Vyvanse Side Effects

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Answer the side-effect intent for vyvanse 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 Vyvanse?

Vyvanse contains the active ingredient Lisdexamfetamine dimesilate.

• Active ingredient — Lisdexamfetamine dimesilate
• Registration number — A48/1.6/0407; A48/1.6/0408; A48/1.6/0409
• Registration holder — Takeda(Pty) Ltd

It is approved for:

• Attention Deficit Hyperactivity Disorder (ADHD) if treatment with methylphenidate and atomoxetine has failed. VYVANSE increases attention and decreases impulsiveness and hyperactivity in patients with ADHD. It is not to be taken by children with ADHD under 13 years of age as the available formulations do not allow for the flexibility to achieve the optimal dose requirements for children 6 to 12 years of age. Safety of VYVANSE in children below 6 years has not been established. VYVANSE should be used as part of a comprehensive treatment program which usually includes psychological, educational and social therapy. The main ingredient in VYVANSE is lisdexamfetamine dimesilate which itself is not active (such medicines are sometimes called a pro-drug). After VYVANSE is taken, it is converted in the blood to dexamfetamine which is the active medicine. Ask your doctor if you have any questions about why VYVANSE has been prescribed for you/your child. VYVANSE can be abused or lead to dependence. VYVANSE is a controlled substance and should be handled responsibly. It is illegal for anyone prescribed VYVANSE to sell or give it to other people. Keep VYVANSE in a safe place to prevent misuse and abuse. Also, return any unused capsules to your pharmacy to safeguard against them being taken by anyone else

Common side effects of Vyvanse

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

• allergic reaction which may result in a rash or a sharp drop in blood pressure, difficulty breathing, and hives/itching (anaphylactic reaction)
• chest pain or tightness in the chest
• shortness of breath
• irregular heart beat
• seizures (fits)
• vision problems
• mood changes such as depression or irritability
• new or worsening aggressive behaviour
• excitement, overactivity and uninhibited behaviour
• confusion, delusion or hallucinations (seeing or feeling things that are not really there)
• abnormal thinking (psychosis)
• swelling of the face, tongue or throat; difficulty swallowing; hives and breathing difficulties (angioedema) or serious skin rash, with or without blisters, of the skin and mucous membranes or skin irritation, sores or swelling in the mouth, throat, eyes, nose and around the genitals (Stevens- Johnson syndrome)
• breathlessness or swelling of the legs These are all serious side effects. If you/your child have them, you may have had a serious reaction to VYVANSE. You/your child may need urgent medical attention or hospitalisation. Tell your doctor or pharmacist if you/your child notice any of the following and they worry you: Very common (may affect more than 1 in 10 adults)
• decreased appetite
• being unable to sleep
• dry mouth
• headache Common (may affect up to 1 in 10 adults)
• feeling agitated, jittery, anxious, or irritable
• feeling unusually tired or restlessness
• unable to get or keep an erection or changes in sex drive
• feeling dizzy
• uncontrolled jerking, shaking, trembling or being unusually active
• hard-to-control, repeated twitching of any parts of the body or repeating sounds and words (tics)
• having mood swings
• high blood pressure, fast or uneven heartbeat (tachycardia)
• difficulty breathing
• feeling sick or diarrhoea
• constipation
• weight loss
• excessive sweating
• stomach pains
• grinding of the teeth Uncommon (may affect up to 1 in 100 adults)
• talking excessively
• feeling depressed, anxious, low, or uneasy (dysphoria)
• feeling excessively happy or excited (euphoria)
• excessive picking of the skin
• uncontrolled twitching or jerking of the body
• feeling unusually sleepy
• itching, rash or raised red itchy rashes (urticaria)
• blurred vision
• high temperature (fever)
• being sick
• metallic taste or changes in taste (dysgeusia)
• fainting Not known: frequency cannot be estimated from the available data
• excessive widening of the pupils
• aggression
• poor blood circulation which makes the toes and fingers go numb and pale (Raynaud’s phenomenon)
• Suppression/slowing of growth (length)
• Dependence on or abuse of VYVANSE Effects on weight VYVANSE may cause weight loss in some people. Your doctor will watch your weight, as well as how well you are eating. If you are losing weight, your doctor may stop treatment with VYVANSE for a short time. Other side effects not listed above may also occur in some people. If you notice any side effects

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

• are allergic (hypersensitive) to amfetamines or any of the other ingredients of VYVANSE listed in “What VYVANSE contains in section 6. of this leaflet
• have a disease of the arteries due to cholesterol deposits e.g. atherosclerosis
• have heart disease such as angina pectoris or myocardial infarction (heart attack) or other heart diseases or disorders including heart rate and rhythm disturbances
• have moderate to severe high blood pressure
• have hyperthyroidism (hyperactive thyroid)
• have an eye condition called glaucoma
• have a tumour of the adrenal gland tissue (phaeochromocytoma)
• have tics (muscle twitching usually in the face and shoulders)
• have Tourette’s syndrome
• have severe depression, suicidal ideation or behaviour, thoughts or acts of self- harm or mental illness
• have periods of severe anxiety, tension or agitation
• suffer with drug dependence or abuse alcohol
• are taking or have taken an antidepressant called a monoamine oxidase inhibitor or MAOI within the past 14 days
• Are pregnant or breastfeeding your baby Do not use VYVANSE beyond the expiry date (month and year) printed on the bottle. If you/your child take VYVANSE after the expiry date has passed, it may have no effect, or worse, there may be an entirely unexpected effect. Do not give it to children unless your doctor has prescribed it. VYVANSE is not recommended for use in children with ADHD under 13 years of age as the available formulations do not allow for optimisation of the dose requirements for children 6 to 12 years of age. VYVANSE must not be used in children under 6 years of age. If you are not sure whether you/your child should start using VYVANSE, contact your doctor

Use with care, and tell your doctor, if

• are allergic to any other medicines, or any foods, dyes or preservatives
• are pregnant or planning to become pregnant
• are breastfeeding or wish to breastfeed
• have any other medical conditions or heart problems, including ischemic heart disease (such as angina pectoris or myocardial infarction), suspicion or presence of any cardiac or heart -related abnormalities, irregular heartbeats or rate, family history of sudden/cardiac death
• suffer from blood pressure and/or taking medications to treat blood pressure
• disorders of the blood vessels of the brain e.g. stroke
• suffer from depression, bipolar illness, or schizophrenia or other mental illness
• have liver or kidney disease. Your doctor may lower the dose if you have kidney disease
• have epilepsy or other seizures or have had an abnormal brain wave test (EEG)
• have circulation problems in fingers and toes
• feeling agitated, anxious or tense If you have not told your doctor or pharmacist about any of the above, tell them before you/your child take any VYVANSE

Pregnancy and breastfeeding

• You should not be treated with VYVANSE if you are pregnant or planning to become pregnant as treatment with VYVANSE may harm your unborn child Tell your doctor immediately if you/your child become pregnant while on VYVANSE
• Breastfeeding You should not breastfeed your baby if you are on treatment with VYVANSE
• VYVANSE may cause serious harm to your baby
• 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 taking VYVANSE

Interactions and medicines to check

The approved leaflet names these interactions.

• depression including MAOIs
• anxiety, mania or bipolar disorder
• high blood pressure
• schizophrenia or schizophrenia-like illness
• strong pain In addition, the following medicines may also interact with VYVANSE
• Urinary acidifying medicines e.g. ascorbic acid (Vitamin C), ammonium chloride, sodium acid phosphate
• Urinary alkalinising medicines e.g. sodium bicarbonate, acetazolamide, some thiazides Tell your doctor or pharmacist if you/your child are taking or have recently taken other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop. Do not start any new medicine while taking VYVANSE without talking to your doctor first. VYVANSE with alcohol If you/your child drink alcohol, it could make some of the unwanted side effects of VYVANSE worse. Your doctor may suggest that you/your child avoid alcohol completely while you are taking VYVANSE

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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