Hydrochlorothiazide Side Effects

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Answer the side-effect intent for hydrochlorothiazide without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

What is hydrochlorothiazide?

Hydrochlorothiazide contains the active ingredient Quinapril/ Hydrochlorothiazide.

• Active ingredient — Quinapril/ Hydrochlorothiazide
• Registration number — 43/7.1.3/1046; 43/7.1.3/1047
• Registration holder — AUROGEN SOUTH AFRICA (PTY) LTD

It is approved for:

• KWINCO is used to treat hypertension (high blood pressure)
• Quinapril is in a group of medicines called ACE inhibitors
• Quinapril works by preventing a chemical in your blood called angiotensin I from converting into a more potent form (angiotensin II) that increases salt and water retention in the body and causes the blood vessels to constrict – two actions that tend to increase blood pressure
• Hydrochlorothiazide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention

Common side effects of hydrochlorothiazide

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Reported side effects

• Hives
• Difficulty breathing
• Swelling of your face, lips, tongue, or throat Call your doctor at once if you have any of these serious side-effects:
• Feeling weak, light-headed, fainting or feeling faint, particularly when standing. This may mean your blood pressure is too low
• Jaundice (yellowing of the skin or eyes)
• A severe red, blistering, peeling skin rash
• A dry mouth, nausea, vomiting, increased thirst, muscle cramps, problems urinating
• Urinating less than usual, or not at all
• Fast or uneven heartbeat, palpitations, or chest pain
• Feeling short of breath
• Severe abdominal and back pain accompanied with feeling very unwell (inflammation of the pancreas)
• Fever, sore throat, chills, and other signs of infection
• Bruising or easy bleeding. Other side-effects include:
• Diarrhoea, indigestion, mild stomach pain, feeling or being sick
• Dizziness, headache, tiredness, feeling weak, sleepiness or sleeplessness
• Painful muscles, muscle weakness, back pain
• High levels of uric acid in your blood causing swollen, painful joints (gout)
• Coughing, bronchitis
• Nose or throat infections, nasal stuffiness and/or runny nose (rhinitis)
• Widening of blood vessels
• Kidney and urinary problems, urinary tract infection
• Numbness or tingling sensation in your limbs, aching joints
• Depression, nervousness, confusion
• Ringing or noise in the ears
• Wind
• Lazy eye
• Feeling of spinning or rotation of surroundings (vertigo)
• Fainting, low blood pressure
• Dry mouth, or throat, taste disturbances
• Fluid retention in the body
• Inflammation of your sinuses (sinusitis)
• Increased sweating, sensitivity of skin to light
• Failure/inability to achieve penile erection
• Viral infection. Tell your doctor if any of the above side-effects are severe, bothersome, do not go away or about any concerns you have while taking KWINCO. Not all side effects reported for KWINCO are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking KWINCO, please consult your doctor, pharmacist or other health care professional for advice

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• If you have ever had an unusual or allergic reaction to quinapril or hydrochlorothiazide or any ingredient of KWINCO
• If you have ever had an unusual or allergic reaction to sulphur medications
• If you have ever had angioedema (a condition that causes difficulty swallowing or breathing and painful swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs) related to previous treatment with an ACE-inhibitor or angiotensin receptor blocker
• If you have hereditary (inherited) / idiopathic (unknown cause) angioedema
• If you have aortic stenosis (a narrowing of the aortic valve in the heart, slowing blood flow from the heart into the main artery leaving the heart)
• If you have hypertrophic cardiomyopathy (heart muscle disease)
• If you have severe kidney disease or are experiencing problems passing water
• If you have renal artery stenosis (narrowing of the artery supplying the kidney with blood)
• If you are taking certain diuretics (water tablets used to reduce the amount of water in the body), such as spironolactone, triamterene, amiloride. These medicines do not cause your body to lose potassium
• If you have porphyria (an inherited disorder of blood pigment metabolism)
• If you have Addison’s disease (a condition in which your adrenal glands do not make enough of certain hormones)
• If you are taking lithium
• If you are pregnant or breastfeeding. See “Take special care with KWINCO” and “Pregnancy and Breastfeeding”

Use with care, and tell your doctor, if

• If you develop swelling of the face around your lips, tongue, or throat or difficulty swallowing, you should contact your doctor immediately
• If you are having desensitising treatment with hymenoptera venom, tell your doctor that you are taking KWINCO
• Some conditions can cause your blood pressure to get too low. This includes vomiting, diarrhoea, heart disease, a low-salt diet, or if you have been previously treated with water pills. If this leads to light-headedness, you should contact your doctor. If you are at risk of low blood pressure, your doctor may need to monitor your therapy closely
• To be sure KWINCO is helping your condition; your blood pressure will need to be checked on a regular basis. Your kidney or liver function may also need to be tested. Do not miss any scheduled visits to your doctor
• The safety and efficacy of KWINCO in children have not been established
• Laboratory tests, including liver function, kidney function, blood pressure, blood counts, and blood electrolytes, may be performed while you use KWINCO. These tests may be used to monitor your condition or check for side-effects. Be sure to keep all doctor and laboratory appointments. Tell your doctor:
• if you have kidney disease
• if you have liver disease
• if you have diabetes
• if you are to undergo surgery or anaesthesia
• if you have a history of allergy or asthma
• if you have lupus
• if you have gout
• if you have congestive heart failure
• if you have the following signs and/or symptoms of fluid or electrolyte imbalance: Dryness of mouth; thirst; weakness; lack of interest and energy; drowsiness; restlessness; muscle pain or cramps; low blood pressure; reduced urine production; increased rate of heart beat; nausea and vomiting. Taking KWINCO with food and drink: Avoid drinking alcohol, which can increase some of the side-effects of KWINCO

Pregnancy and breastfeeding

• You should not use KWINCO if you are pregnant or breastfeeding your baby
• If you are pregnant or breast-feeding your baby, please consult your doctor, pharmacist or other health care professional for advice before taking this medicine
• Driving and using machinery: The ability to engage in activities such as operating machinery or operating a motor vehicle may be impaired due to dizziness and fatigue
• Important Information about some of the ingredients of KWINCO: KWINCO contains lactose (a type of sugar), if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking KWINCO

Interactions and medicines to check

The approved leaflet names these interactions.

• Tetracycline (used to treat infections)
• Lithium (used to treat manic stage of bipolar disorder)
• Potassium supplements
• Potassium-sparing diuretics (water pills)
• Barbiturates, or narcotics (used for sedation and sleep or used in the treatment of pain)
• Diabetes medications such as insulin or oral medications
• Corticosteroids such as prednisone or ACTH (used to treat inflammation)
• Non-steroidal anti-inflammatory medications such as indomethacin (used to treat inflammation)
• Medicines for high blood pressure
• Pressor amines such as (norepinephrine, noradrenaline) (used to decrease heart-rate)
• Skeletal muscle relaxants
• Beta2-agonists (bronchodilators such as salbutamol). If you are using any of these medicines, you may not be able to take KWINCO, or you may need dosage adjustments or your doctor may need to monitor you carefully for side-effects. If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of KWINCO with these medicines may cause undesirable interactions. Please consult your doctor, pharmacist or other healthcare professional, for advice

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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