Reported Reactions

Drugs › alpha-Adrenergic blocker

Brand name · Carvedilol

Coreg: adverse event reports filed with FDA

4,989 reports list it as a suspect or interacting product, 2004–2026. Class: alpha-Adrenergic blocker.

4,989
reports as suspect product
0% of all reports · about 222 a year
29
reports, 12 months to June 2026
27 in the 12 months before
41.4%
marked serious by the reporter
76.2% across the class
4.8%
record death among outcomes, as reported
237 reports · not verified by FDA

Between January 2004 and June 2026, 4,989 adverse event reports received by FDA list the brand name Coreg (carvedilol) as a suspect or interacting product. Reports that mention it only as a concomitant medication (32,439) are left out of every figure here.

In the 12 months to June 2026, 29 reports listed it, close to the 27 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 222 reports a year and 0% of the 20,646,523 reports in the database, and 13% of the reports for the alpha-Adrenergic blocker class. How many people take it is not in the data, so a count is not a rate of occurrence.

Reporters most often recorded dizziness (13%), fatigue (11%) and dyspnoea (9.7%). A report can list several reactions, so shares add to more than 100%; 778 different terms appear across these reports. Dizziness is recorded in 13% of these reports, a larger share than in the median alpha-Adrenergic blocker drug (7.6%).

41.4% of the reports are marked serious by the reporter (76.2% across the class); 4.8% record death among the outcomes and 21.2% record hospitalisation, as reported. 81.9% of the reports came from consumers, and the largest patient age group is 75 and over (19%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

0611Jul 2021: 5Aug 2021: 10Sep 2021: 7Oct 2021: 6Nov 2021: 3Dec 2021: 52022Jan 2022: 7Feb 2022: 6Mar 2022: 2Apr 2022: 7May 2022: 5Jun 2022: 6Jul 2022: 3Aug 2022: 3Sep 2022: 0Oct 2022: 4Nov 2022: 3Dec 2022: 42023Jan 2023: 9Feb 2023: 5Mar 2023: 0Apr 2023: 6May 2023: 2Jun 2023: 11Jul 2023: 2Aug 2023: 2Sep 2023: 11Oct 2023: 5Nov 2023: 1Dec 2023: 52024Jan 2024: 2Feb 2024: 0Mar 2024: 4Apr 2024: 1May 2024: 0Jun 2024: 1Jul 2024: 5Aug 2024: 1Sep 2024: 0Oct 2024: 4Nov 2024: 1Dec 2024: 02025Jan 2025: 4Feb 2025: 5Mar 2025: 3Apr 2025: 2May 2025: 1Jun 2025: 1Jul 2025: 2Aug 2025: 2Sep 2025: 2Oct 2025: 2Nov 2025: 4Dec 2025: 42026Jan 2026: 3Feb 2026: 1Mar 2026: 0Apr 2026: 1May 2026: 1Jun 2026: 7

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

05521,1042004: 25220042005: 4422006: 6972007: 1,10420072008: 3622009: 1862010: 20020102011: 1652012: 1482013: 15020132014: 1942015: 2092016: 14220162017: 1022018: 972019: 19120192020: 922021: 832022: 5020222023: 592024: 192025: 3220252026: 13

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Coreg reports recording the termmedian drug in alpha-adrenergic blocker

  1. Dizzinesslight-headedness or unsteadiness13%651
  2. Fatiguetiredness11%551
  3. Dyspnoeashortness of breath9.7%486
  4. Hypotensionlow blood pressure7.1%355
  5. Drug ineffectivethe medicine did not work as expected6.9%346
  6. Astheniaweakness or lack of energy6.1%302
  7. Nauseafeeling sick4.4%220
  8. Headachehead pain4.2%211
  9. Blood pressure increaseda raised blood pressure reading3.7%184
  10. Weight increasedweight gain3.5%174
  11. Drug hypersensitivityan allergic-type reaction to a medicine3.3%167
  12. Coughcough3.1%155
  13. Diarrhoealoose or frequent stools3.1%155
  14. Blood pressure decreaseda low blood pressure reading3.1%154
  15. Malaisegeneral feeling of being unwell2.9%145
  16. Cardiac failure congestivecongestive heart failure2.8%138
  17. Hypertensionhigh blood pressure2.8%138
  18. Chest painchest pain2.6%131
  19. Feeling abnormalfeeling odd or not right2.6%131
  20. Rashskin rash2.6%130
  21. Blood glucose increasedraised blood sugar reading2.5%125
  22. Insomniadifficulty sleeping2.5%124
  23. Falla fall2.4%119
  24. Deaththe patient died; cause not stated by this term2.3%117
  25. Weight decreasedweight loss2.3%116
  26. Heart rate increaseda fast heart rate reading2.3%115
  27. Palpitationsawareness of the heartbeat2.3%114
  28. Syncopefainting2.3%113
  29. Alopeciahair loss2.2%112

Top 30 of 778 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 12 drugs in the alpha-adrenergic blocker class; it describes the reports, not the patients. 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."

