Skip to main content
PlainMeds

What the label lists and what reports show

Fosinopril side effects

Fosinopril's FDA label lists its adverse reactions in its own words. FAERS holds 4,243 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 (241 reports).

  • Generic listed
  • Boxed warning

Check it at the source: the fosinopril FDA label on DailyMed (effective October 10, 2025, Chartwell RX, LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Fosinopril sodium has been evaluated for safety in more than 2,100 individuals in hypertension and heart failure trials, including approximately 530 patients treated for a year or more. Generally, adverse events were mild and transient, and their frequency was not prominently related to dose within the recommended daily dosage range. Hypertension In placebo-controlled clinical trials (688 fosinopril sodium-treated patients), the usual duration of therapy was two to three months. Discontinuations due to any clinical or laboratory adverse event were 4.1% and 1.1% in fosinopril sodium-treated and placebo-treated patients, respectively. The most frequent reasons (0.4% to 0.9%) were headache, elevated transaminases, fatigue, cough (see PRECAUTIONS, General, Cough ), diarrhea, and nausea and vomiting. …

Source: FDA drug label, Chartwell RX, LLC, effective October 10, 2025 (SPL set ff1323cc-7ad8-488d-94a7-a11555db78a7), via openFDA; the full label on DailyMed

What do FAERS reports show?

4,243 reports list fosinopril among the medicines taken, each a report of something that happened, not proof the medicine caused it; 400 are coded as a death and 1,947 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, 14 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

  • Fatigue (named in the label)241
  • Diarrhoea (named in the label)234
  • Dyspnoea (named in the label)210
  • Nausea (named in the label)205
  • Drug Ineffective (a use or a product term, not a reaction)183
  • Dizziness (named in the label)180
  • Acute Kidney Injury179
  • Asthenia170
  • Renal Failure (named in the label)160
  • Hypotension (named in the label)143
  • Pain142
  • Headache (named in the label)141
  • Vomiting (named in the label)132
  • Myocardial Infarction (named in the label)131
  • Drug Interaction (a use or a product term, not a reaction)130
  • Fall129
  • Renal Failure Acute128
  • Cardiac Failure Congestive116
  • Anaemia (named in the label)115
  • Pain In Extremity113
  • Pruritus (named in the label)113
  • Cough (named in the label)112
  • Bradycardia (named in the label)111
  • Off Label Use (a use or a product term, not a reaction)111
  • Malaise107

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

What next?

Fosinopril: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions