What are the possible side effects of Derihaler?
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Fast, irregular, pounding, or racing heartbeat or pulse
- shakiness in the legs, arms, hands, or feet
- trembling or shaking of the hands or feet
- Abdominal or stomach pain
- bladder pain
- bloody or cloudy urine
- chest discomfort
- chest pain
- cough or hoarseness
- cough producing mucus
- diarrhea
- difficult or labored breathing
- difficulty with swallowing
- dizziness
- feeling of warmth
- fever or chills
- frequent urge to urinate
- hives
- itching
- loss of appetite
- lower back or side pain
- nausea
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness of the face, neck, arms, and occasionally, upper chest
- runny nose
- shortness of breath
- skin rash
- sore throat
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- tightness in the chest
- unusual tiredness or weakness
- weakness
- Hives or welts
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- noisy breathing
- redness of the skin
- swelling of the mouth or throat
- trouble breathing
- Agitation
- anxiety
- arm, back, or jaw pain
- chest tightness or heaviness
- confusion
- convulsions
- decreased urine
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- drowsiness
- dry mouth
- extra heartbeats
- fainting
- flushed, dry skin
- fruit-like breath odor
- hallucinations
- headache
- increased hunger
- increased thirst
- increased urination
- irritability
- lightheadedness
- muscle pain or cramps
- nervousness
- nightmares
- numbness or tingling in the hands, feet, or lips
- pounding in the ears
- rapid, deep breathing
- restlessness
- shakiness
- slow or fast heartbeat
- stomach cramps
- sweating
- unexplained weight loss
- unusual feeling of excitement
- vomiting
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Body aches or pain
- congestion
- fever
- runny nose
- tender, swollen glands in the neck
- trouble with swallowing
- voice changes
- Difficult, burning, or painful urination
- earache
- headache, severe and throbbing
- muscle or bone pain
- pain
- redness of the skin
- redness or swelling in the ear
- redness, swelling, or soreness of the tongue
- sleeplessness
- sneezing
- stuffy nose
- swelling
- tenderness
- trouble in holding or releasing urine
- trouble sleeping
- unable to sleep
- warmth on the skin
- Sleepiness or unusual drowsiness
- Bad, unusual, or unpleasant (after) taste
- change in taste
- feeling of constant movement of self or surroundings
- gagging
- rough, scratchy sound to voice
- sensation of spinning
- tightness in the throat
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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Side effects of Derihaler in details
The adverse reactions to albuterol are similar in nature to those of other sympathomimetic agents. In clinical trials, the most frequent adverse reactions to Derihaler (albuterol sulfate syrup) in adults and older children were:
Percent Incidence of Adverse Reactions in Adults and Children (6-12 Years of Age) | |
Adverse Event | Percent Incidence |
Central Nervous System | |
Tremor | 10 |
Nervousness | 9 |
Shakiness | 9 |
Headache | 4 |
Dizziness | 3 |
Excitement | 2 |
Hyperactivity | 2 |
Sleeplessness | 1 |
Disturbed sleep | <1 |
Irritable behavior | <1 |
Dilated pupils | <1 |
Weakness | 1 |
Cardiovascular | |
Tachycardia | 1 |
Palpitations | <1 |
Sweating | <1 |
Chest Pain | <1 |
Ear, Nose, and Throat | |
Epistaxis | 1 |
Gastrointestinal | |
Increased appetite | 3 |
Epigastric pain | <1 |
Stomachache | <1 |
Musculoskeletal | |
Muscle spasm | <1 |
Respiratory | |
Cough | <1 |
In clinical trials, the following adverse reactions to Derihaler (albuterol sulfate syrup) were noted more frequently in young children 2 to 6 years of age than in adults and older children:
Percent Incidence of Adverse Reactions Noted More Frequently in Children 2 to 6 Years of Age Than in Older Children and Adults | |
Adverse Event | Percent Incidence |
Central Nervous System | |
Excitement | 20 |
Nervousness | 15 |
Hypokinesia | 4 |
Sleeplessness | 2 |
Emotional lability | 1 |
Fatigue | 1 |
Cardiovascular | |
Tachycardia | 2 |
Pallor | 1 |
Gastrointestinal | |
Gastrointestinal symptoms | 2 |
Loss of appetite | 1 |
Ophthalmologic | |
Conjunctivitis | 1 |
Cases of urticaria, angioedema, rash, bronchospasm, oropharyngeal edema, and arrhythmias (including atrial fibrillation, supraventricular tachycardia, and extrasystoles) have been reported after the use of Derihaler (albuterol sulfate syrup).
In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as angina, central nervous system stimulation, drying or irritation of the oropharynx, hypertension, nausea, unusual taste, vertigo, and vomiting.
The reactions are generally transient in nature, and it is usually not necessary to discontinue treatment with Derihaler (albuterol sulfate syrup). In selected cases, however, dosage may be reduced temporarily; after the reaction has subsided, dosage should be increased in small increments to the optimal dosage.
Derihaler contraindications
Hyperthyroidism and cardiac disease. Derihaler may interact with monoamine oxidase inhibitors and should not be given to patients receiving such treatment or within 14 days after stopping treatment.
Use in pregnancy & lactation: Safety in pregnancy and lactating women has not been established.
Derihaler is not indicated for the prevention of premature labor associated with toxemia of pregnancy or ante partum hemorrhage, nor should it be used for threatened abortion during the 1st and 2nd trimesters of pregnancy.
References
- DailyMed. "ALBUTEROL: 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. "albuterol: 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. "Salbutamol: 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).
Reviews
The results of a survey conducted on ndrugs.com for Derihaler 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 Derihaler. 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.User reports
Consumer reported side effects
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Information checked by Dr. Sachin Kumar, MD Pharmacology