Outcomes recorded

Death4.8%237
Life-threatening2.5%125
Hospitalisation (initial or prolonged)21.2%1,058
Disability1.6%79
Congenital anomaly0%1
Other serious23.8%1,188
Not serious58.6%2,923

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 38,454 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Patient age

Under 20.1%4
2 to 110.1%4
12 to 170.1%5
18 to 443.1%154
45 to 6417.7%884
65 to 7416.2%808
75 and over19%950
Age not given43.7%2,180

Patient sex

Female45%2,243
Male45.6%2,273
Not given9.5%473

Who reported

Physician8.3%412
Pharmacist1.9%94
Other health professional5.7%284
Lawyer0.1%5
Consumer or non-health professional81.9%4,087
Not given2.1%107

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 92.9% of reports give the United States as the country of the event or reporter.

Reason for use recorded

Indication as recorded (MedDRA)ReportsShare
Hypertension89217.9%
Cardiac failure congestive1272.5%
Cardiac disorder951.9%
Cardiomyopathy621.2%
Atrial fibrillation470.9%
Left ventricular dysfunction470.9%

The indication field is filled in by the reporter and is often blank; shares are of all 4,989 reports.

Drugs most often listed in the same reports

Drug (any role in the report)ReportsShare of Coreg reports
Aspirin77115.5%
Lasix53110.6%
Lisinopril51310.3%
Lipitor3897.8%
Plavix3426.9%
Furosemide2955.9%
Coumadin2835.7%
Norvasc2545.1%
Spironolactone2164.3%
Digoxin2144.3%

Other products listed in reports where Coreg is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

MeasureCoregalpha-Adrenergic blockerAll reports
Reports as suspect product4,98938,45420,646,523
Share of that pool—13%0%
Reports, latest 12 months29—1,332,454
Marked serious41.4%76.2%57.4%
Death recorded among outcomes, per 1,000 reports4812191
Hospitalisation recorded, per 1,000 reports212370213
Consumer-filed share81.9%39.1%45.8%
Top term, share of reportsDizziness 13%median 7.6%2.4%

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. 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."

Other drugs in the alpha-adrenergic blocker class

DrugName typeReportsLatest 12 monthsMarked serious
Carvedilolgeneric14,16370083%
Tamsulosin hydrochloridegeneric5,44453985%
Doxazosingeneric4,25134195.4%
Coreg CRbrand2,020329.3%
Cardurabrand1,8034184.7%
Doxazosin mesylategeneric1,7317692.4%
Prazosingeneric1,10511590.2%
Uroxatralbrand844139.3%
Silodosingeneric75510688.1%
Terazosingeneric7032273.7%
Alfuzosin hydrochloridegeneric6465685.8%

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." A brand and its generic are separate rows because reporters name them separately.

Questions about Coreg reports

How many adverse event reports has FDA received for Coreg?

4,989 reports list Coreg as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 29 of them arrived in the latest 12 months. Another 32,439 list it only as a concomitant medication.

What reactions are recorded in Coreg reports?

dizziness (13%), fatigue (11%), dyspnoea (9.7%), hypotension (7.1%) and drug ineffective (6.9%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Coreg was responsible.

How serious are the reports?

41.4% are marked serious by the reporter. Among the outcomes recorded, 4.8% of reports include death and 21.2% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.

Who files these reports?

consumer or non-health professional (81.9%), physician (8.3%) and other health professional (5.7%). Most reports reach FDA through the manufacturer, which must forward reports it receives.

Are reports for Coreg rising?

29 reports in the 12 months to June 2026, close to the 27 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.

Do these reports show that Coreg was responsible for these reactions?

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.

Is this a list of the side effects of Coreg?

No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.

How do I report an adverse event?

Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. 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 report counts here when it lists Coreg as a suspect or interacting product; reports listing it only as a concomitant medication (32,439) are excluded. 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.