Reported Reactions

Reactions

MedDRA preferred term

Blood pressure inadequately controlled: adverse event reports recording this term

5,968 reports to FDA record it, 2004–2026; 0% of the database.

5,968
reports recording the term
0% of all reports
163
reports, 12 months to June 2026
100 in the 12 months before
73.2%
marked serious by the reporter
57.4% across all reports
3.6%
record death among outcomes, as reported
9.1% across all reports

5,968 reports in FDA's adverse event database record the MedDRA term "Blood pressure inadequately controlled": 0% of all reports received between January 2004 and June 2026. Coders pick the term that best matches the reporter's description.

163 reports recorded it in the 12 months to June 2026, up 63% from 100 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Of reports recording this term, 73.2% are marked serious, 3.6% include death among the outcomes and 30.6% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Diovan, Norvasc and Amlodipine. That order mostly follows how many reports each drug has overall; the table also gives the term's share within each drug's own reports. 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

02958Jul 2021: 23Aug 2021: 20Sep 2021: 21Oct 2021: 19Nov 2021: 18Dec 2021: 122022Jan 2022: 16Feb 2022: 13Mar 2022: 17Apr 2022: 7May 2022: 13Jun 2022: 11Jul 2022: 10Aug 2022: 10Sep 2022: 11Oct 2022: 10Nov 2022: 14Dec 2022: 42023Jan 2023: 14Feb 2023: 15Mar 2023: 18Apr 2023: 11May 2023: 11Jun 2023: 13Jul 2023: 10Aug 2023: 9Sep 2023: 10Oct 2023: 11Nov 2023: 12Dec 2023: 102024Jan 2024: 8Feb 2024: 13Mar 2024: 6Apr 2024: 16May 2024: 9Jun 2024: 5Jul 2024: 5Aug 2024: 8Sep 2024: 10Oct 2024: 13Nov 2024: 7Dec 2024: 72025Jan 2025: 9Feb 2025: 8Mar 2025: 8Apr 2025: 5May 2025: 4Jun 2025: 16Jul 2025: 15Aug 2025: 5Sep 2025: 3Oct 2025: 20Nov 2025: 5Dec 2025: 92026Jan 2026: 5Feb 2026: 9Mar 2026: 9Apr 2026: 7May 2026: 18Jun 2026: 58

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

Drugs listed as suspect products in these reports

DrugClassReports with this termShare of the drug's own reports
DiovanAngiotensin 2 receptor blocker5163%
NorvascCalcium channel blocker4053.3%
AmlodipineCalcium channel blocker2560.5%
Diovan HCTAngiotensin 2 receptor blocker2033.6%
LisinoprilAngiotensin converting enzyme inhibitor1920.4%
ValsartanAngiotensin 2 receptor blocker1831.1%
Amlodipine Besilate—1502.1%
ExforgeAngiotensin 2 receptor blocker1472.3%
TekturnaRenin inhibitor1215.4%
Metoprolol succinatebeta-Adrenergic blocker1141.1%
AtacandAngiotensin 2 receptor blocker1132.5%
NifedipineDihydropyridine calcium channel blocker1071.1%
Amlodipine besylateDihydropyridine calcium channel blocker1020.9%
HydrochlorothiazideThiazide diuretic990.4%
Atenololbeta-Adrenergic blocker970.6%
Vioxx—960.2%
FurosemideLoop diuretic890.2%
ClonidineCentral alpha-2 adrenergic agonist770.7%
Hydralazine—771.8%
LosartanAngiotensin 2 receptor blocker760.5%
Micardis—751.4%
AspirinNonsteroidal anti-inflammatory drug710.1%
Rasilez—712.5%
Gliclazide—701.3%
Catapres-TTS-1Central alpha-2 adrenergic agonist697.9%

Drugs with a page on this site, ordered by the number of their reports recording this term. The last column is the term's share within that drug's own reports, against 0% across the whole database. 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."

By pharmacologic class

ClassReports with this termShare of class reportsMedian drug in class
Angiotensin 2 receptor blocker1,6750.7%0.7%
Calcium channel blocker6970.9%0.4%
beta-Adrenergic blocker6140.4%0.3%
Angiotensin converting enzyme inhibitor4400.4%0.8%
HMG-CoA reductase inhibitor2560.1%0%
Dihydropyridine calcium channel blocker2430.9%0.6%
Thiazide diuretic1990.6%0.4%
Renin inhibitor1834.4%4.4%
Central alpha-2 adrenergic agonist1660.5%0%
Corticosteroid1430%0%

Classes ordered by count. Class shares follow the class's overall report volume as much as anything else.

Patients in these reports

Patient age

Under 20.1%4
2 to 110.3%16
12 to 170.1%8
18 to 444.8%285
45 to 6421.7%1,295
65 to 7416.8%1,002
75 and over15.1%899
Age not given41.2%2,459

Patient sex

Female61.3%3,658
Male32.1%1,913
Not given6.7%397

Grey bar: all 20,646,523 reports in the database. 56.7% of these reports give the United States as the country.

Questions about "Blood pressure inadequately controlled"

What does "Blood pressure inadequately controlled" mean in an adverse event report?

It is a MedDRA preferred term, the dictionary FDA uses to code what a reporter described. The report's own description is not published by openFDA and is not shown here.

How many reports record blood pressure inadequately controlled?

5,968 reports through June 2026 (0% of all reports), 163 of them in the latest 12 months.

Which drugs appear most often in these reports?

Diovan (516), Norvasc (405), Amlodipine (256), Diovan HCT (203) and Lisinopril (192). Drugs with many reports overall lead almost every term's list. 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."

Does a drug appearing here mean it was responsible for this reaction?

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."

I have this symptom. What should I do?

This site cannot assess anyone. A pharmacist or clinician can; for an emergency, call the local emergency number. Nothing on this page is medical advice.

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. Terms are pooled across spelling and capitalisation variants of one MedDRA preferred term. 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.