Medical Editor: John P. Cunha, DO, FACOEP
- swelling (edema),
- pain in extremities,
- abdominal pain,
- sinus infection,
- high or low blood pressure,
- upper respiratory tract infection,
- urinary tract infection,
- runny or stuffy nose,
- cough, and
- back pain.
For treatment of mild to moderate acute pain, the dosage of Zorvolex is 18 mg or 35 mg three times daily. Zorvolex may interact with aspirin, anticoagulants, ACE inhibitors, diuretics, lithium, methotrexate, or cyclosporine. Tell your doctor all medications and supplements you use. During pregnancy, Zorvolex should be used only if prescribed prior to 30 weeks. Starting at 30 weeks Zorvolex is not recommended for use as it may harm a fetus. This drug may pass into breast milk. Consult your doctor before breastfeeding.
Our Zorvolex (diclofenac) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Cardiovascular Thrombotic Events [see WARNINGS AND PRECAUTIONS]
- GI Bleeding, Ulceration and Perforation [see WARNINGS AND PRECAUTIONS]
- Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
- Hypertension [see WARNINGS AND PRECAUTIONS]
- Heart Failure and Edema [see WARNINGS AND PRECAUTIONS]
- Renal Toxicity and Hyperkalemia [see WARNINGS AND PRECAUTIONS]
- Anaphylactic Reactions [see WARNINGS AND PRECAUTIONS]
- Serious Skin Reactions [see WARNINGS AND PRECAUTIONS]
- Hematologic Toxicity [see WARNINGS AND PRECAUTIONS]
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 ZORVOLEX 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.
Table 1 : Summary of Adverse Reactions ( ≥ 2%
in ZORVOLEX 18 mg or 35 mg group) - Phase 3 Study in Patients With Postsurgical
|Adverse Reactions||ZORVOLEX 18 mg or 35 mg three times daily*
N = 216
N = 106
|Pain in Extremity||3%||1%|
|*One tablet of hydrocodone/acetaminophen 10 mg/325 mg was permitted every 4 to 6 hours as rescue medication for pain management. There was a greater use of concomitant opioid rescue medication in placebo-treated patients than in ZORVOLEX-treated patients. About 82% of patients in the ZORVOLEX 35 mg group, 85% of the patients in the ZORVOLEX 18 mg group, and 97% of patients in the placebo group took rescue medication for pain management during the study.|
Adverse Reactions In Patients With Osteoarthritis Pain
Two-hundred two (202) patients received ZORVOLEX in the completed, 12-week, doubleblind, 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.
Table 2 : Summary of Adverse Reactions ( ≥ 2%)
- 12-week Phase 3 Study in Patients With Osteoarthritis Pain*
|Adverse Reactions||ZORVOLEX 35 mg
|Abdominal Pain Upper||3%||1%|
|Alanine Aminotransferase Increased||2%||0|
|Blood Creatinine Increased||2%||0|
|* Adverse reactions that occurred in ≥ 2% of patients treated with ZORVOLEX and occurred more frequently than in patients treated with placebo|
Six-hundred one (601) patients received ZORVOLEX 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.
Table 3 : Summary of Adverse Reactions ( ≥ 2%)
- 52-week Open-label Study in Patients with Osteoarthritis Pain
|Adverse Reactions||ZORVOLEX 35 mg
|Upper respiratory tract infection||8%|
|Urinary tract infection||7%|
|Alanine aminotransferase increased||4%|
|Abdominal pain upper||3%|
|Aspartate aminotransferase increased||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:
Additional adverse reactions reported occasionally include:
Body as a Whole: fever, infection, sepsis
Metabolic and Nutritional: weight changes
Special Senses: blurred vision
Other adverse reactions, which occur rarely are:
Body as a Whole: anaphylactic reactions, appetite changes, death
Metabolic and Nutritional: hyperglycemia
Nervous System: convulsions, coma, hallucinations, meningitis
Respiratory System: respiratory depression, pneumonia
Special Senses: conjunctivitis, hearing impairment
Read the entire FDA prescribing information for Zorvolex (Diclofenac Capsules)