FENOPROFEN CALCIUM
Generic: FENOPROFEN CALCIUM
Basic Information
Manufacturer
Rising Pharma Holdings, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
4aa38cca-9f8f-4ab6-8103-4f1f48801a43
Indications & Usage
1 INDICATIONS AND USAGE Fenoprofen calcium is indicated for: Relief of mild to moderate pain in adults Relief of the signs and symptoms of rheumatoid arthritis Relief of the signs and symptoms of osteoarthritis Fenoprofen calcium is a nonsteroidal anti-inflammatory drug indicated for: Relief of mild to moderate pain in adults.
( 1 ) Relief of the signs and symptoms of rheumatoid arthritis.
( 1 ) Relief of the signs and symptoms of osteoarthritis.
( 1 )
( 1 ) Relief of the signs and symptoms of rheumatoid arthritis.
( 1 ) Relief of the signs and symptoms of osteoarthritis.
( 1 )
Adverse Reactions
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 6.1 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.
1.5%), vomiting (2.6% vs.
1.9%), abdominal pain (2% vs.
1.1%), and diarrhea (1.8% vs.
4.1%).
The drug was discontinued because of adverse gastrointestinal reactions in less than 2% of patients during premarketing studies.
Nervous System — The most frequent adverse neurologic reactions were headache (8.7% vs.
7.5%) and somnolence (8.5% vs.
6.4%).
Dizziness (6.5% vs.
5.6%), tremor (2.2% vs.
0.4%), and confusion (1.4% vs.
none) were noted less frequently.
Fenoprofen calcium was discontinued in less than 0.5% of patients because of these side effects during premarketing studies.
Skin and Appendages — Increased sweating (4.6% vs.
0.4%), pruritus (4.2% vs.
0.8%), and rash (3.7% vs.
0.4%) were reported.
Fenoprofen calcium was discontinued in about 1% of patients because of an adverse effect related to the skin during premarketing studies.
Special Senses — Tinnitus (4.5% vs.
0.4%), blurred vision (2.2% vs.
none), and decreased hearing (1.6% vs.
none) were reported.
Fenoprofen calcium was discontinued in less than 0.5% of patients because of adverse effects related to the special senses during premarketing studies.
Cardiovascular — Palpitations (2.5% vs.
0.4%).
Fenoprofen calcium was discontinued in about 0.5% of patients because of adverse cardiovascular reactions during premarketing studies.
Miscellaneous — Nervousness (5.7% vs.
1.5%), asthenia (5.4% vs.
0.4%), peripheral edema (5.0% vs.
0.4%), dyspnea (2.8% vs.
none), fatigue (1.7% vs.
1.5%), upper respiratory infection (1.5% vs.
5.6%), and nasopharyngitis (1.2% vs.
none).
Adverse Drug Reactions Reported in <1% of Patients During Clinical Trials Digestive System —Gastritis, peptic ulcer with/without perforation, gastrointestinal hemorrhage, anorexia, flatulence, dry mouth, and blood in the stool.
Increases in alkaline phosphatase, LDH, SGOT, jaundice, and cholestatic hepatitis, aphthous ulcerations of the buccal mucosa, metallic taste, and pancreatitis.
Cardiovascular —Atrial fibrillation, pulmonary edema, electrocardiographic changes, and supraventricular tachycardia.
Genitourinary Tract —Renal failure, dysuria, cystitis, hematuria, oliguria, azotemia, anuria, interstitial nephritis, nephrosis, and papillary necrosis.
Hypersensitivity —Angioedema (angioneurotic edema).
Hematologic —Purpura, bruising, hemorrhage, thrombocytopenia, hemolytic anemia, aplastic anemia, agranulocytosis, and pancytopenia.
Nervous System —Depression, disorientation, seizures, and trigeminal neuralgia.
Special Senses —Burning tongue, diplopia, and optic neuritis.
Skin and Appendages —Exfoliative dermatitis, toxic epidermal necrolysis, Stevens-Johnson syndrome, and alopecia.
Miscellaneous —Anaphylaxis, urticaria, malaise, insomnia, tachycardia, personality change, lymphadenopathy, mastodynia, and fever.
6.2 Postmarketing Experience The following adverse reactions have been identified during the post-approval use of fenoprofen calcium.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Skin and Appendages — Alopecia, bruising, desquamation, erythema, photosensitivity, sweat, angioedema, toxic epidermal necrosis, erythema multiforme, exfoliative dermatitis, onycholysis, Stevens-Johnson Syndrome, fixed drug eruption (FDE), urticaria, vesiculobullous reaction.
( 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 6.1 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.
1.5%), vomiting (2.6% vs.
1.9%), abdominal pain (2% vs.
1.1%), and diarrhea (1.8% vs.
4.1%).
The drug was discontinued because of adverse gastrointestinal reactions in less than 2% of patients during premarketing studies.
Nervous System — The most frequent adverse neurologic reactions were headache (8.7% vs.
7.5%) and somnolence (8.5% vs.
6.4%).
Dizziness (6.5% vs.
5.6%), tremor (2.2% vs.
0.4%), and confusion (1.4% vs.
none) were noted less frequently.
Fenoprofen calcium was discontinued in less than 0.5% of patients because of these side effects during premarketing studies.
Skin and Appendages — Increased sweating (4.6% vs.
0.4%), pruritus (4.2% vs.
0.8%), and rash (3.7% vs.
0.4%) were reported.
Fenoprofen calcium was discontinued in about 1% of patients because of an adverse effect related to the skin during premarketing studies.
Special Senses — Tinnitus (4.5% vs.
0.4%), blurred vision (2.2% vs.
none), and decreased hearing (1.6% vs.
none) were reported.
Fenoprofen calcium was discontinued in less than 0.5% of patients because of adverse effects related to the special senses during premarketing studies.
Cardiovascular — Palpitations (2.5% vs.
0.4%).
Fenoprofen calcium was discontinued in about 0.5% of patients because of adverse cardiovascular reactions during premarketing studies.
Miscellaneous — Nervousness (5.7% vs.
1.5%), asthenia (5.4% vs.
0.4%), peripheral edema (5.0% vs.
0.4%), dyspnea (2.8% vs.
none), fatigue (1.7% vs.
1.5%), upper respiratory infection (1.5% vs.
5.6%), and nasopharyngitis (1.2% vs.
none).
Adverse Drug Reactions Reported in <1% of Patients During Clinical Trials Digestive System —Gastritis, peptic ulcer with/without perforation, gastrointestinal hemorrhage, anorexia, flatulence, dry mouth, and blood in the stool.
Increases in alkaline phosphatase, LDH, SGOT, jaundice, and cholestatic hepatitis, aphthous ulcerations of the buccal mucosa, metallic taste, and pancreatitis.
Cardiovascular —Atrial fibrillation, pulmonary edema, electrocardiographic changes, and supraventricular tachycardia.
Genitourinary Tract —Renal failure, dysuria, cystitis, hematuria, oliguria, azotemia, anuria, interstitial nephritis, nephrosis, and papillary necrosis.
Hypersensitivity —Angioedema (angioneurotic edema).
Hematologic —Purpura, bruising, hemorrhage, thrombocytopenia, hemolytic anemia, aplastic anemia, agranulocytosis, and pancytopenia.
Nervous System —Depression, disorientation, seizures, and trigeminal neuralgia.
Special Senses —Burning tongue, diplopia, and optic neuritis.
Skin and Appendages —Exfoliative dermatitis, toxic epidermal necrolysis, Stevens-Johnson syndrome, and alopecia.
Miscellaneous —Anaphylaxis, urticaria, malaise, insomnia, tachycardia, personality change, lymphadenopathy, mastodynia, and fever.
6.2 Postmarketing Experience The following adverse reactions have been identified during the post-approval use of fenoprofen calcium.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Skin and Appendages — Alopecia, bruising, desquamation, erythema, photosensitivity, sweat, angioedema, toxic epidermal necrosis, erythema multiforme, exfoliative dermatitis, onycholysis, Stevens-Johnson Syndrome, fixed drug eruption (FDE), urticaria, vesiculobullous reaction.