Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: •Cardiovascular Thrombotic Events [ see Warnings and Precautions ( 5.1 ) ] •GI Bleeding, Ulceration and Perforation [ see Warnings and Precautions ( 5.2 ) ] •Hepatotoxicity [ see Warnings and Precautions ( 5.3 ) ] •Hypertension [ see Warnings and Precautions ( 5.4 ) ] •Heart Failure and Edema [ see Warnings and Precautions ( 5.5 ) ] •Renal Toxicity and Hyperkalemia [ see Warnings and Precautions ( 5.6 ) ] •Anaphylactic Reactions [ see Warnings and Precautions ( 5.7 ) ] •Serious Skin Reactions [ see Warnings and Precautions ( 5.9 ) ] •Hematologic Toxicity [ see Warnings and Precautions ( 5.12 ) ] Most common adverse reactions (incidence ≥ 5%) are Dyspepsia, headache, somnolence, nausea, dizziness, constipation, nervousness, asthenia, and peripheral edema.( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc.
at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch ( 6 ) 6.1 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.
During clinical studies for rheumatoid arthritis, osteoarthritis, or mild to moderate pain and studies of pharmacokinetics, complaints were compiled from a checklist of potential adverse reactions, and the following data emerged.
These encompass observations in 6,786 patients, including 188 observed for at least 52 weeks.
For comparison, data are also presented from complaints received from the 266 patients who received placebo in these same trials.
During short-term studies for analgesia, the incidence of adverse reactions was markedly lower than that seen in longer-term studies.
Adverse Drug Reactions Reported in >1% of Patients During Clinical Trials Digestive System — During clinical trials with fenoprofen calcium, the most common adverse reactions were gastrointestinal in nature and occurred in 20.8% of patients receiving fenoprofen calcium as compared to 16.9% of patients receiving placebo.
In descending order of frequency, these reactions included dyspepsia (10.3% fenoprofen calcium vs.
2.3% placebo), nausea (7.7% vs.
7.1%), constipation (7% vs.
5 WARNINGS AND PRECAUTIONS • Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity.
Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop ( 5.3 ) • Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs.
Monitor blood pressure ( 5.4 , 7 ) • Heart Failure and Edema: Avoid use of fenoprofen calcium in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure ( 5.5 ) • Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia.
Avoid use of fenoprofen calcium in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function ( 5.6 ) • Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs ( 5.7 ) • Exacerbation of Asthma Related to Aspirin Sensitivity: Fenoprofen calcium is contraindicated in patients with aspirin-sensitive asthma.
Monitor patients with preexisting asthma (without aspirin sensitivity) ( 5.8 ) • Serious Skin Reactions: Discontinue fenoprofen calcium at first appearance of skin rash or other signs of hypersensitivity ( 5.9 ) • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue and evaluate clinically ( 5.10 ) • Fetal Toxicity;
Like all medications, Fenoprofen Calcium can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: