Neotrex Side effects

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• Side effects of Neotrex in details
• Neotrex contraindications
• Neotrex reviews

What are the possible side effects of Neotrex?

Get emergency medical help if you have any of these signs of an allergic reaction to Neotrex: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Neotrex and call your doctor at once if you have any of these serious side effects:

• depressed mood, trouble concentrating, sleep problems, crying spells, aggression or agitation, changes in behavior, hallucinations, thoughts of suicide or hurting yourself;

• sudden numbness or weakness, especially on one side of the body;

• blurred vision, sudden and severe headache or pain behind your eyes, sometimes with vomiting;

• hearing problems, hearing loss, or ringing in your ears;

• seizure (convulsions);

• severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

• loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• severe diarrhea, rectal bleeding, black, bloody, or tarry stools;

• fever, chills, body aches, flu symptoms, purple spots under your skin, easy bruising or bleeding;

• severe blistering, peeling, and red skin rash; or

• joint stiffness, bone pain or fracture.

Less serious Neotrex side effects may include:

• joint pain, back pain;

• feeling dizzy, drowsy, or nervous;

• dryness of the lips, mouth, nose, or skin; or

• cracking or peeling skin, itching, rash, changes in your fingernails or toenails.

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.

Side effects of Neotrex in details

The following adverse reactions with Neotrex or other Neotrex products are described in more detail in other sections of the labeling:

• Embryofetal Toxicity
• Psychiatric Disorders
• Pseudotumor Cerebri
• Serious Skin Reactions
• Pancreatitis
• Lipid Abnormalities
• Hearing Impairment
• Hepatotoxicity
• Inflammatory Bowel Disease
• Skeletal Abnormalities
• Ocular Abnormalities
• Hypersensitivity

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of Neotrex cannot be directly compared to rates in clinical trials of other drugs and may not reflect the rates observed in practice.

The adverse reactions listed below reflect both clinical experience with Neotrex, and consider other adverse reactions that are known from clinical trials and the post-marketing surveillance with oral Neotrex. The relationship of some of these events to Neotrex therapy is unknown. Many of the side effects and adverse events seen in patients receiving Neotrex are similar to those described in patients taking very high doses of vitamin A (dryness of the skin and mucous membranes, e.g., of the lips, nasal passage, and eyes).

Dose Relationship

Cheilitis and hypertriglyceridemia are adverse reactions that are usually dose related. Most adverse reactions reported in clinical trials with Neotrex were reversible when therapy was discontinued; however, some persisted after cessation of therapy.

Body as a Whole

The following adverse reactions have been reported in a clinical trial conducted with Neotrex and a generic product of Neotrex® (Neotrex): fatigue, irritability, pain. In addition to the above adverse reactions, the following adverse reactions have been reported with Neotrex: allergic reactions, including vasculitis, systemic hypersensitivity, edema, lymphadenopathy, weight loss.

Cardiovascular

The following adverse reactions have been reported with Neotrex: vascular thrombotic disease, stroke, palpitation, tachycardia.

Endocrine/Metabolism and Nutritional

The following adverse reactions have been reported in a clinical trial conducted with Neotrex and a generic product of Neotrex® (Neotrex): decreased appetite, weight fluctuation, hyperlipidaemia. In addition to the above adverse reactions, the following adverse reactions have been reported with Neotrex: hypertriglyceridemia, alterations in blood sugar.

Gastrointestinal

The following adverse reactions have been reported in a clinical trial conducted with Neotrex and a generic product of Neotrex® (Neotrex): lip dry, chapped lips, cheilitis, nausea, constipation, diarrhea, abdominal pain, vomiting. In addition to the above adverse reactions, the following adverse reactions have been reported with Neotrex: inflammatory bowel disease, hepatitis, pancreatitis, bleeding and inflammation of the gums, colitis, esophagitis/esophageal ulceration, ileitis, and other nonspecific gastrointestinal symptoms.

Hematologic

The following adverse reactions have been reported with Neotrex: allergic reactions, anemia, thrombocytopenia, neutropenia, rare reports of agranulocytosis.

Infections and infestations

The following adverse reactions have been reported in a clinical trial conducted with Neotrex and a generic product of Neotrex® (Neotrex): nasopharyngitis, hordeolum, upper respiratory tract infection. In addition to the above adverse reactions, the following adverse reaction has been reported with Neotrex: infections (including disseminated herpes simplex).

Laboratory Abnormalities

The following changes in laboratory tests have been noted in a clinical trial conducted with Neotrex and a generic product of Neotrex® (Neotrex): blood creatine phosphokinase (CPK) increased, blood triglycerides increased, alanine aminotransferase (SGPT) increased, aspartate aminotransferase (SGOT) increased, gamma-glutamyltransferase (GGTP) increased, blood cholesterol increased, low density lipoprotein (LDL) increased, white blood cell count decreased, blood alkaline phosphatase increased, blood bilirubin increased, blood glucose increased, high density lipopoprotein (HDL) decreased, bone mineral density decreased. In addition to the above adverse reactions, the following adverse reactions have been reported with Neotrex: increased LDH, elevation of fasting blood sugar, hyperuricemia, decreases in red blood cell parameters, decreases in white blood cell counts (including severe neutropenia and rare reports of agranulocytosis), elevated sedimentation rates, elevated platelet counts, thrombocytopenia, white cells in the urine, proteinuria, microscopic or gross hematuria.

