Epuris
- Generic Name: isotretinoin capsules
- Brand Name: Epuris
Epuris (Isotretinoin Capsules) side effects drug center
Epuris Side Effects Center
What Is Epuris?
Epuris (isotretinoin) is a retinoid used to treat severe nodular and/or inflammatory acne, acne conglobate, and recalcitrant acne
What Are Side Effects of Epuris?
Side effects of Epuris include:
- dry or chapped lips,
- dry skin,
- back pain,
- dry eyes,
- joint pain,
- nosebleed,
- headache,
- runny or stuffy nose,
- dermatitis,
- increased blood creatine kinase,
- inflammation of the lips,
- musculoskeletal discomfort or pain,
- upper respiratory tract infection,
- vision problems,
- dry nose,
- fatigue,
- increased blood triglycerides,
- eczema,
- rash,
- decreased bone density,
- neck pain,
- pain in extremities,
- nausea,
- insomnia,
- muscle strain, and
- mouth pain.
Dosage for Epuris
The initial dose of Epuris should be individualized according to the patient’s weight and severity of the disease. In general, patients initially should receive Epuris 0.5 mg/kg body weight daily for a period of two to four weeks. The maintenance dose should be adjusted between 0.1 and 1 mg/kg body weight daily and, in exceptional instances, up to 2 mg/kg body weight daily, depending upon individual patient response and tolerance to the drug. A complete course of therapy consists of 12-16 weeks of Epuris administration.
Epuris In Children
The use of Epuris in pediatric patients less than 12 years of age is not recommended.
The use of Epuris for the treatment of severe recalcitrant nodular acne in pediatric patients ages 12 to 17 years should be given careful consideration, especially for those patients where a known metabolic or structural bone disease exists.
What Drugs, Substances, or Supplements Interact with Epuris?
Epuris may interact with other medicines such as:
- tetracyclines,
- supplements containing vitamin A,
- phenytoin,
- norethindrone/ethinyl estradiol,
- microdosed progesterone preparations (minipills),
- systemic corticosteroids, and
- St. John’s wort.
Tell your doctor all medications and supplements you use.
Epuris During Pregnancy and Breastfeeding
Epuris is not recommended for use during pregnancy; there is a high risk of severe birth defects in the fetus. Female patients of childbearing potential must have two negative pregnancy tests before starting Epuris therapy. Effective contraception must be used for at least one month before starting Epuris treatment, during treatment and for at least one month following the discontinuation of Epuris treatment. It is recommended that two reliable forms of contraception be used simultaneously. It is unknown if Epuris passes into breast milk. Because of the potential for adverse effects, breastfeeding is not recommended while using Epuris.
Additional Information
Our Epuris (isotretinoin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Epuris Professional Information
SIDE EFFECTS
Adverse Drug Reaction Overview
The adverse events listed below reflect the experience from the clinical studies conducted with EPURIS® (isotretinoin) and the post-marketing experience. The relationship of some of these events to EPURIS® therapy is unknown.
Many of the side effects and adverse events seen or expected in patients receiving isotretinoin are similar to those described in patients taking high doses of vitamin A.
Clinical Trial Adverse Drug Reactions
Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates.
Table 1 presents common adverse events (≥ 1%) reported in a double-blind, randomized, Phase III, parallel group study of EPURIS® compared to a Reference Product dosed under fed conditions, in 925 patients with severe recalcitrant nodular acne.
In the above-described study (ISOCT.08.01) almost all patients experienced at least one adverse event (AE) in both groups at similar rates (92% with EPURIS® and 90% with the Reference Product (a marketed formulation of isotretinoin)). Most of these AEs were treatment related (87% with EPURIS® and 84% with the reference drug). Adverse events related to the musculoskeletal system and connective tissues were reported in approximately 37% of the patients, and musculoskeletal symptoms in approximately 24% of the patients. Elevations in levels of serum creatine kinase were reported as high alert laboratory values (≥ 350 u/L) in approximately 29% of patients, and incidence of the AE “blood creatine kinase increase” in 6% of patients.
Systematic assessment of visual acuity (Snellen chart) was performed in most patients and revealed that 20% of patients in the EPURIS® group and 15% of patients in the Reference group experienced VA worsening that was reversible for most. However, 3.7% (17/464) of patients in the EPURIS® group and 3% (14/460) of patients in the Reference group did not fully recover baseline visual acuity values.
No deaths were reported during the study, and the rate of serious adverse events (SAE) was relatively low in both groups (1.1% to 1.5%). Three serious AEs were considered to be possibly related to EPURIS® and recovered completely: severe abdominal pain, severe upper abdominal pain and moderate migraine.
