Fluoxetine Side Effects

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

Part of mental health medication side effects side effects.

What is fluoxetine?

Fluoxetine contains the active ingredient Fluoxetine hydrochloride.

• Active ingredient — Fluoxetine hydrochloride
• Registration holder — Aurogen South Africa (Pty) Ltd

It is approved for:

• Fluoxetine belongs to a group of medicines called selective serotonin reuptake inhibitor (SSRI) antidepressants
• TINEXIFLO is used to treat the following conditions: Depression: a mental health disorder characterised by persistently depressed mood or loss of interest in activities, causing significant impairment in daily life
• TINEXIFLO is indicated for the treatment of major depressive episodes i.e
• single episode and recurrent depression with associated anxiety

Common side effects of fluoxetine

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

• Weight gain
• Agitation, amnesia, confusion, emotional lability, sleep disorder
• Ear pain, tinnitus (ringing in ear)
• High blood pressure, fast heart-beat
• Increased appetite, nausea and vomiting
• Urinary frequency increased
• Chest pain, chills

Less frequent side effects

• Anaemia, discolouration of the skin
• Hypothyroidism (a condition in which the thyroid gland is not able to produce enough thyroid hormone
• Dehydration
• Generalised oedema (a condition characterized by an excess of watery fluid collecting in the cavities or tissues of the body)
• Gout (a form of arthritis characterised by severe pain, redness and tenderness in joints)
• High cholesterol levels in the blood or high concentration of fats in the blood
• Low levels of potassium in the blood
• Impairment of your mental state or a state in which one’s thoughts and feelings seem unreal or not to belong to oneself
• Restlessness, inability to sit still, lack of interest, enthusiasm, or concern
• Impaired balance or a feeling of spinning and dizziness
• A feeling or state of intense excitement and happiness
• An experience involving the apparent perception of something not present
• Paranoid reaction, personality disorder , psychosis (disconnection from reality
• Abnormal movement of the legs while walking or involuntary movement of the body
• Muscle spasm, increased tightness of muscle tone, a decreased capacity for physical sensation, especially of the skin
• Spasmodic jerky contraction of groups of muscles, stabbing, burning, and often severe pain due to an irritated or damaged nerve
• Weakness, numbness and pain from nerve damage, usually in the hands and feet
• Increased sexual drive
• Inflammation or infection of the outer membrane of the eyeball and the inner eyelid., dry eyes, dilation of the pupil of the eye, pain to the eyes due to exposure to light
• An inflammation of the eyelid that affects the eyelashes or tear production, double vision, bulging of the eyes, bright red patch appearing in the white of the eye, abnormal pressure in eye, inflammation of the eye, loss of part of the usual field of vision
• Disorder in which the eyes don’t look in exactly the same direction at the same time
• Partial or complete hearing loss, condition which affects how you perceive sounds
• Condition that distorts the sense of smell
• Bleeding from nose
• Chest pain caused by reduced blood flow to the heart
• Improper beating of the heart, whether irregular, too fast or too slow
• Congestive heart failure – A chronic condition in which the heart doesn’t pump blood as well as it should
• Low blood pressure, headache, heart attack, low blood pressure when standing up or sitting or lying down
• Fainting or a sudden temporary loss of consciousness
• Asthma (airways become inflamed, narrow and swell and produce extra mucus, which makes it difficult to breathe)
• Hiccup, hyperventilation
• A small, shallow sore inside the mouth or at the base of the gums
• A hardened deposit within the fluid in the gallbladder
• Inflammation in the colon
• Difficulty swallowing foods or liquids, arising from the throat or oesophagus, ranging from mild difficulty to complete and painful blockage
• Oesophagitis (Inflammation that damages the tube running from the throat to the stomach)
• Inflammation of the stomach lining, intestine, tongue and gums
• High acid levels in stomach
• Increased salivation
• Liver function tests abnormal, melena
• Black tarry stool
• One or more painful sores on inner lips, gums, tongue, roof of the mouth or throat that may interfere with eating
• Nausea, vomiting, diarrhoea
• Acne, hair loss from the scalp or elsewhere on the body, contact dermatitis, itchy inflammation of the skin, rash, skin discolouration, skin ulcer, blisters
• Inflammation of one or more joints, causing pain and stiffness, bone pain, Inflammation of the fluid-filled pads (bursae) that act as cushions at the joints., leg cramps, Inflammation of the tendon sheath where muscle connects to bone
• Resulting in termination of pregnancy
• An excess of protein in the urine
• Breast enlargement, breast pain
