diclofenac sodium / misoprostol
Arthrotec (diclofenac / misoprostol) is a combination medication used to treat osteoarthritis (OA) and rheumatoid arthritis (RA) in non-pregnant adults. The diclofenac in Arthrotec is a non-steroidal anti-inflammatory drug (NSAID) that helps with pain and swelling, while the misoprostol is a prostaglandin E1 analog that lowers the risk of stomach and intestinal ulcers from diclofenac. Arthrotec (diclofenac / misoprostol) is taken by mouth, typically two to four times per day. Common side effects of this medication include stomach cramps (pain) and diarrhea. Avoid drinking alcohol with Arthrotec (diclofenac / misoprostol) because doing so can raise the risk of stomach bleeding.
What is Arthrotec (diclofenac / misoprostol)?
What is Arthrotec (diclofenac / misoprostol) used for?
Treatment of osteoarthritis (OA) and rheumatoid arthritis (RA) in adults who are at high risk for stomach and intestinal ulcers
How Arthrotec (diclofenac / misoprostol) works
Arthrotec (diclofenac / misoprostol) is a combination of two medications:
Diclofenac is a non-steroidal anti-inflammatory drug (NSAID). It blocks proteins in your body called cyclooxygenase or COX. This helps lower inflammation, swelling, and pain.
Misoprostol is a prostaglandin E1 analog. Prostaglandins are natural chemicals that protect the stomach. But NSAIDs, like diclofenac, lower the amount of natural prostaglandins in the stomach, which raises the risk of bleeding and ulcers (open sores). Misoprostol acts like natural prostaglandins, which helps lower the risk of ulcers from diclofenac.
Drug Facts
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What are the side effects of Arthrotec (diclofenac / misoprostol)?
Common Side Effects
- Stomach pain (21%)
- Diarrhea (19%)
- Upset stomach or indigestion (14%)
- Nausea (11%)
- Gas (9%)
Other Side Effects
- Vomiting
- Constipation
- Dry mouth
- Headache
- Dizziness
- Fatigue
- Vaginal bleeding
- Menstrual cramps
Serious Side Effects
- Heart attack: dizziness, tiredness, cold sweat, trouble breathing, chest pain or tightness, anxiety
- Stroke: tiredness, lightheadedness, blurred vision, difficulty speaking, difficulty walking, weakness on one side of the body
- Stomach bleeds: blood in your vomit, stool that looks like black coffee grounds, pain in your stomach that doesn't go away
- Heart failure: trouble breathing, tiredness, swelling in your body, sudden weight gain
- Liver damage: fever, chills, fatigue, nausea, vomiting, yellowing of the skin or whites of the eyes, clay-colored stool, dark urine
- Kidney damage and high potassium: nausea, muscle weakness, tingling sensations in your muscles, changes in how much you urinate
- Severe asthma attack: chest pain, cough, difficulty breathing, wheezing
- Serious allergic or skin reaction: fever, rash, body aches, cough, swelling of the face, peeling skin, painful blisters all over your body
Source: DailyMed
The following side effects have also been reported
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
Stomach pain
Less common
Black, tarry stools
bladder pain
bloody or cloudy urine
burning feeling in the chest or stomach
burning while urinating
chest pain, discomfort, or tightness
chills
deep or fast breathing with dizziness
difficult, burning, or painful urination
difficulty swallowing
dizziness
double vision
feeling of constant movement of self or surroundings
frequent urge to urinate
increased sensitivity of the skin to sunlight
increased volume of pale, dilute urine
indigestion
itching, skin rash
lightheadedness
longer or heavier menstrual periods
lower back or side pain
nosebleed
numbness of the feet, hands, and around the mouth
pain or burning in the throat
pain with swallowing
redness or other discoloration of the skin
seeing double
sensation of spinning
severe sunburn
sores, ulcers, or white spots on the lips or in the mouth
stomach upset or tenderness
swollen glands
unusual bleeding or bruising
unusual tiredness or weakness
vaginal bleeding
vomiting with or without blood
Incidence not known
Ankle, knee, or great toe joint pain
black, tarry stools
bleeding gums
blindness
blistering, peeling, or loosening of the skin
bloating or swelling of the face, arms, hands, lower legs, or feet
bluish color of the skin
blurred vision
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
burning, dry, or itching eyes
cloudy or dark urine
decreased frequency or amount of urine
decreased vision
difficulty in speaking
dilated neck veins
discharge, excessive tearing
dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position
drowsiness
excessive muscle tone
extreme tiredness or weakness
fainting
fast, irregular, pounding, or racing heartbeat or pulse
general feeling of illness
headache, severe and throbbing
hoarseness
inability to move the arms, legs, or facial muscles
inability to speak
increased sensitivity to pain or touch
increased thirst
irregular, fast or slow, or shallow breathing
joint pain, stiffness, or swelling
large, hive-like swelling on the pain, face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
light-colored stools
lightheadedness
loss of appetite
loss of consciousness
muscle stiffness, tension, or tightness
nervousness
night blindness
