Ciprofloxacin Side Effects

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

What is ciprofloxacin?

Ciprofloxacin contains the active ingredient Ciprofloxacin.

• Active ingredient — Ciprofloxacin
• Registration number — 45/20.1.1/0797; 45/20.1.1/0798; 45/20.1.1/0799
• Registration holder — FRESENIUS KABI SOUTH AFRICA (PTY) LTD

It is approved for:

• CIPROFLOXACIN FRESENIUS is an antibiotic belonging to the fluoroquinolone family
• The active substance is ciprofloxacin and works by killing bacteria that cause infections
• It only works with specific strains of bacteria
• CIPROFLOXACIN FRESENIUS is used in adults to treat severe and/or complicated bacterial infections of the lower respiratory tract (lungs), urinary tract (kidneys or bladder), skin and soft tissue, gastrointestinal tract (stomach or intestines), or bone

Common side effects of ciprofloxacin

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.

Frequent side effects

• nausea, diarrhoea, vomiting
• increase in transaminases (substance in blood)
• skin rash
• injection site reaction

Less frequent side effects

• yeast/mould superinfections, inflammation of the bowel linked to antibiotic use (antibiotic-related colitis)
• high concentration of a type of white blood cells (eosinophils), changes in blood count (leukopenia, anaemia, neutropenia, leucocytosis), increased or decreased amounts of blood platelets (thrombocytopenia or thrombocytaemia)
• a special type of anaemia due to red blood destruction (haemolytic anaemia)
• a drop in a type of white blood cells (agranulocytosis) or a dangerous drop in the number of red and white blood cells and platelets (pancytopenia) which may be life-threatening
• bone marrow depression, which may also be life-threatening
• allergic reaction, swelling (oedema) or rapid swelling of the skin and mucous membranes (angioedema), severe allergic reaction which may be life-threatening (anaphylactic shock), an allergic reaction (serum sickness-like reaction)
• loss of appetite (anorexia), blood glucose disorders: low blood sugar levels (hypoglycaemia), high blood sugar levels (hyperglycaemia)
• hyperactivity/agitation, confusion and disorientation, anxiety reactions, abnormal (strange) dreams, depression or hallucinations, mental disturbances (psychotic reactions) which may lead to self-harm, such as thoughts of suicide and attempted or completed suicide
• headache, dizziness, sleep problems (insomnia or nightmares), taste disorders, pins and needles (paraesthesia), disturbed sensation (dysesthesia) or reduced sensation (hypoesthesia), tremors, seizures including status epilepticus (prolonged or repeated fits or seizures without any recovery between attacks), vertigo, migraine, disturbed coordination, smell disorders, hyperesthesia (increased sensitivity to stimuli), or intracranial hypertension including pseudo tumour cerebri (pressure on the brain)
• visual disturbances (eyesight problems such as double vision), visual colour distortions
• tinnitus (ringing in the ears), loss of hearing, impaired hearing
• tachycardia (rapid heartbeat)
• vasodilatation (expansion of blood vessels), hypotension (low blood pressure), or syncope (fainting), inflammation of the walls of the blood vessels (vasculitis), inflammation of the blood vessels (phlebitis or thrombophlebitis)
• dyspnoea (shortness of breath) including asthmatic condition
• stomach and abdominal pain, indigestion/heartburn, flatulence (gas), pancreatitis (inflammation of the pancreas)
• increased bilirubin (substance in blood), hepatic impairment (liver disorders), jaundice, or non-infective hepatitis, liver necrosis very rarely progressing to life-threatening hepatic failure
• itching or hives, photosensitivity reactions (sensitivity to light), blistering (blistering of the skin), petechiae (small, pin-point bleeding under the skin), erythema multiforme, erythema nodosum (various skin eruptions, blisters, peeling or rashes), Stevens- Johnson syndrome or toxic epidermal necrolysis which may be life-threatening (severe allergic skin reactions)
• pain in the hands or feet, back pain, chest pain, joint pain, muscle pain (myalgia), arthritis (inflammation of the joints), or increased muscle tone and cramping, muscular weakness, tendinitis, tendon rupture predominantly Achilles tendon (especially of the large tendon at the back of the ankle), worsening of the symptoms of myasthenia gravis, a muscle weakness
• poor kidney function, kidney failure, blood in the urine (haematuria), crystals in the urine (crystalluria) or a type of urinary tract inflammation (tubule-interstitial nephritis)
• unspecific pain, fever or feeling unwell, unsteady walk (gait disturbance), excessive sweating
• increase in blood alkaline phosphatase, abnormal clotting (prothrombin) factor level or increased levels of the enzyme amylase (increased amylase)
• very rare cases of long lasting (up to months or years) or permanent adverse drug reactions, such as tendon inflammation, tendon rupture, joint pain, pain in the limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, burning, numbness or pain (neuropathy), depression, fatigue, sleep disorders, memory impairment, as well as impairment of hearing, vision, and taste and smell have been associated with administration of quinolone and fluoroquinolone antibiotics, in some cases irrespective of pre-existing risk factors. Side effects with an unknown frequency:
• syndrome associated with impaired water excretion and low levels of sodium (SIADH)
• coma because of low blood sugar levels (hypoglycaemic coma)
• overactive energy, mood, behaviour, and activity levels significantly different from your normal state of mind (mania)
• cases of an enlargement and weakening of the aortic wall or a tear in the aortic wall (aneurysms and dissections), which may rupture and may be fatal, and of leaking heart valves have been reported in patients receiving fluoroquinolones
• skin reactions and organ dysfunction related to conditions called acute generalised exanthematous pustulosis (AGEP) and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Ask your doctor if you are unsure
• increased International Normalised Ratio (INR) in patients treated with certain blood thinning medicines

