ZITHROMAX® TABLET, SUSPENSION What are the possible side effects of ZITHROMAX?

(azithromycin dihydrate TABLET, SUSPENSION)

What are the possible side effects of ZITHROMAX?

ZITHROMAX can cause serious side effects, including:

•
Serious allergic reactions. Allergic reactions can happen in people taking azithromcyin the active ingredient in ZITHROMAX, even after only 1 dose. Stop taking ZITHROMAX and get emergency medical help right away if you have any of the following symptoms of a severe allergic reaction:
o
trouble breathing or swallowing
o
swelling of the lips, tongue, face
o
throat tightness, hoarseness
o
rapid heartbeat
o
faintness
o
skin rash (hives)
o
new onset of fever and swollen lymph nodes
 
Stop taking ZITHROMAX at the first sign of a skin rash and call your healthcare provider. Skin rash may be a sign of a more serious reaction to ZITHROMAX.
•
Liver damage (hepatotoxicity). Hepatotoxicity can happen in people who take ZITHROMAX. Call your healthcare provider right away if you have unexplained symptoms such as:
o
nausea or vomiting
o
stomach pain
o
fever
o
weakness
o
abdominal pain or tenderness
o
itching
o
unusual tiredness
o
loss of appetite
o
change in the color of your bowel movements
o
dark colored urine
o
yellowing of your skin or of the whites of your eyes
 
Stop taking ZITHROMAX and tell your healthcare provider right away if you have yellowing of your skin or white part of your eyes, or if you have dark urine. These can be signs of a serious reaction to ZITHROMAX (a liver problem).
•
Serious heart rhythm changes that can be life-threatening, including heart stopping (cardiac arrest), QT prolongation, torsades de pointes, feeling that your heart is pounding or racing (palpitations), chest discomfort, or irregular heartbeat.
Tell your healthcare provider right away if you or your child feel a fast or irregular heartbeat, get dizzy or faint. ZITHROMAX may cause a rare heart problem known as prolongation of the QT interval. This condition can cause an abnormal heartbeat and can be very dangerous. The chances of this happening are higher in people:
o
who are elderly
o
with a family history of prolonged QT interval
o
with low blood potassium
o
who take certain medicines to control heart rhythm (antiarrhythmics)
•
Worsening of myasthenia gravis (a problem that causes muscle weakness). Certain antibiotics like ZITHROMAX may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems.
•
Diarrhea. Tell your healthcare provider right away if you have watery diarrhea, diarrhea that does not go away, or bloody stools. You may experience cramping and a fever. This could happen after you have finished your ZITHROMAX.
The most common side effects of ZITHROMAX include:
o
nausea
o
stomach pain
o
vomiting

These are not all the possible side effects of ZITHROMAX. Tell your healthcare provider about any side effect that bothers you or that does not go away.

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

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What are the possible side effects of ZITHROMAX?

What are the possible side effects of ZITHROMAX?

ZITHROMAX can cause serious side effects, including:

•
Serious allergic reactions. Allergic reactions can happen in people taking azithromcyin the active ingredient in ZITHROMAX, even after only 1 dose. Stop taking ZITHROMAX and get emergency medical help right away if you have any of the following symptoms of a severe allergic reaction:
o
trouble breathing or swallowing
o
swelling of the lips, tongue, face
o
throat tightness, hoarseness
o
rapid heartbeat
o
faintness
o
skin rash (hives)
o
new onset of fever and swollen lymph nodes
 
Stop taking ZITHROMAX at the first sign of a skin rash and call your healthcare provider. Skin rash may be a sign of a more serious reaction to ZITHROMAX.
•
Liver damage (hepatotoxicity). Hepatotoxicity can happen in people who take ZITHROMAX. Call your healthcare provider right away if you have unexplained symptoms such as:
o
nausea or vomiting
o
stomach pain
o
fever
o
weakness
o
abdominal pain or tenderness
o
itching
o
unusual tiredness
o
loss of appetite
o
change in the color of your bowel movements
o
dark colored urine
o
yellowing of your skin or of the whites of your eyes
 
Stop taking ZITHROMAX and tell your healthcare provider right away if you have yellowing of your skin or white part of your eyes, or if you have dark urine. These can be signs of a serious reaction to ZITHROMAX (a liver problem).
•
Serious heart rhythm changes that can be life-threatening, including heart stopping (cardiac arrest), QT prolongation, torsades de pointes, feeling that your heart is pounding or racing (palpitations), chest discomfort, or irregular heartbeat.
Tell your healthcare provider right away if you or your child feel a fast or irregular heartbeat, get dizzy or faint. ZITHROMAX may cause a rare heart problem known as prolongation of the QT interval. This condition can cause an abnormal heartbeat and can be very dangerous. The chances of this happening are higher in people:
o
who are elderly
o
with a family history of prolonged QT interval
o
with low blood potassium
o
who take certain medicines to control heart rhythm (antiarrhythmics)
•
Worsening of myasthenia gravis (a problem that causes muscle weakness). Certain antibiotics like ZITHROMAX may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems.
•
Diarrhea. Tell your healthcare provider right away if you have watery diarrhea, diarrhea that does not go away, or bloody stools. You may experience cramping and a fever. This could happen after you have finished your ZITHROMAX.
The most common side effects of ZITHROMAX include:
o
nausea
o
stomach pain
o
vomiting

These are not all the possible side effects of ZITHROMAX. Tell your healthcare provider about any side effect that bothers you or that does not go away.

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

Health Professional Information

What are the possible side effects of ZITHROMAX?

What are the possible side effects of ZITHROMAX?

ZITHROMAX can cause serious side effects, including:

•
Serious allergic reactions. Allergic reactions can happen in people taking azithromcyin the active ingredient in ZITHROMAX, even after only 1 dose. Stop taking ZITHROMAX and get emergency medical help right away if you have any of the following symptoms of a severe allergic reaction:
o
trouble breathing or swallowing
o
swelling of the lips, tongue, face
o
throat tightness, hoarseness
o
rapid heartbeat
o
faintness
o
skin rash (hives)
o
new onset of fever and swollen lymph nodes
 
Stop taking ZITHROMAX at the first sign of a skin rash and call your healthcare provider. Skin rash may be a sign of a more serious reaction to ZITHROMAX.
•
Liver damage (hepatotoxicity). Hepatotoxicity can happen in people who take ZITHROMAX. Call your healthcare provider right away if you have unexplained symptoms such as:
o
nausea or vomiting
o
stomach pain
o
fever
o
weakness
o
abdominal pain or tenderness
o
itching
o
unusual tiredness
o
loss of appetite
o
change in the color of your bowel movements
o
dark colored urine
o
yellowing of your skin or of the whites of your eyes
 
Stop taking ZITHROMAX and tell your healthcare provider right away if you have yellowing of your skin or white part of your eyes, or if you have dark urine. These can be signs of a serious reaction to ZITHROMAX (a liver problem).
•
Serious heart rhythm changes that can be life-threatening, including heart stopping (cardiac arrest), QT prolongation, torsades de pointes, feeling that your heart is pounding or racing (palpitations), chest discomfort, or irregular heartbeat.
Tell your healthcare provider right away if you or your child feel a fast or irregular heartbeat, get dizzy or faint. ZITHROMAX may cause a rare heart problem known as prolongation of the QT interval. This condition can cause an abnormal heartbeat and can be very dangerous. The chances of this happening are higher in people:
o
who are elderly
o
with a family history of prolonged QT interval
o
with low blood potassium
o
who take certain medicines to control heart rhythm (antiarrhythmics)
•
Worsening of myasthenia gravis (a problem that causes muscle weakness). Certain antibiotics like ZITHROMAX may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems.
•
Diarrhea. Tell your healthcare provider right away if you have watery diarrhea, diarrhea that does not go away, or bloody stools. You may experience cramping and a fever. This could happen after you have finished your ZITHROMAX.
The most common side effects of ZITHROMAX include:
o
nausea
o
stomach pain
o
vomiting

These are not all the possible side effects of ZITHROMAX. Tell your healthcare provider about any side effect that bothers you or that does not go away.

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

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