Musculoskeletal and Connective Tissue

The following adverse reactions have been reported in a clinical trial conducted with Neotrex and a generic product of Neotrex® (Neotrex): decreases in bone mineral density, musculoskeletal symptoms (sometimes severe) including back pain, athralgia, musculoskeletal discomfort, musculoskeletal pain, neck pain, pain in extremity, myalgia, musculoskeletal stiffness. In addition to the above adverse reactions, the following adverse reactions have been reported with Neotrex: skeletal hyperostosis, calcification of tendons and ligaments, premature epiphyseal closure, tendonitis, arthritis, transient pain in the chest, and rare reports of rhabdomyolysis.

Neurological

The following adverse reactions have been reported in a clinical trial conducted with Neotrex and a generic product of Neotrex® (Neotrex): headache, syncope. In addition to the above adverse reactions, other adverse reactions reported with Neotrex include: pseudotumor cerebri, dizziness, drowsiness, lethargy, malaise, nervousness, paresthesias, seizures, stroke, weakness.

Psychiatric

The following adverse reactions have been reported in clinical trials conducted with Neotrex and a generic product of Neotrex® (Neotrex): suicidal ideation, insomnia, anxiety, depression, irritability, panic attack, anger, euphoria, violent behaviors, emotional instability. In addition to the above adverse reactions, the following adverse reactions have been reported with Neotrex: suicide attempts, suicide, aggression, psychosis and hallucination auditory. Of the patients reporting depression, some reported that the depression subsided with discontinuation of therapy and recurred with reinstitution of therapy.

Reproductive System

The following adverse reaction has been reported with Neotrex: abnormal menses.

Respiratory

The following adverse reactions have been reported in a clinical trial conducted with Neotrex and a generic product of Neotrex® (Neotrex): epistaxis, nasal dryness. In addition to the above adverse reactions, the following adverse reactions have been reported with Neotrex: bronchospasms (with or without a history of asthma), respiratory infection, voice alteration.

Skin and Subcutaneous Tissue

The following adverse reactions have been reported in a clinical trial conducted with Neotrex and a generic product of Neotrex® (Neotrex): dry skin, dermatitis, eczema, rash, dermatitis contact, alopecia, pruritus, sunburn, erythema. In addition to the above adverse reactions, the following adverse reactions have been reported with Neotrex: acne fulminans, alopecia (which in some cases persists), bruising, dry nose, eruptive xanthomas, erythema multiforme, flushing, fragility of skin, hair abnormalities, hirsutism, hyperpigmentation and hypopigmentation, nail dystrophy, paronychia, peeling of palms and soles, photoallergic/photosensitizing reactions, pruritus, pyogenic granuloma, rash (including facial erythema, seborrhea, and eczema), Stevens-Johnson syndrome, sunburn susceptibility increased, sweating, toxic epidermal necrolysis, urticaria, vasculitis (including Wegener's granulomatosis), abnormal wound healing (delayed healing or exuberant granulation tissue with crusting).

Special Senses

Hearing: The following adverse reactions have been reported with Neotrex: tinnitus and hearing impairment.

Ocular: The following adverse reactions have been reported in clinical trials conducted with Neotrex and a generic product of Neotrex® (Neotrex): dry eye, visual acuity reduced, vision blurred, eye pruritis, eye irritation, asthenopia, decreased night vision, ocular hyperemia, increased lacrimation, and conjunctivitis. In addition to the above adverse reactions, the following adverse reactions have been reported with Neotrex: corneal opacities, decreased night vision which may persist, cataracts, color vision disorder, conjunctivitis, eyelid inflammation, keratitis, optic neuritis, photobia, visual disturbances.

Renal and Urinary

The following adverse reactions have been reported in clinical trials conducted with Neotrex: glomerulonephritis, nonspecific urogenital findings.

What is the most important information I should know about Neotrex?

