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Welchol

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Welchol

Welchol Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Welchol (colesevelam hydrochloride) is used to lower "bad" cholesterol in the blood. It is sometimes used together with other cholesterol-lowering medications. Welchol is also used to improve glycemic control in people with type 2 diabetes. It is a lipid-lowering and glucose-lowering agent. Common side effects include constipation and upset stomach.

The recommended dose of Welchol to treat primary hyperlipidemia or type 2 diabetes mellitus in adults is 6 tablets once daily or 3 tablets twice daily. Take with a meal and liquid. Do not take other medications at the same time unless your doctor has told you to, as Welchol may make it harder for your body to absorb certain other medications. Welchol may interact with phenytoin, blood thinners, glyburide, thyroid hormone replacement, or birth control pills. Tell your doctor all medications you use. During pregnancy, Welchol should be used only if prescribed. This medication is unlikely to pass into breast milk or harm a nursing infant. Consult your doctor before breast-feeding.

Our Welchol (colesevelam hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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 is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Welchol in Detail - Patient Information: Side Effects

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

Stop using colesevelam and call your doctor at once if you have severe constipation or stomach pain.

Less serious side effects may include:

  • mild constipation;
  • nausea, vomiting, upset stomach, gas, indigestion;
  • feeling weak or tired;
  • headache;
  • muscle pain; or
  • runny nose, sore throat, flu symptoms.

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.

Read the entire detailed patient monograph for Welchol (Colesevelam Hcl) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Welchol Overview - Patient Information: Side Effects

SIDE EFFECTS: Constipation and upset stomach may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To help prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist in selecting a stool softener or a laxative.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: nausea/vomiting, stomach/abdominal pain, trouble swallowing, unusual bleeding/bruising.

This medication does not usually cause low blood sugar (hypoglycemia). Low blood sugar may occur if this drug is prescribed with other anti-diabetic medications, or if you do not consume enough calories from food, or if you do unusually heavy exercise.

Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor immediately about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.

Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor immediately. Your dosage may need to be increased.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Welchol (Colesevelam Hcl)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Welchol FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in clinical studies of another drug and may not reflect the rates observed in practice.

Primary Hyperlipidemia

In 7 double-blind, placebo-controlled, clinical trials, 807 patients with primary hyperlipidemia (age range 18-86 years, 50% women, 90% Caucasians, 7% Blacks, 2% Hispanics, 1% Asians) and elevated LDL-C were treated with WELCHOL 1.5 g/day to 4.5 g/day from 4 to 24 weeks (total exposure 199 patient-years).

In clinical trials for the reduction of LDL-C, 68% of patients receiving WELCHOL vs. 64% of patients receiving placebo reported an adverse reaction.

Table 1 : Placebo-Controlled Clinical Studies of WELCHOL for Primary Hyperlipidemia: Adverse Reactions Reported in ≥ 2% of Patients and More Commonly than in Patients Given Placebo, Regardless of Investigator Assessment of Causality

  Number of Patients (%)
WELCHOL
N = 807
Placebo
N = 258
Constipation 89 (11.0) 18 (7.0)
Dyspepsia 67 (8.3) 9 (3.5)
Nausea 34 (4.2) 10 (3.9)
Accidental injury 30 (3.7) 7 (2.7)
Asthenia 29 (3.6) 5 (1.9)
Pharyngitis 26 (3.2) 5 (1.9)
Flu syndrome 26 (3.2) 8 (3.1)
Rhinitis 26 (3.2) 8 (3.1)
Myalgia 17 (2.1) 1 (0.4)

Pediatric Patients 10 to 17 Years of Age

In an 8-week double-blind, placebo-controlled study boys and post-menarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (heFH) (n=192), were treated with WELCHOL tablets (1.9-3.8 g, daily) or placebo tablets [See Clinical Studies].

Table 2 : Placebo-Controlled Clinical Study of WELCHOL for Primary Hyperlipidemia in heFH Pediatric Patients: Adverse Reactions Reported in ≥ 2% of Patients and More Commonly than in Patients Given Placebo, Regardless of Investigator Assessment of Causality

  Number of Patients (%)
WELCHOL
N = 129
Placebo
N = 65
Nasopharyngitis 8 (6.2) 3 (4.6)
Headache 5 (3.9) 2 (3.1)
Fatigue 5 (3.9) 1 (1.5)
Creatine Phosphokinase Increase 3 (2.3) 0 (0.0)
Rhinitis 3 (2.3) 0 (0.0)
Vomiting 3 (2.3) 1 (1.5)

The reported adverse reactions during the additional 18-week open-label treatment period with WELCHOL 3.8 g per day were similar to those during the double-blind period and included headache (7.6%), nasopharyngitis (5.4%), upper respiratory tract infection (4.9%), influenza (3.8%), and nausea (3.8%) [See Clinical Studies].

Type 2 Diabetes Mellitus

The safety of WELCHOL in patients with type 2 diabetes mellitus was evaluated in 5 add-on combination and 1 monotherapy double-blind, 12-26 week, placebo-controlled clinical trials [see Clinical Studies]. In these studies 1022 patients were exposed to WELCHOL. The mean exposure duration was 20 weeks (total exposure 393 patient-years). Patients were to receive 3.8 grams of WELCHOL per day. The mean age of patients exposed to WELCHOL was 55.7 years, 52.8 percent of the population was male and 61.9% were Caucasian, 4.8% were Asian, and 15.9% were Black or African American. At baseline the population had a mean HbA1C of 8.2% and 26% had past medical history suggestive of microvascular complications of diabetes. Baseline characteristics in the placebo group were comparable.

In clinical trials of type 2 diabetes, 57% of patients receiving WELCHOL vs. 52% of patients receiving placebo reported an adverse reaction.

Table 3 shows common adverse reactions associated with the use of WELCHOL in the 1015 patients with type 2 diabetes. These adverse reactions were not present at baseline, occurred more commonly on WELCHOL than on placebo, and occurred in at least 2% of patients treated with WELCHOL.

Table 3 : Placebo-Controlled Clinical Studies of WELCHOLfor Type 2 Diabetes:: Adverse Reactions Reported in ≥ 2% of Patients and More Commonly than in Patients Given Placebo, Regardless of Investigator Assessment of CausalityNumber of Patients (%)

  WELCHOL
N = 1015
Placebo
N = 1010
Constipation 66 (6.5) 22 (2.2)
Hypoglycemia 35 (3.4) 31 (3.1)
Dyspepsia 28 (2.8) 10 (1.0)
Nausea 26 (2.6) 16 (1.6)
Hypertension 26 (2.6) 19 (1.9)
Back Pain 23 (2.3) 13 (1.3)

A total of 5.3% of WELCHOL-treated patients and 3.6% of placebo-treated patients were discontinued from the diabetes trials due to adverse reactions. This difference was driven mostly by gastrointestinal adverse reactions such as abdominal pain and constipation.

One patient in the add-on to sulfonylurea trial discontinued due to body rash and mouth blistering that occurred on the first day of dosing of WELCHOL, which may represent a hypersensitivity reaction to WELCHOL.

Hypertriglyceridemia: Patients with fasting serum TG levels above 500 mg/dL were excluded from the diabetes clinical trials. In the diabetes trials, 1292 (67.7%) patients had baseline fasting serum TG levels less than 200 mg/dL, 426 (22.3%) had baseline fasting serum TG levels between 200 and less than 300 mg/dL, 175 (9.2%) had baseline fasting serum TG levels between 300 and 500 mg/dL, and 16 (0.8%) had fasting serum TG levels greater than or equal to 500 mg/dL. The median baseline fasting TG concentration for the study population was 160 mg/dL; the median post-treatment fasting TG was 180 mg/dL in the WELCHOL group and 162 mg/dL in the placebo group. WELCHOL therapy resulted in a median placebo-corrected increase in serum TG of 9.7% (p=0.03) in the monotherapy study and of 5% (p=0.22), 11% (p < 0.001), 18% (p < 0.001), and 22% (p < 0.001), when added to metformin, pioglitazone, sulfonylureas, and insulin, respectively [See WARNINGS AND PRECAUTIONS and Clinical Studies]. In comparison, WELCHOL resulted in a median increase in serum TG of 5% compared to placebo (p=0.42) in a 24-week monotherapy lipid-lowering trial [See Clinical Studies].

Treatment-emergent fasting TG concentrations ≥ 500 mg/dL occurred in 0.9% of WELCHOL-treated patients compared to 0.7% of placebo-treated patients in the diabetes trials. Among these patients, the TG concentrations with WELCHOL (median 606 mg/dL; interquartile range 570-794 mg/dL) were similar to that observed with placebo (median 663 mg/dL; interquartile range 542-984 mg/dL). Five (0.6%) patients on WELCHOL and 3 (0.3%) patients on placebo developed TG elevations > 1000 mg/dL. In all WELCHOL clinical trials, including studies in patients with type 2 diabetes and patients with primary hyperlipidemia, there were no reported cases of acute pancreatitis associated with hypertriglyceridemia. It is unknown whether patients with more uncontrolled, baseline hypertriglyceridemia would have greater increases in serum TG levels with WELCHOL [See CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].

Cardiovascular adverse events: During the diabetes clinical trials, the incidence of patients with treatment-emergent serious adverse events involving the cardiovascular system was 2.2% (22/1015)) in the WELCHOL group and 1% (10/1010) in the placebo group. These overall rates included disparate events (e.g., myocardial infarction, aortic stenosis, and bradycardia); therefore, the significance of this imbalance is unknown.

Post-Marketing Experience

The following additional adverse reactions have been identified during post-approval use of WELCHOL. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Drug Interactions with concomitant WELCHOL administration include
  • Increased seizure activity or decreased phenytoin levels in patients receiving phenytoin. Phenytoin should be administered 4 hours prior to WELCHOL.
  • Reduced International Normalized Ratio (INR) in patients receiving warfarin therapy. In warfarin-treated patients, INR should be monitored frequently during WELCHOL initiation then periodically thereafter.
  • Elevated thyroid-stimulating hormone (TSH) in patients receiving thyroid hormone replacement therapy. Thyroid hormone replacement should be administered 4 hours prior to WELCHOL [See DRUG INTERACTIONS].
Gastrointestinal Adverse Reactions

Bowel obstruction (in patients with a history of bowel obstruction or resection), dysphagia (tablet and oral suspension formulations) or esophageal obstruction (occasionally requiring medical intervention), fecal impaction, pancreatitis, abdominal distension, exacerbation of hemorrhoids, and increased transaminases.

Laboratory Abnormalities

Hypertriglyceridemia

Read the entire FDA prescribing information for Welchol (Colesevelam Hcl) »

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Welchol - User Reviews

Welchol User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Welchol sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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