pain or discomfort in the arms, jaw, back, or neck
pains in the stomach, side, or abdomen, possibly radiating to the back
pain, warmth, or burning in the fingers, toes, and legs
pale or blue lips, fingernails, or skin pale skin
pinpoint red spots on the skin
pounding in the ears
problems with vision or hearing
rapid weight gain
red skin lesions, often with a purple center
redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
redness or soreness of the skin
seizures
severe stomach cramping
slow heartbeat
slow speech
sores, welts, or blisters
stiff neck or back
trouble breathing
unusual bleeding or bruising
unusual weight gain or loss
upper right stomach pain
uterine cramping and bleeding
vomiting of material that looks like coffee grounds, severe and continuing
yellow eyes or skin
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:
Less common
Breast pain
change in or loss of taste
confusion about identity, place, and time
continuing ringing or buzzing or other unexplained noise in the ears
decreased concentration
difficulty in moving
frequent urge to defecate
increased clear or white vaginal discharge
irritability
itching of the vagina or genital area
lack or loss of strength
loss or thinning of hair
pain during sexual intercourse
seeing, hearing, or feeling things that are not there
straining while passing stool
thick, white vaginal discharge with no odor or with a mild odor
trouble sleeping
Incidence not known
Blemishes on the skin
decreased interest in sexual intercourse
inability to have or keep an erection
loss in sexual ability, desire, drive, or performance
sleepiness or unusual drowsiness
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.
Pros and cons of Arthrotec (diclofenac / misoprostol)
Pros
Diclofenac works well to relieve symptoms of pain and swelling and misoprostol works well to lower the risk of stomach and intestinal ulcers and bleeding
Conveniently combines two medication in one pill
Available as a lower-cost generic
Cons
Needs to be taken multiple times a day
Not safe to take at any time of pregnancy
Might not be the best option if you're 65 years or older or if you have kidney, heart, liver, or bleeding problems
Pharmacist tips for Arthrotec (diclofenac / misoprostol)
Arthrotec (diclofenac / misoprostol) works well to treat arthritis pain, but it won't prevent your condition from getting worse. Some things you can do to prevent your arthritis from getting worse include physical therapy, exercise, or taking other medications. Discuss with your healthcare team what the best options are for you.
Diarrhea, upset stomach, and stomach pain are common side effects of Arthrotec (diclofenac / misoprostol). Taking it with food might help ease or prevent some of these from happening.
Don't crush or chew the Arthrotec (diclofenac / misoprostol) tablets. Doing so can cause the medication to irritate your mouth and stomach. Contact your prescriber if you're having trouble swallowing the tablets. You might need to be switched to a different medication.
Diclofenac in Arthrotec can raise the risk for stomach bleeding. Tell your prescriber right away if you have unexplained vomiting or stomach pain or blood in your vomit or stool. They can let you know whether you need more medical attention.
Diclofenac in Arthrotec might raise your blood pressure. If you already have high blood pressure, your prescriber might ask you to check your blood pressure at home more often. If needed, they might make changes to your blood pressure medications.
Avoid taking Arthrotec (diclofenac / misoprostol) with other NSAIDs, such as ibuprofen (Advil). Arthrotec already contains diclofenac, which is an NSAID. Taking more than one NSAID at the same time puts you at higher risk for stomach bleeds, stroke, and heart attack. Carefully check the manufacturer's label of over-the-counter medications because they might contain NSAIDs. Ask a pharmacist if you're not sure whether you're already taking a medication with an NSAID.
Make sure to tell your prescriber and pharmacist about all of the medications you're taking or planning to take. Arthrotec (diclofenac / misoprostol) can interact with many medications, such as many blood pressure medications and blood thinners (including aspirin). These interactions can raise your risk for side effects. Your care team can check that your medications are safe to take together.
Avoid using magnesium-containing antacids (e.g., Rolaids (calcium carbonate / magnesium hydroxide) or Mylanta (aluminum hydroxide / magnesium hydroxide / simethicone)) because these antacids can worsen diarrhea from Arthrotec (diclofenac / misoprostol).
Tell your healthcare professional if you're allergic to aspirin. There's a chance you might be allergic to the diclofenac in Arthrotec as well because the two medications are related to each other.
Arthrotec (diclofenac / misoprostol) isn't safe at any time during pregnancy. Females who are able to have children and are prescribed Arthrotec (diclofenac / misoprostol) must use birth control and have a negative pregnancy test within 2 weeks of starting the medication. If you're pregnant or thinking of becoming pregnant, talk to your prescriber right away because you'll need to be switched to a different medication.
Talk to your care team about the risks and benefits of taking Arthrotec (diclofenac / misoprostol) if you're breastfeeding. Research suggests diclofenac and misoprostol are acceptable while breastfeeding. But it's best to check your obstetrician-gynecologist (OB-GYN) to learn about your options during nursing.
Frequently asked questions about Arthrotec (diclofenac / misoprostol)
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What are the risks and warnings for Arthrotec (diclofenac / misoprostol)?
Arthrotec (diclofenac / misoprostol) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Harm to mother and unborn baby
Risk factors: Sexually active women of childbearing age | Pregnant women
Arthrotec (diclofenac / misoprostol) can cause life-threatening problems for both the mother and the unborn baby, including spontaneous abortion, premature birth, and birth defects. Don't take Arthrotec (diclofenac / misoprostol) at any stage of pregnancy, or if you're planning on getting pregnant. Females who are able to get pregnant and prescribed Arthrotec (diclofenac / misoprostol) must use a reliable and effective form of birth control. You'll also need to have a negative pregnancy test within 2 weeks of starting this medication. If you get pregnant while taking this medication, let your prescriber know right away. You'll need to immediately stop taking it.
Stomach bleeding
Risk factors: Older adults | History of stomach bleeding or bleeding problems | Liver problems | Taking other medications that raise your risk of bleeds | Drinking alcohol | Smoking | Taking Arthrotec (diclofenac / misoprostol) for a long time
Even though Arthrotec contains misoprostol to help protect your stomach lining, taking this medication can still raise your risk for stomach ulcers (sores) and bleeds because of diclofenac. These stomach injuries can happen at any time while you're taking Arthrotec (diclofenac / misoprostol); it's a dangerous side effect that requires treatment right away. Tell your prescriber or pharmacist about all of your medical conditions and medications before you start Arthrotec (diclofenac / misoprostol) so they can talk with you about your risk for stomach bleeding.
Oftentimes, people who have stomach bleeds don't have noticeable symptoms, especially if the bleeding is slow and happens over a long period of time. Stomach ulcers can feel like a gnawing pain in the stomach area. Seek medical attention right away if you're feeling faint, vomiting blood, have bloody or dark stools, or have severe stomach pain or discomfort that doesn't go away while you're taking Arthrotec (diclofenac / misoprostol).
Heart attack and stroke
Risk factors: Heart problems | Taking higher doses of Arthrotec (diclofenac / misoprostol) | Taking Arthrotec (diclofenac / misoprostol) for a long time | Past or planned heart surgery
Diclofenac in Arthrotec might raise your risk of having blood clots, which can sometimes lead to a heart attack or stroke. Talk to your prescriber before you start taking Arthrotec (diclofenac / misoprostol) if you have heart problems. Don't take this medication if you had, or will have, heart surgery.
To lower your risk of blood clots, heart attack, and stroke, your prescriber will recommend that you take Arthrotec (diclofenac / misoprostol) for the shortest time needed to treat your condition. Call 911 or get immediate help if you experience chest pain, shortness of breath, weakness on one side of your body, or trouble speaking or walking. These can be signs of a serious blood clot.
High blood pressure and heart failure
Risk factors: Heart problems
Diclofenac in Arthrotec can cause your body to hold onto extra fluid. This can raise your blood pressure or put you at risk for heart failure. Tell your prescriber if you have a history of a heart condition or if you're taking blood pressure medications before you start Arthrotec (diclofenac / misoprostol). Your prescriber will also check for heart problems before your treatment with Arthrotec (diclofenac / misoprostol) starts. Contact your healthcare team if you have unexplained fainting, chest pain with physical activity, or irregular heartbeat while you're taking Arthrotec (diclofenac / misoprostol). These can be signs of heart problems from fluid build-up.
Kidney damage
Risk factors: Older adults | Kidney problems | Heart failure | Liver problems | Taking other medications that can cause kidney problems
Long-term use of NSAIDs, like diclofenac, in Arthrotec can cause injury to the kidneys. Your risk is higher if you're of older age, if you have certain medical problems like kidney problems, or if you take medications that can cause kidney damage such as diuretics (water pills). Contact your care team if you develop any signs or symptoms of kidney problems, including changes in your need to urinate, tiredness, dry and itchy skin, low appetite, and muscle cramps.
Liver problems
Risk factors: History of liver problems
Some people who took Arthrotec (diclofenac / misoprostol) had higher liver enzyme levels in their blood, which can mean harm to your liver. Although rare, there have been reports of serious liver problems that can lead to liver failure. Get medical attention right away if you notice swelling of your stomach; stomach pain; yellowing of your skin or the whites of your eyes; stool changes (black, tarry, or bloody stools); nausea; or dark or brown urine. These can be signs of liver damage, and you might need to stop taking Arthrotec (diclofenac / misoprostol) to prevent further harm.
