Possible side effects of Oral Isotretinoin
Mental problems
Rare effects (may affect up to 1 in every 1000 people)
- Depression or related disorders. Signs of this include sad or empty mood, mood changes, anxiety, crying spells, irritability, loss of pleasure or interest in social or sports activities, sleeping too much or too little, changes in weight or appetite, school or work performance going down or trouble concentrating.
- Existing depression getting worse.
- Becoming violent or aggressive.
Very rare effects (may affect up to 1 in every 10,000 people)
- Some people have had thoughts about hurting themselves or ending their own lives (suicidal thoughts), have tried to end their own lives (attempted suicide), or have ended their lives (suicide). These people may not appear to be depressed.
- Unusual behaviour.
- Signs of psychosis: a loss of contact with reality, such as hearing voices or seeing things that are not there.
Contact your doctor straight away if you get signs of any of these mental problems. Your doctor may tell you to stop taking Isotretinoin capsules. That may not be enough to stop the effects: you may need more help, and your doctor can arrange this.
Allergic reactions
Rare effects (may affect up to 1 in every1000) people
- Serious (anaphylactic) reactions: difficulty breathing or swallowing caused by sudden swelling of the throat, face, lips and mouth. Also sudden swelling of the hands, feet and ankles.
- Allergic reactions such as rash, itchiness.
If you have a serious reaction, get emergency medical help immediately.
If you have any allergic reaction, stop taking Isotretinoin capsules and contact your doctor.
Skin and hair problems
Unknown Frequency
- Serious skin rashes (erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), which are potentially life-threatening and require immediate medical attention. These appear initially as circular patches often with central blisters usually on arms and hands or legs and feet, more severe rashes may include blistering of the chest and back.
- Additional symptoms such as infection of the eye (conjunctivitis) or ulcers of the mouth, throat or nose may occur.
- Severe forms of rash may progress to widespread peeling of the skin which can be life threatening. These serious skin rashes are often preceded by headache, fever, body aches (flu-like symptoms).
If you develop a rash or these skin symptoms, stop taking Isotretinoin capsules and contact your doctor immediately.
Very common effects (may affect more than 1 in every 10 people)
- Dryness of the skin, especially of the lips and face; inflamed skin, chapped and inflamed lips, rash, mild itching and slight peeling. Use a moisturising cream from the start of treatment.
- Skin becomes more fragile and redder than usual, especially the face.
Rare effects (may affect up to 1 in every 1000 people}
- Hair loss (alopecia). This is usually only temporary. Your hair should return to normal after the treatment ends.
Very rare effects (may affect up to 1 in every 10,000 people)
- Acne can get worse in the first few weeks, but symptoms should improve with time.
- Skin inflamed, swollen, and darker than usual, especially on the face.
- Excess sweating or itching.
- Increased sensitivity to light.
- Bacterial infections at the base of the nail, changes to nails.
- Swellings, discharching , pus
- Thickened scarring after surgery
- Increased body hair.
Liver and kidney problems
Very common effects (may affect more than 1 in every 10 people)
- Raised liver enzymes seen in blood tests.
Very rare effects (may affect up to 1 in every 10,000 people)
- Yellow skin or eyes, and feeling tired. These can be signs of hepatitis. Stop taking Isotretinoin capsules straight away and contact your doctor.
- Difficulty urinating (passing water), swollen and puffy eyelids, feeling excessively tired. These may be signs of kidney inflammation. Stop taking Isotretinoin capsules straight away and contact your doctor.
Nervous system problems
Common effects (may affect up to 1 in every 10 people)
- Headache
Very rare effects (may affect up to 1 in every 10,000 people)
- Lasting headache, along with feeling sick (nausea), being sick (vomiting) and change in your eyesight including blurred vision. These may be signs of benign intracranial hypertension, especially if Isotretinoin capsules is taken with antibiotics called tetracycline. Stop taking Isotretinoin capsules straight away and contact your doctor.
- Convulsions
- Drowsiness
- Dizziness
Gut and stomach problems
Very rare effects (may affect up to 1 in every 10,000 people)
- Severe abdominal (tummy) pain, with or without severe bloody diarrhoea, feeling sick (nausea) and being sick (vomiting). These can be signs of serious gut conditions. Stop taking Isotretinoin capsules straight away and contact your doctor.
Blood problems
Very common effects (may affect more than 1 in every 10 people)
- Bruising, bleeding or clotting more easily – if clotting cells are affected.
- Anaemia – weakness, dizziness, pale skin – if red blood cells are affected.
- More liable to get infections – if the white blood cells are affected.
Very rare effects (may affect up to 1 in every 10,000 people)
- Lymph glands may become swollen.
Eye disorders
Very common effects (may affect more than 1 in every 10 people)
- Inflammation of the eye (conjunctivitis) and eyelid area; eyes feel dry and irritated. Ask a pharmacist for suitable eye drops. If you get dry eyes and wear contact lenses, you may need to wear glasses instead.
Very rare effects (may affect up to 1 in every 10,000 people)
- You may see less well at night; colour blindness and colour vision gets worse.
- Sensitivity to light may increase; you may find that you need to wear sunglasses to protect your eyes from too bright sunlight.
- Other sight problems including blurred vision, distorted vision, cloudy surface on the eye (corneal opacity, cataracts).
If you get blurred vision, stop taking Isotretinoin capsules straight away and contact your doctor.
If your sight is affected in any other way tell a doctor as soon as you can.
Ear, nose and throat problems
Common effects (may affect 1 in every 10 people)
- Inside of the nose becomes dry and crusted, causing mild nosebleeds.
- Sore or inflamed throat and nose.
Very rare effects (may affect up to 1 in every 10,000 people)
- Dry throat, hoarseness.
- Sudden tight chest, shortness of breath and wheezing, particularly if you have asthma.
- Hearing difficulties.
Diabetes
Very rare effects (may affect up to 1 in every 10,000 people)
- Excessive thirst; frequent need to urinate; blood tests show an increase in your blood sugar. These can all be signs of diabetes.
Bones and Muscles
Very common effects (may affect more than 1 in every 1O people)
- Back pain; muscle pain; joint pain particularly in children and teenagers.
Very rare effects (may affect up to 1 in every 10,000 people)
- Arthritis; bone disorders (delayed growth, extra growth and changes to bone density); growing bones may stop growing.
- Calcium deposits in soft tissue, sore tendons, high levels of muscle breakdown products in your blood if you exercise vigorously.
To avoid making any bone or muscle problems worse, cut down on intensive physical activity while you’re on Isotretinoin capsules.
Other types of reaction
Very common effects (may affect more than 1 in every 10 people)
- Changed levels of fats in the blood (including HDL or triglycerides).
Common effects (may affect up to 1 in every 10 people)
- Higher levels of cholesterol in the blood.
- Protein or blood in the urine.
Very rare effects (may affect up to 1 in every 10,000 people)
- Generally feeling unwell.
- High levels of uric acid in the blood.
- Bacterial infections.
- Inflammation of the blood vessels (sometimes with bruising, red patches).
If you notice any side effects that you are worried about, whether they are listed in this leaflet or not, talk to your doctor.
Sexual side effects
Speak to a doctor if you start having problems with sex such as erectile dysfunction (impotence), low sex drive (loss of libido), vaginal dryness, loss of feeling in your genitals or difficulty reaching orgasm. This can last a long time and can sometimes carry on after you stop taking isotretinoin.