Norepinephrine bitartrate: adverse event reports filed with FDA

1,545

reports as suspect product

0% of all reports · about 70 a year

361

reports, 12 months to June 2026

308 in the 12 months before

92.4%

marked serious by the reporter

75.4% across the class

34.6%

record death among outcomes, as reported

534 reports · not verified by FDA

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 Norepinephrine bitartrate reports recording the termmedian drug in catecholamine

1. Drug ineffectivethe medicine did not work as expected22.2%343
2. Condition aggravatedthe condition being treated got worse17.7%274
3. Off label useused for a purpose or in a way not on the label13.7%211
4. Multiple organ dysfunction syndromeseveral organs failing12.4%191
5. Cardiogenic shockshock from the heart failing to pump12%186
6. General physical health deteriorationgeneral decline in health11.1%172
7. Hypotensionlow blood pressure10.7%166
8. Sepsisa severe body-wide response to infection10.7%166
9. Hyponatraemialow blood sodium10.4%161
10. Abdominal painstomach or belly pain10.1%156
11. Abdominal distensiona bloated abdomen10%155
12. Stressstress10%155
13. Ascitesfluid in the abdomen9.7%150
14. Appendicitis9.6%149
15. Appendicolith9.6%148
16. Constipationconstipation9.5%147
17. Vomitingbeing sick9.5%147
18. Nauseafeeling sick9.1%141
19. Somnolencedrowsiness9%139
20. Ventricular fibrillationa chaotic rhythm from the lower heart chambers8.8%136
21. Drug hypersensitivityan allergic-type reaction to a medicine8.3%129
22. Blood phosphorus increased8.2%126
23. Dry mouthdry mouth8.1%125
24. Anaemialow red blood cells7.6%117
25. Diabetes mellitusdiabetes7.6%117
26. Myasthenia gravis7.5%116
27. Drug intolerancethe medicine was not tolerated7.4%114
28. Bacterial infectiona bacterial infection7.1%110
29. Thrombosis7.1%110
30. Pulmonary embolisma blood clot in the lung7.1%109

Top 30 of 442 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 7 drugs in the catecholamine 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 22,692 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

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 36.9% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 1,545 reports.

Drugs most often listed in the same reports

Other products listed in reports where Norepinephrine bitartrate 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

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 catecholamine class

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.

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 Norepinephrine bitartrate as a suspect or interacting product; reports listing it only as a concomitant medication (1,064) 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.