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

• CIPROFLOXACIN FRESENIUS may cause damage to the cartilage of the fetus
• Do not receive CIPROFLOXACIN FRESENIUS if you are breastfeeding
• CIPROFLOXACIN FRESENIUS is excreted in breastmilk and may harm your baby
• Driving and using machinery

Use with care, and tell your doctor, if

• have ever had kidney problems as your doctor may need to adjust the dose
• suffer from epilepsy or other neurological conditions, such as fits
• have a history of tendon problems during previous treatment with antibiotics such as CIPROFLOXACIN FRESENIUS
• have a muscle disorder called myasthenia gravis
• have heart problems. Tell your doctor if you are born with or have family history of prolonged QT interval (seen on ECG, electrical recording of the heart), have salt imbalance in the blood (especially low level of potassium or magnesium in the blood), have a very slow heart rate (called ‘bradycardia’), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), you are female or elderly or you are taking other medicines that result in abnormal ECG changes
• have a damaged mitral and/or aortic heart valve which cannot close properly, i.e. leaking heart valves (heart valve regurgitation)
• have a family history of aortic aneurysm or aortic dissection or congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan Syndrome, Ehlers-Danlos syndrome, Turner syndrome, Sjögren’s syndrome (an inflammatory autoimmune disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet’s disease, high blood pressure or known atherosclerosis, rheumatoid arthritis (a disease of the joints) or endocarditis (an infection of the heart))
• have, or ever had depression or other mental health problems
• have a genetic disorder that affect your red blood cells, called glucose-6-phosphate dehydrogenase deficiency
• are a diabetic
• are currently taking other medicines that can reduce your blood potassium levels
• Tell your doctor immediately, if any of the following occurs while receiving CIPROFLOXACIN FRESENIUS. Your doctor will decide whether treatment with CIPROFLOXACIN FRESENIUS needs to be stopped
• Severe, sudden allergic reaction (an anaphylactic reaction/shock, angioedema). Even with the first dose, there is a risk that you may experience a severe allergic reaction with the following symptoms: tightness in the chest, feeling dizzy, sick or faint, or experiencing dizziness when standing up. If this happens, stop receiving CIPROFLOXACIN FRESENIUS and contact your doctor immediately
• Severe skin reactions, called severe cutaneous adverse reactions (SCARs), which could be life-threatening or fatal, including conditions such as toxic epidermal necrolysis (TEN), Stevens Johnson syndrome (SJS) and drug reaction with eosinophilia and systemic symptoms (DRESS). If you notice signs and symptoms of severe skin reactions, stop receiving CIPROFLOXACIN FRESENIUS and contact your doctor immediately
• If you feel sudden, severe pain in your abdomen, chest or back, which can be symptoms of aortic aneurysm and dissection, go to an emergency room immediately. Your risk may be increased if you are being treated with systemic corticosteroids
• If you start experiencing a rapid onset of shortness of breath, especially when you lie down flat in your bed, or you notice swelling of your ankles, feet or abdomen, or a new onset of heart palpitations (sensation of rapid or irregular heartbeat), you should inform a doctor immediately
• Pain and swelling in the joints and tendons may occur (inflammation of your ligaments), particularly if you are elderly and are also being treated with corticosteroids. Inflammation and tearing of tendons may occur even within the first 48 hours of treatment or up to several months after stopping CIPROFLOXACIN FRESENIUS therapy. At the first sign of any pain or inflammation, stop receiving CIPROFLOXACIN FRESENIUS and rest the painful area. Avoid any unnecessary exercise, as this might increase the risk of your tendon tearing. The recovery process for your tendons, muscles and joints may take weeks or months and full recovery to what it was before treatment with CIPROFLOXACIN FRESENIUS may not occur
• If you suffer from epilepsy or other neurological conditions such as cerebral ischaemia or stroke, you may experience side effects associated with the central nervous system. If this happens, stop receiving CIPROFLOXACIN FRESENIUS and contact your doctor immediately
• You may experience mental health problems (psychiatric reactions) the first time you receive CIPROFLOXACIN FRESENIUS. If you suffer from depression or psychosis, your symptoms may become worse under treatment with CIPROFLOXACIN FRESENIUS. Depression or psychosis can progress to thoughts of suicide, suicide attempts, or completed suicide. If this happens, stop receiving CIPROFLOXACIN FRESENIUS and contact your doctor immediately
• You may experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness and/or weakness in your limbs. If this happens, stop receiving CIPROFLOXACIN FRESENIUS and contact your doctor immediately. The recovery process for your nerve condition may take weeks or months and full recovery to what it was before your treatment with CIPROFLOXACIN FRESENIUS may not occur
• CIPROFLOXACIN FRESENIUS may cause liver damage. If you notice any symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or tenderness of the stomach, stop receiving CIPROFLOXACIN FRESENIUS and contact your doctor immediately
• Diarrhoea may develop while you are on CIPROFLOXACIN FRESENIUS, or even several weeks after you have stopped receiving it. If the diarrhoea becomes severe or persistent, or you notice that your stool contains blood or mucous, stop receiving CIPROFLOXACIN FRESENIUS and contact your doctor immediately, as this can be life- threatening. Do not take medicines that stop or slow down bowel movements
• Your skin may become more sensitive to sunlight or ultraviolet (UV) light when receiving CIPROFLOXACIN FRESENIUS. Avoid exposure to strong sunlight, or artificial UV light such as sunbeds
• If your vision becomes impaired or if you experience any effects on your eyes, consult an eye specialist immediately
• Very rare cases of long lasting (up to months or years) or permanent adverse drug reactions, such as tendon inflammation, tendon rupture, joint pain, pain in the limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, burning, numbness or pain (neuropathy), depression, fatigue, sleep disorders, memory impairment, as well as impairment of hearing, vision, and taste and smell have been associated with administration of quinolone and fluoroquinolone antibiotics, in some cases irrespective of pre-existing risk factors. At the first signs or symptoms of any serious adverse drug reaction, stop receiving CIPROFLOXACIN FRESENIUS immediately and contact your doctor for advice. Receiving CIPROFLOXACIN FRESENIUS with food and drink CIPROFLOXACIN FRESENIUS may be administered with or without food

