This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Soriatane (Acitretin) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (74)
Death (5)
Life Threatening Events (2)
Disability (6)
Reports by Reaction Type
Drug Ineffective (8),
Alopecia (8),
Pruritus (6),
Skin Exfoliation (6),
Erythema (6),
Acne (5),
Chapped Lips (5),
Vision Blurred (5),
Chills (4),
Psoriasis (4),
Visual Acuity Reduced (4),
Headache (4)
Below are a few examples of reports where side effects / adverse reactions may be related to Soriatane (Acitretin). For a complete list or a specific selection of reports, please use the links above.
Possible Soriatane side effects in male
Reported by a physician from United States on 2012-08-23
Patient: male
Reactions: Swelling, Nasal Dryness, Traumatic Haematoma, Haematoma
Drug(s) suspected as cause:
Soriatane
Other drugs received by patient: Methotrexate
Possible Soriatane side effects in male
Reported by a physician from France on 2012-08-23
Patient: male
Reactions: Toxic Skin Eruption, Eosinophilia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Soriatane
Other drugs received by patient: Daivobet; Locapred; ART 50; Locoid; Diprosalic; Diprosone
Possible Soriatane side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-22
Patient: male
Reactions: Haematoma
Drug(s) suspected as cause:
Soriatane
Other drugs received by patient: Methotrexate
Possible Soriatane side effects in 64 year old male
Reported by a physician from United States on 2012-08-17
Patient: 64 year old male
Reactions: Visual Acuity Reduced, Retinal Artery Thrombosis
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Enbrel
Dosage: 50mg weekly
Indication: Psoriasis
Start date: 2012-01-01
Soriatane
Dosage: 20mg see dosage text
Administration route: Oral
Indication: Psoriasis
Start date: 2012-05-02
End date: 2012-07-10
Other drugs received by patient: Diovan; Narrowband UV-B Phototherapy; Aspirin; M.v.i.; Ascorbic Acid; Vitamin D; Ibuprofen
Possible Soriatane side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-16
Patient: male
Reactions: B-Cell Lymphoma, Drug Ineffective, Toxic Epidermal Necrolysis
Adverse event resulted in: death
Drug(s) suspected as cause:
Allopurinol
Indication: Tumour Lysis Syndrome
End date: 2011-07-01
Cyclosporine
Indication: Psoriasis
Start date: 2011-06-01
End date: 2011-07-01
Humira
Indication: Psoriasis
End date: 2011-06-01
Remicade
Indication: Psoriasis
Start date: 2011-06-01
End date: 2011-07-01
Soriatane
Indication: Psoriasis
Start date: 2011-06-01
End date: 2011-07-01
Possible Soriatane side effects in 22 year old female
Reported by a physician from United States on 2012-08-16
Patient: 22 year old female
Reactions: Maternal Exposure Before Pregnancy
Drug(s) suspected as cause:
Soriatane
Other drugs received by patient: Birth Control Pills
Possible Soriatane side effects in female
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-13
Patient: female
Reactions: Blood Alkaline Phosphatase Increased, Hypercholesterolaemia, Microcytic Anaemia, Hypertriglyceridaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Effexor
Dosage: 75mg three times per day
Administration route: Oral
Indication: Depression
Nozinan
Dosage: 25mg per day
Administration route: Oral
Indication: Depression
Soriatane
Dosage: 10mg per day
Administration route: Oral
Start date: 2011-11-30
End date: 2012-02-13
Soriatane
Dosage: 20mg per day
Administration route: Oral
Indication: Ichthyosis
End date: 2011-11-29
Sulfarlem
Trimeprazine Tartrate
Dosage: 10mg per day
Administration route: Oral
Indication: Depression
Other drugs received by patient: Oxazepam; Duphaston; Fenofibrate; Atarax; Retinol; Cetirizine; Havlane; Primperan TAB; Sulfarlem; Transipeg; Nexium; Stresam; Morphine Sulfate; Morphine Sulfate; Zopiclone; Artificial Tears
Possible Soriatane side effects in 48 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-09
Patient: 48 year old female
Reactions: General Physical Health Deterioration, Microcytic Anaemia, Hypertriglyceridaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Effexor XR
Dosage: 75 mg, 3x/day
Administration route: Oral
Indication: Depression
Nozinan
Dosage: 25 mg, daily
Administration route: Oral
Indication: Depression
Soriatane
Dosage: 10 mg, daily
Administration route: Oral
Start date: 2011-11-30
End date: 2012-02-13
Soriatane
Dosage: 20 mg, daily
Administration route: Oral
Indication: Ichthyosis
End date: 2011-11-29
Theralene
Dosage: 10 mg, daily
Administration route: Oral
Indication: Depression
Other drugs received by patient: Duphaston; Fenofibrate; Atarax; Transipeg; Havlane; Sulfarem; Nexium; Oxazepam; Zopiclone; Vitamin A; Primperan TAB; Cetirizine; Stresam
Possible Soriatane side effects in 64 year old male
Reported by a consumer/non-health professional from United States on 2012-08-08
