruritus, bullous rash, exfoliative dermatitis, photosensitivity, toxic epidermal necrolysis, positive Nikolsky sign, and skin discoloration. Topical ketoprofen (the active ingredient contained in Actron) preparations are associated with contact dermatitis and contact photoallergy.

Hypersensitivity

Hypersensitivity side effects have included urticaria, laryngeal edema, fever, conjunctivitis, bronchospasm, and anaphylaxis.

A 21-year-old female developed a pruritic macropapular rash 48 hours after taking a second dose of flurbiprofen 200 mg for a sore throat. Two days later, the patient developed angioedema of the hands and feet along with hypotension. After treatment with methylprednisolone, the skin healed.

Respiratory

Respiratory side effects have included bronchospasm, which may occur in patients with underlying asthma. Caution should be used when administering ketoprofen (the active ingredient contained in Actron) to these patients. Dyspnea, hemoptysis, epistaxis, pharyngitis, rhinitis, bronchospasm, and laryngeal edema have also been reported.

Cardiovascular

Nonsteroidal anti-inflammatory drugs (NSAIDs) may elevate blood pressure and increase the risk for the initiation of antihypertensive therapy. Furthermore, NSAIDs may antagonize the blood-pressure lowering effect of antihypertensive medications in patients already being treated with antihypertensive drugs.

Cardiovascular side effects have included hypertension, palpitation, tachycardia, congestive heart failure, peripheral vascular disease, vasodilation, arrhythmias and myocardial infarction.

Psychiatric

Psychiatric effects and including persecutory delusions, and auditory and visual scenic hallucinations have been reported in a 64-year-old white woman after taking 600 mg to 700 mg of ketoprofen (the active ingredient contained in Actron) in a 24 hour period.

Psychiatric side effects have included reports of depression, nervousness, and dreams in greater than 1% of patients in clinical trials.

Metabolic

Metabolic side effects have included weight gain, weight loss, hyponatremia, and thirst.

Musculoskeletal

Musculoskeletal side effects have included myalgia.

Ocular

Ocular side effects have included visual disturbance, conjunctivitis, conjunctivitis sicca, eye pain, retinal hemorrhage and pigmentation change.

Endocrine

Endocrine side effects have included aggravation of diabetes mellitus.

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