Adverse events leading to discontinuation were reported in 4.1% of patients with EPURIS®, and 3.3% of patients with the Reference Product. These AEs were classified as psychiatric events and gastrointestinal events in the EPURIS® group, and as psychiatric events and musculoskeletal/connective tissue events in the Reference Product group.
Table 1: Adverse Events Reported in ≥ 1% of
Patients in the EPURIS® group versus the Reference Product Group in the
Double-Blind, Phase III Study
| Adverse Event | EPURIS® (N = 464) |
Reference Product (N = 460) |
Adverse Event | EPURIS® (N = 464) |
Reference Product (N = 460) |
| Patients with any adverse events | 428 (92.2) | 413 (89.8) | Sunburn | 10 (2.2) | 8 (1.7) |
| Lip dry | 209 (45.0) | 210 (45.7) | Excoriation | 10 (2.2) | 4 (0.9) |
| Dry skin | 205 (44.2) | 206 (44.8) | Eye Pruritus | 9 (1.9) | 17 (3.7) |
| Back pain | 96 (20.7) | 89 (19.3) | Nasal congestion | 9 (1.9) | 5 (1.1) |
| Dry eye | 87 (18.8) | 78 (17.0) | X-ray limb abnormal | 9 (1.9) | 8 (1.7) |
| Arthralgia | 64 (13.8) | 60 (13.0) | Asparate aminotransferase increased | 8 (1.7) | 10 (2.2) |
| Epistaxis | 54 (11.6) | 42 (9.1) | Myalgia | 8 (1.7) | 7 (1.5) |
| Headache | 37 (8.0) | 36 (7.8) | Abdominal pain | 8 (1.7) | 3 (0.7) |
| Nasopharyngitis | 36 (7.8) | 48 (10.4) | Cough | 7 (1.5) | 12 (2.6) |
| Chapped lips | 34 (7.3) | 32 (7.0) | Joint sprain | 7 (1.5) | 10 (2.2) |
| Dermatitis | 28 (6.0) | 23 (5.0) | Musculoskeletal stiffness | 7 (1.5) | 6 (1.3) |
| Blood creatine kinase increased | 26 (5.6) | 27 (5.9) | Gastroenteritis viral | 7 (1.5) | 5 (1.1) |
| Cheilitis | 26 (5.6) | 19 (4.1) | Vomiting | 7 (1.5) | 4 (0.9) |
| Musculoskeletal discomfort | 25 (5.4) | 16 (3.5) | Influenza | 6 (1.3) | 11 (2.4) |
| Upper respiratory tract infection | 25 (5.4) | 14 (3.0) | Pharyngitis | 6 (1.3) | 11 (2.4) |
| Visual acuity reduced | 23 (5.0) | 25 (5.4) | Pharyngitis streptococcal | 6 (1.3) | 4 (0.9) |
| Nasal dryness | 21 (4.5) | 23 (5.0) | Night blindness | 6 (1.3) | 3 (0.7) |
| Fatigue | 20 (4.3) | 11 (2.4) | Erythema | 6 (1.3) | 2 (0.4) |
| Musculoskeletal pain | 19 (4.1) | 23 (5.0) | Migraine | 6 (1.3) | 0 |
| Eczema | 17 (3.7) | 20 (4.3) | Hordeolum | 5 (1.1) | 10 (2.2) |
| Blood triglycerides increased | 17 (3.7) | 14 (3.0) | Constipation | 5 (1.1) | 8 (1.7) |
| Rash | 17 (3.7) | 14 (3.0) | Anxiety | 5 (1.1) | 7 (1.5) |
| Bone density decreased | 17 (3.7) | 7 (1.5) | Decreased appetite | 5 (1.1) | 7 (1.5) |
| Neck pain | 14 (3.0) | 22 (4.8) | Diarrhoea | 5 (1.1) | 7 (1.5) |
| Pain in extremity | 14 (3.0) | 15 (3.3) | Weight fluctuation | 5 (1.1) | 6 (1.3) |
| Vision blurred | 14 (3.0) | 15 (3.3) | Eye irritation | 5 (1.1) | 5 (1.1) |
| Nausea | 14 (3.0) | 10 (2.2) | Asthenopia | 5 (1.1) | 4 (0.9) |
| Insomnia | 14 (3.0) | 9 (2.0) | Ingrowing nail | 5 (1.1) | 4 (0.9) |
| Muscle strain | 14 (3.0) | 8 (1.7) | Pyrexia | 5 (1.1) | 4 (0.9) |
| Oropharyngeal pain | 12 (2.6) | 8 (1.7) | Bronchitis | 5 (1.1) | 3 (0.7) |
| Alanine aminotransferase increased | 10 (2.2) | 11 (2.4) | Conjunctivitis | 5 (1.1) | 2 (0.4) |
| Sinusitis | 10 (2.2) | 11 (2.4) | Ear infection | 5 (1.1) | 1 (0.2) |
| Dermatitis contact | 10 (2.2) | 9 (2.0) | |||
Some AEs tended to be reported with a differential in frequency according to gender in both treatment groups: For example, triglycerides increased, arthralgia, pain, and blurred vision tended to be more often reported in females, while chapped lips, cheilitis, epistaxis, creatine kinase increased, and bone density decreased tended to be more reported in males.
