What the label lists and what reports show
Amlodipine and hydrochlorothiazide and olmesartan side effects
Amlodipine and hydrochlorothiazide and olmesartan's FDA label: “Most common adverse reactions (incidence ≥2%) are dizziness, peripheral edema, headache, fatigue, nasopharyngitis, muscle spasms, nausea, upper respiratory tract infection, diarrhea, urinary tract infection, and joint swelling ( 6.1 ).” FAERS holds 1,260 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 sprue-like enteropathy (231 reports).
- Generic listed
- Boxed warning
Check it at the source: the amlodipine and hydrochlorothiazide and olmesartan FDA label on DailyMed (effective July 12, 2023, Cosette Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥2%) are dizziness, peripheral edema, headache, fatigue, nasopharyngitis, muscle spasms, nausea, upper respiratory tract infection, diarrhea, urinary tract infection, and joint swelling ( 6.1 ).
Table 1
| Adverse Reaction | OM40/ AML10/ HCTZ25 mg (N = 574) n (%) | OM40/ AML10 mg (N = 596) n (%) | OM40/ HCTZ25mg (N = 580) n (%) | AML10/ HCTZ25 mg (N = 552) n (%) |
|---|---|---|---|---|
| Edema peripheral | 44 (7.7) | 42 (7.0) | 6 (1.0) | 46 (8.3) |
| Headache | 37 (6.4) | 42 (7.0) | 38 (6.6) | 33 (6.0) |
| Fatigue | 24 (4.2) | 34 (5.7) | 31 (5.3) | 36 (6.5) |
| Nasopharyngitis | 20 (3.5) | 11 (1.8) | 20 (3.4) | 16 (2.9) |
| Muscle spasms | 18 (3.1) | 12 (2.0) | 14 (2.4) | 13 (2.4) |
| Nausea | 17 (3.0) | 12 (2.0) | 22 (3.8) | 12 (2.2) |
| Upper respiratory tract infection | 16 (2.8) | 26 (4.4) | 18 (3.1) | 14 (2.5) |
| Diarrhea | 15 (2.6) | 14 (2.3) | 12 (2.1) | 9 (1.6) |
| Urinary tract infection | 14 (2.4) | 8 (1.3) | 6 (1.0) | 7 (1.3) |
| Joint swelling | 12 (2.1) | 17 (2.9) | 2 (0.3) | 16 (2.9) |
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, continuedMost common adverse reactions (incidence ≥2%) are dizziness, peripheral edema, headache, fatigue, nasopharyngitis, muscle spasms, nausea, upper respiratory tract infection, diarrhea, urinary tract infection, and joint swelling ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials 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. Tribenzor In the controlled trial of Tribenzor, patients were randomized to Tribenzor (olmesartan medoxomil/amlodipine/hydrochlorothiazide 40/10/25 mg), olmesartan medoxomil/amlodipine 40/10 mg, olmesartan medoxomil/hydrochlorothiazide 40/25 mg, or amlodipine/hydrochlorothiazide 10/25 mg. Subjects who received triple combination therapy were treated between two and four weeks with one of the three dual combination therapies. Safety data from this study were obtained in 574 patients with hypertension who received Tribenzor for 8 weeks. …
Source: FDA drug label, Cosette Pharmaceuticals, Inc., effective July 12, 2023 (SPL set 2f56d0bc-236b-41a0-9fc0-21cdfea8d890), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,260 reports list amlodipine and hydrochlorothiazide and olmesartan among the medicines taken, each a report of something that happened, not proof the medicine caused it; 36 are coded as a death and 460 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 24 reactions below, 11 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?
- Amlodipine and hydrochlorothiazide and olmesartan: 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