Patient: 64 year old male
Reactions: Visual Acuity Reduced, Retinal Artery Thrombosis
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Soriatane
Other drugs received by patient: M.v.i.; Vitamin D; Aspirin; Diovan; Ibuprofen; Enbrel; Ascorbic Acid
Possible Soriatane side effects in 49 year old male
Reported by a consumer/non-health professional from United States on 2012-08-02
Patient: 49 year old male
Reactions: Chills, Dermatitis Exfoliative
Adverse event resulted in: life threatening event, disablity
Drug(s) suspected as cause:
Soriatane
Other drugs received by patient: Prednisone; Cyclosporine
Possible Soriatane side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-02
Patient: female
Reactions: Oncologic Complication
Adverse event resulted in: death
Drug(s) suspected as cause:
Soriatane
Possible Soriatane side effects in 64 year old male
Reported by a physician from United States on 2012-07-18
Patient: 64 year old male
Reactions: Visual Acuity Reduced, Retinal Artery Thrombosis
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Soriatane
Other drugs received by patient: Ascorbic Acid; Enbrel; Vitamin D; M.v.i.; Aspirin; Ibuprofen; Diovan
Possible Soriatane side effects in male
Reported by a physician from United States on 2012-07-18
Patient: male
Reactions: B-Cell Lymphoma, Drug Ineffective, Toxic Epidermal Necrolysis
Adverse event resulted in: death
Drug(s) suspected as cause:
Allopurinol
Indication: Tumour Lysis Syndrome
Start date: 2011-01-01
End date: 2011-07-01
Allopurinol
Indication: Prophylaxis
Cyclosporine
Indication: Psoriasis
Start date: 2011-06-01
End date: 2011-07-01
Humira
Indication: Psoriasis
End date: 2011-06-01
Infliximab
Indication: Psoriasis
Start date: 2011-06-01
End date: 2011-07-01
Soriatane
Indication: Psoriasis
Start date: 2011-06-01
End date: 2011-07-01
Possible Soriatane side effects in male
Reported by a health professional (non-physician/pharmacist) from Algeria on 2012-07-09
Patient: male
Reactions: Lymphadenopathy, Oedema Peripheral, Visual Acuity Reduced, Musculoskeletal Stiffness, Asthenia
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Soriatane
Possible Soriatane side effects in 40 year old male
Reported by a physician from France on 2012-07-02
Patient: 40 year old male
Reactions: Acne
Drug(s) suspected as cause:
Baclofen
Dosage: 120mg per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-10-01
Dantrium
Dosage: 300mg per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-10-01
End date: 2012-02-01
Isotretinoin
Administration route: Oral
Indication: Acne
Start date: 2011-12-13
Sertraline Hydrochloride
Dosage: 1ud per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-12-01
Soriatane
Administration route: Oral
Indication: Dermatosis
Start date: 2011-08-15
End date: 2011-12-13
Trospium Chloride
Dosage: 40mg per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-10-01
Possible Soriatane side effects in 49 year old male
Reported by a consumer/non-health professional from United States on 2012-06-18
Patient: 49 year old male
Reactions: Chills, Dermatitis Exfoliative
Adverse event resulted in: life threatening event, disablity
Drug(s) suspected as cause:
Soriatane
Other drugs received by patient: Prednisone
Possible Soriatane side effects in 40 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-05-25
Patient: 40 year old male
Reactions: Acne
Drug(s) suspected as cause:
Baclofen
Dosage: 120mg per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-10-01
Dantrium
Dosage: 300mg per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-10-01
End date: 2012-02-01
Isotretinoin
Administration route: Oral
Indication: Acne
Start date: 2011-12-13
Sertraline Hydrochloride
Dosage: 1ud per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-12-01
Soriatane
Administration route: Oral
Indication: Dermatosis
Start date: 2011-08-15
End date: 2011-12-13
Trospium Chloride
Dosage: 40mg per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-10-01
Possible Soriatane side effects in 44 year old male
Reported by a consumer/non-health professional from United States on 2012-05-17
Patient: 44 year old male, weighing 74.8 kg (164.6 pounds)
Reactions: Pustular Psoriasis, Psoriasis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Crestor
Administration route: Oral
Indication: Blood Cholesterol
Soriatane
Other drugs received by patient: Cortisone Shots
Possible Soriatane side effects in 66 year old male
Reported by a consumer/non-health professional from United States on 2012-05-17
Patient: 66 year old male
Reactions: Osteonecrosis
Drug(s) suspected as cause:
Soriatane
Other drugs received by patient: Lisinopril; Fluticasone Furoate
Possible Soriatane side effects in 83 year old female
Reported by a physician from France on 2012-04-30
