Zorvolex
- Generic Name: diclofenac capsules
- Brand Name: Zorvolex
Zorvolex (Diclofenac Capsules) side effects drug center
Zorvolex Side Effects Center
What Is Zorvolex?
Zorvolex (diclofenac) is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate acute pain in adults.
What Are Side Effects of Zorvolex?
Common side effects of Zorvolex include:
- swelling (edema),
- nausea,
- headache,
- dizziness,
- vomiting,
- constipation,
- itching,
- gas,
- pain in extremities,
- indigestion,
- diarrhea,
- abdominal pain,
- sinus infection,
- high or low blood pressure,
- upper respiratory tract infection,
- urinary tract infection,
- runny or stuffy nose,
- arthritis,
- cough, and
- back pain.
Dosage for Zorvolex
For treatment of mild to moderate acute pain, the dosage of Zorvolex is 18 mg or 35 mg three times daily.
What Drugs, Substances, or Supplements Interact with Zorvolex?
Zorvolex may interact with aspirin, anticoagulants, ACE inhibitors, diuretics, lithium, methotrexate, or cyclosporine. Tell your doctor all medications and supplements you use.
Zorvolex During Pregnancy and Breastfeeding
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.
Additional Information
Our Zorvolex (diclofenac) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Zorvolex Consumer Information
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.
Stop using diclofenac and call your doctor at once if you have:
- the first sign of any skin rash, no matter how mild;
- flu-like symptoms;
- heart problems--swelling, rapid weight gain, feeling short of breath;
- kidney problems--little or no urinating, painful or difficult urination, swelling in your arms or legs, feeling tired or short of breath;
- liver problems--nausea, diarrhea, stomach pain (upper right side), tiredness, itching, dark urine, jaundice (yellowing of the skin or eyes); or
- signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.
Common side effects may include:
- indigestion, gas, nausea, vomiting, stomach pain;
- diarrhea, constipation;
- headache, dizziness, drowsiness;
- abnormal lab tests;
- itching, sweating;
- stuffy nose;
- increased blood pressure; or
- swelling or pain in your arms or legs.
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.
Read the entire detailed patient monograph for Zorvolex (Diclofenac Capsules)
Zorvolex Professional Information
SIDE EFFECTS
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 Pain
| Adverse Reactions | ZORVOLEX 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% |
| *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, 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.
Table 2 : Summary of Adverse Reactions (≥2%) - 12-week Phase 3 Study in Patients With Osteoarthritis Pain*
| Adverse Reactions | ZORVOLEX 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% |
| * 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 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
DRUG INTERACTIONS
See Table 4 for clinically significant drug interactions with diclofenac.
Table 4 : Clinically Significant Drug Interactions with Diclofenac
| Drugs That Interfere with Hemostasis | |
| Clinical Impact: |
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The concomitant use of diclofenac and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone.
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| Intervention: | Monitor patients with concomitant use of ZORVOLEX with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding [see WARNINGS AND PRECAUTIONS]. |
| Aspirin | |
| Clinical Impact: | Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone [see WARNINGS AND PRECAUTIONS]. |
| Intervention: | Concomitant use of ZORVOLEX and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [see WARNINGS AND PRECAUTIONS]. ZORVOLEX is not a substitute for low dose aspirin for cardiovascular protection. |
| ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers | |
| Clinical Impact: |
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| Intervention: |
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| Diuretics | |
| Clinical Impact: | Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis. |
| Intervention: | During concomitant use of ZORVOLEX with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects [see WARNINGS AND PRECAUTIONS]. |
| Digoxin | |
| Clinical Impact: | The concomitant use of diclofenac with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin. |
| Intervention: | During concomitant use of ZORVOLEX and digoxin, monitor serum digoxin levels. |
| Lithium | |
| Clinical Impact: | NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis. |
| Intervention: | During concomitant use of ZORVOLEX and lithium, monitor patients for signs of lithium toxicity. |
| Methotrexate | |
| Clinical Impact: | Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction). |
| Intervention: | During concomitant use of ZORVOLEX and methotrexate, monitor patients for methotrexate toxicity. |
| Cyclosporine | |
| Clinical Impact: | Concomitant use of ZORVOLEX and cyclosporine may increase cyclosporine’s nephrotoxicity. |
| Intervention: | During concomitant use of ZORVOLEX and cyclosporine, monitor patients for signs of worsening renal function. |
| NSAIDs and Salicylates | |
| Clinical Impact: | Concomitant use of diclofenac with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy [see WARNINGS AND PRECAUTIONS]. |
| Intervention: | The concomitant use of diclofenac with other NSAIDs or salicylates is not recommended. |
| Pemetrexed | |
| Clinical Impact: | Concomitant use of ZORVOLEX and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information). |
| Intervention: | During concomitant use of ZORVOLEX and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity. NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed. In the absence of data regarding potential interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following pemetrexed administration. |
| Inhibitors or Inducers of Cytochrome P450 2C9 | |
| Clinical Impact: | Diclofenac is metabolized by cytochrome P450 enzymes, predominantly by CYP2C9. Co-administration of diclofenac with CYP2C9 inhibitors (e.g. voriconazole) may enhance the exposure and toxicity of diclofenac whereas coadministration with CYP2C9 inducers (e.g. rifampin) may lead to compromised efficacy of diclofenac. |
| Intervention: | A dosage adjustment may be warranted when diclofenac is administered with CYP2C9 inhibitors or inducers [see CLINICAL PHARMACOLOGY]. |
Read the entire FDA prescribing information for Zorvolex (Diclofenac Capsules)
&Copy; Zorvolex Patient Information is supplied by Cerner Multum, Inc. and Zorvolex Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.