SYMDEKO® SAFETY & SIDE EFFECTS OVERVIEW

Learn about SYMDEKO safety and side effects. 

 

Serious and most 
common side effects

Additional safety considerations

What are the possible side effects of SYMDEKO?

SYMDEKO can cause serious side effects, including: 

liver problems

High liver enzymes in the blood have been reported in some patients treated with SYMDEKO or treated with ivacaftor alone.

To monitor this, your doctor will do blood tests to check your liver:

  • Before you start SYMDEKO
  • Every 3 months during your first year of taking SYMDEKO  
  • Every year while you are taking SYMDEKO

Your doctor may do blood tests to check the liver more often if you have had high liver enzymes in your blood in the past.

Call your doctor right away if you have any of the following symptoms of liver problems:

  • Pain or discomfort in the upper right stomach (abdominal) area
  • Yellowing of your skin or the white part of your eyes
  • Loss of appetite
  • Nausea or vomiting
  • Dark, amber-colored urine
eyes

Abnormality of the eye lens (cataract) has been noted in some children and adolescents treated with SYMDEKO or treated with ivacaftor alone. If you are a child or adolescent, your doctor should perform eye examinations before and during treatment with SYMDEKO to look for cataracts.

person

The most common side effects of SYMDEKO in two different clinical studies include headache, nausea, sinus congestion, and dizziness.

Headache

15% of people who took SYMDEKO

headache

15% of people who took SYMDEKO

13% of people who took placebo

Nausea

9% of people who took SYMDEKO

nausea

9% of people who took SYMDEKO

7% of people who took placebo

Sinus congestion

4% of people who took SYMDEKO

sinus congestion

4% of people who took SYMDEKO

2% of people who took placebo

Dizziness

4% of people who took SYMDEKO

dizziness

4% of people who took SYMDEKO

2% of people who took placebo

The most common side effect information is based on what was reported in 2 different studies of people age 12 years and older where a total of 334 people took SYMDEKO and 343 people took placebo.

Additional safety information in people age 12 years and older

Respiratory events (breathing problems) were monitored

Respiratory events such as chest tightness and difficulty breathing were experienced by:

  • 11.3% of people who took SYMDEKO
  • 14.7% of people who took placebo

People who stopped treatment due to side effects

A percentage of people dropped out of the study due to side effects:

  • 1.6% of people who took SYMDEKO
  • 2.0% of people who took placebo

These are not all the possible side effects of SYMDEKO. Call your doctor for medical advice about side effects. You are encouraged to report side effects to FDA at 1-800-FDA-1088.

Do not take SYMDEKO if you take certain medicines or herbal supplements such as:
 

Antibiotics such as rifampin (RIFAMATE®, RIFATER®) or rifabutin (MYCOBUTIN®)
Seizure medicines such as phenobarbital, carbamazepine (TEGRETOL®, CARBATROL®, EQUETRO®), or phenytoin (DILANTIN®, PHENYTEK®)
Herbal supplements St. John’s wort


Talk to your doctor before taking SYMDEKO if you take any of the medicines or supplements listed above.

Before taking SYMDEKO, tell your doctor about all of your medical conditions, including if you:

liver pr

Have or have had liver problems

kidney

Have kidney problems

pregnant

Are pregnant or plan to become pregnant. It is not known if SYMDEKO will harm your unborn baby. You and your doctor should decide if you will take SYMDEKO while you are pregnant

breastfeeding

Are breastfeeding or planning to breastfeed. It is not known if SYMDEKO passes into your breast milk. You and your doctor should decide if you will take SYMDEKO while you are breastfeeding

 

SYMDEKO may affect the way other medicines work, and other medicines may affect how SYMDEKO works.

Tell your doctor about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements, because the dose of SYMDEKO may need to be adjusted when taken with certain medicines.

Especially tell your doctor if you take:

 

Antifungal medicines

ketoconazole (NIZORAL®), itraconazole (SPORANOX®), posaconazole (NOXAFIL®), voriconazole (VFEND®), fluconazole (DIFLUCAN®)
Antibiotics telithromycin (KETEK®), clarithromycin (BIAXIN®), erythromycin (ERY-TAB®)

 

SYMDEKO is not known to interact with some medicines, including:

 

Certain oral
contraceptives

eg, ethinyl estradiol/norethindrone
Certain antibiotics eg, ciprofloxacin

 

Remember, it’s important to know the medicines you take. Keep a list to show your doctor and pharmacist when you get a new medicine.

food drinkAvoid food or drink that contains grapefruit while you are taking SYMDEKO.