Description:

Zorvolex (Oral)

Generic name: diclofenac (oral route) [ dye-KLOE-fen-ak ]
Drug class: Nonsteroidal anti-inflammatory drugs

Medically reviewed by Drugs.com. Last updated on Nov 21, 2022.

Oral route(Capsule)

NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Diclofenac is contraindicated in the setting of CABG surgery. NSAIDs also cause an increased risk of serious gastrointestinal (GI) adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events .

Oral route(Tablet, Delayed Release;Tablet, Enteric Coated;Tablet, Extended Release)

NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Diclofenac sodium is contraindicated in the setting of coronary artery bypass graft surgery. NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events .

Oral route(Tablet;Capsule, Liquid Filled;Powder for Solution)

NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Diclofenac is contraindicated in the setting of coronary artery bypass graft surgery. NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events .

Commonly used brand name(s)

In the U.S.

Cambia
Cataflam
Voltaren
Voltaren-XR
Zipsor
Zorvolex

Available Dosage Forms:

Capsule
Tablet, Enteric Coated
Tablet, Extended Release
Tablet
Powder for Solution
Capsule, Liquid Filled

Therapeutic Class: Central Nervous System Agent

Pharmacologic Class: NSAID

Chemical Class: Acetic Acid (class)

Uses for Zorvolex

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild-to-moderate pain, and helps to relieve symptoms of arthritis (eg, osteoarthritis or rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain. This medicine does not cure arthritis and will only help you as long as you continue to take it.

This medicine is also used to treat ankylosing spondylitis, which is a type of arthritis that affects the joints in the spine, and other painful conditions such as menstrual cramps.

Diclofenac is also used to treat acute migraine attacks, with or without aura, in adults. It will not prevent or lessen the number of migraine attacks.

This medicine is available only with your doctor''s prescription.

Before using Zorvolex

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of diclofenac in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Zipsor® capsules in children 12 to 17 years of age. Safety and efficacy have been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of diclofenac in the elderly. However, elderly patients are more likely to have age-related kidney or stomach problems, which may require caution for patients receiving diclofenac.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Ketorolac

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abciximab
Acenocoumarol
Amiloride
Amineptine
Amitriptyline
Amitriptylinoxide
Amoxapine
Anagrelide
Apixaban
Ardeparin
Argatroban
Aspirin
Bemiparin
Bendroflumethiazide
Benzthiazide
Betamethasone
Betrixaban
Bivalirudin
Budesonide
Bumetanide
Cangrelor
Capecitabine
Ceritinib
Certoparin
Chlorothiazide
Chlorthalidone
Cilostazol
Citalopram
Clomipramine
Clopamide
Clopidogrel
Cortisone
Cyclopenthiazide
Cyclosporine
Dabigatran Etexilate
Dalteparin
Danaparoid
Deferiprone
Deflazacort
Desipramine
Desirudin
Desmopressin
Desvenlafaxine
Dexamethasone
Dexketoprofen
Diazoxide
Dibenzepin
Diflunisal
Digoxin
Dipyridamole
Dipyrone
Dothiepin
Doxepin
Droxicam
Duloxetine
Edoxaban
Enoxaparin
Eplerenone
Epoprostenol
Eptifibatide
Escitalopram
Ethacrynic Acid
Etodolac
Etofenamate
Etoricoxib
Felbinac
Fenoprofen
Fepradinol
Feprazone
Feverfew
Floctafenine
Flufenamic Acid
Fluocortolone
Fluoxetine
Flurbiprofen
Fluvoxamine
Fondaparinux
Furosemide
Ginkgo
Gossypol
Heparin
Hydrochlorothiazide
Hydrocortisone
Hydroflumethiazide
Ibuprofen
Iloprost
Imipramine
Indapamide
Inotersen
Ketoprofen
Lepirudin
Levomilnacipran
Lithium
Lofepramine
Lornoxicam
Loxoprofen
Lumiracoxib
Magnesium Salicylate
Meadowsweet
Meclofenamate
Mefenamic Acid
Melitracen
Meloxicam
Mesalamine
Methotrexate
Methyclothiazide
Methylprednisolone
Metolazone
Milnacipran
Morniflumate
Nabumetone
Nadroparin
Naproxen
Nefazodone
Nepafenac
Niflumic Acid
Nimesulide
Nimesulide Beta Cyclodextrin
Nortriptyline
Olsalazine
Opipramol
Oxaprozin
Oxyphenbutazone
Paramethasone
Parecoxib
Parnaparin
Paroxetine
Pemetrexed
Pentosan Polysulfate Sodium
Pentoxifylline
Phenindione
Phenprocoumon
Phenylbutazone
Phenyl Salicylate
Piketoprofen
Piroxicam
Polythiazide
Potassium Citrate
Prasugrel
Prednisolone
Prednisone
Proglumetacin
Propyphenazone
Proquazone
Protein C
Protriptyline
Reboxetine
Reviparin
Rivaroxaban
Rofecoxib
Salicylamide
Salicylic Acid
Salsalate
Sertraline
Sibutramine
Sodium Salicylate
Spironolactone
Sulfasalazine
Sulindac
Tacrolimus
Tenofovir Disoproxil Fumarate
Tenoxicam
Tianeptine
Tiaprofenic Acid
Ticagrelor
Ticlopidine
Tinzaparin
Tirofiban
Tolfenamic Acid
Tolmetin
Torsemide
Trazodone
Treprostinil
Triamterene
Trichlormethiazide
Trimipramine
Trolamine Salicylate
Valdecoxib
Venlafaxine
Vilazodone
Vorapaxar
Vortioxetine
Warfarin
Xipamide

