What the label lists and what reports show
Nifedipine side effects
Nifedipine's FDA label: “The most common adverse event reported with nifedipine extended-release tablets were peripheral edema.” FAERS holds 41,059 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 dyspnoea (2,178 reports).
- Generic listed
Check it at the source: the nifedipine FDA label on DailyMed (effective December 24, 2024, Aurobindo Pharma Limited); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse event reported with nifedipine extended-release tablets were peripheral edema.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Reaction | NIFEDIPINE EXTENDED-RELEASE TABLETS (%) (n=370) | PLACEBO (%) (n=126) |
|---|---|---|
| Headache | 19 | 13 |
| Flushing/heat sensation | 4 | 0 |
| Dizziness | 4 | 2 |
| Fatigue/asthenia | 4 | 4 |
| Nausea | 2 | 1 |
| Constipation | 1 | 0 |
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.
From the label: adverse reactions, continuedADVERSE EXPERIENCES The incidence of adverse events during treatment with nifedipine extended-release tablets in doses up to 90 mg daily were derived from multi-center placebo-controlled clinical trials in 370 hypertensive patients. Atenolol 50 mg once daily was used concomitantly in 187 of the 370 patients on nifedipine extended-release tablets and in 64 of the 126 patients on placebo. All adverse events reported during nifedipine extended-release tablets therapy were tabulated independently of their causal relationship to medication. The most common adverse event reported with nifedipine extended-release tablets were peripheral edema. This was dose related and the frequency was 18% on nifedipine extended-release tablets 30 mg daily, 22% on nifedipine extended-release tablets 60 mg daily and 29% on nifedipine extended-release tablets 90 mg daily versus 10% on placebo. Other common adverse events reported in the above placebo-controlled trials include: NIFEDIPINE EXTENDED-RELEASE TABLETS (%) (n=370) PLACEBO (%) (n=126) Adverse Event Headache 19 13 Flushing/heat sensation 4 0 Dizziness 4 2 Fatigue/asthenia 4 4 Nausea 2 1 Constipation 1 0 Where the frequency of adverse events with nifedipine extended-release tablets and placebo is similar, causal relationship cannot be established.
Source: FDA drug label, Aurobindo Pharma Limited, effective December 24, 2024 (SPL set eb70b7ff-f9f0-41d0-901a-f4c04ae9ed46), via openFDA; the full label on DailyMed
What do FAERS reports show?
41,059 reports list nifedipine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 4,780 are coded as a death and 17,345 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 19 reactions below, 12 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?
- Nifedipine: 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