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Vivlodex Side Effects

What should I watch for?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

Do not take other medicines that contain aspirin, ibuprofen, or naproxen with this medicine. Side effects such as stomach upset, nausea, or ulcers may be more likely to occur. Many medicines available without a prescription should not be taken with this medicine.

This medicine can cause ulcers and bleeding in the stomach and intestines at any time during treatment. This can happen with no warning and may cause death. There is increased risk with taking this medicine for a long time. Smoking, drinking alcohol, older age, and poor health can also increase risks. Call your doctor right away if you have stomach pain or blood in your vomit or stool.

This medicine does not prevent heart attack or stroke. In fact, this medicine may increase the chance of a heart attack or stroke. The chance may increase with longer use of this medicine and in people who have heart disease. If you take aspirin to prevent heart attack or stroke, talk with your doctor or health care professional.

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Common and Rare 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:

Less common

Arm, back, or jaw pain

bleeding gums

bloating

blood in the urine

blurred vision

burning upper abdominal or stomach pain

canker sores

chest tightness or heaviness

chills

cloudy urine

cough

cramping

dark urine

decreased frequency or amount of urine

difficult or labored breathing

dilated neck veins

dizziness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

general tiredness and weakness

headache

hives or welts

increased blood pressure

increased sensitivity of the skin to sunlight

increased thirst

irregular breathing

itching, redness, or other discoloration of the skin

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

light-colored stools

loss of appetite

lower side or back pain

noisy breathing

pain or discomfort in the arms, jaw, back, or neck

painful or difficult urination

pains in the stomach, side, or abdomen, possibly radiating to the back

pinpoint red or purple spots on the skin

pounding in the ears

redness, soreness, or itching skin

seizures

severe and continuing nausea

severe sunburn

shakiness in the legs, arms, hands, or feet

skin blisters

sore throat

sores, ulcers, or white spots on the lips or tongue or inside the mouth

sores, welting, or blisters

stomach bloating, burning, cramping, tenderness, or pain

sweating

swelling or puffiness of the face

swollen glands

trembling or shaking of the hands or feet

trouble breathing

unusual bleeding or bruising

upper right abdominal or stomach pain

watery or bloody diarrhea

weight gain or loss

yellow eyes or skin

Rare

Area rash

blistering, peeling, or loosening of the skin

bloody or black, tarry stools

clay-colored stools

cold, clammy skin

continuing vomiting

cough or hoarseness

cracks in the skin

difficulty with swallowing

fast, weak pulse

fever with or without chills

greatly decreased frequency of urination or amount of urine

joint or muscle pain

lightheadedness

loss of heat from the body

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red skin lesions, often with a purple center

red, irritated eyes

red, swollen skin

scaly skin

severe stomach pain

tightness in the chest

unpleasant breath odor

unusual tiredness or weakness

vomiting of blood or material that looks like coffee grounds

Incidence not known

Difficulty with speaking

double vision

inability to move the arms, legs, or facial muscles

inability to speak

pains in the chest, groin or legs, especially the calves

severe headaches of sudden onset

slow speech

sudden loss of coordination

sudden onset of shortness of breath for no apparent reason

sudden onset of slurred speech

sudden vision changes

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

Symptoms of overdose

Blue lips, fingernails, or skin

convulsions (seizures)

pain in the chest, upper stomach, or throat

severe stomach pain

skin rash

slow or fast heartbeat

swelling around the eyes, face, lips, or tongue

weight gain (rapid)

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

Diarrhea

gas

heartburn

indigestion

Less common or rare

Abdominal or stomach pain

abnormal dreaming

anxiety

appetite increased

bad, unusual, or unpleasant after taste

belching

bloated or full feeling

burning feeling in the chest or stomach

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

burning, dry, or itching eyes

change in taste

changes in vision

confusion

constipation

continuing ringing or buzzing or other unexplained noise in the ears

decreased urination

discharge

discouragement

dry mouth

excess air or gas in the stomach

excessive tearing

feeling of constant movement of self or surroundings

feeling sad or empty

general feeling of discomfort or illness

hair loss

hearing loss

hot flushes

irritability

loss of interest or pleasure

nausea or vomiting

nervousness

pain or burning in the throat

rapid breathing

redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

sensation of spinning

sleepiness

stomach upset

sunken eyes

tenderness in the stomach area

thinning of the hair

thirst

tiredness

trouble concentrating

trouble sleeping

wrinkled skin

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.

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