Colcrys

Last updated on RxList: 12/7/2020
Colcrys Side Effects Center

What Is Colcrys?

Colcrys (colchicine) is an alkaloid that 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 Behçet's syndrome (swelling, redness, warmth, and pain).

What Are Side Effects of Colcrys?

Common side effects of Colcrys include:

  • diarrhea,
  • nausea,
  • cramping,
  • stomach or abdominal pain, and
  • vomiting.

Dosage for Colcrys

The dosing regimens for Colcrys are different for each condition being treated, and must be individualized.

What Drugs, Substances, or Supplements Interact with Colcrys?

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 and supplements you use.

Colcrys During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Colcrys; it is unknown if it would affect a fetus. Colcrys passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

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.

QUESTION

Gout is a form of arthritis. See Answer
Colcrys Consumer Information

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

Call your doctor at once if you have:

  • muscle pain or weakness;
  • numbness or tingly feeling in your fingers or toes;
  • pale or gray appearance of your lips, tongue, or hands;
  • severe or ongoing vomiting or diarrhea;
  • fever, chills, body aches, flu symptoms; or
  • easy bruising, unusual bleeding, feeling weak or tired.

Common side effects may include:

  • nausea, vomiting, stomach pain; or
  • diarrhea.

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 Colcrys (Colchicine Tablets)

SLIDESHOW

Gout Attack Symptoms, Causes, Treatment, and Diet See Slideshow
Colcrys Professional 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%).

FMF

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 TermCOLCRYS DosePlacebo
(N=59)
n (%)
High
(N=52)
n (%)
Low
(N=74)
n (%)
Number of Patients with at Least One Drug-Related TEAE40 (77)27 (37)16 (27)
Gastrointestinal Disorders40 (77)19 (26)12 (20)
Diarrhea40 (77)17 (23)8 (14)
Nausea9 (17)3 (4)3 (5)
Vomiting9 (17)00
Abdominal Discomfort002 (3)
General Disorders and Administration Site Conditions4 (8)1 (1)1 (2)
Fatigue2 (4)1 (1)1 (2)
Metabolic and Nutrition Disorders03 (4)2 (3)
Gout03 (4)1 (2)
Nervous System Disorders1 (2)1 (1.4)2 (3)
Headache1 (2)1 (1)2 (3)
Respiratory Thoracic Mediastinal Disorders1 (2)2 (3)0
Pharyngolaryngeal Pain1 (2)2 (3)0

Postmarketing Experience

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 identified with colchicine. These have been generally reversible upon temporarily interrupting treatment or lowering the dose of colchicine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Neurological: sensory motor neuropathy

Dermatological: alopecia, maculopapular rash, purpura, rash

Digestive: abdominal cramping, abdominal pain, diarrhea, lactose intolerance, nausea, vomiting

Hematological: leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, aplastic anemia

Hepatobiliary: elevated AST, elevated ALT

Musculoskeletal: myopathy, elevated CPK, myotonia, muscle weakness, muscle pain, rhabdomyolysis

Reproductive: azoospermia, oligospermia

Read the entire FDA prescribing information for Colcrys (Colchicine Tablets)

© Colcrys Patient Information is supplied by Cerner Multum, Inc. and Colcrys Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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