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acebutolol
Alacepril
Atenolol
Azilsartan
Azilsartan Medoxomil
Benazepril
Betaxolol
Bisoprolol
Candesartan
Captopril
Carteolol
Carvedilol
Celiprolol
Cholestyramine
Cilazapril
Ciprofloxacin
Colestipol
Enalapril
Enalaprilat
Eprosartan
Esmolol
Fosinopril
Irbesartan
Labetalol
Levobunolol
Lisinopril
Losartan
Metipranolol
Metoprolol
Moexipril
Nadolol
Nebivolol
Olmesartan
Oxprenolol
Penbutolol
Perindopril
Pindolol
Practolol
Propranolol
Quinapril
Ramipril
Sotalol
Spirapril
Telmisartan
Timolol
Trandolapril
Valsartan
Zofenopril

Interactions with food/tobacco/alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper use of Zorvolex

This section provides information on the proper use of a number of products that contain diclofenac. It may not be specific to Zorvolex. Please read with care.

Keep using this medicine for the full time of treatment. However, do not use this medicine more often or for a longer time than your doctor ordered. This medicine is not for long-term use.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

When used for severe or continuing arthritis, this medicine must be taken every day as ordered by your doctor in order for it to help you. This medicine usually begins to work within one week, but in severe cases up to two weeks or longer may pass before you begin to feel better. Several weeks may pass before you feel the full effects of this medicine.

You may take this medicine with or without food. However, diclofenac capsules should be taken on an empty stomach.

To use the oral solution:

Open the packet of medicine right before you use it.
Empty the contents of the packet into a cup with 1 to 2 ounces (30 to 60 milliliters [mL]) of water. Do not use any liquid other than water for mixing the medicine.
Mix well and drink it immediately on an empty stomach.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor''s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (Zipsor® capsules):
- For acute pain:
  - Adults and children 12 years of age and older—25 milligrams (mg) 4 times a day.
  - Children younger than 12 years of age—Use and dose must be determined by your doctor.
For oral dosage form (Zorvolex® capsules):
- For acute pain:
  - Adults—18 or 35 milligrams (mg) 3 times a day.
  - Children—Use and dose must be determined by your doctor.
- For osteoarthritis:
  - Adults—35 milligrams (mg) 3 times a day.
  - Children—Use and dose must be determined by your doctor.
For oral dosage forms (delayed-release tablets, enteric-coated tablets):
- For ankylosing spondylitis:
  - Adults—25 milligrams (mg) 4 times a day, with an extra 25 mg dose at bedtime if necessary.
  - Children—Use and dose must be determined by your doctor.
- For osteoarthritis:
  - Adults—50 milligrams (mg) 2 or 3 times a day, or 75 mg two times a day.
  - Children—Use and dose must be determined by your doctor.
- For rheumatoid arthritis:
  - Adults—50 milligrams (mg)3 or 4 times a day, or 75 mg two times a day.
  - Children—Use and dose must be determined by your doctor.
For oral dosage form (immediate-release tablets):
- For osteoarthritis:
  - Adults—50 milligrams (mg) 2 or 3 times a day.
  - Children—Use and dose must be determined by your doctor.
- For pain or menstrual cramps:
  - Adults—50 milligrams (mg) 3 times a day. Your doctor may direct you to take 100 mg for the first dose only.
  - Children—Use and dose must be determined by your doctor.
- For rheumatoid arthritis:
  - Adults—50 milligrams (mg) 3 or 4 times a day.
  - Children—Use and dose must be determined by your doctor.
For oral dosage form (solution):
- For migraine headaches:
  - Adults—One packet (50 milligrams) as a single, one time dose.
  - Children—Use and dose must be determined by your doctor.

Missed dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Detailed Zorvolex dosage information

Precautions while using Zorvolex

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease or in people who use this medicine for a long time.

This medicine may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or are using certain medicines (eg, steroid medicine, blood thinner).

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Serious skin reactions, including Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) can occur during treatment with this medicine. Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.