Patient: 83 year old female
Reactions: Cheilitis, Intertrigo, Skin Ulcer, Rash Erythematous, Conjunctivitis, Rash Pruritic, Skin Plaque
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Allopurinol
Dosage: 100 mg;qd;po
Administration route: Oral
Indication: Hyperuricaemia
Start date: 2012-02-11
End date: 2012-02-13
Allopurinol
Dosage: 100 mg;qd;po
Administration route: Oral
Indication: Gout
Start date: 2012-02-11
End date: 2012-02-13
Amycor (Amycor / 01609101 / )
Dosage: cut
Indication: Product Used FOR Unknown Indication
End date: 2012-02-12
Diprosone
Dosage: cut
Indication: Product Used FOR Unknown Indication
End date: 2012-02-21
Econazole Nitrate
Dosage: cut
Indication: Product Used FOR Unknown Indication
End date: 2012-02-21
Soriatane
Dosage: 30 mg;qd
Indication: Psoriasis
Start date: 2012-01-01
End date: 2012-02-16
Other drugs received by patient: Lasix; Ramipril; Vitabact; Levothyroxine Sodium; Silver Sulfadiazine; Potassium Chloride; Nitroglycerin; Hyperium; Colchicine; Acetaminophen; Vitamin C; Locoid; Bisoprolol Fumarate; Ferrous Fumarate; Pantoprazole Sodium
Possible Soriatane side effects in 40 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-04-19
Patient: 40 year old male
Reactions: Acne
Drug(s) suspected as cause:
Baclofen
Dosage: 120mg per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-10-01
Dantrium
Dosage: 300mg per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-10-01
Isotretinoin
Administration route: Oral
Indication: Acne
Start date: 2011-12-13
Sertraline Hydrochloride
Dosage: 1ud per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-12-01
Soriatane
Administration route: Oral
Indication: Dermatosis
Start date: 2011-08-15
End date: 2011-12-13
Trospium Chloride
Dosage: 40mg per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-10-01
Possible Soriatane side effects in female
Reported by a consumer/non-health professional from United States on 2012-04-13
Patient: female, weighing 63.5 kg (139.7 pounds)
Reactions: Nausea, Presyncope, Vision Blurred
Drug(s) suspected as cause:
Soriatane
Possible Soriatane side effects in female
Reported by a consumer/non-health professional from United States on 2012-04-11
Patient: female
Reactions: Exposure VIA Semen, Maternal Exposure During Pregnancy, Abortion Spontaneous
Drug(s) suspected as cause:
Soriatane
Possible Soriatane side effects in 43 year old male
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-04-03
Patient: 43 year old male
Reactions: Haemorrhoid Operation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Soriatane
Possible Soriatane side effects in 85 year old female
Reported by a consumer/non-health professional from United States on 2012-03-26
Patient: 85 year old female
Reactions: Death, Aortic Bypass, Alopecia, Post Procedural Complication, Nail Disorder
Adverse event resulted in: death
Drug(s) suspected as cause:
Soriatane
Other drugs received by patient: Levothyroxine Sodium; Simvastatin; Lisinopril
Possible Soriatane side effects in 65 year old male
Reported by a physician from United States on 2012-03-14
Patient: 65 year old male, weighing 81.8 kg (180.0 pounds)
Reactions: Alcohol Withdrawal Syndrome, Delirium Tremens, Chills, Gait Disturbance
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Alcohol
Indication: Product Used FOR Unknown Indication
Soriatane
Dosage: 25mg five times per week
Administration route: Oral
Indication: Psoriasis
Start date: 2012-02-01
End date: 2012-02-01
Possible Soriatane side effects in 27 year old female
Reported by a consumer/non-health professional from United States on 2012-02-01
Patient: 27 year old female
Reactions: Maternal Exposure During Pregnancy
Drug(s) suspected as cause:
Soriatane
Possible Soriatane side effects in male
Reported by a physician from France on 2012-01-31
Patient: male
Reactions: Myalgia, Rhabdomyolysis, Blood Creatine Phosphokinase Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Soriatane
Other drugs received by patient: Gaviscon; Lansoprazole; Nexium
Possible Soriatane side effects in 54 year old male
Reported by a physician from United States on 2012-01-29
Patient: 54 year old male
Reactions: Drug Dose Omission, Blood Cholesterol Increased, Facial Bones Fracture, Psoriasis, Laceration, Ear Congestion
Drug(s) suspected as cause:
Humira
Indication: Psoriasis
Start date: 2007-12-01
Soriatane
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Aspirin; Lisinopril
Possible Soriatane side effects in 54 year old female
Reported by a consumer/non-health professional from United States on 2012-01-20
Patient: 54 year old female, weighing 61.4 kg (135.1 pounds)
Reactions: NO Adverse Event
Drug(s) suspected as cause:
Soriatane
Other drugs received by patient: NO Concurrent Medication
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