Side Effects / Dosage / Special Warnings
Vioxx side effects are rarely serious enough for patients to discontinue
use, some may require medical attention. Contact your doctor if you
experience any of the following while taking Vioxx.
Vioxx side effects: Cold-like symptoms (fever, sore throat, sneezing,
cough), skin rash, swelling in the extremities.
common Vioxx side effects: Burning sensation in chest or stomach, chest
congestion, diarrhea, decreased appetite, difficulty sleeping, dizziness,
flu-like symptoms (muscle aches, weakness, nausea, chills), high blood
pressure, stomach tenderness, indigestion, back pain, or runny nose.
Vioxx side effects: Anxiety, susceptibility to infection, constipation,
breathing problems, breast problems, eye infection, cataract, dermatitis,
diabetes, difficult urination, sweating, numb or tingling fingers or
toes, ear infection, fungal infection, hepatitis, inflamed digestive
tract or bladder, kidney stones, skin sensitivity or increased reaction
to sunlight, tendonitis, hair loss, laryngitis, menstrual difficulties,
herniated stomach, migraine, hypercholesterolemia, hyperglycemia, leg
cramps, or nosebleeds.
Certain conditions are incompatible with Vioxx treatment, or indicate
that treatment should proceed with care. Advise your doctor of any of
the following reactions.
reactions to Vioxx mean that you should end treatment immediately. Allergies
to Sulfonamides (sulfadiazine, sulfisoxazole, Gantanol, or Thiosulfil),
other NSAIDs, or Aspirin also indicate that a person should not take
Anemia - This medication may trigger this condition in rare cases, and
should be used cautiously in individuals with a prior history of this
iron deficiency. Do not take supplemental iron unless your doctor has
diagnosed you with anemia and directly advised it.
Asthma - Vioxx could trigger an attack, make sure that your doctor closely
monitors any adverse reaction. Asthmatics with a sensitivity to Aspirin
are at the highest risk for an allergic reaction to Vioxx.
Dehydration - This problem should be corrected before beginning treatment
with Vioxx, as it increases the risk of kidney damage.
Diabetics - Consult with your physician before taking Vioxx, as you
may be especially vulnerable to side effects.
Heart problems - Long-term Vioxx treatment may cause renal toxicity
and decreased blood flow to the heart. Patients with pre-existing heart
conditions, liver problems, and those taking diuretics or ACE-inhibitors
are most likely to be affected. High blood pressure is also a possible
side effect of this medication. Normal function is usually restored
when the patient stops taking Vioxx. This medication has been associated
with a higher risk of heart attack and chest pain than comparable drugs
like Naprosyn (naproxen).
Kidney or liver impairment - Vioxx could aggravate or trigger these
conditions. If you have a history of kidney or liver problems, use Vioxx
with caution. Kidney damage may result from long-term use, always drink
extra water with your treatment. Liver problems may be indicated by
yellowing skin, pain to the right of your stomach, itchy skin, nausea,
drowsiness, or other flu-like symptoms. Stop taking Vioxx and contact
your doctor immediately if these conditions develop. Do not consume
alcohol during the time of treatment with this medication if you have
any history of liver problems.
Pregnancy - COX II inhibitors should not be taken in the last 3 months
of pregnancy, and have not been studied for safety earlier in pregnancy.
Ulcer or Gastrointestinal Bleeding - Any history of these conditions
is an indication for extreme caution in the use of any NSAID, including
the COX II inhibitors. These medications may cause or aggravate deterioration
and bleeding in the GI tract. Active ulcers are a contraindication for
Water retention - Vioxx can aggravate any problems related to fluid
retention such as heart failure, high blood pressure, or swelling.
Warning signs: Stop taking Vioxx and contact your doctor immediately
if you notice severe stomach cramps, swelling in your face or extremities,
skin rash, black stools, vomiting bloody or black material, or sudden
emergency treatment if any of the following symptoms occur while taking
Vioxx, as they are signs of anaphylaxis, a severe allergic reaction
most common in asthmatic patients with aspirin sensitivity: severe breathing
difficulties (breathing too fast, shortness of breath, irregular breathing
or fainting), hive-like rash, fast or irregular heartbeat, swelling
around eyes. Have someone drive you to the hospital or call for an ambulance,
it is extremely dangerous to drive in this condition. If you must wait
for an ambulance, lie down with your feet elevated and be sure to keep
warm. If this rare reaction occurs, or you have had a similar reaction
to aspirin or a sulfonamide, you will have to stop taking Vioxx.