Reduced visual acuity, blurred vision, increased triglycerides, headache and fatigue tended to be more often reported in adults as compared to adolescents (12 to 17 years).
Decreased bone density was reported in adolescents of both treatment groups (4% to 8%) but not in adults.
Adverse reactions were generally reversible when therapy was discontinued; however, some have persisted after cessation of therapy.
Less Common (<1%) Clinical Trial Adverse Reactions
Adverse events in subjects receiving EPURIS® in any clinical trial are listed below.
Body as a Whole: Herpes simplex, irritability, oedema peripheral, thirst, chest pain, cyst, impaired healing, influenza like illness, lymphadenopathy, xerosis, discomfort, oedema, gravitational oedema, mucous membrane disorder and swelling.
Cardiovascular: Palpitations, tachycardia and coronary artery disease.
Endocrine and Metabolism: Increased appetite and thyroid disorder.
Gastrointestinal: Bleeding and inflammation of the gums, dry mouth, abdominal discomfort, dyspepsia, haemorrhoids, rectal haemorrhage, abdominal pain lower, lip swelling, mouth ulceration, oral pain, tooth impacted, abdominal distension, abdominal tenderness, anal fissure, frequent bowel movement, gastrooesophageal reflux disease, gingival recession, haematochezia, hypoaesthesia oral, lip haemorrhage, lip ulceration, oesophageal pain, painful defaecation, rectal fissure, tooth disorder and toothache.
Hearing Disorders: Tinnitus, ear pain, hypoacusis, ear discomfort, external ear inflammation, cerumen impaction, hyperacusis and vertigo.
Mucocutaneous and Dermatologic: Bruising, pruritus, alopecia, eczema nummular, scar, eczema asteatotic, acne, rash popular, skin exfoliation, acne cystic, blister, hair texture abnormal, intertrigo, pain of skin, photosensitivity reaction, pyogenic granuloma, skin discolouration, acrodermatitis, alopecia effluvium, androgenic alopecia, dermatitis atopic, dermatitis exfoliative, exfoliative rash, livedo reticularis, onycholysis, pityriasis rosea, psoriasis, rash follicular, paronychia, seborrhoea, skin depigmentation, skin fissures, skin irritation, skin infections, skin lesion, skin ulcer, swelling face and telangiectasia.
Musculoskeletal: Tendonitis, muscle spasms, arthropathy, joint stiffness, joint swelling, joint pain, muscle tightness, musculoskeletal chest pain, arthritis, bone pain, fibromyalgia, groin pain, intervertebral disc space narrowing, joint crepitation, limb discomfort, muscle atrophy, myositis, spinal osteoarthritis, synovial cyst and tendon pain.
Neurologic: Dizziness, drowsiness, malaise, memory impairment, nervousness, paresthesia, presyncope, sinus headache, syncope, weakness.
Ophthalmologic: Ocular hyperaemia, lacrimation increased, photophobia, xerophthalmia, blepharitis, eye pain, visual impairment, blepharospasm, conjunctival haemorrhage, conjunctival hyperaemia, conjunctivitis allergic, diplopia, eczema eyelids, eye haemorrhage, eye swelling, eyelid oedema, foreign body sensation in eyes, keratitis, myopia, orbital edema, photopsia, pinguecula and punctuate keratitis.
Psychiatric Disorders: Depression, attention deficit/hyperactivity disorder, mood swings, sleep disorder, panic attack, restlessness, stress, adjustment disorder, affect lability, anger, bradyphrenia, delusion, depressed mood, disorientation, dysthymic disorder, emotional distress, hallucination auditory, libido decreased, middle insomnia, obsessive thoughts, paranoia and substance abuse.
Respiratory: Rhinorrhoea, sinus congestion, asthma, respiratory tract congestion, dry throat, nasal mucosal disorder, rales, rhinitis seasonal, sleep apnoea syndrome, throat irritation, voice hoarseness and wheezing.
Reproductive System: Metrorrhagia, menstruation irregular, vulvovaginal bleeding, vulvovaginal discomfort, amenorrhoea, breast cyst, dysmenorrhoea, epididymitis, erectile dysfunction, menorrhagia, ovarian cyst, ovarian cyst ruptured, pruritus genital, testicular cyst, vaginal discharge and vulva cyst.
