Drugs › Macrolide antimicrobial
Generic name
Clarithromycin: adverse event reports filed with FDA
21,814 reports list it as a suspect or interacting product, 2004–2026. Class: Macrolide antimicrobial. Also reported as Clarithromycin 500mg Tablets, Clarithromycin 250mg Tablets, Clarithromycin Extended Release.
- 21,814
- reports as suspect product
- 0.1% of all reports · about 970 a year
- 1,044
- reports, 12 months to June 2026
- 1,015 in the 12 months before
- 95%
- marked serious by the reporter
- 82.7% across the class
- 6.6%
- record death among outcomes, as reported
- 1,441 reports · not verified by FDA
Between January 2004 and June 2026, 21,814 adverse event reports received by FDA list clarithromycin, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (13,114) are left out of every figure here.
In the 12 months to June 2026, 1,044 reports listed it, close to the 1,015 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 970 reports a year and 0.1% of the 20,646,523 reports in the database, and 45% of the reports for the macrolide antimicrobial class. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are drug interaction (12.9%), drug ineffective (9.4%) and nausea (7.7%). A report can list several reactions, so shares add to more than 100%; 2,247 different terms appear across these reports. Drug interaction is recorded in 12.9% of these reports, a larger share than in the median macrolide antimicrobial drug (4.3%).
95% of the reports are marked serious by the reporter (82.7% across the class); 6.6% record death among the outcomes and 39.1% record hospitalisation, as reported. 42.9% of the reports came from other health professionals, and the largest patient age group is 45 to 64 (22.6%). 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
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
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Clarithromycin reports recording the termmedian drug in macrolide antimicrobial
- Drug interactionan interaction between medicines12.9%2,812
- Drug ineffectivethe medicine did not work as expected9.4%2,052
- Nauseafeeling sick7.7%1,688
- Diarrhoealoose or frequent stools6.4%1,397
- Dyspnoeashortness of breath5.7%1,241
- Malaisegeneral feeling of being unwell5.6%1,211
- Headachehead pain5.2%1,143
- Vomitingbeing sick4.7%1,030
- Pyrexiafever4.6%1,010
- Off label useused for a purpose or in a way not on the label4.5%991
- Dizzinesslight-headedness or unsteadiness3.9%849
- Rashskin rash3.7%801
- Macular degenerationa disease of the central retina3.6%784
- Abdominal painstomach or belly pain3.4%748
- Drug hypersensitivityan allergic-type reaction to a medicine3.3%720
- Dysgeusiaaltered taste3.3%717
- Abdominal pain upperupper stomach pain3%656
- Hypersensitivityan allergic-type reaction3%656
- Insomniadifficulty sleeping3%656
- Fatiguetiredness3%655
- Acute kidney injurysudden loss of kidney function3%649
- Anxietyanxiety3%648
- Erythemaskin redness2.9%637
- Pruritusitching2.8%607
- Painpain, site not specified2.6%573
- Confusional stateconfusion2.6%571
- Coughcough2.4%526
- Weight decreasedweight loss2.3%495
- Astheniaweakness or lack of energy2.2%481
- Pneumonialung infection2.2%471
Top 30 of 2,247 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 5 drugs in the macrolide antimicrobial 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
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 48,453 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
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 10.1% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Helicobacter infection | 1,865 | 8.5% |
| Lower respiratory tract infection | 1,280 | 5.9% |
| Pneumonia | 1,121 | 5.1% |
| Mycobacterium avium complex infection | 345 | 1.6% |
| Bronchitis | 325 | 1.5% |
| Helicobacter gastritis | 206 | 0.9% |
The indication field is filled in by the reporter and is often blank; shares are of all 21,814 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Clarithromycin reports |
|---|---|---|
| Amoxicillin | 3,513 | 16.1% |
| Metronidazole | 2,375 | 10.9% |
| Prednisone | 1,678 | 7.7% |
| Omeprazole | 1,643 | 7.5% |
| Acetaminophen | 1,549 | 7.1% |
| Lansoprazole | 1,490 | 6.8% |
| Pantoprazole | 1,171 | 5.4% |
| Morphine sulfate | 989 | 4.5% |
| Azithromycin | 986 | 4.5% |
| Aspirin | 919 | 4.2% |
Other products listed in reports where Clarithromycin 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
| Measure | Clarithromycin | Macrolide antimicrobial | All reports |
|---|---|---|---|
| Reports as suspect product | 21,814 | 48,453 | 20,646,523 |
| Share of that pool | — | 45% | 0.1% |
| Reports, latest 12 months | 1,044 | — | 1,332,454 |
| Marked serious | 95% | 82.7% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 66 | 72 | 91 |
| Hospitalisation recorded, per 1,000 reports | 391 | 351 | 213 |
| Consumer-filed share | 19.2% | 20.8% | 45.8% |
| Top term, share of reports | Drug interaction 12.9% | median 4.3% | 0.8% |
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 macrolide antimicrobial class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Azithromycin | generic | 17,500 | 2,070 | 82.5% |
| Zithromax | brand | 7,379 | 130 | 56.2% |
| Azasite | brand | 1,035 | 8 | 7.1% |
| Azithromycin dihydrate | generic | 725 | 68 | 97.7% |
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 Clarithromycin reports
How many adverse event reports has FDA received for Clarithromycin?
21,814 reports list Clarithromycin as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 1,044 of them arrived in the latest 12 months. Another 13,114 list it only as a concomitant medication.
What reactions are recorded in Clarithromycin reports?
drug interaction (12.9%), drug ineffective (9.4%), nausea (7.7%), diarrhoea (6.4%) and dyspnoea (5.7%). 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 Clarithromycin was responsible.
How serious are the reports?
95% are marked serious by the reporter. Among the outcomes recorded, 6.6% of reports include death and 39.1% 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?
other health professional (42.9%), physician (24.8%) and consumer or non-health professional (19.2%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Clarithromycin rising?
1,044 reports in the 12 months to June 2026, close to the 1,015 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 Clarithromycin 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 Clarithromycin?
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 Clarithromycin as a suspect or interacting product; reports listing it only as a concomitant medication (13,114) 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.