Azomid Side Effects

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

What is Azomid?

Azomid contains the active ingredient Acetazolamide.

• Active ingredient — Acetazolamide
• Registration holder — Adcock Ingram Limited

It is approved for:

• AZOMID is used for the treatment of acute primary and secondary glaucoma
• AZOMID contains the active ingredient acetazolamide and belongs to a class of medicines known as carbonic anhydrase inhibitors
• AZOMID works by reducing the rate at which fluid is produced in the eye, and thus decreases pressure within the eye

Common side effects of Azomid

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

• Hyperpnoea (abnormally rapid or deep breathing) Side effects occurring with unknown frequency:
• Agranulocytosis (low levels of granulocytes – a type of white blood cell)
• Aplastic anaemia (a condition that causes the bone marrow to stop producing new blood cells)
• Thrombocytosis (a condition in which your body produces too many platelets)
• Leukopenia (low levels of white blood cells)
• Bone marrow depression (a condition in which the bone marrow cannot make enough blood cells)
• Pancytopenia (low levels of all type of blood cells)
• Hypokalaemia acidosis (caused by low levels of potassium in the blood.)
• Thirst
• Metabolic acidosis (develops when too much acid is produced in the body usually due to kidney disease or failure)
• Electrolyte imbalance (when the body’s fluid or mineral levels are either too high or too low)
• Excitement
• Depression
• Irritability
• Reduced libido
• Occasional instances of confusion
• Drowsiness
• Numbness and tingling of face and extremities
• Dizziness
• Headache
• Ataxia (inability to coordinate muscle movements)
• Paraesthesia (sensations like numbness, tingling, pins and needles)
• Flaccid paralysis (weakness and looseness in the limbs)
• Transient myopia (near sightedness or short-sightedness)
• Tinnitus (ringing or buzzing in the ears)
• Hearing loss
• Gastrointestinal disturbances
• Melaena (abnormally dark tarry faeces, usually containing blood)
• Taste disturbances
• Nausea
• Vomiting
• Diarrhoea
• Fulminant hepatic necrosis (damage to liver cells causing liver injury)
• Hepatitis or cholestatic jaundice (build-up of bile leading to inflammation of the liver)
• Skin rash, including erythema multiforme (inflammation of the skin and skin lesions caused by an allergic reaction), Stevens-Johnson syndrome (life-threatening reaction with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals), toxic epidermal necrolysis (skin disorder that causes blistering and peeling of skin)
• Urticaria (itchy rash)
• Thrombocytic purpura ( rare disorder that causes blood clots to form in small blood vessels)
• Photosensitivity (sun-burn like reactions)
• Acute generalized exanthematous pustulosis – AGEP (a drug-related skin reaction)
• Renal lesions (Abnormal growths or masses on the kidney)
• Haematuria (blood in the urine)
• Crystalluria (particles in the urine)
• Renal and ureteral colic (urinary stones causing obstruction in urinary tract)
• Kidney failure
• Calculus formation (kidney stones)
• Glycosuria (sugar or glucose in the urine)
• Polyuria (increase in urine production)
• Fatigue
• Fever
• Anaphylaxis (sudden, severe allergic reaction with breathing difficulty, swelling, lightheadedness, fast heartbeat, sweating and loss of consciousness)
• Flushing (reddening of the skin)
• Abnormal liver function

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 are allergic to sulphonamides, sulphonamide derivatives including acetazolamide or to any of the ingredients in the medicine (listed in section 6)
• If you have low blood levels of sodium; sodium bicarbonate and/or potassium
• if you have reduced function of the adrenal glands – glands above the kidneys – (also known as Addison’s disease)
• if you have severe liver or kidney problems
• if you have a specific type of glaucoma known as chronic, non-congested closed angle glaucoma
• if you are in your first trimester of pregnancy S3

Use with care, and tell your doctor, if

• if you have a particular condition called hepatic cirrhosis (scarring and damage of the liver)
• if you are on long-term therapy with AZOMID, as you may experience low blood levels of sodium and potassium
• if you are taking medication such as Quinidine, Methenamine or any psychostimulant drugs
• if you are being treated with anti-epileptics, as some patients have had thoughts of harming or killing themselves. If at any time you experience these feelings, immediately contact your doctor. Patients (and caregivers of patients) should to seek medical advice should signs of suicidal ideation or behaviour emerge
• if you experience an unusual rash or a fever. If at any time you notice this, immediately contact your doctor
• if you have pulmonary obstruction or emphysema (conditions that cause difficulty breathing and poor airflow to the lungs)
• if you have or ever had kidney problems such as kidney stones
• if you have intolerance to some sugars AZOMID may affect some medical tests. If you visit a hospital or clinic for any medical tests, you should tell the doctor concerned that you are taking AZOMID. It is also advisable to do regular blood tests, as AZOMID may alter your blood cell counts. Children and adolescents Safety and efficacy in children have not been established

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking this medicine
• Pregnancy Taking AZOMID should be avoided in the first trimester of pregnancy
• Breastfeeding Caution should be exercised if you are breastfeeding
• Consult your doctor for advice
• Fertility There is no information available on the effects of fertility

Interactions and medicines to check

The approved leaflet names these interactions.

• medicines that interfere with folic acid, e.g. methotrexate, pyrimethamine, or trimethoprim
• medicines used to decrease blood sugar levels (e.g. metformin, gliclazide)
• medicines used to prevent blood clots, such as Warfarin
• aspirin and related medicines, e.g. salicylic acid or choline salicylate used for mouth ulcers
• medicines for your heart such as cardiac glycosides (e.g. digoxin)
• medicines used to reduce blood pressure
• medicines used to treat epilepsy or fits (in particular, phenytoin, primidone or carbamazepine or topiramate)
• other medicines that are classified as carbonic anhydrase inhibitors (e.g. dorzolamide or brinzolamide, which are also used to treat glaucoma)
• amphetamines (a stimulant), quinidine (treats an irregular heartbeat), methenamine (prevents urine infections) or lithium (for the treatment of mental issues)
• ciclosporin (used to suppress the immune system)
• sodium bicarbonate therapy (used to treat high levels of acid in the body)
• medicines containing ammonium chloride

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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