What the label lists and what reports show
Ranolazine side effects
Ranolazine's FDA label: “Most common adverse reactions (>4% and more common than with placebo) are dizziness, headache, constipation, nausea.” FAERS holds 10,376 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 myocardial infarction (646 reports).
- Generic listed
Check it at the source: the ranolazine FDA label on DailyMed (effective January 23, 2026, Glenmark Pharmaceuticals Inc., USA); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of ranolazine extended-release tablets?Ranolazine extended-release tablets may cause serious side effects, including: • changes in the electrical activity of your heart called QT prolongation. Your doctor may check the electrical activity of your heart with an ECG. Tell your doctor right away if you feel faint, lightheaded, or feel your heart beating irregularly or fast while taking ranolazine extended-release tablets. These may be symptoms related to QT prolongation. • kidney failure in people who already have severe kidney problems. Your doctor may need to do tests to check how your kidneys are working. The most common side effects of ranolazine extended-release tablets include: • dizziness • headache • constipation • nausea Tell your doctor if you have any side effect that bothers you or does not go away. These are not all the possible side effects of ranolazine extended-release tablets. […]
Source: FDA drug label, Glenmark Pharmaceuticals Inc., USA, effective January 23, 2026 (SPL set 0cf58732-c242-49b0-8e3f-248778b4458d), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (>4% and more common than with placebo) are dizziness, headache, constipation, nausea.
From the label: adverse reactions, continuedMost common adverse reactions (>4% and more common than with placebo) are dizziness, headache, constipation, nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 2,018 patients with chronic angina were treated with ranolazine in controlled clinical trials. Of the patients treated with ranolazine, 1,026 were enrolled in three double-blind, placebo-controlled, randomized studies (CARISA, ERICA, MARISA) of up to 12 weeks’ duration. In addition, upon study completion, 1,251 patients received treatment with ranolazine in open-label, long-term studies; 1,227 patients were exposed to ranolazine for more than 1 year, 613 patients for more than 2 years, 531 patients for more than 3 years, and 326 patients for more than 4 years. At recommended doses, about 6% of patients discontinued treatment with ranolazine because of an adverse event in controlled studies in angina patients compared to about 3% on placebo. …
Source: FDA drug label, Glenmark Pharmaceuticals Inc., USA, effective January 23, 2026 (SPL set 0cf58732-c242-49b0-8e3f-248778b4458d), via openFDA; the full label on DailyMed
What do FAERS reports show?
10,376 reports list ranolazine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,337 are coded as a death and 4,453 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, 6 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?
- Ranolazine: 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