Severe allergic reactions and skin reactions
Risk factors: Aspirin or NSAID allergy | Aspirin-sensitive asthma | Asthma with rhinitis (runny or stuffy nose), with or without nasal polyps
Severe allergic reactions to diclofenac in Arthrotec are possible, including life-threatening reactions like facial swelling and anaphylaxis. Tell your prescriber if you have an allergy to aspirin or other NSAIDs; you might be at risk for an allergic reaction to Arthrotec (diclofenac / misoprostol). Get medical help right away if you notice hives, swelling of the lips or tongue, or difficulty breathing after you take Arthrotec (diclofenac / misoprostol).
Although rare, diclofenac in Arthrotec can also cause serious skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). Stop taking Arthrotec (diclofenac / misoprostol) and get medical attention right away if you notice changes in your skin, such as rash, blisters, skin reddening, or skin peeling.
Risk for bleeding
Risk factors: Taking with other blood thinners (e.g. aspirin, warfarin) | Taking with selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs) | Blood-clotting problems
NSAIDs like diclofenac in Arthrotec can raise your risk for bleeding. Let a healthcare professional know if you bleed more easily, if bleeding takes longer to stop, or if bleeding doesn't stop while you're taking this medication.
Arthrotec (diclofenac / misoprostol) dosage forms
Typical dosing for Arthrotec (diclofenac / misoprostol)
Arthrotec and its generics come in 2 different strengths:
Arthrotec 50 contains 50 mg of diclofenac and 200 mcg of misoprostol
Arthrotec 75 contains 75 mg of diclofenac and 200 mcg of misoprostol
Osteoarthritis
The typical dose is Arthrotec 50 by mouth twice to three times a day, or Arthrotec 75 mg twice a day.
Rheumatoid arthritis
The typical dose is Arthrotec 50 by mouth twice to four times a day, or Arthrotec 75 mg twice a day.
Interactions between Arthrotec (diclofenac / misoprostol) and other drugs
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.
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
- 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
- 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 Cilexetil
- Captopril
- Carteolol
- Carvedilol
- Celiprolol
- Cholestyramine
- Ciprofloxacin
- Colestipol
- Enalapril
- Enalaprilat
- Eprosartan
- Esmolol
- Fosinopril
- Irbesartan
- Labetalol
- Levobunolol
- Lisinopril
- Losartan
- Metipranolol
- Metoprolol
- Moexipril
- Nadolol
- Nebivolol
- Olmesartan Medoxomil
- Oxprenolol
- Penbutolol
- Perindopril Erbumine
- Phenylbutazone
- Pindolol
- Practolol
- Propranolol
- Quinapril
- Ramipril
- Sotalol
- Spirapril
- Telmisartan
- Timolol
- Trandolapril
- Valsartan
How much does Arthrotec (diclofenac / misoprostol) cost?
Arthrotec (diclofenac / misoprostol) contraindications
History of asthma, hives, or other allergic reactions after taking aspirin or another NSAID
Use of Arthrotec (diclofenac / misoprostol) after coronary artery bypass graft surgery (CABG)
Active stomach bleeding
Pregnancy
What are alternatives to Arthrotec (diclofenac / misoprostol)?
Treatment of osteoarthritis (OA) and rheumatoid arthritis (RA) in adults who are at high risk for stomach and intestinal ulcers
Treatment of osteoarthritis (OA) and rheumatoid arthritis (RA) in adults, while lowering the risk of stomach ulcers
Treatment of different kinds of arthritis while lowering the risk for stomach ulcers
What is the latest news about Arthrotec (diclofenac / misoprostol)?
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References
Best studies we foundDrugs and Lactation Database (LactMed®). (2022). Misoprostol. National Institute of Child Health and Human Development.
Drugs and Lactation Database (LactMed®). (2024). Diclofenac. National Institute of Child Health and Human Development.
Greenstone LLC. (2024). Diclofenac sodium and misoprostol tablet, film coated [package insert]. DailyMed.
National Heart, Lung, and Blood Institute. (2022). What is coronary artery bypass grafting?
National Kidney Foundation. (2020). 10 signs you may have kidney disease.
Pfizer Laboratories Div Pfizer. (2024). Arthrotec- diclofenac sodium and misoprostol tablet, film coated [package insert]. DailyMed.
Wallace, J. L. (2008). Prostaglandins, NSAIDs, and gastric mucosal protection: Why doesn’t the stomach digest itself? Physiological Reviews.
Watkinson, G., et al. (1988). The therapeutic efficacy of misoprostol in peptic ulcer disease. Postgraduate Medical Journal.
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