What the label lists and what reports show
Nisoldipine side effects
Nisoldipine's FDA label lists its adverse reactions in its own words. FAERS holds 1,197 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (89 reports).
- Generic listed
Check it at the source: the nisoldipine FDA label on DailyMed (effective March 12, 2026, Covis Pharma US, Inc); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsADVERSE EXPERIENCES More than 6000 patients world-wide have received nisoldipine in clinical trials for the treatment of hypertension, either as the immediate release or the SULAR extended release formulation. Of about 1,500 patients who received SULAR in hypertension studies, about 55% were exposed for at least 2 months and about one third were exposed for over 6 months, the great majority at doses equivalent to 17 mg and above. SULAR is generally well-tolerated. In the U.S. clinical trials of SULAR in hypertension, 10.9% of the 921 SULAR patients discontinued treatment due to adverse events compared with 2.9% of 280 placebo patients. The frequency of discontinuations due to adverse experiences was related to dose, with a 5.4% and 10.9% discontinuation rate at the lowest and highest daily dose, respectively. …
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Adverse Event | Nisoldipine (%) (n=663) | Placebo (%) (n=280) |
|---|---|---|
| Peripheral Edema | 22 | 10 |
| Headache | 22 | 15 |
| Dizziness | 5 | 4 |
| Pharyngitis | 5 | 4 |
| Vasodilation | 4 | 2 |
| Sinusitis | 3 | 2 |
| Palpitation | 3 | 1 |
| Chest Pain | 2 | 1 |
| Nausea | 2 | 1 |
| Rash | 2 | 1 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, NDA020356 (Azurity), as published by Covis Pharma US, Inc, effective March 12, 2026 (SPL set 589157fa-d129-4de3-be3d-e0e1c22c5873), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,197 reports list nisoldipine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 123 are coded as a death and 394 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Nisoldipine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions