What the label lists and what reports show

Candesartan side effects

Candesartan's FDA label: “Most common adverse reactions which caused adult patients to discontinue therapy for: Hypertension were headache (0.6%) and dizziness (0.3%) ( 6.1 ).” FAERS holds 60,889 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 fatigue (4,914 reports).

Generic listed
Boxed warning

Check it at the source: the candesartan FDA label on DailyMed (effective January 15, 2026, Golden State Medical Supply, Inc.); 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 candesartan cilexetil?
Candesartan cilexetil may cause serious side effects, including: Injury or death to your unborn baby. See “What is the most important information I should know about candesartan cilexetil?” Low blood pressure (hypotension). Low blood pressure is most likely to happen if you: take water pills (diuretics) are on a low salt diet get dialysis treatments are dehydrated (decreased body fluids) due to vomiting and diarrhea have heart problems If you feel dizzy or faint lie down and call your doctor right away. Low blood pressure can also happen if you have major surgery or anesthesia. You will be monitored for this and treated if needed. See “What should I tell my doctor before taking candesartan cilexetil?” Worsening kidney problems. Kidney problems may get worse in people that already have kidney disease or heart problems. Your doctor may do blood tests to check for this. […]

Source: FDA drug label, NDA020838 (Ani Pharms), as published by Golden State Medical Supply, Inc., effective January 15, 2026 (SPL set 15601654-76da-04cf-e063-6394a90a2cb5), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions
Most common adverse reactions which caused adult patients to discontinue therapy for: Hypertension were headache (0.6%) and dizziness (0.3%) ( 6.1 ).

From the label: adverse reactions, continued
Most common adverse reactions which caused adult patients to discontinue therapy for: Hypertension were headache (0.6%) and dizziness (0.3%) ( 6.1 ). Heart Failure were hypotension (4.1%) (5.3), abnormal renal function (6.3%) (5.4), and hyperkalemia (2.4%) ( 5.5 ). To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adult Hypertension Candesartan cilexetil has been evaluated for safety in more than 3600 patients/subjects, including more than 3200 patients treated for hypertension. About 600 of these patients were studied for at least 6 months and about 200 for at least 1 year. In general, treatment with candesartan cilexetil was well tolerated. The overall incidence of adverse events reported with candesartan cilexetil was similar to placebo. The rate of withdrawals due to adverse events in all trials in patients (7510 total) was 3.3% (i.e., 108 of 3260) of patients treated with candesartan cilexetil as monotherapy and 3.5% (i.e., 39 of 1106) of patients treated with placebo.

What do FAERS reports show?

60,889 reports list candesartan among the medicines taken, each a report of something that happened, not proof the medicine caused it; 7,200 are coded as a death and 30,964 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 21 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

Fatigue4,914
Off Label Use (a use or a product term, not a reaction)4,896
Dyspnoea4,885
Nausea4,662
Dizziness (named in the label)4,314
Diarrhoea (named in the label)4,301
Headache (named in the label)4,153
Drug Ineffective (a use or a product term, not a reaction)4,029
Pain3,647
Vomiting (named in the label)3,466
Malaise3,352
Arthralgia3,305
Hypertension (a use or a product term, not a reaction)3,220
Asthenia3,167
Fall3,005
Pyrexia2,745
General Physical Health Deterioration2,738
Pneumonia2,729
Condition Aggravated (a use or a product term, not a reaction)2,683
Acute Kidney Injury2,463
Rash (named in the label)2,439
Confusional State2,357
Pain In Extremity2,342
Cough (named in the label)2,324
Abdominal Pain Upper2,293

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Candesartan: 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