"The U.S. Food and Drug Administration today took action against companies that manufacture, distribute, and/or market unapproved single-ingredient oral colchicine, a medication commonly used for the daily prevention of gout, to treat acute gout f"...
Colcrys Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Colcrys (colchicine, USP) is FDA-approved to treat gout in adults, and to treat a genetic condition called Familial Mediterranean Fever in adults and children who are at least 4 years old. Colchicine was developed prior to federal regulations requiring FDA review of drug products, not all uses for colchicine are approved by the FDA. As of 2009, Colcrys is the only brand of colchicine approved by the FDA. Generic forms of colchicine have been used to treat or prevent attacks of gout, or to treat symptoms of Behcets syndrome (swelling, redness, warmth, and pain). Common side effects include diarrhea, nausea, cramping, abdominal pain, and vomiting.
The dosing regimens for Colcrys are different for each condition being treated, and must be individualized. Colcrys may interact with conivaptan, digoxin, diclofenac, imatinib, isoniazid, quinidine, antidepressants, antibiotics, antifungal medications, cholesterol-lowering medicines, heart or blood pressure medication, HIV or AIDS medication, or medicines used to prevent organ transplant rejection. Tell your doctor all medications you are taking. During pregnancy, Colcrys should be used only when prescribed. This medication passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.
Our Colcrys (colchicine, USP) 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.
Colcrys in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- muscle pain or weakness;
- numbness or tingly feeling in your fingers or toes;
- pale or gray appearance of your lips, tongue, or hands;
- severe vomiting or diarrhea;
- easy bruising or bleeding, feeling weak or tired;
- fever, chills, body aches, flu symptoms;
- blood in your urine; or
- urinating less than usual or not at all.
Less serious side effects may include:
- mild nausea or vomiting, stomach pain; or
- mild diarrhea.
Read the entire detailed patient monograph for Colcrys (Colchicine Tablets) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Colcrys Overview - Patient Information: Side Effects
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.
Stop taking this medication and seek immediate medical attention if any of these rare but serious side effects occur: unusual bleeding/bruising, severe diarrhea or vomiting, muscle weakness or pain, numbness/tingling in your fingers or toes, pale or gray color of the lips/tongue/palms of hands, signs of infection (such as fever, persistent sore throat), unusual weakness/tiredness.
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 Colcrys (Colchicine Tablets)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Colcrys FDA Prescribing Information: Side Effects
Prophylaxis of Gout Flares
The most commonly reported adverse reaction in clinical trials of colchicine for the prophylaxis of gout was diarrhea.
Treatment of Gout Flares
The most common adverse reactions reported in the clinical trial with COLCRYS for treatment of gout flares were diarrhea (23%) and pharyngolaryngeal pain (3%).
Gastrointestinal tract adverse effects are the most frequent side effects in patients initiating COLCRYS, usually presenting within 24 hours, and occurring in up to 20% of patients given therapeutic doses. Typical symptoms include cramping, nausea, diarrhea, abdominal pain and vomiting. These events should be viewed as dose-limiting if severe, as they can herald the onset of more significant toxicity.
Clinical Trials Experience In Gout
Because clinical studies are conducted under widely varying and controlled conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not predict the rates observed in a broader patient population in clinical practice.
In a randomized, double-blind, placebo-controlled trial in patients with a gout flare, gastrointestinal adverse reactions occurred in 26% of patients using the recommended dose (1.8 mg over one hour) of COLCRYS compared to 77% of patients taking a nonrecommended high dose (4.8 mg over six hours) of colchicine and 20% of patients taking placebo. Diarrhea was the most commonly reported drug-related gastrointestinal adverse event. As shown in Table 3, diarrhea is associated with COLCRYS treatment. Diarrhea was more likely to occur in patients taking the high-dose regimen than the low-dose regimen. Severe diarrhea occurred in 19% and vomiting occurred in 17% of patients taking the nonrecommended high-dose colchicine regimen but did not occur in the recommended low-dose COLCRYS regimen.
Table 3: Number (%) of Patients with at Least One
Drug-Related Treatment-Emergent Adverse Event with an Incidence of ≥ 2% of
Patients in Any Treatment Group
|MedDRA System Organ Class MedDRA Preferred Term||COLCRYS Dose||Placebo
|Number of Patients with at Least One Drug-Related TEAE||40 (77)||27 (37)||16 (27)|
|Gastrointestinal Disorders||40 (77)||19 (26)||12 (20)|
|Diarrhea||40 (77)||17 (23)||8 (14)|
|Nausea||9 (17)||3 (4)||3 (5)|
|Abdominal Discomfort||0||0||2 (3)|
|General Disorders and Administration Site Conditions||4 (8)||1 (1)||1 (2)|
|Fatigue||2 (4)||1 (1)||1 (2)|
|Metabolic and Nutrition Disorders||0||3 (4)||2 (3)|
|Gout||0||3 (4)||1 (2)|
|Nervous System Disorders||1 (2)||1 (1.4)||2 (3)|
|Headache||1 (2)||1 (1)||2 (3)|
|Respiratory Thoracic Mediastinal Disorders||1 (2)||2 (3)||0|
|Pharyngolaryngeal Pain||1 (2)||2 (3)||0|
Serious toxic manifestations associated with colchicine include myelosuppression, disseminated intravascular coagulation and injury to cells in the renal, hepatic, circulatory and central nervous systems.
These most often occur with excessive accumulation or overdosage [see OVERDOSAGE].
The following adverse reactions have been reported with colchicine. These have been generally reversible upon temporarily interrupting treatment or lowering the dose of colchicine.
Neurological: sensory motor neuropathy
Digestive: abdominal cramping, abdominal pain, diarrhea, lactose intolerance, nausea, vomiting
Hepatobiliary: elevated AST, elevated ALT
Read the entire FDA prescribing information for Colcrys (Colchicine Tablets) »
Additional Colcrys Information
Colcrys - User Reviews
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