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What is Zithromax?

Zithromax (azithromycin) is an antibiotic that fights bacteria.

Zithromax is used to treat many different types of infections caused by bacteria, such as respiratory infections, skin infections, ear infections, and sexually transmitted diseases.

Zithromax may also be used for purposes not listed in this medication guide.

Important information about Zithromax

You should not use Zithromax if you have ever had jaundice or liver problems caused by taking azithromycin.

Before taking Zithromax

You should not use Zithromax if you are allergic to azithromycin or to similar drugs such as clarithromycin, erythromycin, or telithromycin.

To make sure Zithromax is safe for you, tell your doctor if you have:

  • liver disease;

  • kidney disease;

  • myasthenia gravis;

  • a heart rhythm disorder; or

  • a history of Long QT syndrome.

FDA pregnancy category B. Zithromax is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether azithromycin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give Zithromax to a child younger than 6 months old.

Older adults may be more likely to have side effects on heart rhythm, including a life-threatening fast heart rate.

How should I take Zithromax?

Take Zithromax exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. The dose and length of treatment with Zithromax may not be the same for every type of infection.

To use the Zithromax oral suspension single dose packet: Open the packet and pour the medicine into 2 ounces of water. Stir this mixture and drink all of it right away. Do not save for later use. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

Shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Use Zithromax for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Zithromax will not treat a viral infection such as the common cold or flu.

Store at room temperature away from moisture and heat. Throw away any unused liquid medicine after 10 days.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Zithromax?

Do not take antacids that contain aluminum or magnesium within 2 hours before or after you take Zithromax. This includes Acid Gone, Aldroxicon, Alternagel, Di-Gel, Gaviscon, Gelusil, Genaton, Maalox, Maldroxal, Milk of Magnesia, Mintox, Mylagen, Mylanta, Pepcid Complete, Rolaids, Rulox, and others. These antacids can make azithromycin less effective when taken at the same time.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking Zithromax and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Avoid exposure to sunlight or tanning beds. Zithromax can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Zithromax side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Zithromax: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • diarrhea that is watery or bloody;

  • headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;

  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common Zithromax side effects may include:

  • mild diarrhea;

  • mild stomach pain or upset;

  • dizziness; or

  • vaginal itching or discharge.

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.

What other drugs will affect Zithromax?

Many drugs can interact with Zithromax. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Zithromax, especially:

  • droperidol;

  • methadone;

  • nelfinavir;

  • another antibiotic--clarithromycin, erythromycin, moxifloxacin, pentamidine;

  • a blood thinner (warfarin, Coumadin);

  • cancer medicine--arsenic trioxide, vandetanib;

  • an antidepressant--citalopram, escitalopram;

  • anti-malaria medication--chloroquine, halofantrine;

  • heart rhythm medicine--amiodarone, disopyramide, dofetilide, flecainide, ibutilide, procainamide, quinidine, sotalol; or

  • medicine to treat a psychiatric disorder--chlorpromazine, haloperidol, mesoridazine, pimozide, thioridazine.

This list is not complete and many other drugs can interact with Zithromax. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

For the Consumer

Applies to azithromycin: oral capsule, oral powder for suspension, oral powder for suspension extended release, oral tablet

Along with its needed effects, azithromycin (the active ingredient contained in Zithromax) 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 while taking azithromycin:

More common
  • Diarrhea
  • loose stools
Less common
  • Blistering, crusting, irritation, itching, or reddening of the skin
  • cracked, dry, or scaly skin
  • fever
  • swelling
Rare
  • Abdominal or stomach pain
  • blistering, peeling, or loosening of the skin
  • bloody or cloudy urine
  • bloody, black, or tarry stools
  • body aches or pain
  • burning while urinating
  • chest pain
  • chills
  • congestion
  • cough increased
  • cough producing mucus
  • dark urine
  • difficult or labored breathing
  • difficult or painful urination
  • dizziness
  • drowsiness
  • dryness or soreness of the throat
  • earache
  • fainting
  • fast, irregular, pounding, or racing heartbeat or pulse
  • general feeling of discomfort or illness
  • general feeling of tiredness or weakness
  • headache
  • indigestion
  • irregular or slow heart rate
  • itching
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • light-colored stools
  • loss of appetite
  • muscle aches and pains
  • nausea or vomiting
  • noisy breathing
  • passing of gas
  • rash
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • redness or swelling in the ear
  • runny nose
  • shivering
  • shortness of breath
  • sneezing
  • sores, ulcers, or white spots on the lips or in the mouth
  • stomach pain, continuing
  • stomach pain, fullness, or discomfort
  • stuffy nose
  • sweating
  • swelling of the face, ankles, hands, feet, or lower legs
  • tender, swollen glands in the neck
  • tightness in the chest
  • trouble with sleeping
  • trouble with swallowing
  • unpleasant breath odor
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • upper right abdominal or stomach pain
  • voice changes
  • vomiting of blood
  • wheezing
  • yellow eyes or skin
Incidence not known
  • Abdominal or stomach cramps or tenderness
  • bleeding gums
  • bloating
  • blood in the urine or stools
  • blurred vision
  • change in hearing
  • clay-colored stools
  • coma
  • confusion
  • constipation
  • continuing ringing or buzzing or other unexplained noise in the ears
  • decreased urine output
  • depression
  • diarrhea, watery and severe, which may also be bloody
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fainting
  • greatly decreased frequency of urination or amount of urine
  • hives
  • hostility
  • increased thirst
  • irritability
  • lethargy
  • loss of hearing
  • lower back or side pain
  • muscle twitching
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pale skin
  • pinpoint red spots on the skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid weight gain
  • seizures
  • stupor
  • unusual weight loss

