Pharmacologic class (EPC) · 2 drug pages

Alkaloid: adverse event reports filed with FDA

9,578 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

9,578
reports across the class: 0.1% of all reports; 857
reports, 12 months to June 2026: 891 in the 12 months before; 82.9%
marked serious by the reporter: 57.4% across all reports; 2
drugs with a page: brand and generic names counted separately

Alkaloid is a pharmacologic class (an FDA Established Pharmacologic Class) with 2 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 9,578 adverse event reports received by FDA, 0.1% of the database, from January 2004 to June 2026.

857 reports arrived in the 12 months to June 2026, close to the 891 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 82.9% of the class's reports are marked serious, 17.5% record death among the outcomes and 43.5% record hospitalisation, as reported.

Across the class the reactions recorded most often are diarrhoea (15.4%), drug ineffective (11.7%) and toxicity to various agents (11.5%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
Colchicine	generic	8,633	854	89.1%	Diarrhoea
ColcrysColchicine	brand	945	3	25.6%	Diarrhoea

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Diarrhoealoose or frequent stools15.4%1,476
Drug ineffectivethe medicine did not work as expected11.7%1,124
Toxicity to various agentspoisoning or toxic effect of one or more substances11.5%1,104
Off label useused for a purpose or in a way not on the label10.5%1,001
Drug interactionan interaction between medicines9.9%950
Vomitingbeing sick7%675
Acute kidney injurysudden loss of kidney function6%577
Nauseafeeling sick6%577
Abdominal painstomach or belly pain4.6%438
Rhabdomyolysismuscle breakdown4.3%408
Goutgout4.2%406
Overdosea dose above the recommended amount4.1%390
Fatiguetiredness3.8%361
Completed suicidedeath by suicide3.6%344
Condition aggravatedthe condition being treated got worse3.6%342
Hypotensionlow blood pressure3.5%340
Multiple organ dysfunction syndromeseveral organs failing3.5%336
Pancytopenialow counts of all blood cells3.4%322
Thrombocytopenialow platelets3.2%303
Arthralgiajoint pain3.1%301
Drug intolerancethe medicine was not tolerated3.1%294
Intentional overdosea deliberate overdose3%289
Dyspnoeashortness of breath3%288
Pyrexiafever2.9%281
Rashskin rash2.8%271

Solid bar: share of all class reports. Hollow bar: the median share across the 2 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death17.5%1,674

Life-threatening7.6%727

Hospitalisation (initial or prolonged)43.5%4,165

Disability1.7%161

Congenital anomaly0.6%53

Other serious51.9%4,974

Not serious17.1%1,642

Patient age

Under 20.5%44

2 to 112.9%274

12 to 173.9%370

18 to 4417.8%1,704

45 to 6420.4%1,955

65 to 7414.8%1,415

75 and over15.2%1,456

Age not given24.6%2,360

Who reported

Physician32.9%3,148

Pharmacist6.3%603

Other health professional40.4%3,872

Lawyer0.1%11

Consumer or non-health professional15%1,441

Not given5.3%503

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Alkaloid reports

Which drugs are in the Alkaloid class on this site?

Colchicine and Colcrys. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

9,578 reports through June 2026, 857 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

diarrhoea (15.4%), drug ineffective (11.7%), toxicity to various agents (11.5%), off label use (10.5%) and drug interaction (9.9%).

Can the members table be used to rank the drugs?

No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.