Welchol Side Effects
Please note - some side effects for Welchol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of Welchol - for the Consumer
Welchol
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Welchol:
Seek medical attention right away if any of these SEVERE side effects occur when using Welchol:Constipation; headache; indigestion; mild stomach pain; muscle aches; nausea; sore throat; stomach discomfort; tiredness; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); choking; difficulty swallowing; severe or persistent constipation, diarrhea, or stomach pain; severe or persistent dizziness or headache; symptoms of pancreas inflammation (eg, severe stomach or back pain with or without nausea or vomiting, stomach tenderness or swelling); throat pain or irritation.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
Welchol Suspension
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Welchol Suspension:
Seek medical attention right away if any of these SEVERE side effects occur when using Welchol Suspension:Constipation; headache; indigestion; mild stomach pain; muscle aches; nausea; sore throat; stomach discomfort; tiredness; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty swallowing; severe or persistent constipation, diarrhea, or stomach pain; severe or persistent dizziness or headache; symptoms of pancreas inflammation (eg, severe stomach or back pain with or without nausea or vomiting, stomach tenderness or swelling); throat pain or irritation.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopWelchol Side Effects - for the Professional
Welchol
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.
In the lipid-lowering trials, 807 adult patients received at least one dose of Welchol (total exposure 199 patient-years). In the type 2 diabetes trials, 566 patients received at least one dose of Welchol (total exposure 209 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. In clinical trials of type 2 diabetes, 60% of patients receiving Welchol vs. 56% of patients receiving placebo reported an adverse reaction.
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.
| 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 (14.1)].
| Number of Patients (%) | ||
| Welchol | Placebo | |
| N = 129 | 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 (14.1)].
Type 2 Diabetes Mellitus: The safety of Welchol in patients with type 2 diabetes mellitus was evaluated in 4 double-blind, 12-26 week, placebo-controlled clinical trials. These trials involved 1128 patients (566 patients on Welchol; 562 patients on placebo) with inadequate glycemic control on metformin, sulfonylurea, or insulin when these agents were used alone or in combination with other anti-diabetic agents. Upon completion of the pivotal trials, 492 patients entered a 52-week open-label uncontrolled extension study during which all patients received Welchol 3.8 g/day while continuing background treatment with metformin, sulfonylurea, or insulin alone or in combination with other anti-diabetic agents.
A total of 6.7% of Welchol-treated patients and 3.2% 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 pivotal trials discontinued due to body rash and mouth blistering that occurred after the first dose of Welchol, which may represent a hypersensitivity reaction to Welchol.
| Number of Patients (%) | ||
| Welchol N = 566 |
Placebo N = 562 |
|
| Constipation | 49 (8.7) | 11 (2.0) |
| Nasopharyngitis | 23 (4.1) | 20 (3.6) |
| Dyspepsia | 22 (3.9) | 8 (1.4) |
| Hypoglycemia | 17 (3.0) | 13 (2.3) |
| Nausea | 17 (3.0) | 8 (1.4) |
| Hypertension | 16 (2.8) | 9 (1.6) |
Hypertriglyceridemia: Patients with fasting serum TG levels above 500 mg/dL were excluded from the diabetes clinical trials. In the phase 3 diabetes trials, 637 (63%) patients had baseline fasting serum TG levels less than 200 mg/dL, 261 (25%) had baseline fasting serum TG levels between 200 and 300 mg/dL, 111 (11%) had baseline fasting serum TG levels between 300 and 500 mg/dL, and 9 (1%) had fasting serum TG levels greater than or equal to 500 mg/dL. The median baseline fasting TG concentration for the study population was 172 mg/dL; the median post-treatment fasting TG was 195 mg/dL in the Welchol group and 177 mg/dL in the placebo group. Welchol therapy resulted in a median placebo-corrected increase in serum TG of 5% (p=0.22), 22% (p<0.001), and 18% (p<0.001) when added to metformin, insulin and sulfonylureas, respectively [See Warnings and Precautions (5.2) and Clinical Studies (14.2)]. 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 (14.1)].
Treatment-emergent fasting TG concentrations ≥500 mg/dL occurred in 4.1% of Welchol-treated patients compared to 2.0% of placebo-treated patients. Among these patients, the TG concentrations with Welchol (median 604 mg/dL; interquartile range 538-712 mg/dL) were similar to that observed with placebo (median 644 mg/dL; interquartile range 574-724 mg/dL). Two (0.4%) patients on Welchol and 2 (0.4%) 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 (4) and Warnings and Precautions (5.2)].
Cardiovascular adverse events: During the diabetes clinical trials, the incidence of patients with treatment-emergent serious adverse events involving the cardiovascular system was 3% (17/566) in the Welchol group and 2% (10/562) 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.
Hypoglycemia: Adverse events of hypoglycemia were reported based on the clinical judgment of the blinded investigators and did not require confirmation with fingerstick glucose testing. The overall reported incidence of hypoglycemia was 3.0% in patients treated with Welchol and 2.3% in patients treated with placebo. No Welchol treated patients developed severe hypoglycemia.
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 (7)].
Gastrointestinal Adverse Reactions
Bowel obstruction (in patients with a history of bowel obstruction or resection), dysphagia or esophageal obstruction (occasionally requiring medical intervention), fecal impaction, pancreatitis, abdominal distension, exacerbation of hemorrhoids, and increased transaminases.
Laboratory Abnormalities
Hypertriglyceridemia
Side Effects by Body System - for Healthcare Professionals
Cardiovascular
Cardiovascular side effects including hypertension, myocardial infarction, aortic stenosis, and bradycardia have been reported in 3% of patients.
Gastrointestinal
Gastrointestinal side effects have included flatulence (12%), constipation (8.7% to 11%), dyspepsia (3.9% to 8%), diarrhea (5%), and nausea (3% to 4%). Bowel obstruction (in patients with a history of bowel obstruction or resection), dysphagia or esophageal obstruction (occasionally requiring medical intervention), fecal impaction, pancreatitis, abdominal distension, exacerbation of hemorrhoids, and increased transaminases have been reported in postmarketing experience.
Immunologic
Immunologic side effects have included infection (10%).
General
In the lipid-lowering trials, 807 patients received at least one dose of colesevelam therapy (total exposure 199 patient-years). In the type 2 diabetes trials, 566 patients received at least one dose of colesevelam therapy (total exposure 209 patient years). In clinical trials for the reduction of LDL-C, 68% of patients receiving colesevelam therapy versus 64% of patients receiving placebo reported an adverse event. In clinical trials of type 2 diabetes, 60% of patients receiving colesevelam therapy versus 56% of patients receiving placebo reported an adverse event.
Respiratory
Respiratory side effects have included nasopharyngitis (4%), pharyngitis (3%), rhinitis (3%), sinusitis (2%), and increased cough (2%).
Musculoskeletal
Musculoskeletal side effects have included myalgia (2%).
Metabolic
Metabolic side effects have included hypoglycemia (3%). Hypertriglyceridemia has been reported in postmarketing experience.
Nervous system
Nervous system side effects have included headache (6%), pain (6%), and back pain (3%).
Other
Other side effects have included abdominal pain (5%), accidental injury (4%), asthenia (4%), and flu syndrome (3%).
TopMore Welchol resources
- Welchol Concise Consumer Information (Cerner Multum)
- Welchol MedFacts Consumer Leaflet (Wolters Kluwer)
- Welchol Advanced Consumer (Micromedex) - Includes Dosage Information
- Welchol Prescribing Information (FDA)
- WelChol Monograph (AHFS DI)
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