• Neotrex may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Neotrex with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do NOT take more than the recommended dose or take Neotrex for longer than prescribed without checking with your doctor. Doing so will not improve your condition faster and may increase your risk for side effects.
• A sudden decrease in night vision may occur while you are taking Neotrex. Use caution when driving at night and avoid driving at night if you experience decreased night vision.
• If you wear contact lenses, you may have difficulty wearing them during and after therapy.
• Do not donate blood while taking Neotrex and for 1 month after you stop taking Neotrex.
• Do not drink alcohol while taking Neotrex.
• Worsening of acne may occur during the first part of therapy. This does not suggest failure or a need to stop the medicine.
• To prevent cracking of lips, use a lip moisturizer or balm.
• Do not have cosmetic procedures to smooth your skin, including waxing, dermabrasion, or laser procedures, while you are taking Neotrex and for at least 6 months after you stop taking it. Neotrex can increase your chance of scarring from these procedures.
• Neotrex may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Neotrex. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Some patients have become depressed or developed serious mental or mood problems while taking Neotrex. Stop using Neotrex and tell your health care provider right away if you have any new, worsened, or sudden symptoms, such as feeling sad or having crying spells; feeling anxious; becoming more irritable, angry, or aggressive than usual; losing pleasure or interest in social or sports activities; sleeping too much or too little; changes in weight or appetite; feeling like you have no energy; having trouble concentrating; or having thoughts about taking your life or hurting yourself (suicidal thoughts).
• Neotrex may cause decreased bone strength in some patients. Patients who play vigorous impact sports may be at increased risk of bone problems (eg, fractures). Discuss any questions or concerns with your doctor.
• Women who may become pregnant must use 2 effective forms of birth control at least 1 month before starting therapy, during therapy, and for 1 month after stopping the medicine. Your health care provider should conduct pregnancy tests on a monthly basis while you are taking Neotrex.
• Do not use progestin-only pills or "minipills" (pills that do not contain estrogen) for birth control because they may not work as well with Neotrex. Ask your doctor or pharmacist if you are not sure what type of birth control pills you are using.
• Women who use hormonal birth control should avoid the use of the herbal supplement St. John's wort because it may decrease the effectiveness of hormonal birth control.
• Diabetes patients - Neotrex may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Lab tests, including pregnancy tests, cholesterol and lipid levels, liver function, blood sugar levels, and white blood cell counts, may be performed while you use Neotrex. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Neotrex may affect normal growth in some CHILDREN. Caution is advised when using Neotrex in children; they may be more sensitive to its effects. Consult your doctor for more details.
• Neotrex should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use Neotrex if you are pregnant. It has been shown to cause serious birth defects, miscarriage, early birth, or death of the fetus. Avoid becoming pregnant while you are taking it. If you have sex at any time without using 2 forms of effective birth control, become pregnant, think you may be pregnant, or miss your menstrual period, stop using Neotrex and call your doctor right away. It is not known if Neotrex is found in breast milk. Do not breast-feed while taking Neotrex and for 1 month after stopping Neotrex.

Neotrex contraindications

Hypersensitivity to Neotrex or to any of the excipients of Neotrex. Hepatic or renal insufficiency; hypervitaminosis A; patients with excessively elevated blood lipid values.

Use in pregnancy: Pregnancy Category X: Neotrex is highly teratogenic. It is, therefore, contraindicated not only in women who are pregnant or who may become pregnant while undergoing treatment but also in all women of childbearing potential. There is an extremely high risk that a deformed infant will result if pregnancy occurs while taking Neotrex in any amount even for short periods. Potentially all exposed foetuses can be affected.

Neotrex is contraindicated in women of childbearing potential unless the female patient meets all of the following conditions: Severe disfiguring cystic acne resistant to standard therapies; reliability in understanding and carrying out instructions; compliance with the mandatory contraceptive measures; informed by the physician of the hazards of becoming pregnant during and 1 month after treatment with Neotrex and warned of the possibility of contraceptive failure; confirms that patient has understood the warnings; negative pregnancy test within 2 weeks prior to beginning therapy, monthly repetition of pregnancy testing is recommended; use effective contraception without any interruption for at least 1 month before beginning Neotrex therapy, during therapy and for 1 month following discontinuation of therapy. At least 1 and preferably 2 complementary forms of contraception including a barrier method should be used. Microdosed progesterone preparations (minipills) may be an inadequate method of contraception during Neotrex therapy. If the patient starts Neotrex therapy only on the 2nd or 3rd day of the next menstrual period; in the event of relapse treatments, patient must also use the same uninterrupted and effective contraceptive measures 1 month prior to, during and for 1 month after Neotrex therapy; must fully understand the precautions and confirm patient understanding and willingness to comply with reliable contraceptive measures as explained.

Even female patients, who normally do not employ contraception because of a history of infertility, should be advised to do so while taking Neotrex, following the previously stated guidelines.

Should pregnancy occur inspite of these precautions during treatment with Neotrex or in the month following, there is a great risk of very severe malformation of the foetus (involving in particular the central nervous system, heart and large blood vessels). If pregnancy does occur, the physician and patient should discuss the advisability of continuing the pregnancy.

Major human foetal abnormalities related to Neotrex administration have been documented, including hydrocephalus, microcephalus, abnormalities of the external ear (micropinna, small or absent external auditory canals), microphthalmia, cardiovascular abnormalities, facial dysmorphia, thymus gland abnormalities, parathyroid hormone deficiency and cerebellar malformation. There is also an increased risk of spontaneous abortion.

Neotrex is highly teratogenic and must not be given to women who are pregnant. Neotrex crosses the placental barrier in amounts that lead to congenital deformities. There is an extremely high risk that a deformed infant will result if pregnancy occurs while taking Neotrex in any amount even for short periods. Potentially all exposed foetuses can be affected.

References

1. DailyMed. "ISOTRETINOIN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. DTP/NCI. "Isotretinoin: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
3. European Chemicals Agency - ECHA. "Isotretinoin: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology