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ISOtretinoin

Brand names


US: Absorica, Amnesteem, Claravis, Myorisan, Zenatane
CAN: Accutane, Clarus, Epuris
INT: Show/Hide

Forms of this drug

ISOtretinoin (Oral Pill)

Prescrire drugs to avoid

None

Anticholinergic burden

Score: 0

Beers criteria for older adults

None

Screening tool of older people's prescriptions (STOPP)

None

Black box warning

See product data sheet for complete boxed warning.

CONTRAINDICATIONS AND WARNINGS: Isoniazid must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking isotretinoin capsules in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected. Birth defects which have been documented following isotretinoin exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. Cases of IQ scores less than 85 with or without other abnormalities have been reported.

QT Interval

None

Serotonin syndrome

None

Product data sheet

Absorica - Packager: Ranbaxy

Sotret - Packager: Ranbaxy

Side effects reported

Side effect Reports PRR
Inflammatory bowel disease 12,1351,899.0
Depression 8,91412.8
Colitis ulcerative 8,519225.4
Crohn's disease 5,66285.8
Irritable bowel syndrome 4,748144.5
Pregnancy 4,54959.5
Colitis 4,31568.4
Anxiety 4,2705.4
Intestinal haemorrhage3,355352.7
Suicidal ideation 3,03711.9
Dry skin 2,99732.4
Rectal haemorrhage 2,90626.6
Gastrointestinal disorder 2,81021.3
Drug exposure during pregnancy2,7809.4
Lip dry2,513304.2
Headache 2,5032.0
Arthralgia 2,4433.3
Anaemia 2,4214.5
Unintended pregnancy 2,33784.1
Intestinal obstruction 1,99225.5
Injury 1,9655.5
Blood triglycerides increased 1,95932.5
Abdominal pain 1,6462.7
Multi-organ disorder1,621216.7
Blood cholesterol increased 1,61910.8
Back pain 1,6013.0
No adverse effect1,574329.8
Fatigue 1,5051.1
Abortion induced 1,44548.3
Emotional distress 1,4406.4
Haemorrhoids 1,43722.7
Gastrointestinal injury1,350538.2
Insomnia 1,2942.0
Epistaxis 1,2928.2
Acne 1,25021.3
Gastrooesophageal reflux disease 1,2495.6
Nausea 1,2360.7
Weight decreased 1,1942.0
Arthritis 1,1216.7
No adverse event9865.9
Stress 9756.1
Small intestinal obstruction 95930.5
Myalgia 9282.3
Anal fissure920127.7
Diarrhoea 9160.8
Proctitis 876198.7
Dry eye 86715.9
Vomiting 8530.7
Suicide attempt 8254.8
Anal fistula 82184.5
Rash 7930.9
Dizziness 7470.6
Pain 7280.6
Panic attack 7257.5
Abortion spontaneous 7136.4
Cheilitis 71347.5
Iron deficiency anaemia69225.8
Treatment noncompliance 6927.0
Gastritis 6747.4
Alopecia 6722.7
Proctitis ulcerative665903.0
Ileitis664220.4
Chest pain6341.1
Hepatic enzyme increased 6264.4
Chapped lips61174.7
Pyrexia 5940.6
Dehydration 5661.4
Haematochezia 5535.6
Mood swings 5536.5
Mood altered 5499.1
Osteopenia 54311.5
Vision blurred 5361.7
Nephrolithiasis 5205.1
Sinusitis 5122.4
Dyspnoea 5090.4
Constipation 4951.2
Nasal dryness47643.2
Dyspepsia 4642.0
Pancreatitis 4622.6
Aspartate aminotransferase increased 4592.1
Pouchitis458361.2
Hypertension 4520.8
Depressed mood 4464.7
Perirectal abscess433112.5
Drug ineffective4320.2
Anger4284.6
Anhedonia 4283.9
Alanine aminotransferase increased 4241.8
Bipolar disorder 41911.2
Asthenia 4170.5
Colonic polyp41518.6
Mental disorder 4103.6
Decreased appetite 4081.0
Oesophagitis 3929.9
Completed suicide 3851.6
Normal newborn38432.8
Night blindness 381107.3
Erythema 3791.0
Urinary tract infection 3791.0
Eczema 3768.1