Applies to hydrochlorothiazide / olmesartan: oral tablet.

Serious side effects

Along with its needed effects, hydrochlorothiazide/olmesartan may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking hydrochlorothiazide / olmesartan:

Less common

• Bladder pain
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody or cloudy urine
• blurred vision
• chest pain
• difficult, burning, or painful urination
• flushed, dry skin
• frequent urge to urinate
• fruit-like breath odor
• increased hunger
• increased urination
• joint pain, stiffness, or swelling
• lower back, side, or stomach pain
• rapid weight gain
• sweating
• swelling of the feet or lower legs
• tingling of the hands or feet
• troubled breathing
• unexplained weight loss
• unusual weight gain or loss

Rare

• Swelling or puffiness of the face

Incidence not known

• Convulsions
• decrease in amount of urine
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• rash
• severe diarrhea with weight loss

Other side effects

Some side effects of hydrochlorothiazide / olmesartan may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Back pain
• body aches or pain
• chills
• cough
• difficulty with breathing
• ear congestion or pain
• fever
• headache
• head congestion
• hoarseness or other voice changes
• loss of voice
• runny or stuffy nose
• sneezing
• sore throat

Less common

• Acid or sour stomach
• belching
• difficulty with moving
• dizziness or lightheadedness
• feeling of constant movement of self or surroundings
• heartburn
• indigestion
• joint pain, stiffness, or swelling
• loss of appetite
• muscle pain or stiffness
• pain, swelling, or redness in the joints
• sensation of spinning
• stomach discomfort or upset
• weakness

Incidence not known

• Diarrhea
• muscle pain or stiffness
• nervousness
• weakness or heaviness of the legs

For Healthcare Professionals

Applies to hydrochlorothiazide / olmesartan: oral tablet.

General

The most common side effect was dizziness.^[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache

Uncommon (0.1% to 1%): Syncope

Hydrochlorothiazide:

Common (1% to 10%): Dizziness, headache

Postmarketing reports: Lightheadedness, paresthesia

Olmesartan:

Common (1% to 10%): Dizziness, headache^[Ref]

Respiratory

Common (1% to 10%): Bronchitis, pharyngitis, sinusitis, upper respiratory tract infection, coughing, nasopharyngitis

Hydrochlorothiazide:

Common (1% to 10%): Bronchitis, nasopharyngitis, pharyngitis

Uncommon (0.1% to 1%): Sinusitis, upper respiratory tract infection, cough

Frequency not reported: Pneumonitis, pulmonary edema

Olmesartan:

Common (1% to 10%): Bronchitis, nasopharyngitis, sinusitis, upper respiratory tract infection, cough, pharyngitis, rhinitis^[Ref]

Other

Common (1% to 10%): Vertigo, Influenza-like symptoms, chest pain, fatigue, peripheral edema

Uncommon (0.1% to 1%): Weakness

Postmarketing reports: Asthenia, lethargy, malaise

Hydrochlorothiazide:

Common (1% to 10%): Vertigo, influenza-like symptoms

Uncommon (0.1% to 1%): Chest pain, fatigue, peripheral edema

Frequency not reported: Weakness, fever

Olmesartan:

Common (1% to 10%): Vertigo, chest pain, fatigue, influenza-like symptoms, peripheral edema, pain

Postmarketing reports: Asthenia, lethargy, malaise^[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, gastroenteritis, nausea, abdominal pain, dyspepsia

Postmarketing reports: Sprue-like enteropathy, vomiting

Hydrochlorothiazide:

Uncommon (0.1% to 1%): Diarrhea, dyspepsia, nausea, gastroenteritis

Frequency not reported: Sialadenitis, cramping, gastric irritation

Postmarketing reports: Constipation

Olmesartan:

Common (1% to 10%): Diarrhea, dyspepsia, nausea, gastroenteritis, abdominal pain

Postmarketing reports: Vomiting, sprue-like enteropathy^[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, creatine phosphokinase increased, arthralgia, arthritis, myalgia

Uncommon (0.1% to 1%): Pain in limb, spinal disorder

Postmarketing reports: Rhabdomyolysis

Hydrochlorothiazide:

Common (1% to 10%): Arthralgia, back pain, pain in limb

Uncommon (0.1% to 1%): Spinal disorder

Frequency not reported: Muscle spasm

Olmesartan:

