If you experience symptoms that are concerning after starting Linzess, don't delay seeking medical attention. Contact your doctor promptly to discuss what you're experiencing. They can help determine if your symptoms may be related to Linzess and advise you on any changes to your treatment plan that may be needed.

Dehydration Risk

Linzess comes with a boxed warning issued by the Food and Drug Administration (FDA). This warning specifically addresses the risk of serious dehydration in children under the age of 2 years. A boxed warning serves as an important alert to doctors and patients, highlighting the potential risks of taking a medication. [1]

Animal studies found that young animals experienced severe diarrhea leading to dehydration, which in some cases was fatal. Due to these findings and the potential risk, Linzess is not approved for use in children under six years of age. [1]

If your child is prescribed Linzess, carefully monitor them for signs of dehydration during treatment. Symptoms of dehydration in young children include:

• Dry mouth or sticky saliva
• Little or no tears when crying
• Sunken eyes
• Urinating less frequently
• Irritability
• Dizziness or sleepiness [3]

Severe Diarrhea

Diarrhea may be a side effect of Linzess treatment. In fact, diarrhea was the most reported side effect among individuals participating in clinical trials, with approximately 20% of participants encountering it. Although severe diarrhea was less common, affecting around 2% of participants, it is essential to be aware of its symptoms and take appropriate action if they arise. [1]

Symptoms of severe diarrhea may include:

• Abdominal pain
• Abdominal cramping
• Bloating
• Nausea
• Urgent need to go to the bathroom
• Fever
• Blood stools
• Dehydration
• Leaking stool and not being able to control your bowels [4]

In clinical trials, diarrhea typically manifested within the first two weeks of initiating Linzess treatment. It is crucial to note that diarrhea was the primary reason for discontinuing therapy for approximately 5% of participants. [1]

If you experience severe diarrhea, stop taking Linzess and let your doctor know immediately.

Severe Allergic Reaction

As with most medications, Linzess can cause an allergic reaction in some individuals. After the FDA approved Linzess, they received reports from people describing experiences of allergic reactions they believed were connected to taking the drug. [1]

The symptoms they reported included:

• Difficulty breathing
• Swelling under their skin
• Hives [1]

Because these reports were voluntarily submitted without a defined study population, the FDA could not reliably determine how frequently these reactions occurred or confirm that they were directly caused by the medication. [1]

However, if you experience any concerning symptoms that may indicate an allergic reaction after starting Linzess, contact your doctor right away to evaluate your condition.

Linzess Contraindications

As with any medication, your doctor must consider certain factors before prescribing Linzess. These factors include conditions that could potentially harm you if you take the medication.