Did you have any side effects with this medicine?
What are the possible side effects of Hydrocortisone Actavis?
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Mild skin burning, irritation, or dryness.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; burning, cracking, itching, pain, peeling, redness, or swelling not present before using Hydrocortisone Actavis lotion; inflamed hair follicles; inflammation around the mouth; numbness of the fingers; severe or persistent skin irritation; thinning, softening, or discoloration of the skin.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
Side effects of Hydrocortisone Actavis 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 Actavis
- 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 Actavis (Hydrocortisone Actavis butyrate) clinical trials reflect exposure to Hydrocortisone Actavis 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 Actavis (Hydrocortisone Actavis butyrate).
Table 1 : Frequency of adverse reactions in pediatric subjects with mild to moderate atopic dermatitis
|Hydrocortisone Actavis |
|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 Actavis (Hydrocortisone Actavis 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 Actavis?
- Hydrocortisone Actavis lotion is for external use only. Do not get Hydrocortisone Actavis 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 Actavis 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 Actavis 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 Actavis 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 Actavis 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 Actavis lotion is absorbed through the skin. This may be more likely to occur if you use Hydrocortisone Actavis 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 Actavis 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 Actavis lotion.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Hydrocortisone Actavis lotion while you are pregnant. It is not known if Hydrocortisone Actavis lotion is found in breast milk after topical use. If you are or will be breast-feeding while you use Hydrocortisone Actavis lotion, check with your doctor. Discuss any possible risks to your baby.
Hydrocortisone Actavis contraindications
You should not use this medication if you are allergic to Hydrocortisone Actavis, or if you have a fungal infection anywhere in your body.
Before taking Hydrocortisone Actavis, 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 Actavis. Vaccines may not work as well while you are taking a steroid.
Do not stop using Hydrocortisone Actavis 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 Actavis 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 Actavis. 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
There are no reviews yet. Be the first to write one!
Information checked by Dr. Sachin Kumar, MD Pharmacology