DICLOFENAC (Page 3 of 7)
5.10 Premature Closure of Fetal Ductus Arteriosus
Diclofenac may cause premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including Diclofenac Capsules, in pregnant women starting at 30 weeks of gestation (third trimester) [see Use in Specific Populations (8.1) ].
5.11 Hematologic Toxicity
Anemia has occurred in NSAID-treated patients. This may be due to occult or gross blood loss, fluid retention, or an incompletely described effect on erythropoiesis. If a patient treated with Diclofenac Capsules has any signs or symptoms of anemia, monitor hemoglobin or hematocrit.
NSAIDs, including Diclofenac Capsules, may increase the risk of bleeding events. Co-morbid conditions, such as coagulation disorders, concomitant use of warfarin, other anticoagulants, antiplatelet agents (e.g., aspirin), serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs) may increase this risk. Monitor these patients for signs of bleeding [see Drug Interactions (7) ].
5.12 Masking of Inflammation and Fever
The pharmacological activity of Diclofenac Capsules in reducing inflammation, and possibly fever, may diminish the utility of diagnostic signs in detecting infections.
5.13 Laboratory Monitoring
Because serious GI bleeding, hepatotoxicity, and renal injury can occur without warning symptoms or signs, consider monitoring patients on long-term NSAID treatment with a CBC and a chemistry profile periodically [see Warnings and Precautions (5.2, 5.3, 5.6)].
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 (5.11) ]
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 clinical practice.
Adverse Reactions in Patients with Acute Pain
Two-hundred sixteen (216) patients received Diclofenac Capsules in the completed, 48-hour, double-blind, placebo-controlled, clinical trial of acute pain following bunionectomy. The most frequent adverse reactions in this study are summarized in Table 1.
| Adverse Reactions | Diclofenac Capsules 18 mg or 35 mg three times daily *N = 216 | Placebo *N = 106 |
|---|---|---|
| ||
| Edema | 33% | 32% |
| Nausea | 27% | 37% |
| Headache | 13% | 15% |
| Dizziness | 10% | 16% |
| Vomiting | 9% | 12% |
| Constipation | 8% | 4% |
| Pruritus | 7% | 6% |
| Flatulence | 3% | 2% |
| Pain in Extremity | 3% | 1% |
| Dyspepsia | 2% | 1% |
Adverse Reactions in Patients with Osteoarthritis Pain
Two-hundred two (202) patients received Diclofenac Capsules in the completed, 12-week, double-blind, placebo-controlled, clinical trial of osteoarthritis pain of the knee or hip. The most frequent adverse reactions in this study are summarized in Table 2.
| Adverse Reactions | Diclofenac Capsules 35 mg N=202 | Placebo N=103 |
|---|---|---|
| ||
| Nausea | 7% | 2% |
| Diarrhea | 6% | 3% |
| Headache | 4% | 3% |
| Abdominal Pain Upper | 3% | 1% |
| Sinusitis | 3% | 1% |
| Vomiting | 3% | 1% |
| Alanine Aminotransferase Increased | 2% | 0 |
| Blood Creatinine Increased | 2% | 0 |
| Dyspepsia | 2% | 1% |
| Flatulence | 2% | 0 |
| Hypertension | 2% | 1% |
Six-hundred one (601) patients received Diclofenac Capsules 35 mg either twice or three times daily in a 52-week, open-label, clinical trial in osteoarthritis pain of the knee or hip. Of those, 360 (60%) patients completed the trial. The most frequent adverse reactions in this study are summarized in Table 3.
| Adverse Reactions | Diclofenac Capsules 35 mg N=601 |
|---|---|
| Upper respiratory tract infection | 8% |
| Headache | 8% |
| Urinary tract infection | 7% |
| Diarrhea | 6% |
| Nasopharyngitis | 6% |
| Nausea | 6% |
| Constipation | 5% |
| Sinusitis | 5% |
| Osteoarthritis | 5% |
| Cough | 4% |
| Alanine aminotransferase increased | 4% |
| Back pain | 3% |
| Dyspepsia | 3% |
| Procedural pain | 3% |
| Bronchitis | 3% |
| Hypertension | 3% |
| Abdominal pain upper | 3% |
| Influenza | 3% |
| Arthralgia | 3% |
| Contusion | 3% |
| Vomiting | 3% |
| Abdominal discomfort | 2% |
| Aspartate aminotransferase increased | 2% |
| Dizziness | 2% |
| Fall | 2% |
| Abdominal pain | 2% |
Adverse reactions reported for diclofenac and other NSAIDs:
In patients taking other NSAIDs, the most frequently reported adverse reactions occurring in approximately 1%-10% of patients are:
Gastrointestinal experiences including: abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, GI ulcers (gastric/duodenal) and vomiting.
Abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritus, rashes and tinnitus.
Additional adverse reactions reported occasionally include:
Body as a Whole: fever, infection, sepsis
Cardiovascular System: congestive heart failure, hypertension, tachycardia, syncope
Digestive System: dry mouth, esophagitis, gastric/peptic ulcers, gastritis, gastrointestinal bleeding, glossitis, hematemesis, hepatitis, jaundice
Hemic and Lymphatic System: ecchymosis, eosinophilia, leukopenia, melena, purpura, rectal bleeding, stomatitis, thrombocytopenia
Metabolic and Nutritional: weight changes
Nervous System: anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, nervousness, paresthesia, somnolence, tremors, vertigo
Respiratory System: asthma, dyspnea
Skin and Appendages: alopecia, photosensitivity, sweating increased
Special Senses: blurred vision
Urogenital System: cystitis, dysuria, hematuria, interstitial nephritis, oliguria/polyuria, proteinuria, renal failure
Other adverse reactions, which occur rarely are:
Body as a Whole: anaphylactic reactions, appetite changes, death
Cardiovascular System: arrhythmia, hypotension, myocardial infarction, palpitations, vasculitis
Digestive System: colitis, eructation, fulminant hepatitis with and without jaundice, liver failure, liver necrosis, pancreatitis
Hemic and Lymphatic System: agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, pancytopenia
Metabolic and Nutritional: hyperglycemia
Nervous System: convulsions, coma, hallucinations, meningitis
Respiratory System: respiratory depression, pneumonia
Skin and Appendages: angioedema, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, urticaria
Special Senses: conjunctivitis, hearing impairment
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