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What are the possible side effects of Hydrocortisone ABM?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
blurred vision, tunnel vision, eye pain, or seeing halos around lights;
muscle weakness, loss of muscle mass;
new or unusual pain in your joints, bones, or muscles;
severe headaches, ringing in your ears, pain behind your eyes;
unusual changes in mood or behavior;
hollowing or other skin changes where the injection was given;
numbness or tingling;
fluid retention--shortness of breath (even while lying down), swelling, rapid weight gain (especially in your face and midsection);
new signs of infection--such as fever, chills, cough, trouble breathing, sores in your mouth or on your skin, diarrhea, or burning when you urinate;
increased adrenal gland hormones--slow wound healing, skin discoloration, thinning skin, increased body hair, tiredness, menstrual changes, sexual changes; or
decreased adrenal gland hormones--weakness, tiredness, diarrhea, nausea, menstrual changes, skin discoloration, craving salty foods, and feeling light-headed.
Hydrocortisone ABM can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using Hydrocortisone ABM.
Common side effects may include:
acne, dry skin;
increased appetite, weight gain; or
sleep problems (insomnia).
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 (in more detail)
Side effects of Hydrocortisone ABM in details
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- HPA axis suppression. This has been observed in pediatric subjects using Hydrocortisone ABM
- Concomitant skin infections
- Skin irritation
Clinical Trials Experience: Adults
The following additional local adverse reactions have been reported infrequently with topical corticosteroids but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, drying, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.
Clinical Trials Experience: Pediatrics
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety data derived from Hydrocortisone ABM (Hydrocortisone ABM butyrate) clinical trials reflect exposure to Hydrocortisone ABM twice daily for up to four weeks in separate clinical trials involving pediatric subjects 3 months to 18 years of age with mild to moderate atopic dermatitis.
Adverse reactions shown in the tables below include those for which there is some basis to believe there is a causal relationship to Hydrocortisone ABM (Hydrocortisone ABM butyrate).
Table 1 : Frequency of adverse reactions in pediatric subjects with mild to moderate atopic dermatitis
|Hydrocortisone ABM |
|Application site reactions, including application site folliculitis, irritation, dermatitis, or erythema||1.5%||1.5%|
The following adverse reactions have been identified during post approval use of Hydrocortisone ABM (Hydrocortisone ABM butyrate). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Skin: Erythema, Rash and Application site irritation.
What is the most important information I should know about Hydrocortisone ABM?
- Hydrocortisone ABM lotion is for external use only. Do not get Hydrocortisone ABM lotion in your eyes, nose, or mouth. If you get it in any of these areas, rinse immediately with cool water.
- Do not use Hydrocortisone ABM lotion for other skin conditions at a later time.
- Do NOT use more than the recommended dose, use for longer than prescribed, or use over a large area of the body without checking with your doctor.
- If Hydrocortisone ABM lotion was prescribed to treat the diaper area of a child, avoid using tight-fitting diapers or plastic pants.
- Check with your doctor before having vaccinations while you are using Hydrocortisone ABM lotion.
- The cleanser may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Hydrocortisone ABM lotion. Use a sunscreen or wear protective clothing while you are using the cleanser and for 1 week after you stop using it if you must be outside for more than a short time.
- Serious side effects may occur if too much of Hydrocortisone ABM lotion is absorbed through the skin. This may be more likely to occur if you use Hydrocortisone ABM lotion over a large area of the body. It may also be more likely if you wrap or bandage the area after you apply Hydrocortisone ABM lotion. The risk is greater in children. Do not use more than the prescribed dose. Contact your doctor right away if you develop unusual weight gain (especially in the face), muscle weakness, increased thirst or urination, confusion, unusual drowsiness, severe or persistent headache, or vision changes. Discuss any questions or concerns with your doctor.
- Corticosteroids may affect the growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Hydrocortisone ABM lotion.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Hydrocortisone ABM lotion while you are pregnant. It is not known if Hydrocortisone ABM lotion is found in breast milk after topical use. If you are or will be breast-feeding while you use Hydrocortisone ABM lotion, check with your doctor. Discuss any possible risks to your baby.
Hydrocortisone ABM contraindications
You should not use this medication if you are allergic to Hydrocortisone ABM, or if you have a fungal infection anywhere in your body.
Before taking Hydrocortisone ABM, tell your doctor about all of your medical conditions, and about all other medicines you are using. There are many other diseases that can be affected by steroid use, and many other medicines that can interact with steroids.
Your steroid medication needs may change if you have any unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you during treatment.
Steroid medication can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.
Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.
Do not receive a "live" vaccine while you are taking Hydrocortisone ABM. Vaccines may not work as well while you are taking a steroid.
Do not stop using Hydrocortisone ABM suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.
Carry an ID card or wear a medical alert bracelet stating that you are taking a steroid, in case of emergency.
- DailyMed. "CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE: 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).
- DTP/NCI. "hydrocortisone: 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).
- European Chemicals Agency - ECHA. "Hydrocortisone: 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).
ReviewsThe results of a survey conducted on ndrugs.com for Hydrocortisone ABM are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Hydrocortisone ABM. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
Consumer reported side effectsNo survey data has been collected yet
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Information checked by Dr. Sachin Kumar, MD Pharmacology