Common (1% to 10%): Arthralgia, back pain, pain in limb, arthritis, skeletal pain, creatine phosphokinase increased

Uncommon (0.1% to 1%): Spinal disorder, myalgia

Postmarketing reports: Rhabdomyolysis^[Ref]

Metabolic

Common (1% to 10%): Hyperlipemia, hyperglycemia, blood uric acid increased, hyperuricemia

Uncommon (0.1% to 1%): Blood glucose increased, blood potassium decreased, blood potassium increased, hypertriglyceridemia

Postmarketing reports: Hyperkalemia

Hydrochlorothiazide:

Common (1% to 10%): Blood glucose increased, blood potassium decreased

Uncommon (0.1% to 1%): Blood uric acid increased

Frequency not reported: Hyperglycemia, glycosuria, hyperuricemia

Postmarketing reports: Anorexia, loss of appetite

Olmesartan:

Common (1% to 10%): Hypertriglyceridemia, hyperglycemia, hyperuricemia

Uncommon (0.1% to 1%): Blood glucose increased, blood potassium decreased, blood uric acid increased

Rare (less than 0.1%): Hyperkalemia

Frequency not reported: Hypercholesterolemia^[Ref]

Hepatic

Common (1% to 10%): GGT increased, AST increased, ALT increased

Hydrochlorothiazide:

Uncommon (0.1% to 1%): ALT increased, AST increased, GGT increased

Frequency not reported: Pancreatitis, intrahepatic cholestatic jaundice

Olmesartan:

Common (1% to 10%): ALT increased, AST increased, GGT increased^[Ref]

Genitourinary

Common (1% to 10%): Hematuria, urinary tract infection

Hydrochlorothiazide:

Common (1% to 10%): Urinary tract infection

Olmesartan:

Common (1% to 10%): Urinary tract infection, hematuria^[Ref]

Psychiatric

Uncommon (0.1% to 1%): Anxiety, insomnia

Hydrochlorothiazide:

Uncommon (0.1% to 1%): Anxiety, insomnia

Frequency not reported: Restlessness

Postmarketing reports: Sleep disturbances, depression

Olmesartan:

Common (1% to 10%): Insomnia

Uncommon (0.1% to 1%): Anxiety^[Ref]

Dermatologic

Common (1% to 10%): Rash, facial edema

Uncommon (0.1% to 1%): Eczema

Postmarketing reports: Alopecia, pruritus, urticaria

Hydrochlorothiazide:

Frequency not reported: Purpura, photosensitivity, urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis

Postmarketing reports: Rash, cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus, erythematosus

Olmesartan:

Uncommon (0.1% to 1%): Rash

Postmarketing reports: Alopecia, pruritus, urticaria^[Ref]

Immunologic

Common (1% to 10%): Influenza

Uncommon (0.1% to 1%): Viral infection

Frequency not reported: Angioedema

Postmarketing reports: Anaphylactic reactions

Hydrochlorothiazide:

Uncommon (0.1% to 1%): Influenza, viral infection

Frequency not reported: Anaphylactic reactions

Olmesartan:

Common (1% to 10%): Influenza

Uncommon (0.1% to 1%): Viral infection

Postmarketing reports: Angioedema, anaphylactic reactions^[Ref]

Renal

Uncommon (0.1% to 1%): Blood creatinine increased

Postmarketing reports: Acute renal failure

Hydrochlorothiazide:

Uncommon (0.1% to 1%): Blood creatinine increased

Frequency not reported: Renal failure, renal dysfunction, interstitial nephritis

Olmesartan:

Uncommon (0.1% to 1%): Blood creatinine increased

Postmarketing reports: Acute renal failure^[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Palpitations, hypotension, orthostatic hypotension

Hydrochlorothiazide:

Frequency not reported: Vasculitis, cutaneous vasculitis

Postmarketing reports: Cardiac arrhythmias, postural hypotension

Olmesartan:

Uncommon (0.1% to 1%): Tachycardia, angina pectoris

Rare (less than 0.1%): Hypotension^[Ref]

Hematologic

Hydrochlorothiazide:

Frequency not reported: Aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia

Postmarketing reports: Bone marrow depression^[Ref]

Ocular

Ocular side effects have included idiosyncratic reactions to the hydrochlorothiazide component resulting in acute transient myopia and acute angle-closure glaucoma.^[Ref]