• Inflammation of the bladder, discomfort, pain or burning when urinating, blood in urine
• Urinating frequently at night, passing abnormally large amounts of urine, loss of bladder control or difficulty urinating and completely emptying the bladder, urine output below normal
• A whitish or yellowish discharge of mucus form the vagina
• Heavy or prolonged vaginal bleeding with menstrual cycle
• Any vaginal bleeding unrelated to normal menstruation
• Bleeding from the uterus that occurs in between periods, may occur every few weeks and the flow may be heavier than usual
• The absence of monthly menstrual periods
• Persistent inability to achieve orgasm despite responding to sexual stimulation
• Producing breastmilk
• Non-cancerous changes that give a breast a lumpy or rope-like texture
• Chills and fever, face swelling, intentional overdose
• General sense of being unwell, often accompanied by fatigue, diffuse pain or lack of interest in activities
• Pelvic pain
• Suicide attempt
• Diseases or disorders of the blood
• Diabetic acidosis, diabetes mellitus
• Alcohol intolerance, immediate unpleasant reactions after drinking alcohol
• Increased levels of alkaline phosphatase, BUN, creatine phosphokinase, potassium and uric acid
• Low levels of calcium in the blood
• Iron deficiency anaemia
• Abnormal electroencephalogram (EEG)
• Antisocial reaction
• Tingling around the mouth, weakness in the muscles used for speech, which often causes slowed or slurred speech
• Coma, delusions
• Involuntary muscle contractions that cause repetitive or twisting movements
• Extrapyramidal syndrome – symptoms include continuous spasms and muscle contractions, motor restlessness, rigidity, slowness of movement, tremor and irregular, jerky movements
• Difficulty lifting the front part of the foot
• Excessive physical sensitivity, especially of the skin
• Inflammation of a peripheral nerve or nerves, usually causing pain and loss of function
• Complete or partial loss of muscle function
• A state of near-unconsciousness or insensibility
• Severe, destructive, vision-threatening inflammation involving the deep episclera and sclera
• Abnormal heart rhythm, slower than expected heart rate, sudden blockage of an artery, heart attack
• Insufficient blood flow to the brain
• Unhealthy pale appearance
• Peripheral vascular disorder – is a blood circulation disorder that causes the blood vessels outside of your heart and brain to narrow, block, or spasm
• Inflammation of a vein, blood clot in vein causing inflammation, blood clots, sudden constriction of blood vessel
• Abnormal heartbeats from the lower chambers of the heart, premature contractions of the heart and erratic rapid heart-beat
• Temporary cessation of breathing, especially during sleep
• Complete or partial collapse of a lung, damage to the air sacs (alveoli) in the lungs, small amounts of blood mixed with sputum (or more seriously, large amounts of bright red blood) brought up by a forceful cough
• Hypoventilation, not enough oxygen in the tissues of the body
• Swelling of the larynx, excess fluid in the lungs, collapsed lung
• A high-pitched, whistling sound most often heard while taking in a breath
• Biliary pain, pain that occurs when a gallstone is being passed and is blocking a bile duct, inflammation of the gallbladder
• Ulcers in the intestine or oesophagus, or inflammation in the intestine
• Bloody diarrhoea, leakage from the bowel, gastrointestinal bleeding, vomiting of blood, bleeding of the colon, inflammation of the liver, intestinal blockage, liver fatty deposit, inflammation of the pancreas, sores on the lining of the intestine and stomach, bleeding form the rectum, salivary gland enlargement, stomach ulcer bleeds, swelling of the tongue
• Furunculosis- A painful, pus-filled bump under the skin caused by infected, inflamed hair follicles
• Herpes zoster resulting in painful rash
• Hirsutism – unwanted male-pattern hair growth on a women’s face
• Petechial rash – Tiny round, brown-purple spots due to bleeding under the skin)
• Psoriasis – A condition in which skin cells build up and form scales and itchy, dry patches
• Purpuric rash – small purple spots on the skin. The rash can look a lot like tiny clusters of bruises
• Seborrhoea – excessive discharge of sebum from the sebaceous glands
• Arthrosis – A type of arthritis that occurs when flexible tissue at the ends of bones wears down
• Chondrodystrophy – Condition that affects the development of the cartilage
• Myasthenia gravis – A weakness and rapid fatigue of muscles under voluntary control
• Myopathy – a disease of the muscle in which the muscle fibers do not function properly
• Osteomyelitis – inflammation of bone caused by infection
• Osteoporosis – is a bone disease that occurs when the body loses too much bone
• Rheumatoid arthritis – A chronic inflammatory disorder affecting many joints, including those in the hands and feet
• Breast engorgement- breast are painfully overfull of milk
• Glycosuria – excess sugar in the urine
• kidney pain
• Priapism – A prolonged erection of the penis, usually without sexual arousal