Certain drugs react with Vioxx. Your doctor may adjust the dosage of one
of the medications, or may indicate that they should not be taken together.
Always consult your doctor or pharmacist about potential drug interactions.
Enzyme) Inhibitors - Medications like Accupril (quinapril), Aceon (perindopril),
Altace (ramipril), Capoten (captopril), Lotensin (benazepril), Mavik
(trandolapril), Monopril (fosinopril), Prinivil or Zestril (lisinopril),
Univasc (moexipril), and Vasotec (enalapril) may be less effective when
combined with Vioxx treatment.
Alcohol - Do not drink alcoholic beverages while using Vioxx, as it
puts you at risk for stomach problems and liver degeneration.
Aspirin - Taking Aspirin with Vioxx may increase the risk of gastrointestinal
bleeding. If you have ever had an allergic reaction to Aspirin, you
should not take Vioxx.
Cordarone (amiodarone) - Lower doses of Vioxx recommended.
Corticosteroids - mixing these drugs with Vioxx increses the risk of
Coumadin (warfarin) - Increased risk of bleeding, do not combine.
Diflucan (fluconazole) - May increase risk of side effects.
Fosamax (alendronate) - The effectiveness of this osteoporosis medication
may be decreased by Vioxx.
Lithium (Eskalith, Lithane, etc.) - May prevent Vioxx from clearing
from the blood and increase side effects
Methotrexate (Amethopterin) - This medication may build up to toxic
levels with combined use.
NSAIDs of any other type, such as Naprosyn or Motrin may increase risk
of side effects when mixed with Vioxx, particularly GI bleeding or stomach
irritation. If you have ever had an allergic reaction to one of these
drugs, you should not take Vioxx.
Plavix (clopidogrel) - Increased risk of GI bleeding.
Protease inhibitors like Norvir (ritonavir) may need to be accompanied
by lower doses of Vioxx.
Rhythmol (propafenone) - Dosing adjustment may be necessary.
SSRIs like Prozac (fluoxetine) and Zoloft (sertraline) may reduce clearance
of COX II inhibitors and increase side effects. Lower doses are recommended
if you are currently being treated with one of these medications.
Thiazide (hydrochlorothiazide, Dyazide, Corzide) - Vioxx may interfere
with these diuretics and increase the risk of heart problems.
Tobacco - May increase the risk of side effects.
Toradol (ketorolac) - Do not take this medication while taking Vioxx.
Vioxx is commonly prescribed in the following doses. Follow your doctor's
advice if he suggest a different dosage, always use the minimum effective
12.5 mg once a day, up to a maximum of 25 mg once daily.
Acute or Menstrual Pain - 50 mg once a day, for up to 5 days
Kidney Impairment: This medication is not recommended in acute kidney
disease or failure.
Liver Impairment: Patients with liver disease or impairment may be prescribed
half the regular dose. This medication is not recommended in acute liver
Vioxx is available in the following forms and strengths:
12.5 mg, off-white
25 mg, yellow tablet
50 mg, orange tablet
12.5 mg/5 mL oral suspension, white to light yellow, strawberry flavored
25 mg/5 mL oral suspension, white to light yellow, strawberry flavored
Vioxx should be taken according to your doctor's instructions about
dosage and frequency. If you miss a dose, take it immediately if you
remember soon after missing it. If it's close to the time when you would
ordinarily take another dose, wait until your scheduled time to take
the next dose. Do not take a double dose of Vioxx.
Store Vioxx away
from direct light and heat. Store in a dry location, avoid storing it
in the bathroom, near sinks, or other areas where it may become damp.
Do not use after the expiration date.
The oral suspension
form should not be allowed to freeze, and should be shaken before use.
Keep Vioxx away
from children; both when storing it, and when discarding any unused
Vioxx and Pregnancy
Vioxx has been shown to cause an increase of birth defects and difficulties
carrying a child to term in animals. Vioxx may also pass to a child
during breastfeeding, and may cause adverse reactions. Vioxx is not
recommended for pregnant or nursing women.
does not appear to affect fertility or the health of future children
Vioxx and Children
Vioxx has not been shown to be safe or effective in children under 18.
Vioxx and Seniors
Vioxx does not appear to behave very differently in adults over 65 than
in the rest of the adult population, though there is a slight increase
in unwanted side effects. Spontaneous gastrointestinal bleeding has
been responsible for most of the increase in adverse reactions in elderly
and debilitated populations. Seniors with a history of heart problems,
water retention, ulcers, or gastrointestinal bleeding should be treated
with caution, and for as short a time as possible.