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 healthcare provider for advice before receiving CIPROFLOXACIN FRESENIUS

Interactions and medicines to check

The approved leaflet names these interactions.

• medicines that affect the way your heart beats: medicines that belong to the group of Class IA and III antidysrhythmics, tricyclic antidepressants, some antibiotics (macrolides), some antipsychotics (used for schizophrenia)
• anti-coagulants (prevent blood clots) which inhibits vitamin K (e.g. warfarin acenocoumarol, phenprocoumon or fluindione)
• methotrexate (treatment of certain types of cancer, psoriasis or rheumatism)
• theophylline (for breathing problems)
• clozapine (treatment of schizophrenia)
• ropinirole (treatment of Parkinson’s disease)
• ciclosporin (for skin conditions, rheumatoid arthritis and in organ transplants)
• oral antidiabetic medicines (to lower blood sugar) mainly sulfonylureas, e.g. glibenclamide, glimepiride (both for diabetes)
• insulin (used in diabetes to lower blood sugar)
• agomelatine (an antidepressant)
• duloxetine (antidepressant medicines, diabetic nerve damage or incontinence)
• lidocaine (lignocaine) (anaesthetic use or heart conditions)
• sildenafil (a medicine used for erectile dysfunction and high blood pressure)
• nonsteroidal anti-inflammatory medicines (NSAIDs) such as ibuprofen (for pain, fever or inflammation)
• caffeine (a stimulant)
• pentoxifylline (a medicine to treat circulation disorders)
• phenytoin (an antiseizure medicine)
• ACE inhibitors/angiotensin receptor blockers (medicines for high blood pressure). Ask your doctor if you are not sure
• probenecid
• zolpidem (for sleeping). Interaction with tests CIPROFLOXACIN FRESENIUS may interfere with the results of tests for tuberculosis (TB). Tell the doctor or laboratory staff that you are receiving CIPROFLOXACIN FRESENIUS if you have to provide a blood or urine sample for testing

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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