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 hypersensitive (allergic) to fluoxetine or any of the ingredients of TINEXIFLO
• If you are less than 18 years of age, as safety and efficacy in children have not been established
• If you have a severe kidney disease
• If you are taking or have recently taken (within the last two weeks) another medicine known as a monoamine oxidase inhibitor (MAOI)
• If you are taking or have recently taken anti-psychotic medicine known as Thioridazine

Use with care, and tell your doctor, if

• If you experience worsening of your depression, or if you think of harming or killing yourself. You should contact your doctor or go to the hospital doctor immediately
• If you experience muscle stiffness or tremor, appearance of fever, changes in your mental state like confusion, irritability and extreme agitation; you may suffer from the so-called “serotonin syndrome”. Although this syndrome occurs rarely it may result in potentially life threatening conditions; contact your doctor immediately
• If you experience swollen face or tongue, or shortness of breath or difficulty breathing, often with skin rashes (this may be a serious allergic reaction)
• If you experience epilepsy or fits. If you have a fit (seizures) or experience an increase in seizure frequency, contact your doctor immediately
• If you suffer from kidney problems you should not take TINEXIFLO
• If you are diabetic
• If you have eye problems or suffer from, or have a history of, glaucoma
• If you have moderate or severe heart failure
• If you are taking diuretic medications (medication which increases the excretion of water and salt from the body). As this may result in hyponatraemia (a condition that occurs when the level of sodium in the blood is too low), when taken together with TINEXIFLO
• If you experience abnormal bleeding
• If you feel restless and feel like you cannot sit or stand still, tell your doctor. Do not increase the dose of [PN] it may make these feelings worse

Pregnancy and breastfeeding

• TINEXIFLO is not recommended to be used in pregnancy, due to the potential risk to the foetus
• TINEXIFLO is excreted in human milk
• Patients should be advised not to breast feed if they are taking TINEXIFLO
• If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before taking TINEXIFLO

Interactions and medicines to check

The approved leaflet names these interactions.

• Certain irreversible, non-selective monoamine oxidase inhibitors (MAOIs), some used to treat depression. Irreversible, non-selective MAOIs must not be used with TINEXIFLO as serious or even fatal reactions (serotonin syndrome) can occur. Treatment with TINEXIFLO should only be started at least 2 weeks after discontinuation of an irreversible, non-selective MAOI. Do not take any irreversible, non-selective MAOIs for at least 5 weeks after you stop taking TINEXIFLO. If TINEXIFLO has been prescribed for a long period and/or at a high dose, a longer interval than 5 weeks may need to be considered by your doctor
• Selective serotonin reuptake inhibitors (SSRIs) or lithium The following combinations require precautions for use:
• CNS-active substances
• Pimozide (used to treat Tourette syndrome) – TINEXIFLO can increase the level of pimozide
• Thioridazine (used to treat schizophrenia, a disorder that affects a person’s ability to think, feel and behave clearly. Thioridazine should not be administered with TINEXIFLO or within a minimum of 5 weeks after TINEXIFLO has been discontinued. Thioridazine administration produces a dose related prolongation of the QTc (a heart rhythm condition that can potentially cause fast, chaotic heartbeats)
• Tryptophan – there is an increased risk of mild serotonin syndrome when this medicine is taken with TINEXIFLO
• Anti-depressants such as tricyclic anti-depressants
• Benzodiazepines (such as diazepam) – TINEXIFLO may influence the blood levels of this medicine
• Selective serotonin reuptake inhibitors (SSRIs) such as haloperidol and clozapine
• Anti-coagulants (such as warfarin), NSAID (such as ibruprofen, diclofenac), aspirin and other medicines which can thin the blood. TINEXIFLO may alter the effect of these medicines on the blood. If TINEXIFLO treatment is started or stopped when you are taking warfarin, your doctor will need to perform certain tests, adjust your dose and check on you more frequently
• Terfenadine and Astemizole, an anti-histamine used to treat allergies
• Cisapride, a medicine used to increase motility in the gut
• Metoprolol when used for heart failure; there is an increased risk of your heart beat becoming too slow
• Midazolam, a benzodiazepine used to treat anxiety

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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