Urinary System: Proteinuria, haematuria, dysuria, nephrolithiasis and polyuria
Abnormal Laboratory Findings
Blood potassium increased, blood alkaline phosphatase increased, blood bilirubin increased, blood urea increased, elevated platelet counts, eosinophil count increased, false positive tuberculosis test, gamma-glutamyltransferase abnormal, blood cholesterol increased, glucose urine present, haematocrit decreased, protein urine, thrombocytopenia, white blood cell count decreased.
Post-Marketing Adverse Drug Reactions
The following additional adverse reactions have been identified during post-approval use of EPURIS®.
Body as a whole: Weight loss, anemia, allergic responses and hypertriglyceridemia.
Cardiovascular: Transient pain in the chest and vascular thrombotic disease.
Endocrine and Metabolism: New cases of diabetes (see WARNING AND PRECAUTIONS: Endocrine and Metabolism).
Gastrointestinal: Inflammatory bowel disease, colitis, esophagitis/esophageal ulceration and other nonspecific gastrointestinal symptoms (see WARNINGS AND PRECAUTIONS: Gastrointestinal).
Hearing Disorders: Impaired hearing at certain frequencies.
Hepatic/Biliary/Pancreatic: Pancreatitis (see WARNINGS AND PRECAUTIONS: Hepatic/Biliary/Pancreatic).
Laboratory Abnormalities: Elevated fasting blood sugar and red blood cells in the urine.
Mucocutaneous and Dermatologic: Acne flare, hair loss, hypopigmentation, sweating and urticaria.
Musculoskeletal: Other types of bone abnormalities and rhabdomyolysis.
Neurologic: Seizures and benign intracranial hypertension (see WARNINGS AND PRECAUTIONS: Serious WARNINGS AND PRECAUTIONS, Neurologic).
Ophthalmologic: Visual disturbances.
Psychiatric Disorders: Emotional instability, suicidal ideation, suicide attempts, suicide, aggression and violent behaviors.
Urinary system: Nonspecific urogenital findings.
The following additional adverse reactions have been identified during the use of other isotretinoin products.
Body as a Whole: Allergic vasculitis, systemic hypersensitivity.
Cardiovascular: Stroke.
Dose-Relationship: Cheilitis and hypertriglyceridemia were usually dose related.
Gastrointestinal: Ileitis and other nonspecific gastrointestinal symptoms.
Hepatic/Biliary/Pancreatic: Patients treated with isotretinoin, especially those with high triglyceride levels are at risk of developing pancreatitis. Rare cases of fatal pancreatitis and several cases of clinical hepatitis have been reported (see WARNINGS AND PRECAUTIONS: Hepatic/Biliary/Pancreatic).
Laboratory Abnormalities: Decreases in red blood cell parameters, decrease in serum high density lipoprotein (HDL), hyperuricemia, elevated sedimentation rates, white blood cells in the urine and blood protein present.
A rise in serum levels of liver enzymes may occur, especially with higher dosages. Although the changes have usually been within the normal range, and may return to baseline levels despite continued treatment, significant increases have occurred in a few cases, necessitating dosage reduction or discontinuation of isotretinoin (see WARNINGS AND PRECAUTIONS: Hepatic/Biliary/Pancreatic).
Mucocutaneous and Dermatologic: Acne fulminans, desquamation, eruptive xanthomas, facial erythema, nail dystrophy, flushing, fragility of skin, hirsutism, hyperpigmentation, peeling of palms and soles, photoallergic, vasculitis (including Wegener’s granulomatosis), abnormal wound healing (delayed healing or exuberant granulation tissue with crusting), erythema nodosum and exanthema. Erythema multiforme (EM), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) have been reported to be associated with isotretinoin (see WARNING AND PRECAUTIONS: Serious Skin Reactions).
Musculoskeletal: Calcification of tendons and ligaments, premature epiphyseal closure, skeletal hyperostosis (see WARNINGS AND PRECAUTIONS: Musculoskeletal, Hyperostosis) and other types of bone abnormalities. There have been post-marketing serious reports of rhabdomyolysis, often leading to hospitalization, particularly in those undergoing strenuous physical activity.
Neurologic: Lethargy.
Ophthalmologic: Cataracts, colour vision disorder, optic neuritis, papilledema as a sign of benign intracranial hypertension and colour vision disturbances. Corneal opacities were reported in nodular and/or inflammatory acne patients (see WARNINGS AND PRECAUTIONS: Ophthalmologic). Decreases in night vision were reported and, in rare instances, persisted after cessation of therapy (see WARNINGS AND PRECAUTIONS: Ophthalmologic).
Respiratory: Voice alteration and bronchospasm, sometimes in patients with pre-history of asthma.
Urinary system: Glomerulonephritis.
Read the entire FDA prescribing information for Epuris (Isotretinoin Capsules)
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