Some possible warning signs of serious side effects that can occur during treatment with this medicine may include black, tarry stools, decreased urination, severe stomach pain, skin rash, swelling of the face, fingers, feet, or lower legs, unusual bleeding or bruising, unusual weight gain, vomiting of blood or material that looks like coffee grounds, or yellow skin or eyes. Also, signs of serious heart problems could occur, including chest pain or tightness, fast or irregular heartbeat, unusual flushing or warmth of the skin, weakness, or slurring of speech. Check with your doctor right away if you notice any of these warning signs.

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have stomach pain, confusion, difficulty with breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, or weakness or heaviness of the legs.

This medicine may cause a serious allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. It may occur often in patients who are allergic to aspirin or other nonsteroidal anti-inflammatory drugs. Call your doctor right away if you have a rash, itching, trouble breathing or swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Using this medicine during the later part of pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

Using too much of Cambia® or any other migraine medicines (eg, ergotamine, triptans, opioids, NSAIDs, or a combination treatment for 10 or more days per month) may worsen your headache. Talk to your doctor about this risk. It may also be helpful to note of how often your migraine attacks occur and how much medicines you use.

Call your doctor right away if you have confusion, drowsiness, fever, general feeling of illness, headache, loss of appetite, nausea, stiff neck or back, or vomiting. These could be symptoms of meningitis.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may cause a delay in ovulation for women and may affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.

Before having any kind of surgery or medical tests, tell your doctor that you are using this medicine. It may be necessary for you to stop treatment for awhile, or to change to a different nonsteroidal antiinflammatory drug before your procedure.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Zorvolex side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Acid or sour stomach
belching
bleeding gums
blood in the urine or stools
bloody or black, tarry stools
burning while urinating
chest pain
chills
cough
clay-colored stools
cloudy urine
constipation
dark urine
decrease in urine output or decrease in urine-concentrating ability
diarrhea
dizziness
feeling of indigestion
fever
frequent urge to urinate
headache
heartburn
increased bleeding time
indigestion
itching skin or rash
light-colored stools
loss of appetite
nausea and vomiting
pain in the chest below the breastbone
painful or difficult urination
pale skin
pinpoint red spots on the skin
stomach bloating, burning, cramping, discomfort, upset, or pain
sore throat
sores, ulcers, or white spots on the lips or in the mouth
swelling or inflammation of the mouth
swollen glands
trouble breathing
unpleasant breath odor
unusual bleeding or bruising
unusual tiredness or weakness
upper right abdominal or stomach pain
vomiting of blood or material that looks like coffee grounds
weight loss
yellow eyes and skin

Less common

Blistering, peeling, loosening of the skin
blurred vision
burning, crawling, itching, numbness, prickling, "pins and needles" , or tingling feelings
confusion
change in consciousness
discouragement
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
feeling of constant movement of self or surroundings
feeling sad or empty
irritability
joint or muscle pain
lack of appetite
lack or loss of strength
loss of consciousness
loss of interest or pleasure
nervousness
pain or discomfort in the arms, jaw, back, or neck
pale or blue lips, fingernails, or skin
red irritated eyes
red skin lesions, often with a purple center
redness, soreness, or itching skin
sensation of spinning
shakiness in the legs, arms, hands, or feet
sleepiness or unusual drowsiness
stiff neck or back
trembling or shaking of the hands or feet
trouble concentrating
trouble sleeping

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Agitation
blurred vision
change in consciousness
change in the ability to see colors, especially blue or yellow
confusion
depression
difficult or trouble breathing
hives
hostility
irregular, fast or slow, or shallow breathing
irritability
loss of consciousness
muscle twitching
nervousness
pain or discomfort in the chest, upper stomach, or throat
pale or blue lips, fingernails, or skin
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
rapid weight gain
seizures
sleepiness
slow or fast heartbeat
stupor
swelling of the face, ankles, or hands
tightness in the chest
trouble sleeping
unusual drowsiness, dullness, or feeling of sluggishness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Bloated
continuing ringing or buzzing or other unexplained noise in the ears
difficulty in swallowing
excess air or gas in the stomach or intestines
hearing loss
lack or loss of strength
pain or burning in the throat
passing gas

Less common

Burning, dry or itching eyes
discharge, excessive tearing
hair loss, thinning of the hair
increased sensitivity of the skin to sunlight
pain in the arms or legs
redness, pain, swelling of the eye, eyelid, or inner lining of eyelid
redness or other discoloration of the skin
severe sunburn

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Zorvolex side effects (more detail)

Frequently asked questions

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More about Zorvolex (diclofenac)

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Side effects
Dosage information
During pregnancy
FDA approval history
Drug class: Nonsteroidal anti-inflammatory drugs
Breastfeeding

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Drug name: Zorvolex (Oral)