Some side effects of azithromycin 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:

Rare
  • Acid or sour stomach
  • aggressive or angry
  • bad, unusual, or unpleasant (after) taste
  • belching
  • burning feeling in the chest or stomach
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • change in taste
  • changes in the color of the tongue
  • crying
  • depersonalization
  • dry mouth
  • dysphoria
  • euphoria
  • excess air or gas in the stomach or intestines
  • feeling of constant movement of self or surroundings
  • full feeling
  • heartburn
  • hyperventilation
  • increase in body movements
  • itching of the vagina or genital area
  • lack or loss of strength
  • mental depression
  • nervousness
  • pain during sexual intercourse
  • paranoia
  • quick to react or overreact emotionally
  • rapidly changing moods
  • rash with flat lesions or small raised lesions on the skin
  • redness of the skin
  • restlessness
  • sensation of spinning
  • shaking
  • shortness of breath
  • sleepiness or unusual drowsiness
  • sleeplessness
  • sore mouth or tongue
  • stomach upset
  • thick, white vaginal discharge with no odor or with a mild odor
  • unable to sleep
  • white patches in the mouth, tongue, or throat
Incidence not known
  • Difficulty with moving
  • fear or nervousness
  • increased sensitivity of the skin to sunlight
  • muscle pain or stiffness
  • pain in the joints
  • redness or other discoloration of the skin
  • severe sunburn
  • trouble sitting still

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Applies to azithromycin: intravenous powder for injection, oral capsule, oral powder for reconstitution, oral powder for reconstitution extended release, oral tablet

Gastrointestinal

Gastrointestinal side effects have included nausea, abdominal discomfort, vomiting, and diarrhea in up to 10% of patients. However, patients rarely (less than 1%) discontinued therapy due to these side effects. Dyspepsia, flatulence, mucositis, oral moniliasis, constipation, melena, and gastritis have been reported with a frequency of 1% or less. Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of azithromycin (the active ingredient contained in Zithromax) Anorexia, vomiting/diarrhea rarely resulting in dehydration, pancreatitis, oral candidiasis, pyloric stenosis, and rare cases of tongue discoloration have been reported during postmarketing experience.

Hypersensitivity

Reappearance of allergic symptoms may occur without further azithromycin (the active ingredient contained in Zithromax) exposure when symptomatic therapy is discontinued. This phenomenon may be related to the long tissue half-life of the drug. Patients experiencing allergic symptoms may require prolonged periods of observation and symptomatic treatment.

Hypersensitivity side effects have rarely included angioedema, anaphylaxis, Stevens-Johnson syndrome, and toxic epidermal necrolysis. Toxic pustuloderma with fever has been reported in at least one patient receiving azithromycin. There is also an isolated report of azithromycin-induced hypersensitivity syndrome. Allergic reactions (including arthralgia, edema, urticaria, and angioedema) and anaphylaxis (rarely fatal) have been reported during postmarketing experience.

Cardiovascular

Cardiovascular side effects have rarely included arrhythmias (including ventricular tachycardia), prolongation of the QT interval, torsades de pointes, palpitations, hypotension, and chest pain in postmarketing experience. A causal relationship has not been established.

Hepatic

Hepatic side effects have infrequently included transient elevations of liver function tests (including AST and ALT) and elevated bilirubin. Hepatitis and cholestatic jaundice, as well as rare cases of hepatic necrosis and hepatic failure (some resulting in death), have been reported during postmarketing experience.

Local

Local side effects associated with intravenous administration of the drug have included pain at injection site (6.5%) and local inflammation (3.1%).

Nervous system

Nervous system side effects have included headache, somnolence, vertigo, and dizziness in approximately 1% of patients. Hearing disturbances including hearing loss, deafness, and/or tinnitus have been reported rarely. Paresthesia, convulsions, hyperactivity, nervousness, agitation, and syncope have been reported during postmarketing experience.

Dermatologic

Dermatologic side effects have included rash, pruritus, and urticaria. Photosensitivity and, rarely, serious skin reactions (including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis) have been reported during postmarketing experience.

Other

Other side effects have included asthenia. Taste/smell perversion and/or loss (rare), fatigue, and malaise have been reported during postmarketing experience.

Renal

Renal side effects have rarely included elevations in serum creatinine and blood urea nitrogen. Interstitial nephritis and acute renal failure have been reported during postmarketing experience. Interstitial nephritis resulting in permanent renal failure has been reported in a patient receiving azithromycin (the active ingredient contained in Zithromax) monotherapy.

Hematologic

Hematologic side effects have included decreased lymphocytes, increased eosinophils, leukopenia, and neutropenia. Thrombocytopenia has been reported during postmarketing experience.

Metabolic

Metabolic side effects have included reduced bicarbonate and alterations in potassium.

Psychiatric

Psychiatric side effects have included aggressive reaction and anxiety during postmarketing experience.

Genitourinary

Genitourinary side effects have included vaginitis. Moniliasis has been reported during postmarketing experience.